Trial Outcomes & Findings for A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (NCT NCT05971940)
NCT ID: NCT05971940
Last Updated: 2026-04-22
Results Overview
* Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time. * Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \[less than or equal to\] 8.0%, \> \[greater than\] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
559 participants
Primary outcome timeframe
Baseline, Week 40
Results posted on
2026-04-22
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received once daily (QD) doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 milligram (mg) and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
138
|
143
|
137
|
141
|
|
Overall Study
Received at Least One Dose of Study Drug
|
138
|
143
|
137
|
141
|
|
Overall Study
COMPLETED
|
131
|
134
|
125
|
136
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
12
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Participants received once daily (QD) doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 milligram (mg) and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
3
|
1
|
|
Overall Study
Death
|
1
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
0
|
|
Overall Study
Site Terminated By Sponsor
|
1
|
0
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
4
|
1
|
|
Overall Study
Participant not entering safety follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Non-Compliance With Study Drug
|
0
|
0
|
1
|
0
|
|
Overall Study
Other - as reported by the investigator
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Baseline characteristics by cohort
| Measure |
Placebo
n=138 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=143 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=137 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=141 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
Total
n=559 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.30 years
STANDARD_DEVIATION 12.51 • n=60 Participants
|
53.30 years
STANDARD_DEVIATION 11.28 • n=56 Participants
|
54.10 years
STANDARD_DEVIATION 11.76 • n=116 Participants
|
52.80 years
STANDARD_DEVIATION 11.83 • n=7 Participants
|
53.40 years
STANDARD_DEVIATION 11.83 • n=3 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=60 Participants
|
63 Participants
n=56 Participants
|
71 Participants
n=116 Participants
|
72 Participants
n=7 Participants
|
269 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=60 Participants
|
80 Participants
n=56 Participants
|
66 Participants
n=116 Participants
|
69 Participants
n=7 Participants
|
290 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
56 Participants
n=60 Participants
|
57 Participants
n=56 Participants
|
55 Participants
n=116 Participants
|
55 Participants
n=7 Participants
|
223 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=60 Participants
|
86 Participants
n=56 Participants
|
82 Participants
n=116 Participants
|
85 Participants
n=7 Participants
|
335 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
35 Participants
n=60 Participants
|
35 Participants
n=56 Participants
|
38 Participants
n=116 Participants
|
35 Participants
n=7 Participants
|
143 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
61 Participants
n=60 Participants
|
63 Participants
n=56 Participants
|
59 Participants
n=116 Participants
|
62 Participants
n=7 Participants
|
245 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=60 Participants
|
8 Participants
n=56 Participants
|
9 Participants
n=116 Participants
|
4 Participants
n=7 Participants
|
24 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=60 Participants
|
37 Participants
n=56 Participants
|
30 Participants
n=116 Participants
|
40 Participants
n=7 Participants
|
145 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
|
Region of Enrollment
China
|
13 Participants
n=60 Participants
|
14 Participants
n=56 Participants
|
12 Participants
n=116 Participants
|
12 Participants
n=7 Participants
|
51 Participants
n=3 Participants
|
|
Region of Enrollment
India
|
21 Participants
n=60 Participants
|
21 Participants
n=56 Participants
|
19 Participants
n=116 Participants
|
22 Participants
n=7 Participants
|
83 Participants
n=3 Participants
|
|
Region of Enrollment
Japan
|
25 Participants
n=60 Participants
|
26 Participants
n=56 Participants
|
25 Participants
n=116 Participants
|
25 Participants
n=7 Participants
|
101 Participants
n=3 Participants
|
|
Region of Enrollment
Mexico
|
38 Participants
n=60 Participants
|
40 Participants
n=56 Participants
|
41 Participants
n=116 Participants
|
40 Participants
n=7 Participants
|
159 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=60 Participants
|
42 Participants
n=56 Participants
|
40 Participants
n=116 Participants
|
42 Participants
n=7 Participants
|
165 Participants
n=3 Participants
|
|
HemoglobinA1c (HbA1c)
|
7.96 Percentage of HbA1c
STANDARD_DEVIATION 0.89 • n=60 Participants
|
7.93 Percentage of HbA1c
STANDARD_DEVIATION 0.86 • n=56 Participants
|
7.98 Percentage of HbA1c
STANDARD_DEVIATION 0.91 • n=116 Participants
|
8.07 Percentage of HbA1c
STANDARD_DEVIATION 0.90 • n=7 Participants
|
7.99 Percentage of HbA1c
STANDARD_DEVIATION 0.89 • n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
* Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time. * Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \[less than or equal to\] 8.0%, \> \[greater than\] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=143 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=137 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=141 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Change From Baseline in HbA1c
|
-0.15 percentage of HbA1c
Standard Error 0.113
|
-1.26 percentage of HbA1c
Standard Error 0.114
|
-1.59 percentage of HbA1c
Standard Error 0.087
|
-1.45 percentage of HbA1c
Standard Error 0.104
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
Percentage of participants with an HbA1c target value of less than (\<) 7.0% (53 millimoles per mole \[mmol/mol\]) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \>8.0%) and prior use of any antihyperglycemic medication (yes or no).
Outcome measures
| Measure |
Placebo
n=97 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=119 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=112 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=119 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol)
|
37.11 percentage of participants
|
78.15 percentage of participants
|
81.25 percentage of participants
|
78.99 percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
Percentage of Participants with an HbA1c target value of less than or equal to (≤) 6.5% (48 mmol/mol) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \>8.0%) and prior use of any antihyperglycemic medication (yes or no).
Outcome measures
| Measure |
Placebo
n=97 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=119 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=112 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=119 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Percentage of Participants With an HbA1c Target Value of ≤6.5% (48 mmol/Mol)
|
18.56 percentage of participants
|
66.39 percentage of participants
|
68.75 percentage of participants
|
68.91 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \[less than or equal to\] 8.0%, \> \[greater than\] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=133 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=136 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=130 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=136 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Serum Glucose (FSG)
|
-1.1 milligram per deciliter (mg/dL)
Standard Error 4.01
|
-30.6 milligram per deciliter (mg/dL)
Standard Error 3.66
|
-37.4 milligram per deciliter (mg/dL)
Standard Error 3.08
|
-37.8 milligram per deciliter (mg/dL)
Standard Error 2.94
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=143 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=137 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=141 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight
|
-1.6 percent change
Standard Error 0.43
|
-4.7 percent change
Standard Error 0.47
|
-6.1 percent change
Standard Error 0.55
|
-7.9 percent change
Standard Error 0.58
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=143 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=137 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=141 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight
|
-1.3 kilogram (kg)
Standard Error 0.36
|
-4.4 kilogram (kg)
Standard Error 0.43
|
-5.5 kilogram (kg)
Standard Error 0.49
|
-7.3 kilogram (kg)
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis : log (Actual Measurement/Baseline) = country, treatment by time, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=135 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=136 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=131 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=137 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol
|
3.19 percent change
Standard Error 2.085
|
-1.82 percent change
Standard Error 2.193
|
-4.80 percent change
Standard Error 2.273
|
-7.91 percent change
Standard Error 1.760
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis : log (Actual Measurement/Baseline) = country, treatment by time, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=135 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=136 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=130 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=136 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides
|
0.0 percent change
Standard Error 3.56
|
-9.1 percent change
Standard Error 3.61
|
-16.5 percent change
Standard Error 3.06
|
-14.0 percent change
Standard Error 2.84
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=128 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=138 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=129 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=130 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)
|
-17.6 milligram per deciliter (mg/dL)
Standard Error 3.99
|
-43.6 milligram per deciliter (mg/dL)
Standard Error 3.73
|
-56.0 milligram per deciliter (mg/dL)
Standard Error 2.29
|
-58.1 milligram per deciliter (mg/dL)
Standard Error 1.80
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \>8.0%) and prior use of any antihyperglycemic medication (yes or no).
Outcome measures
| Measure |
Placebo
n=96 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=119 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=111 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=119 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction
|
14.58 percentage of participants
|
47.06 percentage of participants
|
58.56 percentage of participants
|
66.39 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=143 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=137 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=141 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP)
|
-0.5 millimeters of mercury (mmHg)
Standard Error 0.88
|
-3.2 millimeters of mercury (mmHg)
Standard Error 0.91
|
-6.1 millimeters of mercury (mmHg)
Standard Error 0.97
|
-6.0 millimeters of mercury (mmHg)
Standard Error 0.91
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \> 14 days of use).
The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.
Outcome measures
| Measure |
Placebo
n=136 Participants
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=143 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=137 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=139 Participants
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores
Physical Component Score
|
2.25 T-score
Standard Error 0.592
|
2.06 T-score
Standard Error 0.513
|
2.21 T-score
Standard Error 0.574
|
1.58 T-score
Standard Error 0.632
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores
Mental Component Score
|
0.09 T-score
Standard Error 0.689
|
0.11 T-score
Standard Error 0.687
|
-0.37 T-score
Standard Error 0.587
|
-0.46 T-score
Standard Error 0.777
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 110 other events
Deaths: 1 deaths
3 mg Orforglipron
Serious events: 8 serious events
Other events: 118 other events
Deaths: 2 deaths
12 mg Orforglipron
Serious events: 7 serious events
Other events: 118 other events
Deaths: 1 deaths
36 mg Orforglipron
Serious events: 4 serious events
Other events: 123 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=138 participants at risk
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=143 participants at risk
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=137 participants at risk
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=141 participants at risk
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Septic shock
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=138 participants at risk
Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
|
3 mg Orforglipron
n=143 participants at risk
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
|
12 mg Orforglipron
n=137 participants at risk
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
|
36 mg Orforglipron
n=141 participants at risk
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Bundle branch block left
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Bundle branch block right
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Left atrial enlargement
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Rhythm idioventricular
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
2.2%
3/138 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Goitre
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Thyroid mass
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Arteriosclerotic retinopathy
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Astigmatism
|
0.72%
1/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Blepharitis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
4/137 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Cataract cortical
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Cataract nuclear
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Central serous chorioretinopathy
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Chalazion
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Conjunctivitis allergic
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Diabetic retinal oedema
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Diabetic retinopathy
|
15.2%
21/138 • Number of events 35 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.7%
21/143 • Number of events 37 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
8/137 • Number of events 18 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.0%
24/141 • Number of events 46 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Dry eye
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye pain
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Glaucoma
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Lenticular opacities
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Macular oedema
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Ophthalmic artery occlusion
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Optic disc haemorrhage
|
0.72%
1/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Pathologic myopia
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Retinopathy hypertensive
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Vitreous detachment
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
4/137 • Number of events 6 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
11/138 • Number of events 11 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
6/143 • Number of events 10 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
7/137 • Number of events 8 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.3%
16/141 • Number of events 22 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
4/137 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
7/141 • Number of events 8 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
8/137 • Number of events 13 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
3.6%
5/138 • Number of events 10 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.4%
12/143 • Number of events 14 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.8%
23/137 • Number of events 29 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.2%
20/141 • Number of events 22 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
13/138 • Number of events 18 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
18.9%
27/143 • Number of events 61 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.2%
29/137 • Number of events 43 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.5%
36/141 • Number of events 81 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.2%
10/138 • Number of events 13 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.9%
17/143 • Number of events 20 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.2%
29/137 • Number of events 42 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.6%
22/141 • Number of events 31 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
5/143 • Number of events 13 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.4%
6/137 • Number of events 10 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
10/141 • Number of events 22 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Faeces hard
|
0.72%
1/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 9 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
5/141 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
7/137 • Number of events 9 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
7/141 • Number of events 7 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hyperechogenic pancreas
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.6%
18/143 • Number of events 23 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
19.0%
26/137 • Number of events 30 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.0%
24/141 • Number of events 34 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.9%
7/143 • Number of events 9 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.6%
9/137 • Number of events 11 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.2%
20/141 • Number of events 43 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chills
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Early satiety
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
3.6%
5/138 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Feeling abnormal
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Hyperthermia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pain
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Peripheral swelling
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
3.6%
5/138 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
5/143 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.4%
6/137 • Number of events 6 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Swelling face
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Temperature intolerance
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Thirst
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Vaccination site pain
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Metabolic dysfunction-associated liver disease
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Acute sinusitis
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bacterial vaginosis
|
1.6%
1/63 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/71 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Body tinea
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchiolitis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cervicitis
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/71 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
2.9%
4/138 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Dengue fever
|
2.9%
4/138 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
5/141 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Dengue haemorrhagic fever
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Ear infection
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Fungal infection
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/143 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastrointestinal fungal infection
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
5/137 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Laryngitis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
8/138 • Number of events 11 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
5/143 • Number of events 7 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.3%
10/137 • Number of events 13 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis externa
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis media
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Parotitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.72%
1/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Skin infection
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
3/138 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/143 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/143 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/71 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/72 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/71 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/72 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
4/137 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
2/138 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Albumin urine present
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Amylase increased
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatine increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.3%
6/138 • Number of events 7 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood homocysteine increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood potassium increased
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood pressure increased
|
2.9%
4/138 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood uric acid increased
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Capillary fragility increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Colonoscopy
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Creatinine urine increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Fibrin d dimer increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
2/138 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/143 • Number of events 7 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Glomerular filtration rate decreased
|
3.6%
5/138 • Number of events 6 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haematocrit increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Heart rate increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Hepatic enzyme increased
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/143 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
7/137 • Number of events 9 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Mean cell volume increased
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Occult blood positive
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Pancreatic enzymes increased
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Platelet count increased
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Protein total increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Protein urine present
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Qrs axis abnormal
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Sars-cov-2 test positive
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Transaminases increased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Urinary occult blood
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight increased
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
5/143 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.2%
14/137 • Number of events 18 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.1%
17/141 • Number of events 22 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 9 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
4.3%
6/138 • Number of events 6 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
5/143 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
7/141 • Number of events 7 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
26.8%
37/138 • Number of events 39 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
11/143 • Number of events 12 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.4%
6/137 • Number of events 8 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
9/141 • Number of events 10 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.6%
5/138 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.9%
4/138 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
4/137 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 12 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
5/137 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
5/141 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
2/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 7 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.72%
1/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Brain fog
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral infarction
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cervical cord compression
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
6/143 • Number of events 6 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
4/137 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
5/141 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
5.8%
8/138 • Number of events 8 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.0%
10/143 • Number of events 11 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
8/137 • Number of events 8 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
11/141 • Number of events 11 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/141 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Increased need for sleep
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Lhermitte's sign
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Nerve compression
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Tension headache
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.72%
1/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anger
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety disorder
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depressed mood
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
2.9%
4/138 • Number of events 5 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Stress
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/143 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal impairment
|
2.9%
4/138 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
4/143 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
1.6%
1/63 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/71 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/75 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/66 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/69 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
2/71 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
3/141 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/137 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Social circumstances
Overwork
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/141 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Cold urticaria
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
3/138 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin discharge
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Social circumstances
Family stress
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Drainage
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Extracorporeal shock wave therapy
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Eye laser surgery
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Iridotomy
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Polypectomy
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Retinal laser coagulation
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Aortic stenosis
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.72%
1/138 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
5.8%
8/138 • Number of events 8 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
6/143 • Number of events 6 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
4/137 • Number of events 4 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
5/141 • Number of events 6 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
3/137 • Number of events 3 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
1/141 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/143 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
1/137 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/138 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.70%
1/143 • Number of events 1 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Varicose vein
|
1.4%
2/138 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
2/143 • Number of events 2 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/137 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/141 • Baseline to end of safety follow-up (up to 42 weeks)
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60