Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH) (NCT NCT04166773)
NCT ID: NCT04166773
Last Updated: 2025-01-24
Results Overview
NASH resolution is defined as the absence of fatty liver disease or simple steatosis without steatohepatitis; the absence of hepatocellular ballooning (nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) 0 for ballooning); with or without mild lobular inflammation (NAS 0 or 1 for inflammation); and any value for steatosis. No worsening of fibrosis is defined as no increase in fibrosis stage from baseline to Week 52.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
190 participants
Primary outcome timeframe
Week 52
Results posted on
2025-01-24
Participant Flow
Participant milestones
| Measure |
5 Milligram (mg) Tirzepatide
Participants received 5 mg tirzepatide administered subcutaneously (SC) once a week (QW) for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
Participants received placebo administered SC QW for 52 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
48
|
48
|
|
Overall Study
Received at Least One Dose of Study Drug
|
47
|
47
|
48
|
48
|
|
Overall Study
COMPLETED
|
40
|
44
|
43
|
38
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
5
|
10
|
Reasons for withdrawal
| Measure |
5 Milligram (mg) Tirzepatide
Participants received 5 mg tirzepatide administered subcutaneously (SC) once a week (QW) for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
Participants received placebo administered SC QW for 52 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
5
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
5 mg Tirzepatide
n=47 Participants
Participants received 5 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
n=47 Participants
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
n=48 Participants
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
n=48 Participants
Participants received placebo administered SC QW for 52 weeks.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.00 years
STANDARD_DEVIATION 11.62 • n=99 Participants
|
54.30 years
STANDARD_DEVIATION 12.08 • n=107 Participants
|
54.90 years
STANDARD_DEVIATION 10.02 • n=206 Participants
|
53.50 years
STANDARD_DEVIATION 11.60 • n=7 Participants
|
54.40 years
STANDARD_DEVIATION 11.28 • n=31 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
109 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
81 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
69 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
97 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
164 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
France
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Region of Enrollment
Mexico
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
107 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
NASH resolution is defined as the absence of fatty liver disease or simple steatosis without steatohepatitis; the absence of hepatocellular ballooning (nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) 0 for ballooning); with or without mild lobular inflammation (NAS 0 or 1 for inflammation); and any value for steatosis. No worsening of fibrosis is defined as no increase in fibrosis stage from baseline to Week 52.
Outcome measures
| Measure |
5 mg Tirzepatide
n=39 Participants
Participants received 5 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
n=41 Participants
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
n=40 Participants
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
n=35 Participants
Participants received placebo administered SC QW for 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology
|
51.84 Percentage of participants
|
63.13 Percentage of participants
|
73.92 Percentage of participants
|
12.62 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. Participants were evaluated with the NASH CRN scoring system with ≥1-point reduction without worsening of NASH (defined as no increase in the NAS score).
Outcome measures
| Measure |
5 mg Tirzepatide
n=39 Participants
Participants received 5 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
n=41 Participants
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
n=40 Participants
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
n=35 Participants
Participants received placebo administered SC QW for 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology
|
59.21 Percentage of participants
|
53.35 Percentage of participants
|
54.3 Percentage of participants
|
32.51 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
Participants were evaluated with the NASH CRN scoring system with ≥1 stage increase in fibrosis.
Outcome measures
| Measure |
5 mg Tirzepatide
n=39 Participants
Participants received 5 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
n=41 Participants
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
n=40 Participants
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
n=35 Participants
Participants received placebo administered SC QW for 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology
|
12.04 Percentage of participants
|
9.81 Percentage of participants
|
5.53 Percentage of participants
|
13.03 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in at least 2 NAS components (lobular inflammation, hepatocellular ballooning or steatosis). The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8, with the higher score indicating more aggressive disease.
Outcome measures
| Measure |
5 mg Tirzepatide
n=39 Participants
Participants received 5 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
n=41 Participants
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
n=40 Participants
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
n=35 Participants
Participants received placebo administered SC QW for 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants That Achieve a ≥2 Point Decrease in NAFLD (Non-alcoholic Fatty Liver Disease) Activity Score (NAS) on Liver Histology, With ≥1 Point Reduction in at Least 2 NAS Components
|
81.02 Percentage of participants
|
86.55 Percentage of participants
|
88.77 Percentage of participants
|
38.09 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage (%) and ranges from 0 to 100% with higher values representing higher liver fat level. Least square (LS) mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Diabetes Flag (DIABFL) + REGION1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Outcome measures
| Measure |
5 mg Tirzepatide
n=28 Participants
Participants received 5 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
n=33 Participants
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
n=32 Participants
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
n=27 Participants
Participants received placebo administered SC QW for 52 weeks.
|
|---|---|---|---|---|
|
Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
|
-10.12 absolute percentage of liver fat
Standard Error 1.165
|
-10.15 absolute percentage of liver fat
Standard Error 1.071
|
-11.34 absolute percentage of liver fat
Standard Error 1.107
|
-1.31 absolute percentage of liver fat
Standard Error 1.142
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
Change in body weight at the end of 52 weeks measured in kilogram (kg) using a calibrated scale. LS mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + DIABFL + REGION1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Outcome measures
| Measure |
5 mg Tirzepatide
n=40 Participants
Participants received 5 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
n=42 Participants
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
n=42 Participants
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
n=37 Participants
Participants received placebo administered SC QW for 52 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Body Weight
|
-11.46 Kilogram (kg)
Standard Error 1.404
|
-14.22 Kilogram (kg)
Standard Error 1.380
|
-17.88 Kilogram (kg)
Standard Error 1.376
|
-1.04 Kilogram (kg)
Standard Error 1.392
|
Adverse Events
5 mg Tirzepatide
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
10 mg Tirzepatide
Serious events: 4 serious events
Other events: 43 other events
Deaths: 0 deaths
15 mg Tirzepatide
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg Tirzepatide
n=47 participants at risk
Participants received 5 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
n=47 participants at risk
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
n=48 participants at risk
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
n=48 participants at risk
Participants received placebo administered SC QW for 52 weeks.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/26 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/29 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
3.7%
1/27 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Endometrial thickening
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/26 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/29 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
3.7%
1/27 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Vascular disorders
Phlebitis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Developmental hip dysplasia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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 pneumonia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Rhabdomyolysis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
Other adverse events
| Measure |
5 mg Tirzepatide
n=47 participants at risk
Participants received 5 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\].
|
10 mg Tirzepatide
n=47 participants at risk
Participants received 10 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\].
|
15 mg Tirzepatide
n=48 participants at risk
Participants received 15 mg tirzepatide administered SC QW for 52 weeks \[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\].
|
Placebo
n=48 participants at risk
Participants received placebo administered SC QW for 52 weeks.
|
|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Bacterial test positive
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Biopsy liver
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Blood glucose decreased
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Haematocrit abnormal
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Haemoglobin abnormal
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Lipase increased
|
2.1%
1/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Pancreatic enzymes increased
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Weight decreased
|
10.6%
5/47 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.4%
3/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.3%
4/48 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
19.1%
9/47 • Number of events 9 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
21.3%
10/47 • Number of events 12 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
22.9%
11/48 • Number of events 12 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
10.6%
5/47 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
4.3%
2/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Bursitis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Exostosis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Greater trochanteric pain syndrome
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Immune-mediated myositis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Limb discomfort
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
4.3%
2/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Investigations
Amylase increased
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Anaemia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Lymphadenopathy
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Cardiac disorders
Atrial tachycardia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Cardiac disorders
Bradycardia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Cardiac disorders
Cardiac failure
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Cardiac disorders
Palpitations
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Cardiac disorders
Tachycardia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Endocrine disorders
Thyroid mass
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Eye disorders
Cataract
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Eye disorders
Vision blurred
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.5%
4/47 • Number of events 6 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal distension
|
6.4%
3/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.4%
3/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
12.5%
6/48 • Number of events 8 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.3%
4/48 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal pain
|
12.8%
6/47 • Number of events 12 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.4%
3/47 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.3%
4/48 • Number of events 7 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
12.8%
6/47 • Number of events 10 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Colonic angioectasia
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Constipation
|
23.4%
11/47 • Number of events 12 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
19.1%
9/47 • Number of events 12 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
14.6%
7/48 • Number of events 8 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Diarrhoea
|
31.9%
15/47 • Number of events 17 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
36.2%
17/47 • Number of events 40 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
27.1%
13/48 • Number of events 20 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
22.9%
11/48 • Number of events 14 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Diverticulum
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
2/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
17.0%
8/47 • Number of events 11 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Eructation
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.3%
4/48 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.4%
3/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.4%
3/47 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.3%
4/48 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Nausea
|
36.2%
17/47 • Number of events 69 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
34.0%
16/47 • Number of events 33 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
43.8%
21/48 • Number of events 26 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
12.5%
6/48 • Number of events 7 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Pancreatitis
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Tooth loss
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
3/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.4%
3/47 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
14.6%
7/48 • Number of events 14 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Asthenia
|
6.4%
3/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.5%
4/47 • Number of events 6 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Discomfort
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Energy increased
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Fatigue
|
8.5%
4/47 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.5%
4/47 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
10.4%
5/48 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Injection site bruising
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Injection site erythema
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Injection site inflammation
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Injection site pain
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Injection site rash
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Injection site reaction
|
4.3%
2/47 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 10 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Injection site swelling
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Malaise
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Oedema peripheral
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
General disorders
Pain
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Immune system disorders
Drug hypersensitivity
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
3.8%
1/26 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/29 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Bronchitis
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
10.6%
5/47 • Number of events 6 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
12.8%
6/47 • Number of events 6 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
18.8%
9/48 • Number of events 9 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.3%
4/48 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Folliculitis
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Infected bite
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Oral fungal infection
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Paronychia
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Sinusitis
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.4%
3/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.4%
3/47 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.3%
4/48 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/26 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
3.4%
1/29 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
3.8%
1/26 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/29 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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 bite
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Epicondylitis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Exposure to toxic agent
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Joint injury
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Meniscus injury
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Post procedural bile leak
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Post procedural fever
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Post vaccination syndrome
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Procedural nausea
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Procedural pain
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Rib fracture
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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 abrasion
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Stoma site haemorrhage
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Neck pain
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Osteochondritis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Osteopenia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Osteoporosis
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Rhabdomyolysis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Rheumatic disorder
|
2.1%
1/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Sacral pain
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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 pain
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Systemic lupus erythematosus
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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)
Basal cell carcinoma
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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)
Colorectal adenoma
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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)
Hepatic adenoma
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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)
Meningioma
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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)
Ovarian neoplasm
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/26 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/29 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
3.7%
1/27 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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)
Skin papilloma
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Aphasia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Disturbance in attention
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Dizziness
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
12.8%
6/47 • Number of events 7 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
8.3%
4/48 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Dysgeusia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Headache
|
6.4%
3/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
12.8%
6/47 • Number of events 7 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
10.4%
5/48 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Hypoaesthesia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Lethargy
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Migraine
|
2.1%
1/47 • Number of events 17 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Neuralgia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Neuritis
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Paraesthesia
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Radiculopathy
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Sciatica
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Nervous system disorders
Somnolence
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.4%
3/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Psychiatric disorders
Anxiety
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Psychiatric disorders
Depression
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Psychiatric disorders
Insomnia
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Psychiatric disorders
Major depression
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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 failure
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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 pain
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/20 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/21 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/19 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.8%
1/21 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Breast cyst
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Breast discomfort
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/26 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
3.4%
1/29 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Testicular pain
|
0.00%
0/20 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/21 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/19 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.8%
1/21 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/26 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
3.4%
1/29 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Vulvovaginal discomfort
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/26 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/29 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
3.7%
1/27 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Chronic obstructive pulmonary disease
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
8.5%
4/47 • Number of events 4 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.2%
3/48 • Number of events 5 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Blister
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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 contact
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Ecchymosis
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Intertrigo
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Koilonychia
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
Photosensitivity reaction
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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 hyperpigmentation
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
4.2%
2/48 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Cyst removal
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Eyelid cyst removal
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Gastrointestinal endoscopic therapy
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Nail operation
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Tendon sheath incision
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Surgical and medical procedures
Uterine polypectomy
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/26 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
3.4%
1/29 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/27 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Vascular disorders
Hot flush
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Vascular disorders
Hypertension
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
6.4%
3/47 • Number of events 3 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Vascular disorders
Hypotension
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Vascular disorders
Orthostatic hypotension
|
4.3%
2/47 • Number of events 2 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/48 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/47 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
2.1%
1/47 • Number of events 1 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly
|
0.00%
0/48 • Baseline Up to Week 56
All randomized participants who received at least one dose of study drug. 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