Trial Outcomes & Findings for Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease (NCT NCT02700919)
NCT ID: NCT02700919
Last Updated: 2020-11-30
Results Overview
FEV1 data were recorded daily from Days 1 to 7 of the study using a computer-operated spirometer. Analysis was based on a linear Mixed Model for Repeated Measures (MMRM) with Change from Baseline in parameter as outcome; including treatment, visit, treatment by visit interaction, severity of airflow limitation at Baseline, blood eosinophils (%) at Baseline, time from start of current chronic obstructive pulmonary disease (COPD) exacerbation to first study treatment dosing, presence of cardiovascular comorbidities at Screening and COPD exacerbation treatment at Screening as fixed effects, and Baseline value and Baseline by visit interaction as covariates. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments. Results were presented with adjusted mean (95% confidence interval).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
282 participants
Primary outcome timeframe
Days 1 to 7
Results posted on
2020-11-30
Participant Flow
Participant milestones
| Measure |
BCT197 High Dose Regimen
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
94
|
97
|
91
|
|
Overall Study
COMPLETED
|
82
|
85
|
87
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
4
|
Reasons for withdrawal
| Measure |
BCT197 High Dose Regimen
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
Other
|
2
|
1
|
1
|
Baseline Characteristics
Only part of the participants had pre-bronchodilator spirometry results at Screening.
Baseline characteristics by cohort
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 8.34 • n=87 Participants
|
63.1 years
STANDARD_DEVIATION 8.68 • n=93 Participants
|
64.7 years
STANDARD_DEVIATION 7.06 • n=86 Participants
|
63.8 years
STANDARD_DEVIATION 8.07 • n=266 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=87 Participants
|
26 Participants
n=93 Participants
|
27 Participants
n=86 Participants
|
74 Participants
n=266 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=87 Participants
|
67 Participants
n=93 Participants
|
59 Participants
n=86 Participants
|
192 Participants
n=266 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=87 Participants
|
1 Participants
n=93 Participants
|
0 Participants
n=86 Participants
|
1 Participants
n=266 Participants
|
|
Race/Ethnicity, Customized
White
|
87 Participants
n=87 Participants
|
92 Participants
n=93 Participants
|
85 Participants
n=86 Participants
|
264 Participants
n=266 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=87 Participants
|
0 Participants
n=93 Participants
|
1 Participants
n=86 Participants
|
1 Participants
n=266 Participants
|
|
FEV1 at Screening
Pre-bronchodilator
|
0.875 litre
STANDARD_DEVIATION 0.3649 • n=23 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
0.871 litre
STANDARD_DEVIATION 0.3091 • n=25 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
0.921 litre
STANDARD_DEVIATION 0.2775 • n=20 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
0.887 litre
STANDARD_DEVIATION 0.3166 • n=68 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
|
FEV1 at Screening
Post-bronchodilator
|
1.135 litre
STANDARD_DEVIATION 0.3875 • n=87 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
1.046 litre
STANDARD_DEVIATION 0.4009 • n=93 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
1.033 litre
STANDARD_DEVIATION 0.3558 • n=86 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
1.071 litre
STANDARD_DEVIATION 0.3836 • n=266 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
|
Forced Vital Capacity (FVC) at Screening
Pre-bronchodilator
|
2.410 litre
STANDARD_DEVIATION 0.8883 • n=23 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
2.137 litre
STANDARD_DEVIATION 0.8675 • n=25 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
2.352 litre
STANDARD_DEVIATION 0.7623 • n=20 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
2.293 litre
STANDARD_DEVIATION 0.8416 • n=68 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
|
Forced Vital Capacity (FVC) at Screening
Post-bronchodilator
|
2.619 litre
STANDARD_DEVIATION 0.8167 • n=87 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
2.514 litre
STANDARD_DEVIATION 0.8488 • n=93 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
2.427 litre
STANDARD_DEVIATION 0.7298 • n=86 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
2.521 litre
STANDARD_DEVIATION 0.8022 • n=266 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
|
FEV1/FVC at Screening
Pre-bronchodilator
|
0.381 Ratio
STANDARD_DEVIATION 0.1109 • n=23 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
0.424 Ratio
STANDARD_DEVIATION 0.0982 • n=25 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
0.404 Ratio
STANDARD_DEVIATION 0.0972 • n=20 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
0.403 Ratio
STANDARD_DEVIATION 0.1025 • n=68 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
|
FEV1/FVC at Screening
Post-bronchodilator
|
0.447 Ratio
STANDARD_DEVIATION 0.1245 • n=87 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
0.427 Ratio
STANDARD_DEVIATION 0.1107 • n=93 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
0.436 Ratio
STANDARD_DEVIATION 0.1184 • n=86 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
0.436 Ratio
STANDARD_DEVIATION 0.1177 • n=266 Participants • Only part of the participants had pre-bronchodilator spirometry results at Screening.
