Trial Outcomes & Findings for Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis (NCT NCT03889639)
NCT ID: NCT03889639
Last Updated: 2025-09-17
Results Overview
Number of new Gd-enhancing T1-hyperintense lesions was detected by brain MRI at the end of 12 weeks of SAR442168 treatment (i.e., at Week 12 for Cohort 1 participants and Week 16 for Cohort 2 participants). Data was planned to be collected and analyzed on pooled population of participants at each dose level of SAR442168 (either in Cohort 1 and 2) and pooled population of participants receiving placebo in Cohort 2 and was not planned to collected during placebo administration in Cohort 1 (Weeks 12 to 16).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants) and at Week 4 for Cohort 2 placebo
Results posted on
2025-09-17
Participant Flow
The study was conducted at 44 active centers in 10 countries. A total of 168 participants were screened from 29-March-2019 to 29-August-2019, of which 38 participants were screen failures. Screen failures were mainly due to selection criteria not met.
A total of 130 participants were randomized and treated in this study. Participants were centrally assigned to 1 of 8 arms (4 dose groups at an equal ratio to start with SAR442168 \[all considered as Cohort 1\] or placebo \[all considered as Cohort 2\]).
Participant milestones
| Measure |
Cohort 1: SAR442168 5 mg Then Placebo
Participants received SAR442168 5 milligrams (mg), orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 1: SAR442168 15 mg Then Placebo
Participants received SAR442168 15 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 1: SAR442168 30 mg Then Placebo
Participants received SAR442168 30 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 1: SAR442168 60 mg Then Placebo
Participants received SAR442168 60 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 5 mg
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 5 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 15 mg
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 15 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 30 mg
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 30 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 60 mg
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 60 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
16
|
17
|
16
|
17
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
16
|
16
|
17
|
16
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: SAR442168 5 mg Then Placebo
Participants received SAR442168 5 milligrams (mg), orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 1: SAR442168 15 mg Then Placebo
Participants received SAR442168 15 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 1: SAR442168 30 mg Then Placebo
Participants received SAR442168 30 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 1: SAR442168 60 mg Then Placebo
Participants received SAR442168 60 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 5 mg
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 5 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 15 mg
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 15 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 30 mg
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 30 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 60 mg
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 60 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Cohort 1: SAR442168 15 mg Then Placebo
n=16 Participants
Participants received SAR442168 15 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 1: SAR442168 30 mg Then Placebo
n=16 Participants
Participants received SAR442168 30 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 1: SAR442168 60 mg Then Placebo
n=16 Participants
Participants received SAR442168 60 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 5 mg
n=17 Participants
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 5 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 15 mg
n=16 Participants
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 15 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 30 mg
n=17 Participants
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 30 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Cohort 2: Placebo Then SAR442168 60 mg
n=16 Participants
Participants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 60 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
Total
n=130 Participants
Total of all reporting groups
|
Cohort 1: SAR442168 5 mg Then Placebo
n=16 Participants
Participants received SAR442168 5 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
40.8 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
38.1 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 8.6 • n=31 Participants
|
36.7 years
STANDARD_DEVIATION 10.7 • n=30 Participants
|
37.5 years
STANDARD_DEVIATION 11.6 • n=3 Participants
|
36.1 years
STANDARD_DEVIATION 8.7 • n=6 Participants
|
37.1 years
STANDARD_DEVIATION 9.5 • n=114 Participants
|
37.4 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
91 Participants
n=114 Participants
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
39 Participants
n=114 Participants
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
16 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
119 Participants
n=114 Participants
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants) and at Week 4 for Cohort 2 placeboPopulation: Analysis was performed on modified intent-to-treat (mITT) population that included all randomly assigned participants exposed to the study drug, analyzed according to the treatment assigned by randomization. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Number of new Gd-enhancing T1-hyperintense lesions was detected by brain MRI at the end of 12 weeks of SAR442168 treatment (i.e., at Week 12 for Cohort 1 participants and Week 16 for Cohort 2 participants). Data was planned to be collected and analyzed on pooled population of participants at each dose level of SAR442168 (either in Cohort 1 and 2) and pooled population of participants receiving placebo in Cohort 2 and was not planned to collected during placebo administration in Cohort 1 (Weeks 12 to 16).
