Trial Outcomes & Findings for Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dyslipidemia (NCT NCT04998201)
NCT ID: NCT04998201
Last Updated: 2026-04-14
Results Overview
Least square (LS) mean and standard error (SE) were calculated using mixed model repeated measures (MMRM) which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
353 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2026-04-14
Participant Flow
Participants who successfully passed the requirements during the Screening period were enrolled in the study. All dose cohorts were enrolled in parallel with participants randomized 3:1 to receive ARO-APOC3 or placebo.
Participant milestones
| Measure |
Placebo
Volume-matched placebo subcutaneous (SC) injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
ARO-APOC3 10 milligrams (mg) SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
87
|
67
|
67
|
66
|
66
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
87
|
67
|
67
|
66
|
66
|
|
Overall Study
COMPLETED
|
78
|
60
|
64
|
61
|
61
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
3
|
5
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Volume-matched placebo subcutaneous (SC) injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
ARO-APOC3 10 milligrams (mg) SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
1
|
1
|
2
|
|
Overall Study
Physician Decision
|
3
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
1
|
0
|
|
Overall Study
Protocol deviation
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Other, not specified
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dyslipidemia
Baseline characteristics by cohort
| Measure |
Placebo
n=87 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=67 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=67 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=66 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=66 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 9.70 • n=193 Participants
|
60.2 years
STANDARD_DEVIATION 11.71 • n=193 Participants
|
61.3 years
STANDARD_DEVIATION 11.28 • n=386 Participants
|
62.6 years
STANDARD_DEVIATION 10.53 • n=112 Participants
|
61.3 years
STANDARD_DEVIATION 11.84 • n=103 Participants
|
60.7 years
STANDARD_DEVIATION 10.99 • n=539 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=193 Participants
|
31 Participants
n=193 Participants
|
30 Participants
n=386 Participants
|
29 Participants
n=112 Participants
|
23 Participants
n=103 Participants
|
154 Participants
n=539 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=193 Participants
|
36 Participants
n=193 Participants
|
37 Participants
n=386 Participants
|
37 Participants
n=112 Participants
|
43 Participants
n=103 Participants
|
199 Participants
n=539 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=193 Participants
|
18 Participants
n=193 Participants
|
12 Participants
n=386 Participants
|
12 Participants
n=112 Participants
|
15 Participants
n=103 Participants
|
73 Participants
n=539 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=193 Participants
|
49 Participants
n=193 Participants
|
55 Participants
n=386 Participants
|
53 Participants
n=112 Participants
|
51 Participants
n=103 Participants
|
279 Participants
n=539 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
1 Participants
n=539 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
79 Participants
n=193 Participants
|
62 Participants
n=193 Participants
|
60 Participants
n=386 Participants
|
63 Participants
n=112 Participants
|
62 Participants
n=103 Participants
|
326 Participants
n=539 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
4 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
8 Participants
n=539 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
1 Participants
n=539 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
10 Participants
n=539 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
2 Participants
n=539 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
1 Participants
n=539 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
2 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
5 Participants
n=539 Participants
|
|
Mean Triglycerides (TG)
|
237.22 mg/deciliter (dL)
STANDARD_DEVIATION 76.179 • n=193 Participants
|
253.15 mg/deciliter (dL)
STANDARD_DEVIATION 81.425 • n=193 Participants
|
234.08 mg/deciliter (dL)
STANDARD_DEVIATION 72.746 • n=386 Participants
|
250.25 mg/deciliter (dL)
STANDARD_DEVIATION 81.329 • n=112 Participants
|
248.01 mg/deciliter (dL)
STANDARD_DEVIATION 80.553 • n=103 Participants
|
244.10 mg/deciliter (dL)
STANDARD_DEVIATION 78.289 • n=539 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Least square (LS) mean and standard error (SE) were calculated using mixed model repeated measures (MMRM) which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=81 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=61 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=63 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=62 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=61 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline at Week 24 in Fasting TG
|
-1.7 percentage change
Standard Error 3.07
|
-51.5 percentage change
Standard Error 3.54
|
-57.7 percentage change
Standard Error 3.49
|
-64.1 percentage change
Standard Error 3.51
|
-45.9 percentage change
Standard Error 3.52
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)Population: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=85 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=64 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=67 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=64 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=65 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
Change at Week 4
|
-0.5 percentage change
Standard Error 2.77
|
-51.4 percentage change
Standard Error 3.21
|
-61.5 percentage change
Standard Error 3.14
|
-66.4 percentage change
Standard Error 3.20
|
-62.5 percentage change
Standard Error 3.19
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
Change at Week 8
|
-0.4 percentage change
Standard Error 2.45
|
-48.6 percentage change
Standard Error 2.78
|
-58.1 percentage change
Standard Error 2.77
|
-65.0 percentage change
Standard Error 2.78
|
-59.7 percentage change
Standard Error 2.78
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
Change at Week 12
|
-0.1 percentage change
Standard Error 3.07
|
-43.8 percentage change
Standard Error 3.46
|
-53.6 percentage change
Standard Error 3.50
|
-57.9 percentage change
Standard Error 3.45
|
-51.7 percentage change
Standard Error 3.49
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
Change at Week 16
|
-1.8 percentage change
Standard Error 2.87
|
-58.0 percentage change
Standard Error 3.21
|
-62.0 percentage change
Standard Error 3.21
|
-68.3 percentage change
Standard Error 3.21
|
-50.6 percentage change
Standard Error 3.17
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
Change at Week 20
|
1.2 percentage change
Standard Error 2.85
|
-54.6 percentage change
Standard Error 3.32
|
-62.0 percentage change
Standard Error 3.28
|
-64.7 percentage change
Standard Error 3.28
|
-49.1 percentage change
Standard Error 3.23
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
Change at Week 24
|
-1.7 percentage change
Standard Error 3.07
|
-51.5 percentage change
Standard Error 3.54
|
-57.7 percentage change
Standard Error 3.49
|
-64.1 percentage change
Standard Error 3.51
|
-45.9 percentage change
Standard Error 3.52
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
Change at Week 28
|
3.5 percentage change
Standard Error 2.95
|
-46.2 percentage change
Standard Error 3.41
|
-55.7 percentage change
Standard Error 3.35
|
-61.7 percentage change
Standard Error 3.38
|
-63.4 percentage change
Standard Error 3.39
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
Change at Week 36
|
6.1 percentage change
Standard Error 4.66
|
-44.7 percentage change
Standard Error 5.35
|
-51.5 percentage change
Standard Error 5.25
|
-54.9 percentage change
Standard Error 5.34
|
-60.1 percentage change
Standard Error 5.32
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
Change at Week 48/ET
|
1.7 percentage change
Standard Error 4.35
|
-33.2 percentage change
Standard Error 4.96
|
-42.8 percentage change
Standard Error 4.86
|
-50.2 percentage change
Standard Error 4.94
|
-55.0 percentage change
Standard Error 4.93
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=79 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=59 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=63 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=62 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=61 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline at Week 24 in Apolipoprotein (Apo)C-III
|
23.9 percentage change
Standard Error 21.90
|
-58.9 percentage change
Standard Error 24.86
|
-44.3 percentage change
Standard Error 24.54
|
-65.7 percentage change
Standard Error 24.71
|
-57.9 percentage change
Standard Error 24.70
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ETPopulation: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=84 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=63 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=67 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=64 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=65 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
Change at Week 28
|
35.6 percentage change
Standard Error 21.90
|
-51.7 percentage change
Standard Error 24.87
|
-32.8 percentage change
Standard Error 24.55
|
-53.3 percentage change
Standard Error 24.71
|
-82.5 percentage change
Standard Error 24.70
|
|
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
Change at Week 36
|
30.6 percentage change
Standard Error 21.96
|
-46.3 percentage change
Standard Error 24.91
|
-24.9 percentage change
Standard Error 24.58
|
-34.5 percentage change
Standard Error 24.74
|
-75.8 percentage change
Standard Error 24.70
|
|
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
Change at Week 48/ET
|
27.3 percentage change
Standard Error 21.97
|
-31.2 percentage change
Standard Error 24.97
|
-13.9 percentage change
Standard Error 24.58
|
-17.4 percentage change
Standard Error 24.78
|
-64.8 percentage change
Standard Error 24.72
|
|
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
Change at Week 4
|
19.3 percentage change
Standard Error 21.81
|
-60.7 percentage change
Standard Error 24.78
|
-69.7 percentage change
Standard Error 24.45
|
-78.4 percentage change
Standard Error 24.66
|
-82.7 percentage change
Standard Error 24.64
|
|
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
Change at Week 8
|
19.0 percentage change
Standard Error 21.84
|
-57.3 percentage change
Standard Error 24.72
|
-61.9 percentage change
Standard Error 24.48
|
-71.8 percentage change
Standard Error 24.64
|
-78.1 percentage change
Standard Error 24.62
|
|
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
Change at Week 12
|
20.3 percentage change
Standard Error 21.90
|
-48.7 percentage change
Standard Error 24.77
|
-18.9 percentage change
Standard Error 24.57
|
-59.2 percentage change
Standard Error 24.66
|
-71.5 percentage change
Standard Error 24.68
|
|
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
Change at Week 16
|
10.9 percentage change
Standard Error 21.92
|
-69.9 percentage change
Standard Error 24.79
|
-63.8 percentage change
Standard Error 24.54
|
-78.9 percentage change
Standard Error 24.67
|
-67.7 percentage change
Standard Error 24.62
|
|
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
Change at Week 20
|
21.8 percentage change
Standard Error 21.88
|
-64.0 percentage change
Standard Error 24.87
|
-63.3 percentage change
Standard Error 24.58
|
-69.3 percentage change
Standard Error 24.72
|
-62.6 percentage change
Standard Error 24.65
|
|
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
Change at Week 24
|
23.9 percentage change
Standard Error 21.90
|
-58.9 percentage change
Standard Error 24.86
|
-44.3 percentage change
Standard Error 24.54
|
-65.7 percentage change
Standard Error 24.71
|
-57.9 percentage change
Standard Error 24.70
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=81 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=61 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=63 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=62 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=61 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline at Week 24 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
|
-2.7 percentage change
Standard Error 2.56
|
-19.3 percentage change
Standard Error 2.93
|
-20.1 percentage change
Standard Error 2.90
|
-26.9 percentage change
Standard Error 2.92
|
-10.3 percentage change
Standard Error 2.92
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ETPopulation: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=85 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=64 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=67 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=64 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=65 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-HDL-C
Change at Week 4
|
-1.2 percentage change
Standard Error 2.19
|
-17.3 percentage change
Standard Error 2.53
|
-23.3 percentage change
Standard Error 2.48
|
-26.3 percentage change
Standard Error 2.52
|
-19.6 percentage change
Standard Error 2.53
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-HDL-C
Change at Week 8
|
-1.0 percentage change
Standard Error 2.37
|
-18.2 percentage change
Standard Error 2.69
|
-22.4 percentage change
Standard Error 2.67
|
-27.8 percentage change
Standard Error 2.70
|
-16.2 percentage change
Standard Error 2.70
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-HDL-C
Change at Week 12
|
-0.4 percentage change
Standard Error 2.65
|
-15.5 percentage change
Standard Error 3.00
|
-19.4 percentage change
Standard Error 3.01
|
-21.9 percentage change
Standard Error 3.00
|
-16.0 percentage change
Standard Error 3.02
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-HDL-C
Change at Week 16
|
-1.4 percentage change
Standard Error 2.49
|
-21.2 percentage change
Standard Error 2.80
|
-23.8 percentage change
Standard Error 2.80
|
-28.5 percentage change
Standard Error 2.81
|
-15.5 percentage change
Standard Error 2.79
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-HDL-C
Change at Week 20
|
-1.9 percentage change
Standard Error 2.82
|
-20.9 percentage change
Standard Error 3.24
|
-21.5 percentage change
Standard Error 3.21
|
-27.3 percentage change
Standard Error 3.22
|
-11.7 percentage change
Standard Error 3.20
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-HDL-C
Change at Week 24
|
-2.7 percentage change
Standard Error 2.56
|
-19.3 percentage change
Standard Error 2.93
|
-20.1 percentage change
Standard Error 2.90
|
-26.9 percentage change
Standard Error 2.92
|
-10.3 percentage change
Standard Error 2.92
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-HDL-C
Change at Week 28
|
0.4 percentage change
Standard Error 2.91
|
-17.1 percentage change
Standard Error 3.33
|
-17.7 percentage change
Standard Error 3.29
|
-25.6 percentage change
Standard Error 3.32
|
-20.5 percentage change
Standard Error 3.33
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-HDL-C
Change at Week 36
|
0.0 percentage change
Standard Error 2.71
|
-17.1 percentage change
Standard Error 3.09
|
-17.1 percentage change
Standard Error 3.05
|
-23.4 percentage change
Standard Error 3.10
|
-17.3 percentage change
Standard Error 3.09
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-HDL-C
Change at Week 48/ET
|
1.7 percentage change
Standard Error 2.96
|
-12.1 percentage change
Standard Error 3.37
|
-12.1 percentage change
Standard Error 3.29
|
-21.8 percentage change
Standard Error 3.35
|
-20.0 percentage change
Standard Error 3.35
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=81 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=61 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=63 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=62 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=61 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline at Week 24 in Fasting High-Density Lipoprotein Cholesterol (HDL-C)
|
4.7 percentage change
Standard Error 3.34
|
37.9 percentage change
Standard Error 3.81
|
46.8 percentage change
Standard Error 3.82
|
50.5 percentage change
Standard Error 3.80
|
32.8 percentage change
Standard Error 3.82
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ETPopulation: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=85 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=64 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=67 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=64 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=65 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
Change at Week 16
|
3.2 percentage change
Standard Error 3.46
|
45.8 percentage change
Standard Error 3.90
|
56.4 percentage change
Standard Error 3.93
|
64.2 percentage change
Standard Error 3.91
|
41.6 percentage change
Standard Error 3.91
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
Change at Week 28
|
2.1 percentage change
Standard Error 3.47
|
35.8 percentage change
Standard Error 3.98
|
45.3 percentage change
Standard Error 3.96
|
49.5 percentage change
Standard Error 3.96
|
54.0 percentage change
Standard Error 3.99
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
Change at Week 36
|
1.6 percentage change
Standard Error 3.25
|
30.8 percentage change
Standard Error 3.72
|
37.0 percentage change
Standard Error 3.71
|
43.1 percentage change
Standard Error 3.72
|
49.7 percentage change
Standard Error 3.73
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
Change at Week 4
|
3.6 percentage change
Standard Error 3.38
|
39.3 percentage change
Standard Error 3.88
|
48.3 percentage change
Standard Error 3.86
|
55.4 percentage change
Standard Error 3.88
|
55.5 percentage change
Standard Error 3.90
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
Change at Week 8
|
2.0 percentage change
Standard Error 3.18
|
32.1 percentage change
Standard Error 3.61
|
46.4 percentage change
Standard Error 3.63
|
54.3 percentage change
Standard Error 3.62
|
52.8 percentage change
Standard Error 3.64
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
Change at Week 12
|
2.5 percentage change
Standard Error 3.19
|
31.4 percentage change
Standard Error 3.60
|
40.1 percentage change
Standard Error 3.66
|
49.0 percentage change
Standard Error 3.61
|
45.1 percentage change
Standard Error 3.65
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
Change at Week 20
|
2.8 percentage change
Standard Error 3.27
|
45.0 percentage change
Standard Error 3.75
|
50.6 percentage change
Standard Error 3.76
|
58.2 percentage change
Standard Error 3.74
|
40.3 percentage change
Standard Error 3.73
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
Change at Week 24
|
4.7 percentage change
Standard Error 3.34
|
37.9 percentage change
Standard Error 3.81
|
46.8 percentage change
Standard Error 3.82
|
50.5 percentage change
Standard Error 3.80
|
32.8 percentage change
Standard Error 3.82
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
Change at Week 48/ET
|
4.5 percentage change
Standard Error 3.53
|
25.4 percentage change
Standard Error 4.02
|
30.5 percentage change
Standard Error 3.98
|
34.3 percentage change
Standard Error 4.00
|
44.5 percentage change
Standard Error 4.01
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=79 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=59 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=63 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=62 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=61 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline at Week 24 in Fasting Total Apolipoprotein B (ApoB)
|
0.8 percentage change
Standard Error 2.57
|
-9.5 percentage change
Standard Error 2.94
|
-12.2 percentage change
Standard Error 2.89
|
-18.3 percentage change
Standard Error 2.91
|
-5.7 percentage change
Standard Error 2.91
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ETPopulation: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=84 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=63 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=67 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=64 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=65 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
Change at Week 4
|
-1.3 percentage change
Standard Error 1.99
|
-10.3 percentage change
Standard Error 2.30
|
-15.5 percentage change
Standard Error 2.24
|
-18.5 percentage change
Standard Error 2.28
|
-13.5 percentage change
Standard Error 2.29
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
Change at Week 16
|
0.2 percentage change
Standard Error 2.30
|
-12.8 percentage change
Standard Error 2.60
|
-17.2 percentage change
Standard Error 2.57
|
-20.6 percentage change
Standard Error 2.58
|
-9.4 percentage change
Standard Error 2.58
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
Change at Week 8
|
-0.5 percentage change
Standard Error 2.26
|
-11.0 percentage change
Standard Error 2.56
|
-15.5 percentage change
Standard Error 2.54
|
-20.3 percentage change
Standard Error 2.55
|
-10.9 percentage change
Standard Error 2.56
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
Change at Week 12
|
0.9 percentage change
Standard Error 2.53
|
-8.5 percentage change
Standard Error 2.87
|
-14.3 percentage change
Standard Error 2.86
|
-14.8 percentage change
Standard Error 2.85
|
-10.8 percentage change
Standard Error 2.87
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
Change at Week 20
|
0.5 percentage change
Standard Error 2.61
|
-13.0 percentage change
Standard Error 3.00
|
-14.3 percentage change
Standard Error 2.96
|
-19.3 percentage change
Standard Error 2.97
|
-7.3 percentage change
Standard Error 2.95
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
Change at Week 24
|
0.8 percentage change
Standard Error 2.57
|
-9.5 percentage change
Standard Error 2.94
|
-12.2 percentage change
Standard Error 2.89
|
-18.3 percentage change
Standard Error 2.91
|
-5.7 percentage change
Standard Error 2.91
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
Change at Week 28
|
5.1 percentage change
Standard Error 2.98
|
-9.0 percentage change
Standard Error 3.41
|
-10.0 percentage change
Standard Error 3.35
|
-16.3 percentage change
Standard Error 3.38
|
-12.1 percentage change
Standard Error 3.38
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
Change at Week 36
|
3.7 percentage change
Standard Error 2.68
|
-7.8 percentage change
Standard Error 3.07
|
-9.3 percentage change
Standard Error 3.00
|
-15.4 percentage change
Standard Error 3.05
|
-9.9 percentage change
Standard Error 3.04
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
Change at Week 48/ET
|
3.3 percentage change
Standard Error 2.75
|
-4.7 percentage change
Standard Error 3.14
|
-6.4 percentage change
Standard Error 3.06
|
-12.2 percentage change
Standard Error 3.11
|
-11.9 percentage change
Standard Error 3.11
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=81 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=61 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=63 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=62 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=61 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline at Week 24 in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C)
|
-0.1 percentage change
Standard Error 3.62
|
1.4 percentage change
Standard Error 4.14
|
3.9 percentage change
Standard Error 4.10
|
-4.3 percentage change
Standard Error 4.13
|
7.3 percentage change
Standard Error 4.14
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ETPopulation: Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Outcome measures
| Measure |
Placebo
n=85 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=64 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=67 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=64 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=65 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
Change at Week 20
|
-0.3 percentage change
Standard Error 3.78
|
1.3 percentage change
Standard Error 4.35
|
4.0 percentage change
Standard Error 4.31
|
-3.9 percentage change
Standard Error 4.33
|
7.2 percentage change
Standard Error 4.30
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
Change at Week 28
|
1.6 percentage change
Standard Error 3.86
|
0.2 percentage change
Standard Error 4.42
|
6.1 percentage change
Standard Error 4.37
|
-3.6 percentage change
Standard Error 4.41
|
2.0 percentage change
Standard Error 4.42
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
Change at Week 36
|
1.6 percentage change
Standard Error 3.80
|
0.0 percentage change
Standard Error 4.33
|
5.3 percentage change
Standard Error 4.28
|
-3.5 percentage change
Standard Error 4.35
|
5.7 percentage change
Standard Error 4.34
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
Change at Week 4
|
0.6 percentage change
Standard Error 3.18
|
5.0 percentage change
Standard Error 3.67
|
1.1 percentage change
Standard Error 3.59
|
0.4 percentage change
Standard Error 3.66
|
3.2 percentage change
Standard Error 3.67
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
Change at Week 8
|
1.7 percentage change
Standard Error 3.24
|
0.7 percentage change
Standard Error 3.68
|
0.6 percentage change
Standard Error 3.65
|
-3.6 percentage change
Standard Error 3.69
|
7.4 percentage change
Standard Error 3.70
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
Change at Week 12
|
1.8 percentage change
Standard Error 3.68
|
2.5 percentage change
Standard Error 4.16
|
2.5 percentage change
Standard Error 4.18
|
1.6 percentage change
Standard Error 4.16
|
3.2 percentage change
Standard Error 4.20
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
Change at Week 16
|
1.5 percentage change
Standard Error 3.65
|
2.2 percentage change
Standard Error 4.11
|
0.4 percentage change
Standard Error 4.10
|
-2.7 percentage change
Standard Error 4.11
|
3.2 percentage change
Standard Error 4.09
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
Change at Week 24
|
-0.1 percentage change
Standard Error 3.62
|
1.4 percentage change
Standard Error 4.14
|
3.9 percentage change
Standard Error 4.10
|
-4.3 percentage change
Standard Error 4.13
|
7.3 percentage change
Standard Error 4.14
|
|
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
Change at Week 48/ET
|
1.7 percentage change
Standard Error 3.88
|
2.0 percentage change
Standard Error 4.43
|
6.9 percentage change
Standard Error 4.32
|
-4.0 percentage change
Standard Error 4.40
|
-0.1 percentage change
Standard Error 4.40
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety Analysis Set: All participants who received at least 1 dose of study drug.
An adverse event (AE) was any untoward medical occurrence, which did not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) was an AE that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or was a medically important event or reaction. TEAEs were AEs that occurred following study drug administration or a pre-existing condition exacerbated following study drug administration.
Outcome measures
| Measure |
Placebo
n=87 Participants
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=67 Participants
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=67 Participants
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=66 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=66 Participants
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
All TEAEs
|
55 Participants
|
46 Participants
|
45 Participants
|
47 Participants
|
49 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-related TEAEs
|
8 Participants
|
7 Participants
|
9 Participants
|
12 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious TEAEs
|
5 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs leading to study drug discontinuation
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Deaths
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 55 other events
Deaths: 0 deaths
ARO-APOC3 10 mg Q12W
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
ARO-APOC3 25 mg Q12W
Serious events: 5 serious events
Other events: 44 other events
Deaths: 1 deaths
ARO-APOC3 50 mg Q12W
Serious events: 7 serious events
Other events: 48 other events
Deaths: 2 deaths
ARO-APOC3 50 mg Q24W
Serious events: 5 serious events
Other events: 48 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=87 participants at risk
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=67 participants at risk
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=67 participants at risk
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=66 participants at risk
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=66 participants at risk
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Artery dissection
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lacunar infarction
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Coeliac artery aneurysm
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=87 participants at risk
Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
|
ARO-APOC3 10 mg Q12W
n=67 participants at risk
ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 25 mg Q12W
n=67 participants at risk
ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q12W
n=66 participants at risk
ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
|
ARO-APOC3 50 mg Q24W
n=66 participants at risk
ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
|
|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Anion gap increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal papilloma
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood glucose increased
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood insulin increased
|
3.4%
3/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood iron decreased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
C-reactive protein increased
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
3.4%
3/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Cardiac murmur
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Aortic aneurysm
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haematoma
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
3.4%
3/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Swelling face
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Dystrophic calcification
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Secretion discharge
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Food allergy
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Social circumstances
Postmenopause
|
0.00%
0/41 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.2%
1/31 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/23 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/46 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/36 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/37 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/43 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.2%
1/46 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/36 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/37 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
5.4%
2/37 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/43 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/46 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/36 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/37 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/43 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Cells in urine
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram abnormal
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Haematocrit increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Human metapneumovirus test positive
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood urine present
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Glycosylated haemoglobin increased
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Amylase increased
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood urea increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Pancreatic enzymes increased
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Troponin increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Insulin C-peptide increased
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/46 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/36 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/37 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/43 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lisfranc fracture
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Scratch
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Bundle branch block left
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure chronic
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Left atrial enlargement
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
3.4%
3/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
6.1%
4/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
7.6%
5/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.4%
3/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Radiculopathy
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Cataract
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Dermatochalasis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Myopia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Presbyopia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
6.1%
4/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Non-alcoholic fatty liver
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Sebaceous hyperplasia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Hypertonic bladder
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Chromaturia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
3.4%
3/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
3/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
6.1%
4/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Diffuse idiopathic skeletal hyperostosis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
7/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
10.4%
7/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
13.6%
9/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
13.8%
12/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
11.9%
8/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
16.4%
11/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
13.6%
9/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
9.1%
6/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
6.0%
4/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
7.6%
5/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
6.0%
4/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
6.1%
4/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
6.1%
4/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
6.1%
4/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
3/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
4.5%
3/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
7/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
6.0%
4/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
9.0%
6/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
9.1%
6/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteriuria
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Body tinea
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Localised infection
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis viral
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
2/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis media
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Paronychia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
4.6%
4/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyuria
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
4.6%
4/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
7.5%
5/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
6.0%
4/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
12.1%
8/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
16.7%
11/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Acidosis
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
3.0%
2/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/87 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
1.5%
1/67 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
0.00%
0/66 • Up to Week 48
Safety Analysis Set: All participants who received at least 1 dose of study drug.
|
Additional Information
Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Phone: 1 (626) 304-3400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
- Publication restrictions are in place
Restriction type: OTHER