Trial Outcomes & Findings for Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (NCT NCT03945188)
NCT ID: NCT03945188
Last Updated: 2022-12-20
Results Overview
Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
433 participants
Primary outcome timeframe
At Week 12
Results posted on
2022-12-20
Participant Flow
Participants with moderately to severely active ulcerative colitis (UC) were enrolled in this study. Eligible participants were randomized in a 2:1 ratio to receive either etrasimod 2 milligrams (mg) once daily or matching placebo once daily for up to 52 weeks.
The study included a Screening Period (up to 28 days), a 12-Week Treatment Period (induction) followed by a 40-Week Treatment Period (maintenance; for which no re-randomization took place), and a 2-Week and 4-Week Follow-Up Period.
Participant milestones
| Measure |
Etrasimod 2 mg
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
Placebo
Placebo was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
289
|
144
|
|
Overall Study
COMPLETED
|
161
|
46
|
|
Overall Study
NOT COMPLETED
|
128
|
98
|
Reasons for withdrawal
| Measure |
Etrasimod 2 mg
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
Placebo
Placebo was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Disease worsening
|
79
|
73
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
7
|
4
|
|
Overall Study
Pregnancy
|
2
|
0
|
|
Overall Study
Withdrawal by participant or parent/guardian
|
24
|
10
|
|
Overall Study
Adverse Event
|
10
|
5
|
|
Overall Study
Other
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Etrasimod 2 mg
n=289 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
Placebo
n=144 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Total
n=433 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
272 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
405 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
41.2 Years
STANDARD_DEVIATION 13.97 • n=5 Participants
|
38.9 Years
STANDARD_DEVIATION 14.04 • n=7 Participants
|
40.4 Years
STANDARD_DEVIATION 14.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
275 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
256 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
385 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 12Population: FAS (consisting of all randomized participants who received at least 1 dose of study treatment) with actual Baseline MMS 5 to 9.
Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Remission at Week 12
|
7.4 Percentage of participants
|
27.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Week 52Population: FAS with actual Baseline MMS 5 to 9.
Clinical remission was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Remission at Week 52
|
6.7 Percentage of participants
|
32.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: FAS with actual Baseline MMS 5 to 9.
Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Endoscopic Improvement at Week 12
|
14.1 Percentage of participants
|
35.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 52Population: FAS with actual Baseline MMS 5 to 9.
Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Endoscopic Improvement at Week 52
|
10.4 Percentage of participants
|
37.2 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: FAS with actual Baseline MMS 5 to 9.
Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Symptomatic Remission at Week 12
|
21.5 Percentage of participants
|
46.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 52Population: FAS with actual Baseline MMS 5 to 9.
Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Symptomatic Remission at Week 52
|
18.5 Percentage of participants
|
43.4 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: FAS with actual Baseline MMS 5 to 9.
Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants With Mucosal Healing at Week 12
|
4.4 Percentage of participants
|
21.2 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 52Population: FAS with actual Baseline MMS 5 to 9.
Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants With Mucosal Healing at Week 52
|
8.1 Percentage of participants
|
26.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 52Population: FAS with actual Baseline MMS 5 to 9.
Corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52
|
6.7 Percentage of participants
|
32.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 12 and 52Population: FAS with actual Baseline MMS 5 to 9.
Sustained clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability) at both Week 12 and Week 52. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52
|
2.2 Percentage of participants
|
17.9 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: FAS with actual Baseline MMS 5 to 9.
Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Response at Week 12
|
34.1 Percentage of participants
|
62.4 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 52Population: FAS with actual Baseline MMS 5 to 9.
Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB sub-score ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Response at Week 52
|
23.0 Percentage of participants
|
48.2 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 12 and 52Population: FAS with actual Baseline MMS 5 to 9.
Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52
|
18.5 Percentage of participants
|
44.9 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 12 and 52Population: FAS with actual Baseline MMS 5 to 9.
Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52
|
2.2 Percentage of participants
|
13.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: FAS with actual Baseline MMS 5 to 9.
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Endoscopic Normalization at Week 12
|
4.4 Percentage of participants
|
14.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 52Population: FAS with actual Baseline MMS 5 to 9.
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Endoscopic Normalization at Week 52
|
5.9 Percentage of participants
|
26.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 12 and 52Population: FAS with actual Baseline MMS 5 to 9.
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52
|
1.5 Percentage of participants
|
10.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48Population: FAS with actual Baseline MMS 5 to 9.
Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Week 24
|
23.7 Percentage of participants
|
44.9 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Week 32
|
18.5 Percentage of participants
|
44.5 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Week 2
|
8.9 Percentage of participants
|
15.3 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Week 4
|
13.3 Percentage of participants
|
28.1 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Week 8
|
20.7 Percentage of participants
|
37.6 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Week 16
|
21.5 Percentage of participants
|
43.1 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Week 20
|
20.0 Percentage of participants
|
43.8 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Week 40
|
18.5 Percentage of participants
|
42.0 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Week 48
|
15.6 Percentage of participants
|
42.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52Population: FAS with actual Baseline MMS 5 to 9.
Complete symptomatic remission was defined as an SF subscore = 0 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 2
|
2.2 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 4
|
4.4 Percentage of participants
|
11.3 Percentage of participants
|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 8
|
6.7 Percentage of participants
|
16.8 Percentage of participants
|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 12
|
6.7 Percentage of participants
|
23.0 Percentage of participants
|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 16
|
5.9 Percentage of participants
|
21.2 Percentage of participants
|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 20
|
4.4 Percentage of participants
|
22.3 Percentage of participants
|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 24
|
8.1 Percentage of participants
|
22.3 Percentage of participants
|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 32
|
3.0 Percentage of participants
|
23.0 Percentage of participants
|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 40
|
5.9 Percentage of participants
|
21.2 Percentage of participants
|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 48
|
2.2 Percentage of participants
|
19.7 Percentage of participants
|
|
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Week 52
|
4.4 Percentage of participants
|
24.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52Population: FAS with actual Baseline MMS 5 to 9.
Non-invasive clinical response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores, and a ≥ 1-point decrease from Baseline in RB subscore or RB subscore ≤ 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 2
|
33.3 Percentage of participants
|
38.3 Percentage of participants
|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 4
|
39.3 Percentage of participants
|
56.2 Percentage of participants
|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 8
|
43.0 Percentage of participants
|
63.1 Percentage of participants
|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 12
|
42.2 Percentage of participants
|
65.7 Percentage of participants
|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 16
|
30.4 Percentage of participants
|
55.5 Percentage of participants
|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 20
|
28.1 Percentage of participants
|
57.3 Percentage of participants
|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 24
|
30.4 Percentage of participants
|
56.6 Percentage of participants
|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 32
|
25.2 Percentage of participants
|
54.0 Percentage of participants
|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 40
|
23.0 Percentage of participants
|
51.5 Percentage of participants
|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 48
|
21.5 Percentage of participants
|
51.1 Percentage of participants
|
|
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Week 52
|
23.7 Percentage of participants
|
50.4 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52Population: FAS with actual Baseline MMS 5 to 9.
Symptomatic response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores. The SF subscore ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=274 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 2
|
33.3 Percentage of participants
|
39.4 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 4
|
40.0 Percentage of participants
|
57.3 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 8
|
43.7 Percentage of participants
|
64.6 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 12
|
42.2 Percentage of participants
|
66.4 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 16
|
31.1 Percentage of participants
|
55.5 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 20
|
28.1 Percentage of participants
|
57.7 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 24
|
30.4 Percentage of participants
|
56.9 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 32
|
25.2 Percentage of participants
|
54.7 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 40
|
23.0 Percentage of participants
|
51.8 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 48
|
21.5 Percentage of participants
|
51.5 Percentage of participants
|
|
Percentage of Participants Achieving Symptomatic Response by Study Visit
Week 52
|
23.7 Percentage of participants
|
50.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 52Population: FAS with actual Baseline MMS 5 to 9. Only participants receiving corticosteroids at study entry and who had not been receiving corticosteroids for ≥ 4 weeks prior to Week 52 were included in this analysis.
Four-week corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1, and have not received corticosteroids for ≥ 4 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=40 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=87 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline
|
7.5 Percentage of participants
|
31.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 52Population: FAS with actual Baseline MMS 5 to 9. Only participants in clinical response at Week 12 were included in this analysis.
Clinical remission and clinical response were based on the MMS which is a composite of 3 assessments: SF, RB and ES. Clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo was administered orally once daily for up to 52 weeks.
|
Etrasimod 2 mg
n=171 Participants
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12
|
17.4 Percentage of participants
|
49.1 Percentage of participants
|
Adverse Events
Etrasimod 2 mg
Serious events: 20 serious events
Other events: 204 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etrasimod 2 mg
n=289 participants at risk
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
Placebo
n=144 participants at risk
Placebo was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.1%
6/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Mucosal prolapse syndrome
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Proctitis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Migraine
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Surgical and medical procedures
Breast conserving surgery
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Etrasimod 2 mg
n=289 participants at risk
Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
|
Placebo
n=144 participants at risk
Placebo was administered orally once daily for up to 52 weeks.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
6.6%
19/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
5.6%
8/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.1%
6/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
6/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.4%
4/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cystitis
|
1.4%
4/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.8%
4/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Anal abscess
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Candida infection
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Hordeolum
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pustule
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.8%
4/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Abscess limb
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Acne pustular
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Helicobacter infection
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Liver abscess
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Helminthic infection
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Herpes simplex
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pulpitis dental
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Otitis externa
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Tinea infection
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Tonsillitis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Ear infection staphylococcal
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Tracheitis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Vaginal infection
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Vulval abscess
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
5.9%
17/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
6.9%
10/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
9/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
5/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
6/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
11/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
3.5%
5/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
4/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.4%
7/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
5/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
4/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Mucosal prolapse syndrome
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Small intestine polyp
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.7%
5/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
2.8%
8/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.7%
5/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Transaminases increased
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
SARS-CoV-2 test positive
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Serum ferritin decreased
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood triglycerides increased
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood cholesterol increased
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Weight increased
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Weight decreased
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood glucose increased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood iron decreased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood pressure increased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
C-reactive protein increased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood triglycerides abnormal
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
International normalised ratio increased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Urine ketone body
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Forced expiratory volume decreased
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Bacterial test positive
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Spirometry abnormal
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
FEV1/FVC ratio decreased
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Platelet count increased
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Lung diffusion test decreased
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Pulmonary arterial pressure decreased
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
8.3%
24/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
4.9%
7/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
5.2%
15/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Head discomfort
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Migraine
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Parkinson's disease
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Asterixis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness exertional
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Tension headache
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
13/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
7/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
5/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Ankle deformity
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
24/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
9.7%
14/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
4.8%
14/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
4.2%
6/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
2.4%
7/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
1.7%
5/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Chest discomfort
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Pain
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Vaccination site pain
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Discomfort
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Drug intolerance
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Chills
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Infusion site reaction
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
4/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Malaise
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.1%
6/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Lipomatosis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
5/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia scarring
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Ephelides
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura senile
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Xanthelasma
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Papilloedema
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Cataract
|
1.0%
3/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Myopia
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Amblyopia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Astigmatism
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Blepharitis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Eyelid pain
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Dry eye
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Eyelid cyst
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Macular oedema
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Eye swelling
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Visual impairment
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Keratitis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Uveitis
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Maculopathy
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
4/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
2.8%
8/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hot flush
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Flushing
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Varicose vein
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Peripheral nerve injury
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Bradycardia
|
1.4%
4/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Agitation
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Cushingoid
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Thyroid cyst
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholestasis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.69%
2/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Chromaturia
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Primary biliary cholangitis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal cyst
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Micturition frequency decreased
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Breast mass
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Penile curvature
|
0.35%
1/289 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
|
Additional Information
Arena CT.gov Administrator
Arena Pharmaceuticals, a wholly owned subsidiary of Pfizer
Phone: +1 855-218-9153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place