|
PRIMARY outcome
Timeframe: Days 1 to 7Population: ITT Population
FEV1 data were recorded daily from Days 1 to 7 of the study using a computer-operated spirometer. Analysis was based on a linear Mixed Model for Repeated Measures (MMRM) with Change from Baseline in parameter as outcome; including treatment, visit, treatment by visit interaction, severity of airflow limitation at Baseline, blood eosinophils (%) at Baseline, time from start of current chronic obstructive pulmonary disease (COPD) exacerbation to first study treatment dosing, presence of cardiovascular comorbidities at Screening and COPD exacerbation treatment at Screening as fixed effects, and Baseline value and Baseline by visit interaction as covariates. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments. Results were presented with adjusted mean (95% confidence interval).
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Change From Baseline in FEV1 to Day 7 - ITT Population
|
0.084 litre
Interval 0.019 to 0.149
|
0.115 litre
Interval 0.049 to 0.18
|
0.057 litre
Interval -0.011 to 0.125
|
SECONDARY outcome
Timeframe: Days 3, 10, and 14Population: ITT Population
FEV1 data were recorded daily from Days 1 to 7, and Days 10 and 14 of the study using a computer-operated spirometer. Analysis was based on a linear MMRM with Change from Baseline in parameter as outcome; including treatment, visit, treatment by visit interaction, severity of airflow limitation at Baseline, blood eosinophils (%) at Baseline, time from start of current COPD exacerbation to first study treatment dosing, presence of cardiovascular comorbidities at Screening and COPD exacerbation treatment at Screening as fixed effects, and Baseline value and Baseline by visit interaction as covariates. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Change From Baseline in FEV1 on Days 3, 10, and 14 - ITT Population
Day 3
|
0.026 litre
Standard Deviation 0.2118
|
0.059 litre
Standard Deviation 0.2101
|
0.063 litre
Standard Deviation 0.2392
|
|
Change From Baseline in FEV1 on Days 3, 10, and 14 - ITT Population
Day 10
|
0.095 litre
Standard Deviation 0.2900
|
0.071 litre
Standard Deviation 0.1995
|
0.063 litre
Standard Deviation 0.2879
|
|
Change From Baseline in FEV1 on Days 3, 10, and 14 - ITT Population
Day 14
|
0.047 litre
Standard Deviation 0.2627
|
0.056 litre
Standard Deviation 0.2782
|
0.056 litre
Standard Deviation 0.2670
|
SECONDARY outcome
Timeframe: Baseline, Days 1 to 7, Days 10 and 14, Week 8, Week 12 and Week 26Population: ITT Population
FEV1 data were recorded daily from Days 1 to 7 and on Days 10 and 14 and Weeks 8, 12, and 26 of the study using a computer-operated spirometer. FEV1 normalization was achieved if FEV1 returned to a value ≥ 89% of the most recent FEV1 value measured within the last 12 months outside an exacerbation (pre-study FEV1 value). Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments. Percentages (%) were based on number of non-missing values as denominator.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Week 12
|
70.5 percentage of participants
|
63.0 percentage of participants
|
68.8 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Week 26
|
75.7 percentage of participants
|
67.1 percentage of participants
|
69.3 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Baseline
|
67.9 percentage of participants
|
59.3 percentage of participants
|
64.6 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 2
|
61.9 percentage of participants
|
65.2 percentage of participants
|
73.2 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 3
|
67.5 percentage of participants
|
62.6 percentage of participants
|
75.0 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 4
|
62.7 percentage of participants
|
65.9 percentage of participants
|
75.0 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 5
|
71.1 percentage of participants
|
70.2 percentage of participants
|
74.7 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 6
|
76.8 percentage of participants
|
70.5 percentage of participants
|
75.0 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 7
|
71.6 percentage of participants
|
71.6 percentage of participants
|
70.4 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 10
|
77.2 percentage of participants
|
65.9 percentage of participants
|
66.7 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 14
|
69.1 percentage of participants
|
61.6 percentage of participants
|
75.3 percentage of participants
|
|
Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Week 8
|
74.0 percentage of participants
|
65.4 percentage of participants
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: ITT Population
FEV1 and FVC were recorded daily from Days 1 to 7 and on Days 10 and 14 and Weeks 8, 12, and 26 of the study using a computer-operated spirometer. FEV1/FVC normalization was achieved if FEV1/FVC returned to a value ≥ 89% of the most recent FEV1/FVC value measured within the last 12 months outside an exacerbation (pre-study FEV1/FVC value). Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Baseline
|
49.4 percentage of participants
|
47.8 percentage of participants
|
45.8 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 2
|
51.8 percentage of participants
|
50.0 percentage of participants
|
55.4 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 3
|
54.9 percentage of participants
|
53.3 percentage of participants
|
50.6 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 4
|
53.7 percentage of participants
|
48.8 percentage of participants
|
51.9 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 5
|
57.3 percentage of participants
|
47.0 percentage of participants
|
48.8 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 6
|
51.9 percentage of participants
|
50.6 percentage of participants
|
51.9 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 7
|
53.8 percentage of participants
|
51.7 percentage of participants
|
51.2 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 10
|
52.6 percentage of participants
|
47.1 percentage of participants
|
46.3 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Day 14
|
50.0 percentage of participants
|
48.2 percentage of participants
|
47.6 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Week 8
|
53.9 percentage of participants
|
46.3 percentage of participants
|
51.3 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Week 12
|
51.9 percentage of participants
|
43.8 percentage of participants
|
51.3 percentage of participants
|
|
Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population
Week 26
|
54.8 percentage of participants
|
47.4 percentage of participants
|
51.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: ITT Population
Time to improvement of 100 mL in FEV1 was defined as time (in days) from initiation of study treatment until the change in FEV1 was ≥ +100 mL.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Time to Improvement of 100 mL in FEV1 Over Time - ITT Population
|
3.0 days
Interval 2.0 to 5.0
|
2.0 days
Interval 2.0 to 4.0
|
4.0 days
Interval 2.0 to 9.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 14Population: ITT Population
AUC was calculated according to the trapezoidal rule. The trapezoidal rule is a numerical method to be used to approximate the integral or the area under a curve. Using trapezoidal rule to approximate the area under a curve first involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when the upper end is replaced by a chord. The sum of these approximations gives the final numerical result of the AUC.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Area Under the Curve (AUC) of FEV1 Over Time - ITT Population
Day 1-3
|
1.207 mg/(mL*min)
Standard Deviation 0.4090
|
1.111 mg/(mL*min)
Standard Deviation 0.4245
|
1.097 mg/(mL*min)
Standard Deviation 0.3876
|
|
Area Under the Curve (AUC) of FEV1 Over Time - ITT Population
Day 1-7
|
1.232 mg/(mL*min)
Standard Deviation 0.4296
|
1.143 mg/(mL*min)
Standard Deviation 0.4433
|
1.108 mg/(mL*min)
Standard Deviation 0.3980
|
|
Area Under the Curve (AUC) of FEV1 Over Time - ITT Population
Day 1-10
|
1.263 mg/(mL*min)
Standard Deviation 0.4934
|
1.174 mg/(mL*min)
Standard Deviation 0.4380
|
1.155 mg/(mL*min)
Standard Deviation 0.4061
|
|
Area Under the Curve (AUC) of FEV1 Over Time - ITT Population
Day 1-14
|
1.293 mg/(mL*min)
Standard Deviation 0.4743
|
1.192 mg/(mL*min)
Standard Deviation 0.4007
|
1.125 mg/(mL*min)
Standard Deviation 0.4293
|
SECONDARY outcome
Timeframe: Day 1 to Day 14Population: ITT Population
RR was normalized when it returned to a baseline plateau level achieved after the acute COPD exacerbation during the Stabilization Phase. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
Baseline
|
14.9 percentage of participants
|
20.4 percentage of participants
|
17.4 percentage of participants
|
|
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
Day 2
|
28.7 percentage of participants
|
26.9 percentage of participants
|
26.7 percentage of participants
|
|
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
Day 3
|
28.7 percentage of participants
|
39.8 percentage of participants
|
29.4 percentage of participants
|
|
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
Day 4
|
37.9 percentage of participants
|
45.1 percentage of participants
|
37.6 percentage of participants
|
|
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
Day 5
|
41.4 percentage of participants
|
52.7 percentage of participants
|
39.3 percentage of participants
|
|
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
Day 6
|
44.8 percentage of participants
|
48.4 percentage of participants
|
48.2 percentage of participants
|
|
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
Day 7
|
51.2 percentage of participants
|
51.6 percentage of participants
|
47.1 percentage of participants
|
|
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
Day 10
|
47.6 percentage of participants
|
60.4 percentage of participants
|
48.2 percentage of participants
|
|
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
Day 14
|
57.8 percentage of participants
|
52.3 percentage of participants
|
56.5 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 to 14Population: ITT Population
RR (breaths/min) was recorded over time during the acute exacerbation phase.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Change From Baseline in RR on Days 3, 7, 10 and 14 - ITT Population
Day 3
|
-2.0 breaths/min
Interval -8.0 to 3.0
|
-1.0 breaths/min
Interval -8.0 to 5.0
|
-2.0 breaths/min
Interval -8.0 to 2.0
|
|
Change From Baseline in RR on Days 3, 7, 10 and 14 - ITT Population
Day 7
|
-3.0 breaths/min
Interval -13.0 to 8.0
|
-2.0 breaths/min
Interval -13.0 to 4.0
|
-2.0 breaths/min
Interval -12.0 to 1.0
|
|
Change From Baseline in RR on Days 3, 7, 10 and 14 - ITT Population
Day 10
|
-3.0 breaths/min
Interval -13.0 to 4.0
|
-2.0 breaths/min
Interval -14.0 to 4.0
|
-2.0 breaths/min
Interval -12.0 to 2.0
|
|
Change From Baseline in RR on Days 3, 7, 10 and 14 - ITT Population
Day 14
|
-3.0 breaths/min
Interval -13.0 to 4.0
|
-2.0 breaths/min
Interval -16.0 to 6.0
|
-3.0 breaths/min
Interval -12.0 to 1.0
|
SECONDARY outcome
Timeframe: Days 1 to 29Population: ITT Population
Improvement based on EXACT-PRO total score is defined as a decrease in the Rolling Average EXACT score ≥ 9 points from the previous day's maximum observed value during an event. The EXACT is a 14-item patient reported outcome (PRO) daily diary used to quantify and measure exacerbations of COPD. The health status of the participant is correlated to the global score, meaning a higher score corresponds to a more severe health status of the participant. An EXACT Total score is computed for each day of diary collection. The EXACT Total score is based on a logit scoring system with conversion to a 0 to 100 scale for ease of interpretation and use. The total score was used in the determination of exacerbation frequency, severity and duration of exacerbation. Specifically, changes in the total score were used to define onset and recovery from an exacerbation event and the magnitude of that event.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Time to Improvement Based on the EXAcerbations of Chronic Pulmonary Disease Tool-Patient Reported Outcome (EXACT-PRO) Total Score During the Acute Exacerbation Phase - ITT Population
|
5.0 days
Interval 3.0 to 16.0
|
6.0 days
Interval 3.0 to
Insufficient data to evaluate the upper limit
|
5.0 days
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Days 1 to 29Population: ITT Population
Recovery based on EXACT-PRO total score was defined as the first day in which a participant experiences a persistent, sustained improvement in their condition over the observed period (Day 1 to Day 29). Improvement had to be present for 7 consecutive days. The first day of the 7-day period was designated as the first day of Recovery. An EXACT total score was computed for each day of diary collection.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Time to Recovery Based on EXACT-PRO Total Score During the Acute Exacerbation Phase - ITT Population
|
6.0 days
Insufficient data to evaluate the upper and lower limit
|
6.0 days
Insufficient data to evaluate upper and lower limit
|
6.0 days
Interval 6.0 to 7.0
|
SECONDARY outcome
Timeframe: Days 1 to 29Population: ITT Population
The standardized AUC of the EXACT-PRO were calculated from Day (a) to Day (b) using the trapezoidal rule.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Standardized AUC of EXACT-PRO Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
Day 1-7
|
45.389 mg/(mL*min)
Interval 20.58 to 64.94
|
44.736 mg/(mL*min)
Interval 19.61 to 63.19
|
43.938 mg/(mL*min)
Interval 19.0 to 67.75
|
|
Standardized AUC of EXACT-PRO Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
Day 1-14
|
42.641 mg/(mL*min)
Interval 21.81 to 63.38
|
42.250 mg/(mL*min)
Interval 22.8 to 64.87
|
42.590 mg/(mL*min)
Interval 17.74 to 65.42
|
|
Standardized AUC of EXACT-PRO Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
Day 1-29
|
41.470 mg/(mL*min)
Interval 19.43 to 62.92
|
40.932 mg/(mL*min)
Interval 19.81 to 65.25
|
41.652 mg/(mL*min)
Interval 20.35 to 61.27
|
SECONDARY outcome
Timeframe: Days 1 to 29Population: ITT Population
Information regarding the participant's condition can be obtained through 3 domain scores embedded within the EXACT measure: Breathlessness, Cough \& Sputum, and Chest Symptoms. These scores also range from 0 to 100 with higher scores indicating more severe symptoms.The standardized AUC of the EXACT-PRO were calculated from Day (a) to Day (b) using the trapezoidal rule.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Standardized AUC of EXACT-PRO (Breathlessness) Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
Day 1-7
|
50.083 mg/(mL*min)
Interval 21.58 to 80.0
|
47.861 mg/(mL*min)
Interval 15.58 to 78.0
|
47.556 mg/(mL*min)
Interval 13.13 to 85.5
|
|
Standardized AUC of EXACT-PRO (Breathlessness) Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
Day 1-14
|
45.417 mg/(mL*min)
Interval 21.27 to 79.65
|
45.577 mg/(mL*min)
Interval 20.6 to 77.73
|
44.436 mg/(mL*min)
Interval 17.41 to 80.69
|
|
Standardized AUC of EXACT-PRO (Breathlessness) Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
Day 1-29
|
44.911 mg/(mL*min)
Interval 23.27 to 79.41
|
45.315 mg/(mL*min)
Interval 17.84 to 77.63
|
43.387 mg/(mL*min)
Interval 18.65 to 74.91
|
SECONDARY outcome
Timeframe: Day 1 to End of Study (Day 180)Population: ITT Population
Follow-up time per participant (years) was defined as (date of last contact - date of first study drug administration + 1)/ 365.25. Total follow-up time (years) = sum of individual participant follow-up times. Rate was calculated as total number of positively adjudicated exacerbations divided by the total follow-up time in years of the treatment group.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Rate of Positively Adjudicated Moderate/Severe COPD Exacerbations - ITT Population
|
0.744 proportion of participants
|
0.921 proportion of participants
|
0.904 proportion of participants
|
SECONDARY outcome
Timeframe: Days 1 to 180Population: ITT Population
Cumulative incidences of COPD-related deaths until Day 30/60/90/120/150/180 were obtained.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Number of COPD-Related Deaths During the Study - ITT Population
Until Day 30
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of COPD-Related Deaths During the Study - ITT Population
Until Day 60
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of COPD-Related Deaths During the Study - ITT Population
Until Day 90
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of COPD-Related Deaths During the Study - ITT Population
Until Day 120
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of COPD-Related Deaths During the Study - ITT Population
Until Day 150
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of COPD-Related Deaths During the Study - ITT Population
Until Day 180
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 180Population: ITT Population
Time to next positively adjudicated moderate/severe COPD exacerbation (in days) was defined as date when first moderate/severe COPD exacerbation symptoms started - date when current COPD exacerbation symptoms stopped, where COPD exacerbations experienced during the study were positively adjudicated by the Independent Adjudication Committee. Time to next positively adjudicated COPD exacerbation was presented in 25th percentile (95% confidence interval) as medians were not evaluable.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Time to Next Positively Adjudicated Moderate/Severe COPD Exacerbation- ITT Population
|
168.0 days
Interval 70.0 to
Insufficient data to evaluate the upper limit
|
75.0 days
Interval 45.0 to 136.0
|
143.0 days
Interval 48.0 to
Insufficient data to evaluate the upper limit
|
SECONDARY outcome
Timeframe: Day 1 to Day 30Population: ITT Population
Time from hospitalization admission until the participant is medically ready for discharge (in days) = Date participant was medically ready for discharge from hospital - Date of hospitalization admission. Date of hospitalization admission' and 'Date participant was medically ready for discharge from hospital' were recorded on the 'Current COPD Exacerbation' form of the eCRF. Results were presented with 75th percentile (95% CI) due to the fact that 95% CI for the median was not evaluable.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Time From Hospitalization Admission Until the Participant Is Medically Ready for Discharge (Current COPD) - ITT Population
|
9.0 days
Interval 8.0 to 12.0
|
9.0 days
Interval 8.0 to 13.0
|
9.0 days
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: ITT Population
Participants completed the EXACT-PRO starting from Day 1 and recorded rescue medication use and any occurrences of COPD once a day (evening) in the diary. The percentage of days with intake of rescue medications was evaluated on the basis of the information recorded daily by the participant on the diaries. A day was considered with intake of rescue medications if the answer to the question "How many puffs of rescue medication did you take since last evening?" was\> 0.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=87 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=93 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=86 Participants
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Percentage of Days With Intake of COPD Rescue Therapy - ITT Population
Acute Exacerbation Phase (Overall)
|
73.28 percentage of days
Standard Deviation 32.721
|
71.90 percentage of days
Standard Deviation 33.565
|
69.65 percentage of days
Standard Deviation 35.674
|
|
Percentage of Days With Intake of COPD Rescue Therapy - ITT Population
Stabilization Phase (Overall)
|
70.78 percentage of days
Standard Deviation 37.122
|
71.08 percentage of days
Standard Deviation 40.299
|
67.35 percentage of days
Standard Deviation 38.953
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1 to 5Population: PK Population: all participants who received at least one dose administration and had at least one quantifiable plasma concentration.
Descriptive summary of PK plasma concentration is presented as no-specific PK report is available.
Outcome measures
| Measure |
BCT197 High Dose Regimen
n=92 Participants
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=92 Participants
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 5 (0-2h post-dose)
|
310.20 ng/mL
Interval 277.37 to 346.91
|
155.10 ng/mL
Interval 130.77 to 183.94
|
—
|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 1 (0-2 h post-dose)
|
97.40 ng/mL
Interval 65.13 to 145.66
|
75.98 ng/mL
Interval 47.81 to 120.73
|
—
|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 1 (4-8h post dose)
|
387.65 ng/mL
Interval 343.22 to 437.83
|
283.79 ng/mL
Interval 261.28 to 308.25
|
—
|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 1 (>12h post-dose)
|
413.85 ng/mL
Interval 376.28 to 455.17
|
286.40 ng/mL
Interval 267.2 to 306.97
|
—
|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 3 (pre-dose)
|
271.10 ng/mL
Interval 251.34 to 292.41
|
161.13 ng/mL
Interval 147.69 to 175.8
|
—
|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 3 (0-2h post-dose)
|
318.88 ng/mL
Interval 290.57 to 349.95
|
184.46 ng/mL
Interval 165.72 to 205.31
|
—
|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 3 (4-8h post-dose)
|
496.31 ng/mL
Interval 457.3 to 538.64
|
299.79 ng/mL
Interval 281.99 to 318.71
|
—
|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 3 (>12h post-dose)
|
466.86 ng/mL
Interval 434.7 to 501.4
|
249.60 ng/mL
Interval 231.21 to 269.46
|
—
|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 5 (pre-dose)
|
272.43 ng/mL
Interval 246.62 to 300.95
|
128.38 ng/mL
Interval 111.99 to 147.17
|
—
|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 5 (4-8h post-dose)
|
504.53 ng/mL
Interval 453.33 to 561.52
|
278.73 ng/mL
Interval 246.56 to 315.1
|
—
|
|
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Day 5 (>12h post-dose)
|
465.28 ng/mL
Interval 423.05 to 511.72
|
240.31 ng/mL
Interval 215.77 to 267.63
|
—
|
Adverse Events
BCT197 High Dose Regimen
Serious events: 17 serious events
Other events: 56 other events
Deaths: 2 deaths
BCT197 Low Dose Regimen
Serious events: 27 serious events
Other events: 63 other events
Deaths: 3 deaths
Placebo
Serious events: 29 serious events
Other events: 62 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
BCT197 High Dose Regimen
n=92 participants at risk
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=96 participants at risk
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=91 participants at risk
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Death
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Generalised oedema
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Infection
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
3.1%
3/96 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Viral infection
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Apallic syndrome
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
14.1%
13/92 • Number of events 14 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
21.9%
21/96 • Number of events 28 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
24.2%
22/91 • Number of events 25 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
3.3%
3/91 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
Other adverse events
| Measure |
BCT197 High Dose Regimen
n=92 participants at risk
Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
BCT197 Low Dose Regimen
n=96 participants at risk
Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
Placebo
n=91 participants at risk
Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
3/92 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Cardiac aneurysm
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure acute
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure chronic
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Cor pulmonale
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Intracardiac thrombus
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Myocardial ischaemia
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Eye disorders
Chalazion
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Eye disorders
Scleral hyperaemia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
4.4%
4/91 • Number of events 4 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
4.2%
4/96 • Number of events 6 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric polyps
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Asthenia
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
3.3%
3/91 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Chest discomfort
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Chest pain
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Chills
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Death
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Acarodermatitis
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Cystitis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Infection
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
4/92 • Number of events 4 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
4.2%
4/96 • Number of events 4 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Oesophageal candidiasis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Oral herpes
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
3.3%
3/92 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
3.1%
3/96 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection viral
|
3.3%
3/92 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
3.1%
3/96 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Viral infection
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
3/92 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
3.1%
3/96 • Number of events 4 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
4.2%
4/96 • Number of events 5 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 4 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Blood glucose increased
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Blood phosphorus decreased
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Blood potassium increased
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Blood pressure increased
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Blood urea increased
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Blood uric acid increased
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
3.1%
3/96 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase abnormal
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Haemoglobin decreased
|
1.1%
1/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
International normalised ratio increased
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Monocyte count increased
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Platelet count increased
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Protein total decreased
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Prothrombin time prolonged
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Troponin I increased
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Investigations
Weight decreased
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
4.2%
4/96 • Number of events 4 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
1/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Apallic syndrome
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Arachnoid cyst
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Coma
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Epilepsy
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
3.3%
3/92 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Nervous system disorders
Tremor
|
3.3%
3/92 • Number of events 4 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
3.3%
3/92 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Renal and urinary disorders
Renal cyst
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
26.1%
24/92 • Number of events 33 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
33.3%
32/96 • Number of events 42 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
30.8%
28/91 • Number of events 41 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
3/92 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
4.4%
4/91 • Number of events 5 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural thickening
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
3.3%
3/91 • Number of events 3 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar erythema
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.2%
2/92 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Vascular disorders
Aortic arteriosclerosis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
4.3%
4/92 • Number of events 5 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
4.4%
4/91 • Number of events 4 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Vascular disorders
Hypertensive crisis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.2%
2/91 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Extravasation
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Generalised oedema
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Malaise
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Peripheral swelling
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
2.1%
2/96 • Number of events 2 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
General disorders
Pyrexia
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.0%
1/96 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Hepatobiliary disorders
Non-alcoholic fatty liver
|
1.1%
1/92 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/91 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/92 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
0.00%
0/96 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
1.1%
1/91 • Number of events 1 • Adverse events (AEs) were recorded from signing the informed consent form to completion of the 26 week follow-up period after the last administration of study drug.
Serious AEs are also included in the non-serious AE section as a non-serious AE table was not available. The difference in numbers between the participant flow module and safety population is because some participants were randomized but did not go on to receive at least one dose of study medication.
|
Additional Information
Ian Hodgson, Head of Clinical Operations
Mereo BioPharma Group
Phone: +44 3330237300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60