Outcome measures
| Measure |
Cohort 2: Pooled Placebo
n=59 Participants
All participants in Cohort 2 who received placebo matching to SAR442168 orally once daily for first 4 weeks during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 5 mg
n=31 Participants
All participants who received SAR442168 5 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 15 mg
n=31 Participants
All participants who received SAR442168 15 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 30 mg
n=33 Participants
All participants who received SAR442168 30 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 60 mg
n=31 Participants
All participants who received SAR442168 60 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
|---|---|---|---|---|---|
|
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New Gadolinium (Gd) Enhancing T1-hyperintense Lesions
|
1.03 lesions
Standard Deviation 2.50
|
1.39 lesions
Standard Deviation 3.20
|
0.77 lesions
Standard Deviation 1.48
|
0.76 lesions
Standard Deviation 3.31
|
0.13 lesions
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants), and at Week 4 for Cohort 2 placeboPopulation: Analysis was performed on mITT population. Data was planned to be collected and analyzed on pooled population of participants at each dose level of SAR442168 (either in Cohort 1 and 2) and pooled population of participants receiving placebo in Cohort 2 and was not planned to be collected during placebo administration in Cohort 1 (Week 12 to 16). Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Number of new and enlarging T2 lesions was detected by brain MRI at the end of 12 weeks of SAR442168 treatment (i.e., at Week 12 for Cohort 1 participants and Week 16 for Cohort 2 participants).
Outcome measures
| Measure |
Cohort 2: Pooled Placebo
n=59 Participants
All participants in Cohort 2 who received placebo matching to SAR442168 orally once daily for first 4 weeks during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 5 mg
n=31 Participants
All participants who received SAR442168 5 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 15 mg
n=31 Participants
All participants who received SAR442168 15 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 30 mg
n=33 Participants
All participants who received SAR442168 30 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 60 mg
n=31 Participants
All participants who received SAR442168 60 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
|---|---|---|---|---|---|
|
Number of New or Enlarging T2 Lesions
|
2.12 lesions
Standard Deviation 5.16
|
1.90 lesions
Standard Deviation 3.97
|
1.32 lesions
Standard Deviation 1.83
|
1.30 lesions
Standard Deviation 4.90
|
0.23 lesions
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants), and at Week 4 for Cohort 2 placeboPopulation: Analysis was performed on mITT population. Data was planned to be collected and analyzed on pooled population of participants at each dose level of SAR442168 (either in Cohort 1 and 2) and pooled population of participants receiving placebo in Cohort 2 and was not planned to be collected during placebo administration in Cohort 1 (Weeks 12 to 16). Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Total number of Gd-enhancing T1-hyperintense lesions was detected by brain MRI at the end of 12 weeks of SAR442168 treatment (i.e., at Week 12 for Cohort 1 participants and Week 16 for Cohort 2 participants).
Outcome measures
| Measure |
Cohort 2: Pooled Placebo
n=59 Participants
All participants in Cohort 2 who received placebo matching to SAR442168 orally once daily for first 4 weeks during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 5 mg
n=31 Participants
All participants who received SAR442168 5 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 15 mg
n=31 Participants
All participants who received SAR442168 15 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 30 mg
n=33 Participants
All participants who received SAR442168 30 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 60 mg
n=31 Participants
All participants who received SAR442168 60 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
|---|---|---|---|---|---|
|
Total Number of Gd-enhancing T1-hyperintense Lesions
|
1.36 lesions
Standard Deviation 3.52
|
1.77 lesions
Standard Deviation 4.10
|
0.87 lesions
Standard Deviation 1.59
|
1.18 lesions
Standard Deviation 4.87
|
0.29 lesions
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: From Baseline up to Week 4Population: Analysis was performed on safety population that included all participants from randomized population who had received at least 1 dose or part of dose of study drug. Data was planned to be collected and analyzed on participants at each dose level of SAR442168 in Cohort 1 and pooled population of participants receiving Placebo in Cohort 2 and not planned to be collected during Cohort 1 Placebo administration (Weeks 12 to 16).
Adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, disability/incapacity, congenital anomaly/birth defect, or medical event. TEAEs were defined as AEs (serious/non-serious) that developed, worsened, or became serious during on-treatment period (for this outcome measure- "Weeks 1 to 4 period": time from 1st administration of study drug to Week 4). Cohorts 1 and 2 received SAR442168 and placebo for first 4 weeks, respectively.
Outcome measures
| Measure |
Cohort 2: Pooled Placebo
n=66 Participants
All participants in Cohort 2 who received placebo matching to SAR442168 orally once daily for first 4 weeks during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 5 mg
n=16 Participants
All participants who received SAR442168 5 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 15 mg
n=16 Participants
All participants who received SAR442168 15 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 30 mg
n=16 Participants
All participants who received SAR442168 30 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 60 mg
n=16 Participants
All participants who received SAR442168 60 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs): Weeks 1-4 Period
TEAE
|
23 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs): Weeks 1-4 Period
TESAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 1 to 12 for Cohort 1 participants and Weeks 4 to 16 for Cohort 2 participantsPopulation: Analysis was performed on safety population. Data was planned to be collected and analyzed on pooled participants at each dose level of SAR442168 (either in Cohort 1 or 2), and was not planned to be collected during placebo administration in either Cohort 1 or 2.
AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of study drug. SAE was defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, congenital anomaly/birth defect, or medical event. TEAEs: AEs that developed, worsened, or became serious during on-treatment period (for this outcome measure defined as "SAR442168 treatment period" which was considered as Weeks 1 to 12 for Cohort 1 and Weeks 4 to 16 for Cohort 2).
Outcome measures
| Measure |
Cohort 2: Pooled Placebo
n=33 Participants
All participants in Cohort 2 who received placebo matching to SAR442168 orally once daily for first 4 weeks during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 5 mg
n=32 Participants
All participants who received SAR442168 5 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 15 mg
n=33 Participants
All participants who received SAR442168 15 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 30 mg
n=32 Participants
All participants who received SAR442168 30 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 60 mg
All participants who received SAR442168 60 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events: SAR442168 Treatment Period
TEAE
|
19 Participants
|
17 Participants
|
18 Participants
|
16 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events: SAR442168 Treatment Period
TESAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12 for Cohort 1 participants; Baseline up to Week 4 for Cohort 2 Placebo and from Weeks 4 to 16 for Cohort 2 SAR442168 receiving participantsPopulation: Analysis was performed on safety population. Data was planned to be collected and analyzed on pooled population of participants at each dose level of SAR442168 (either in Cohort 1 or 2), and pooled population of participants receiving Placebo in Cohort 2 and was not planned to be collected during placebo administration in Cohort 1 (Weeks 12 to 16).
Individual clinically relevant abnormalities was defined as potentially clinically significant abnormalities (PCSA) considered as SAEs or TEAEs leading to study treatment discontinuation or study discontinuation during the on-treatment period (time from first study drug administration until Week 16), considering all evaluations performed during the on-treatment period that included unscheduled or repeated evaluations.
Outcome measures
| Measure |
Cohort 2: Pooled Placebo
n=66 Participants
All participants in Cohort 2 who received placebo matching to SAR442168 orally once daily for first 4 weeks during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 5 mg
n=33 Participants
All participants who received SAR442168 5 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 15 mg
n=32 Participants
All participants who received SAR442168 15 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 30 mg
n=33 Participants
All participants who received SAR442168 30 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohorts 1 and 2: SAR442168 60 mg
n=32 Participants
All participants who received SAR442168 60 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
|---|---|---|---|---|---|
|
Number of Participants With Individual Clinically Relevant Abnormalities in Laboratory Tests (Hematology, Chemistry, Urinalysis), Vital Signs, and Electrocardiograms (ECG)
Hematology
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Individual Clinically Relevant Abnormalities in Laboratory Tests (Hematology, Chemistry, Urinalysis), Vital Signs, and Electrocardiograms (ECG)
Chemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Individual Clinically Relevant Abnormalities in Laboratory Tests (Hematology, Chemistry, Urinalysis), Vital Signs, and Electrocardiograms (ECG)
Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Individual Clinically Relevant Abnormalities in Laboratory Tests (Hematology, Chemistry, Urinalysis), Vital Signs, and Electrocardiograms (ECG)
Vitals
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Individual Clinically Relevant Abnormalities in Laboratory Tests (Hematology, Chemistry, Urinalysis), Vital Signs, and Electrocardiograms (ECG)
ECGs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1 and 2: SAR442168 5 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Cohort 1 and 2: SAR442168 15 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort 1 and 2: SAR442168 30 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 1 and 2: SAR442168 60 mg
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort 1: Pooled Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2: Pooled Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 and 2: SAR442168 5 mg
n=33 participants at risk
All participants who received SAR442168 5 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohort 1 and 2: SAR442168 15 mg
n=32 participants at risk
All participants who received SAR442168 15 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohort 1 and 2: SAR442168 30 mg
n=33 participants at risk
All participants who received SAR442168 30 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohort 1 and 2: SAR442168 60 mg
n=32 participants at risk
All participants who received SAR442168 60 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohort 1: Pooled Placebo
n=64 participants at risk
All participants in Cohort 1 who received placebo matching to SAR442168 orally once daily in Weeks 12-16 during the 16 weeks treatment period.
|
Cohort 2: Pooled Placebo
n=66 participants at risk
All participants in Cohort 2 who received placebo matching to SAR442168 orally once daily for first 4 weeks during the 16 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
Other adverse events
| Measure |
Cohort 1 and 2: SAR442168 5 mg
n=33 participants at risk
All participants who received SAR442168 5 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohort 1 and 2: SAR442168 15 mg
n=32 participants at risk
All participants who received SAR442168 15 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohort 1 and 2: SAR442168 30 mg
n=33 participants at risk
All participants who received SAR442168 30 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohort 1 and 2: SAR442168 60 mg
n=32 participants at risk
All participants who received SAR442168 60 mg orally once daily for 12 weeks (either in Cohort 1 or 2) during the 16 weeks treatment period.
|
Cohort 1: Pooled Placebo
n=64 participants at risk
All participants in Cohort 1 who received placebo matching to SAR442168 orally once daily in Weeks 12-16 during the 16 weeks treatment period.
|
Cohort 2: Pooled Placebo
n=66 participants at risk
All participants in Cohort 2 who received placebo matching to SAR442168 orally once daily for first 4 weeks during the 16 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Migraine
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Nervous system disorders
Migraine Without Aura
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.6%
1/64 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Nervous system disorders
Muscle Spasticity
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
6.2%
2/32 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Nervous system disorders
Restless Legs Syndrome
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Nervous system disorders
Syncope
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.6%
1/64 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Eye disorders
Dry Eye
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Eye disorders
Eye Pain
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.6%
1/64 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Cardiac disorders
Sinus Bradycardia
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Vascular disorders
Hot Flush
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.6%
1/64 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pain
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Gastrointestinal disorders
Chronic Gastritis
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
6.2%
2/32 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
6.1%
2/33 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Renal and urinary disorders
Urinary Incontinence
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Renal and urinary disorders
Urinary Tract Inflammation
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.6%
1/64 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Reproductive system and breast disorders
Cervix Inflammation
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.0%
1/33 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Reproductive system and breast disorders
Premenstrual Headache
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Congenital, familial and genetic disorders
Cystic Lymphangioma
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
General disorders
Chronic Fatigue Syndrome
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
General disorders
Fatigue
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.6%
1/64 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
General disorders
Oedema Peripheral
|
6.1%
2/33 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
6.2%
2/32 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
2/64 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
General disorders
Pain
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
General disorders
Pyrexia
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Investigations
Alanine Aminotransferase Increased
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Investigations
Blood Immunoglobulin M Decreased
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Investigations
Red Blood Cell Count Decreased
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Investigations
Reticulocyte Count Decreased
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Investigations
Weight Increased
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
9.4%
3/32 • Number of events 4 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Gastroenteritis
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
6.2%
2/32 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.6%
1/64 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.6%
1/64 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Influenza
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
9.4%
3/32 • Number of events 3 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.6%
1/64 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
2/66 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
6.2%
2/32 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.6%
1/64 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Tonsillitis
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.1%
2/33 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
6.2%
2/32 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Urinary Tract Infection
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
2/66 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Immune system disorders
Allergy To Animal
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Psychiatric disorders
Grief Reaction
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
1/32 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Psychiatric disorders
Irritability
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Number of events 3 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
9.4%
3/32 • Number of events 3 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
12.5%
4/32 • Number of events 7 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
3.1%
2/64 • Number of events 2 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
6.1%
4/66 • Number of events 4 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
|
Nervous system disorders
Hypoaesthesia
|
3.0%
1/33 • Number of events 1 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/33 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/32 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/64 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
0.00%
0/66 • All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment-emergent period (time from the first dose of study treatment until the last study visit). Analysis was performed on safety population. Data is reported for pooled populations of Cohort 1 and 2 for each dose of study drug, i.e., events during the 12 weeks of SAR442168 treatment, and for all participants who received placebo either in Cohort 1 or 2 during the placebo treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER