Trial Outcomes & Findings for Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02105961)
NCT ID: NCT02105961
Last Updated: 2018-08-16
Results Overview
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (\>=24 hours) or result in death. Moderate and severe exacerbations occurring from the start of investigational product (IP) up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on the modified intent-to-treat (mITT) Population (all randomized participants who received at least one dose of study treatment).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
674 participants
Primary outcome timeframe
From randomization to Week 52
Results posted on
2018-08-16
Participant Flow
Participants with chronic obstructive pulmonary disease (COPD) with frequent exacerbations, on high dose inhaled corticosteroid (ICS)-based triple inhaled maintenance therapy were included. Participants were randomized to receive mepolizumab (100 or 300 milligrams \[mg\]) or placebo by subcutaneous (SC) injection every 4 weeks for up to 52 weeks.
A total of 674 participants were randomized and received at least one dose of study treatment and were included in the modified intent to treat (mITT) population. One participant randomized to the mepolizumab 300 mg group was withdrawn without receiving study treatment.
Participant milestones
| Measure |
Placebo
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their standard of care (SoC) therapy. Salbutamol metered dose inhaler (MDI) was issued for use as rescue medication throughout the study.
|
Mepolizumab 100 mg SC
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 300 mg SC
Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
226
|
223
|
225
|
|
Overall Study
Completed Investigational Product (IP)
|
170
|
196
|
183
|
|
Overall Study
Not Completed IP
|
56
|
27
|
42
|
|
Overall Study
Withdrew IP Due to: Adverse Event
|
27
|
9
|
25
|
|
Overall Study
Withdrew IP Due to: Stopping Criteria
|
1
|
1
|
0
|
|
Overall Study
Withdrew IP Due to: Lack of Efficacy
|
6
|
2
|
2
|
|
Overall Study
Withdrew IP Due to: Protocol Deviation
|
2
|
0
|
1
|
|
Overall Study
Withdrew IP Due to: Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Withdrew IP Due to: Physician Decision
|
2
|
3
|
1
|
|
Overall Study
Withdrew IP Due to: Withdrawal by Subj.
|
16
|
11
|
11
|
|
Overall Study
Withdrew IP Due to: Site Closed
|
1
|
0
|
1
|
|
Overall Study
COMPLETED
|
185
|
206
|
195
|
|
Overall Study
NOT COMPLETED
|
41
|
17
|
30
|
Reasons for withdrawal
| Measure |
Placebo
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their standard of care (SoC) therapy. Salbutamol metered dose inhaler (MDI) was issued for use as rescue medication throughout the study.
|
Mepolizumab 100 mg SC
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 300 mg SC
Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
18
|
7
|
13
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
15
|
7
|
11
|
Baseline Characteristics
Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Placebo
n=226 Participants
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 100 mg SC
n=223 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 300 mg SC
n=225 Participants
Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Total
n=674 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.8 Years
STANDARD_DEVIATION 8.64 • n=5 Participants
|
64.8 Years
STANDARD_DEVIATION 9.06 • n=7 Participants
|
64.8 Years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
65.1 Years
STANDARD_DEVIATION 8.89 • n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
446 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Asian-Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Asian-East Asian Heritage
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Asian-Japanese Heritage
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Asian-South East Asian Heritage
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · White-White/Caucasian/European Heritage
|
182 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
542 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From randomization to Week 52Population: mITT Population
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (\>=24 hours) or result in death. Moderate and severe exacerbations occurring from the start of investigational product (IP) up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on the modified intent-to-treat (mITT) Population (all randomized participants who received at least one dose of study treatment).
Outcome measures
| Measure |
Placebo
n=226 Participants
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 100 mg SC
n=223 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 300 mg SC
n=225 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
|---|---|---|---|
|
Rate of Moderate or Severe Exacerbations
|
1.49 Moderate/severe exacerbations per year
Interval 1.29 to 1.72
|
1.19 Moderate/severe exacerbations per year
Interval 1.02 to 1.38
|
1.27 Moderate/severe exacerbations per year
Interval 1.09 to 1.48
|
SECONDARY outcome
Timeframe: From randomization to Week 52Population: mITT Population
Kaplan Meier estimates of the probability of a moderate or severe exacerbation are expressed as the percentage of participants with an exacerbation over time (by Week 8, 16, 24, 32, 40, 48, 52). Analysis of time to first moderate/severe exacerbation was performed on the mITT population and included exacerbations reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study.
Outcome measures
| Measure |
Placebo
n=226 Participants
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 100 mg SC
n=223 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 300 mg SC
n=225 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
|---|---|---|---|
|
Time to First Moderate/Severe Exacerbation
Week 8
|
22.6 Percentage of participants
Interval 17.7 to 28.6
|
22.9 Percentage of participants
Interval 17.9 to 29.0
|
18.3 Percentage of participants
Interval 13.8 to 24.0
|
|
Time to First Moderate/Severe Exacerbation
Week 16
|
40.7 Percentage of participants
Interval 34.6 to 47.5
|
36.0 Percentage of participants
Interval 30.0 to 42.6
|
29.0 Percentage of participants
Interval 23.5 to 35.4
|
|
Time to First Moderate/Severe Exacerbation
Week 24
|
51.1 Percentage of participants
Interval 44.6 to 57.8
|
42.4 Percentage of participants
Interval 36.2 to 49.2
|
36.7 Percentage of participants
Interval 30.8 to 43.4
|
|
Time to First Moderate/Severe Exacerbation
Week 32
|
58.3 Percentage of participants
Interval 51.8 to 64.9
|
46.1 Percentage of participants
Interval 39.8 to 52.9
|
44.9 Percentage of participants
Interval 38.7 to 51.7
|
|
Time to First Moderate/Severe Exacerbation
Week 40
|
62.3 Percentage of participants
Interval 55.8 to 68.7
|
50.8 Percentage of participants
Interval 44.4 to 57.6
|
51.8 Percentage of participants
Interval 45.4 to 58.6
|
|
Time to First Moderate/Severe Exacerbation
Week 48
|
64.2 Percentage of participants
Interval 57.8 to 70.6
|
55.5 Percentage of participants
Interval 49.1 to 62.2
|
58.3 Percentage of participants
Interval 51.9 to 64.9
|
|
Time to First Moderate/Severe Exacerbation
Week 52
|
66.7 Percentage of participants
Interval 60.2 to 73.1
|
57.9 Percentage of participants
Interval 51.5 to 64.5
|
58.8 Percentage of participants
Interval 52.4 to 65.3
|
SECONDARY outcome
Timeframe: From randomization to Week 52Population: mITT Population
COPD exacerbations requiring an ED visit and/or hosp occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. This analysis was performed on the mITT population.
Outcome measures
| Measure |
Placebo
n=226 Participants
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 100 mg SC
n=223 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 300 mg SC
n=225 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
|---|---|---|---|
|
Rate of COPD Exacerbations Requiring Emergency Department (ED) Visits and/or Hospitalizations (Hosp)
|
0.28 Exacerbations requiring ED/hosp per year
Interval 0.2 to 0.4
|
0.17 Exacerbations requiring ED/hosp per year
Interval 0.11 to 0.25
|
0.23 Exacerbations requiring ED/hosp per year
Interval 0.16 to 0.33
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.
The SGRQ for COPD is a 40-item questionnaire derived from the original SGRQ , designed to measure health impairment by addressing the frequency of respiratory symptoms and current state of the participant. SGRQ Total Scores range from 0 to 100 with higher scores indicating worse health-related quality of life and reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product.Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in SGRQ score at Week 52 has been presented.
Outcome measures
| Measure |
Placebo
n=218 Participants
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 100 mg SC
n=218 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 300 mg SC
n=219 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
|---|---|---|---|
|
Change From Baseline in Mean Total St. George's Respiratory Questionnaire (SGRQ) Score
|
-3.1 Score on SGRQ scale
Standard Error 0.98
|
-5.0 Score on SGRQ scale
Standard Error 0.95
|
-3.3 Score on SGRQ scale
Standard Error 0.96
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.
The CAT is an 8-item questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Each question is assessed on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment) with the CAT score ranging from 0-40. Higher scores indicate greater disease impact with reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in CAT score at Week 52 has been presented.
Outcome measures
| Measure |
Placebo
n=222 Participants
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 100 mg SC
n=216 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 300 mg SC
n=219 Participants
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
|---|---|---|---|
|
Change From Baseline in Mean COPD Assessment Test (CAT) Score
|
-0.4 Score on CAT scale
Standard Error 0.42
|
-1.6 Score on CAT scale
Standard Error 0.42
|
-0.8 Score on CAT scale
Standard Error 0.42
|
Adverse Events
Placebo
Serious events: 68 serious events
Other events: 137 other events
Deaths: 9 deaths
Mepolizumab 100 mg SC
Serious events: 57 serious events
Other events: 147 other events
Deaths: 4 deaths
Mepolizumab 300 mg SC
Serious events: 60 serious events
Other events: 137 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Placebo
n=226 participants at risk
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 100 mg SC
n=223 participants at risk
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 300 mg SC
n=225 participants at risk
Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
16.4%
37/226 • Number of events 52 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
11.2%
25/223 • Number of events 34 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
14.2%
32/225 • Number of events 54 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.88%
2/226 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.3%
3/223 • Number of events 4 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.89%
2/225 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.89%
2/225 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.89%
2/225 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.44%
1/226 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pneumonia
|
8.0%
18/226 • Number of events 19 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
7.2%
16/223 • Number of events 21 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
6.7%
15/225 • Number of events 16 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
2.2%
5/226 • Number of events 6 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.3%
3/225 • Number of events 4 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Sepsis
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.3%
3/223 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.3%
3/223 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Lower respiratory tract infection
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Bronchitis
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Influenza
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.89%
2/225 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
0.44%
1/226 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Appendicitis
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Clostridium difficile colitis
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Cystitis
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Gastrointestinal infection
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Lung abscess
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Orchitis
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Osteomyelitis
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pneumonia haemophilus
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pneumonia necrotising
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Viral infection
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
3/226 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.89%
2/225 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
3/226 • Number of events 6 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.3%
3/223 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Coronary artery disease
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.89%
2/225 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Arrhythmia
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.89%
2/225 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.3%
3/223 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.44%
1/226 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Syncope
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Transient ischaemic attack
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
General disorders
Non-cardiac chest pain
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
General disorders
Pyrexia
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
General disorders
Death
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
General disorders
General physical health deterioration
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Hypertensive crisis
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Eye disorders
Cataract
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Delirium
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Investigations
Haematocrit increased
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/223 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/226 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.45%
1/223 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.00%
0/225 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
Other adverse events
| Measure |
Placebo
n=226 participants at risk
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 100 mg SC
n=223 participants at risk
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
Mepolizumab 300 mg SC
n=225 participants at risk
Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
21.2%
48/226 • Number of events 65 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
17.5%
39/223 • Number of events 57 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
17.8%
40/225 • Number of events 52 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
20/226 • Number of events 27 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
7.2%
16/223 • Number of events 19 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
5.3%
12/225 • Number of events 15 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pneumonia
|
3.5%
8/226 • Number of events 9 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.5%
10/223 • Number of events 13 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.4%
10/225 • Number of events 11 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Bronchitis
|
3.5%
8/226 • Number of events 8 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.6%
8/223 • Number of events 12 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.9%
11/225 • Number of events 15 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Sinusitis
|
3.1%
7/226 • Number of events 11 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.6%
8/223 • Number of events 11 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.1%
7/225 • Number of events 9 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Influenza
|
4.9%
11/226 • Number of events 11 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
2.7%
6/223 • Number of events 7 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.3%
3/225 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Oral candidiasis
|
2.2%
5/226 • Number of events 7 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.3%
3/223 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.6%
8/225 • Number of events 9 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Rhinitis
|
2.2%
5/226 • Number of events 6 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.1%
7/223 • Number of events 9 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.8%
4/225 • Number of events 4 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
3.1%
7/226 • Number of events 8 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.1%
7/223 • Number of events 8 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
0.44%
1/225 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
General disorders
Injection site reaction
|
4.4%
10/226 • Number of events 17 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
2.7%
6/223 • Number of events 6 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.9%
11/225 • Number of events 27 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
General disorders
Pyrexia
|
4.0%
9/226 • Number of events 9 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
2.7%
6/223 • Number of events 7 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
5.3%
12/225 • Number of events 17 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
General disorders
Non-cardiac chest pain
|
3.1%
7/226 • Number of events 7 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
2.2%
5/223 • Number of events 8 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.1%
7/225 • Number of events 8 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
General disorders
Fatigue
|
1.8%
4/226 • Number of events 4 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
2.7%
6/223 • Number of events 6 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.6%
8/225 • Number of events 8 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
General disorders
Oedema peripheral
|
1.3%
3/226 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.1%
7/223 • Number of events 7 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.8%
4/225 • Number of events 6 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
12/226 • Number of events 16 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
6.3%
14/223 • Number of events 14 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
7.1%
16/225 • Number of events 22 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
18/226 • Number of events 19 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
5.4%
12/223 • Number of events 14 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.4%
10/225 • Number of events 17 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
4/226 • Number of events 4 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
6.7%
15/223 • Number of events 15 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.9%
11/225 • Number of events 13 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.2%
5/226 • Number of events 9 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.6%
8/223 • Number of events 12 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.4%
10/225 • Number of events 24 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
11/226 • Number of events 11 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
6.7%
15/223 • Number of events 18 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
7.6%
17/225 • Number of events 21 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
6/226 • Number of events 7 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.5%
10/223 • Number of events 10 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
2.7%
6/225 • Number of events 6 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
5/226 • Number of events 6 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.1%
7/223 • Number of events 7 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
2.7%
6/225 • Number of events 10 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.88%
2/226 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.8%
4/223 • Number of events 4 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.1%
7/225 • Number of events 8 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
14/226 • Number of events 14 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
5.8%
13/223 • Number of events 16 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.6%
8/225 • Number of events 12 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Constipation
|
4.4%
10/226 • Number of events 10 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.1%
7/223 • Number of events 8 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
2.2%
5/225 • Number of events 6 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Nausea
|
1.3%
3/226 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.0%
9/223 • Number of events 10 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.0%
9/225 • Number of events 13 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.44%
1/226 • Number of events 1 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
4.0%
9/223 • Number of events 9 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
2.2%
5/225 • Number of events 5 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Headache
|
8.8%
20/226 • Number of events 29 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
15.2%
34/223 • Number of events 62 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
9.8%
22/225 • Number of events 39 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Hypertension
|
1.3%
3/226 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.6%
8/223 • Number of events 9 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.1%
7/225 • Number of events 7 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.88%
2/226 • Number of events 2 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
3.1%
7/223 • Number of events 7 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
1.3%
3/225 • Number of events 3 • Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER