Trial Outcomes & Findings for Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD (NCT NCT01917331)
NCT ID: NCT01917331
Last Updated: 2026-07-20
Results Overview
Changes from baseline in pre-dose morning FEV1 to visit at Week 26. FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1368 participants
Primary outcome timeframe
Baseline (Week 0), Week 26.
Results posted on
2026-07-20
Participant Flow
Participant milestones
| Measure |
CHF 5993 pMDI -- Beclometasone/Formoterol/Glycopyrrolate
CHF 5993 pMDI 100/6/12.5 µg 2 inhalations bid
Beclometasone/Formoterol/Glycopyrrolate: Active drug tested pMDI= Pressurised Metered Dose Inhaler
|
Foster® pMDI -- Beclometasone/Formoterol
Foster® pMDI 100/6 µg 2 inhalations bid
Beclometasone/Formoterol: Active comparator
|
|---|---|---|
|
Overall Study
STARTED
|
687
|
681
|
|
Overall Study
COMPLETED
|
602
|
579
|
|
Overall Study
NOT COMPLETED
|
85
|
102
|
Reasons for withdrawal
| Measure |
CHF 5993 pMDI -- Beclometasone/Formoterol/Glycopyrrolate
CHF 5993 pMDI 100/6/12.5 µg 2 inhalations bid
Beclometasone/Formoterol/Glycopyrrolate: Active drug tested pMDI= Pressurised Metered Dose Inhaler
|
Foster® pMDI -- Beclometasone/Formoterol
Foster® pMDI 100/6 µg 2 inhalations bid
Beclometasone/Formoterol: Active comparator
|
|---|---|---|
|
Overall Study
Adverse event, serious fatal
|
13
|
15
|
|
Overall Study
Withdrawal by Subject
|
45
|
54
|
|
Overall Study
Adverse Event
|
20
|
17
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
6
|
|
Overall Study
Protocol Violation
|
2
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Moved to another state; could not attend study visits.
|
0
|
1
|
Baseline Characteristics
Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
Baseline characteristics by cohort
| Measure |
CHF 5993 pMDI Beclometasone/Formoterol/Glycopyrrolate
n=687 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
CHF 1535 pMDI Foster® Beclometasone/Formoterol
n=680 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
Total
n=1367 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 7.9 • n=20 Participants
|
63.8 years
STANDARD_DEVIATION 8.2 • n=20 Participants
|
63.6 years
STANDARD_DEVIATION 8.1 • n=40 Participants
|
|
Age, Customized
Adults (<65 years)
|
391 Participants
n=20 Participants
|
347 Participants
n=20 Participants
|
738 Participants
n=40 Participants
|
|
Age, Customized
Adults (≥65 years to 74 years)
|
237 Participants
n=20 Participants
|
266 Participants
n=20 Participants
|
503 Participants
n=40 Participants
|
|
Age, Customized
Adults (≥75)
|
59 Participants
n=20 Participants
|
67 Participants
n=20 Participants
|
126 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=20 Participants
|
153 Participants
n=20 Participants
|
331 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
509 Participants
n=20 Participants
|
527 Participants
n=20 Participants
|
1036 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
684 Participants
n=20 Participants
|
679 Participants
n=20 Participants
|
1363 Participants
n=40 Participants
|
|
Region of Enrollment
Argentina
|
28 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
25 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
53 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Belgium
|
4 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
3 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
7 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Bulgaria
|
46 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
46 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
92 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Czechia
|
104 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
104 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
208 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Germany
|
31 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
32 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
63 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Hungary
|
52 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
51 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
103 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Italy
|
11 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
12 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
23 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Mexico
|
3 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
1 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
4 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Poland
|
57 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
56 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
113 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Romania
|
53 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
52 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
105 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Russia
|
160 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
159 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
319 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Slovakia
|
15 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
18 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
33 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
Ukraine
|
113 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
111 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
224 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
10 participants
n=20 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
20 participants
n=40 Participants • Patient disposition by country is shown as 'randomised patients', per country and per treatment group.
|
|
Time since first COPD diagnosis (years
|
7.71 years
STANDARD_DEVIATION 5.75 • n=20 Participants
|
7.67 years
STANDARD_DEVIATION 5.98 • n=20 Participants
|
7.69 years
STANDARD_DEVIATION 5.87 • n=40 Participants
|
|
Main COPD phenotype
Chronic bronchitis only
|
336 Participants
n=20 Participants
|
332 Participants
n=20 Participants
|
668 Participants
n=40 Participants
|
|
Main COPD phenotype
Emphysema only
|
220 Participants
n=20 Participants
|
197 Participants
n=20 Participants
|
417 Participants
n=40 Participants
|
|
Main COPD phenotype
Chronic bronchitis and emphysema
|
114 Participants
n=20 Participants
|
131 Participants
n=20 Participants
|
245 Participants
n=40 Participants
|
|
Main COPD phenotype
Unknown
|
17 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
Number of COPD exacerbations in the previous year
1 Exacerbation
|
551 Participants
n=20 Participants
|
546 Participants
n=20 Participants
|
1097 Participants
n=40 Participants
|
|
Number of COPD exacerbations in the previous year
2 Exacerbations
|
116 Participants
n=20 Participants
|
114 Participants
n=20 Participants
|
230 Participants
n=40 Participants
|
|
Number of COPD exacerbations in the previous year
3 Exacerbations
|
17 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
|
Number of COPD exacerbations in the previous year
>3 Exacerbations
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Time since last documented COPD exacerbation
|
6.22 months
n=20 Participants
|
5.96 months
n=20 Participants
|
6.09 months
n=40 Participants
|
|
COPD medication at study entry
ICS /LABA (Inhaled corticosteroid / Long-acting β2-agonist)
|
506 Participants
n=20 Participants
|
487 Participants
n=20 Participants
|
993 Participants
n=40 Participants
|
|
COPD medication at study entry
ICS/LAMA (Inhaled corticosteroid / Long-acting muscarinic antagonist)
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
COPD medication at study entry
LABA/LAMA (Long-acting β2-agonist / Long-acting muscarinic antagonist)
|
95 Participants
n=20 Participants
|
107 Participants
n=20 Participants
|
202 Participants
n=40 Participants
|
|
COPD medication at study entry
LAMA (Long-acting muscarinic antagonist)
|
76 Participants
n=20 Participants
|
76 Participants
n=20 Participants
|
152 Participants
n=40 Participants
|
|
Spacer device use before study entry
Yes
|
91 Participants
n=20 Participants
|
97 Participants
n=20 Participants
|
188 Participants
n=40 Participants
|
|
Spacer device use before study entry
No
|
596 Participants
n=20 Participants
|
583 Participants
n=20 Participants
|
1179 Participants
n=40 Participants
|
|
Spacer Device use during study
Yes
|
111 Participants
n=20 Participants
|
129 Participants
n=20 Participants
|
240 Participants
n=40 Participants
|
|
Spacer Device use during study
No
|
576 Participants
n=20 Participants
|
551 Participants
n=20 Participants
|
1127 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Week 26.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Changes from baseline in pre-dose morning FEV1 to visit at Week 26. FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=616 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=642 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
1_Change From Baseline in Pre-dose Morning Forced Expiratory Volume in the 1st Second (FEV1) -- at Week 26
|
0.001 litre
Interval -0.019 to 0.021
|
0.082 litre
Interval 0.062 to 0.102
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to 2-hour post-dose at Week 26.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Change from baseline in 2-hour post-dose FEV1, at Week 26. FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=609 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=631 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
2_Change From Baseline in 2-hour Post-dose FEV1 -- at Week 26
|
0.145 litre
Interval 0.123 to 0.166
|
0.261 litre
Interval 0.24 to 0.283
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Week 26.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Transition Dyspnoea Index (TDI) focal score is a symptom-based variable tool, used to assess breathlessness and the impact of intervention. BDI/TDI is a clinical rating method based on a validated tool that measures the impact of dyspnoea based on 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI focal score is the baseline value from which TDI focal score is assessed. BDI scores range from 0 (very severe impairment) to 4 (no impairment) for each domain with the baseline focal score consisting of the sum of each domain (i.e. from 0 to 12). Change from baseline in dyspnoea severity was measured using the TDI. TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain, with the TDI focal score consisting of the sum of each domain (i.e. from -9 to +9). A higher total score indicates improvement, while a lower or negative score indicates worsening symptoms. BDI=Baseline Dyspnoea Index TDI=Transition Dyspnoea Index
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=619 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=642 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
3_Transition Dyspnoea Index (TDI) Focal Score -- at Week 26
|
1.50 score on a scale
Interval 1.29 to 1.71
|
1.71 score on a scale
Interval 1.5 to 1.92
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4. 12, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Change from baseline in pre-dose morning FEV1, at all the other clinic visits. Please note: results at visit Week 26, are presented as the primary outcome measure #1 for this study. FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=670 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=681 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
4_Change From Baseline in Pre-dose Morning FEV1 -- at All the Other Clinic Visits
Week 4
|
0.022 litre
Interval 0.005 to 0.039
|
0.093 litre
Interval 0.076 to 0.109
|
|
4_Change From Baseline in Pre-dose Morning FEV1 -- at All the Other Clinic Visits
Week 12
|
0.010 litre
Interval -0.008 to 0.028
|
0.078 litre
Interval 0.06 to 0.096
|
|
4_Change From Baseline in Pre-dose Morning FEV1 -- at All the Other Clinic Visits
Week 40
|
0.018 litre
Interval -0.004 to 0.04
|
0.095 litre
Interval 0.073 to 0.116
|
|
4_Change From Baseline in Pre-dose Morning FEV1 -- at All the Other Clinic Visits
Week 52
|
0.008 litre
Interval -0.014 to 0.03
|
0.071 litre
Interval 0.05 to 0.093
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, 12, 26, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Changes from baseline for the average in pre-dose morning FEV1 over the treatment period. FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=670 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=681 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
5_Change From Baseline to the Average in Pre-dose Morning FEV1 -- Over the Treatment Period
|
0.012 litre
Interval -0.005 to 0.029
|
0.084 litre
Interval 0.067 to 0.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 26, Week 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Number of participants defined as responders wrt. to FEV1 -- at Week 26 and Week 52. FEV1 response was defined as a change from baseline in pre-dose morning FEV1 of ≥100 mL. If the change from baseline was \<100 mL, the patient was classified as a non-responder in terms of FEV1. Subjects with missing pre-dose morning FEV1 value at the pre-specified tested time points were also classified as non-responders. FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=680 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=687 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
6_Number of Participants Defined as Responders Wrt. to FEV1 -- Change From Baseline in Pre-dose Morning FEV1 ≥100 mL -- at Week 26 and Week 52
Week 26
|
165 Participants
|
287 Participants
|
|
6_Number of Participants Defined as Responders Wrt. to FEV1 -- Change From Baseline in Pre-dose Morning FEV1 ≥100 mL -- at Week 26 and Week 52
Week 52
|
158 Participants
|
259 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, 12, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Change from baseline in 2-hour post-dose of FEV1, at all the other clinic visits. Please note: a) results at visit Week 26, are presented as the primary outcome measure #2 for this study; b) for Week 0, the measurement shown in the results table below was made 2 h after the baseline measurement i.e. pre-treatment at study baseline. FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=679 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=686 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
7_Change From Baseline in 2-hour Post-dose of FEV1 -- at All the Other Clinic Visits
Week 0 (measurement made 2 h after baseline)
|
0.138 litre
Interval 0.126 to 0.15
|
0.215 litre
Interval 0.203 to 0.228
|
|
7_Change From Baseline in 2-hour Post-dose of FEV1 -- at All the Other Clinic Visits
Week 4
|
0.153 litre
Interval 0.135 to 0.171
|
0.268 litre
Interval 0.25 to 0.286
|
|
7_Change From Baseline in 2-hour Post-dose of FEV1 -- at All the Other Clinic Visits
Week 12
|
0.146 litre
Interval 0.125 to 0.166
|
0.261 litre
Interval 0.241 to 0.281
|
|
7_Change From Baseline in 2-hour Post-dose of FEV1 -- at All the Other Clinic Visits
Week 40
|
0.150 litre
Interval 0.127 to 0.174
|
0.253 litre
Interval 0.23 to 0.275
|
|
7_Change From Baseline in 2-hour Post-dose of FEV1 -- at All the Other Clinic Visits
Week 52
|
0.146 litre
Interval 0.122 to 0.17
|
0.249 litre
Interval 0.226 to 0.273
|
SECONDARY outcome
Timeframe: Week 4, 12, 26, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline. Change from pre-dose to 2h post-dose FEV1 was analysed using a separate model for each week.
Change from pre-dose to 2-hour post-dose value of FEV1, at study visits on Week 4, 12, 26, 40, and 52. FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=680 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=687 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
8_Change From Pre-dose to 2-hour Post-dose FEV1 -- at All Study Visits
Week 4
|
0.130 liter
Interval 0.118 to 0.143
|
0.177 liter
Interval 0.165 to 0.189
|
|
8_Change From Pre-dose to 2-hour Post-dose FEV1 -- at All Study Visits
Week 12
|
0.138 liter
Interval 0.126 to 0.149
|
0.183 liter
Interval 0.171 to 0.194
|
|
8_Change From Pre-dose to 2-hour Post-dose FEV1 -- at All Study Visits
Week 26
|
0.149 liter
Interval 0.138 to 0.161
|
0.180 liter
Interval 0.169 to 0.192
|
|
8_Change From Pre-dose to 2-hour Post-dose FEV1 -- at All Study Visits
Week 40
|
0.138 liter
Interval 0.125 to 0.15
|
0.159 liter
Interval 0.147 to 0.171
|
|
8_Change From Pre-dose to 2-hour Post-dose FEV1 -- at All Study Visits
Week 52
|
0.146 liter
Interval 0.133 to 0.159
|
0.180 liter
Interval 0.167 to 0.193
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, 12, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
TDI focal score is a symptom-based tool, used to assess breathlessness and the impact of intervention. BDI/TDI is a clinical rating method based on a validated tool that measures the impact of dyspnoea on 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI tool and its scoring system are defined in the outcome measure #3 of this PRS study entry. Please note: Results at Week 26, are presented as the primary outcome measure #3 for this PRS study entry. BDI=Baseline Dyspnoea Index TDI=Transition Dyspnoea Index
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=672 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=682 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
9_Transition Dyspnoea Index (TDI) Focal Score -- at All Study Visits
Week 4
|
1.12 score on a scale
Interval 0.94 to 1.31
|
1.54 score on a scale
Interval 1.35 to 1.72
|
|
9_Transition Dyspnoea Index (TDI) Focal Score -- at All Study Visits
Week 12
|
1.39 score on a scale
Interval 1.19 to 1.58
|
1.77 score on a scale
Interval 1.58 to 1.97
|
|
9_Transition Dyspnoea Index (TDI) Focal Score -- at All Study Visits
Week 40
|
1.65 score on a scale
Interval 1.43 to 1.86
|
1.80 score on a scale
Interval 1.58 to 2.01
|
|
9_Transition Dyspnoea Index (TDI) Focal Score -- at All Study Visits
Week 52
|
1.81 score on a scale
Interval 1.59 to 2.04
|
2.03 score on a scale
Interval 1.81 to 2.25
|
SECONDARY outcome
Timeframe: Week 26, Week 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Number of participants with transition dyspnoea index (TDI) response (focal score ≥1) -- at Week 26 and Week 52. TDI tool and its scoring system are defined in the outcome measure #3 of this PRS study entry. TDI response was defined as a TDI focal score of ≥1. If the TDI focal score was \<1, the patient was classified as a non-responder in terms of TDI. Patients with missing TDI focal score at the pre-specified tested time points were also classified as non-responders.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=680 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=687 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
10_Number of Participants With Transition Dyspnoea Index (TDI) Response (Focal Score ≥1) -- at Week 26 and Week 52
Week 26
|
352 Participants
|
394 Participants
|
|
10_Number of Participants With Transition Dyspnoea Index (TDI) Response (Focal Score ≥1) -- at Week 26 and Week 52
Week 52
|
354 Participants
|
370 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, 12, 26, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Change from baseline in Saint George's respiratory questionnaire (SGRQ) Total score. SGRQ is a 76-item questionnaire developed to measure health in chronic airflow limitation. SGRQ consists of scores from three component that are used to calculate the total score: Symptoms, Activity, and Impacts on daily life. SGRQ questionnaire was completed by the patient at all study visits (Week 0 baseline, and Week 4, 12, 26, 40, 52). The Total score range is from 0 to 100 (0=Best, 100=Worst); lower scores correspond to better health. SGRQ questionnaire was completed by the patient at all study visits (Week 0 baseline, 4, 12, 26, 40, 52).
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=635 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=651 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
11a_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Total Score
Week 4
|
-2.19 score on a scale
Interval -2.96 to -1.43
|
-3.66 score on a scale
Interval -4.41 to -2.91
|
|
11a_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Total Score
Week 12
|
-2.66 score on a scale
Interval -3.55 to -1.77
|
-4.70 score on a scale
Interval -5.58 to -3.81
|
|
11a_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Total Score
Week 26
|
-3.43 score on a scale
Interval -4.38 to -2.47
|
-4.76 score on a scale
Interval -5.69 to -3.83
|
|
11a_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Total Score
Week 40
|
-4.08 score on a scale
Interval -5.11 to -3.05
|
-5.48 score on a scale
Interval -6.49 to -4.47
|
|
11a_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Total Score
Week 52
|
-3.43 score on a scale
Interval -4.51 to -2.35
|
-5.12 score on a scale
Interval -6.18 to -4.06
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, 12, 26, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Change from baseline in Saint George's respiratory questionnaire (SGRQ) -- Symptoms Score. SGRQ is a questionnaire developed to measure health in chronic airflow limitation. SGRQ questionnaire was completed by the patient at all study visits (Week 0 baseline, 4, 12, 26, 40, 52). Result show the Saint George's Respiratory Questionnaire (SGRQ) as change from baseline for the domain Symptoms. The Symptoms score is calculated on a scale of 0 to 100. A score of 0 indicates no impairment (best health); a score of 100 indicates the worst possible health status.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=654 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=669 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
11b_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Symptoms Score
Week 4
|
-3.83 score on a scale
Interval -4.92 to -2.75
|
-5.02 score on a scale
Interval -6.1 to -3.95
|
|
11b_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Symptoms Score
Week 12
|
-4.56 score on a scale
Interval -5.77 to -3.34
|
-5.09 score on a scale
Interval -6.29 to -3.89
|
|
11b_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Symptoms Score
Week 26
|
-5.17 score on a scale
Interval -6.46 to -3.88
|
-6.80 score on a scale
Interval -8.06 to -5.53
|
|
11b_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Symptoms Score
Week 40
|
-7.12 score on a scale
Interval -8.53 to -5.71
|
-8.35 score on a scale
Interval -9.73 to -6.96
|
|
11b_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Symptoms Score
Week 52
|
-7.26 score on a scale
Interval -8.74 to -5.78
|
-8.22 score on a scale
Interval -9.67 to -6.77
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, 12, 26, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Saint George's respiratory questionnaire (SGRQ) -- Impacts Score. SGRQ is a questionnaire developed to measure health in chronic airflow limitation. SGRQ questionnaire was completed by the patient at all study visits (Week 0 baseline, 4, 12, 26, 40, 52). Result show the Saint George's Respiratory Questionnaire (SGRQ) as change from baseline for the domain Impacts. The Impact score is calculated on a scale of 0 to 100. A score of 0 indicates no impairment (best health); a score of 100 indicates the worst possible health status.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=660 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=672 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
11c_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Impacts Score
Week 4
|
-2.29 score on a scale
Interval -3.2 to -1.38
|
-3.44 score on a scale
Interval -4.34 to -2.54
|
|
11c_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Impacts Score
Week 12
|
-2.72 score on a scale
Interval -3.76 to -1.68
|
-4.65 score on a scale
Interval -5.69 to -3.62
|
|
11c_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Impacts Score
Week 26
|
-3.50 score on a scale
Interval -4.6 to -2.39
|
-4.88 score on a scale
Interval -5.96 to -3.8
|
|
11c_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Impacts Score
Week 40
|
-3.75 score on a scale
Interval -4.89 to -2.6
|
-5.33 score on a scale
Interval -6.45 to -4.2
|
|
11c_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Impacts Score
Week 52
|
-2.59 score on a scale
Interval -3.79 to -1.4
|
-4.68 score on a scale
Interval -5.85 to -3.51
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, 12, 26, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Saint George's respiratory questionnaire (SGRQ) -- Activity score. SGRQ is a questionnaire developed to measure health in chronic airflow limitation. SGRQ questionnaire was completed by the patient at all study visits (Week 0 baseline, 4, 12, 26, 40, 52). Result show the Saint George's Respiratory Questionnaire (SGRQ) as change from baseline for the domain Activity. The Activity score is calculated on a scale of 0 to 100. A score of 0 indicates no impairment (best health); a score of 100 indicates the worst possible health status.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=653 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=667 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
11d_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Activity Score
Week 4
|
-1.21 score on a scale
Interval -2.18 to -0.24
|
-2.69 score on a scale
Interval -3.65 to -1.73
|
|
11d_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Activity Score
Week 12
|
-1.35 score on a scale
Interval -2.46 to -0.24
|
-3.93 score on a scale
Interval -5.03 to -2.83
|
|
11d_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Activity Score
Week 26
|
-2.17 score on a scale
Interval -3.33 to -1.02
|
-3.88 score on a scale
Interval -5.01 to -2.75
|
|
11d_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Activity Score
Week 40
|
-2.74 score on a scale
Interval -3.96 to -1.51
|
-4.35 score on a scale
Interval -5.54 to -3.15
|
|
11d_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Activity Score
Week 52
|
-2.95 score on a scale
Interval -4.21 to -1.68
|
-4.26 score on a scale
Interval -5.49 to -3.02
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 26, Week 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Number of participants with Saint George's Respiratory Questionnaire (SGRQ) response, defined as a change from baseline in SGRQ total score ≤ -4, at Week 26 and Week 52. If the change from baseline was \> -4, the patient was assessed as a non-responder in terms of SGRQ. Patients with missing change from baseline at the pre-specified tested time points were also classified as non-responders. Results shown represent the number of responder participants in terms of SGRQ, for the comparison of CHF 5993 pMDI versus CHF 1535 pMDI.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=680 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=687 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
12_Number of Participants With Saint George's Respiratory Questionnaire (SGRQ) Response (Change From Baseline in Total Score ≤-4) -- at Week 26 and Week 52
Week 26
|
246 Participants
|
321 Participants
|
|
12_Number of Participants With Saint George's Respiratory Questionnaire (SGRQ) Response (Change From Baseline in Total Score ≤-4) -- at Week 26 and Week 52
Week 52
|
244 Participants
|
297 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 4, 12, 26, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Days WITHOUT intake of rescue medication. Change from baseline to each inter-visit period and for the entire treatment period (Week 1-52) in the percentage of days without intake of rescue medication.
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=680 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=687 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
13a_Change From Baseline for Percentage of Days Without Intake of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 1-4
|
2.46 percentage of days
Interval 0.67 to 4.25
|
6.67 percentage of days
Interval 4.89 to 8.44
|
|
13a_Change From Baseline for Percentage of Days Without Intake of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 5-12
|
3.18 percentage of days
Interval 1.12 to 5.24
|
6.23 percentage of days
Interval 4.19 to 8.27
|
|
13a_Change From Baseline for Percentage of Days Without Intake of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 13-26
|
2.40 percentage of days
Interval 0.19 to 4.6
|
5.49 percentage of days
Interval 3.3 to 7.67
|
|
13a_Change From Baseline for Percentage of Days Without Intake of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 27-40
|
2.79 percentage of days
Interval 0.43 to 5.15
|
4.39 percentage of days
Interval 2.07 to 6.72
|
|
13a_Change From Baseline for Percentage of Days Without Intake of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 41-52
|
1.24 percentage of days
Interval -1.17 to 3.65
|
3.82 percentage of days
Interval 1.45 to 6.19
|
|
13a_Change From Baseline for Percentage of Days Without Intake of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 1-52
|
2.36 percentage of days
Interval 0.37 to 4.35
|
5.01 percentage of days
Interval 3.05 to 6.98
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 4, 12, 26, 40, 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Average use of rescue medication, over the entire treatment period (52 Weeks of treatment). Change from baseline to each inter-visit period and for the entire treatment period (Week 1-52) in the average use of rescue medication (number of puffs/day).
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=680 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=687 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
13b_Change From Baseline for the Average Use of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 1-4
|
-0.07 puffs/day
Interval -0.17 to 0.02
|
-0.29 puffs/day
Interval -0.38 to -0.2
|
|
13b_Change From Baseline for the Average Use of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 5-12
|
-0.06 puffs/day
Interval -0.17 to 0.05
|
-0.25 puffs/day
Interval -0.36 to -0.14
|
|
13b_Change From Baseline for the Average Use of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 13-26
|
-0.02 puffs/day
Interval -0.14 to 0.1
|
-0.21 puffs/day
Interval -0.32 to -0.09
|
|
13b_Change From Baseline for the Average Use of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 27-40
|
0.02 puffs/day
Interval -0.11 to 0.15
|
-0.09 puffs/day
Interval -0.22 to 0.04
|
|
13b_Change From Baseline for the Average Use of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 41-52
|
0.07 puffs/day
Interval -0.07 to 0.21
|
-0.04 puffs/day
Interval -0.17 to 0.09
|
|
13b_Change From Baseline for the Average Use of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Week 1-52
|
0.00 puffs/day
Interval -0.11 to 0.12
|
-0.15 puffs/day
Interval -0.26 to -0.04
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 52 (entire treatment period).Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
Rate of moderate AND severe COPD exacerbations over the entire treatment period of treatment (52 weeks). COPD=Chronic obstructive pulmonary disease
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=680 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=687 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
14_Rate of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Rate -- Over Entire Treatment Period (52 Weeks of Treatment)
|
0.530 events per patient per year
Interval 0.468 to 0.6
|
0.410 events per patient per year
Interval 0.358 to 0.469
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 52.Population: Intention-to-Treat (ITT) population: defined as all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after baseline.
First occurrence of at least 1 moderate OR severe COPD exacerbation. First occurrence was analysed by Cox regression as time to first exacerbation and reported as hazard ratio. COPD=Chronic obstructive pulmonary disease
Outcome measures
| Measure |
CHF 1535 pMDI Foster®
n=680 Participants
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
CHF 5993 pMDI
n=687 Participants
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
|---|---|---|
|
15_First Occurrence of All Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
|
240 number of first occurrences
|
214 number of first occurrences
|
Adverse Events
Beclometasone/Formoterol/Glycopyrrolate
Serious events: 106 serious events
Other events: 181 other events
Deaths: 15 deaths
Beclometasone/Formoterol
Serious events: 123 serious events
Other events: 203 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Beclometasone/Formoterol/Glycopyrrolate
n=687 participants at risk
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
Beclometasone/Formoterol
n=680 participants at risk
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage III
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.29%
2/680 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.44%
3/687 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of conjunctiva
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Vascular disorders
Aortic thrombosis
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Vascular disorders
Femoral artery aneurysm
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Vascular disorders
Peripheral ischaemia
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Vascular disorders
Shock
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
General disorders
Death
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
General disorders
Device malfunction
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
General disorders
Sudden death
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.29%
2/680 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
9.6%
66/687 • Number of events 87 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
11.0%
75/680 • Number of events 86 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Respiratory, thoracic and mediastinal disorders
Lung cyst
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.29%
2/687 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.29%
2/680 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Psychiatric disorders
Alcohol abuse
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.44%
3/680 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Angina unstable
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.44%
3/687 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Cardiac arrest
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.29%
2/680 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Cardiac failure
|
0.58%
4/687 • Number of events 4 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.44%
3/680 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.15%
1/687 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.29%
2/687 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Cor pulmonale
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Myocardial infarction
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.44%
3/680 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.59%
4/680 • Number of events 4 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Nervous system disorders
Cerebral infarction
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.29%
2/680 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Nervous system disorders
Migraine
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Eye disorders
Cataract
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Food poisoning
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.29%
2/680 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.29%
2/687 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.29%
2/687 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Hepatobiliary disorders
Biliary colic
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Infections and infestations
Abdominal abscess
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Infections and infestations
Erysipelas
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Infections and infestations
Herpes zoster
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Infections and infestations
Pneumonia
|
2.0%
14/687 • Number of events 16 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.88%
6/680 • Number of events 6 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.15%
1/687 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.00%
0/680 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/687 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
0.15%
1/680 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
Other adverse events
| Measure |
Beclometasone/Formoterol/Glycopyrrolate
n=687 participants at risk
Active drug CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/12.5 µg) 2 inhalations bid
|
Beclometasone/Formoterol
n=680 participants at risk
Active comparator CHF 1535 pMDI Foster® (Beclometasone/Formoterol 100/6 µg ) 2 inhalations bid
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
23.1%
159/687 • Number of events 212 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
27.1%
184/680 • Number of events 274 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
39/687 • Number of events 50 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
5.6%
38/680 • Number of events 45 • Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (Week 52 or early withdrawal).
Analyses of safety parameters were based on the safety set, defined as all randomised patients who received at least one dose of the study treatment. Analysis of AEs was performed on Treatment-Emergent Adverse Event (TEAE) principle, defined as AEs with a date of first randomised study medication intake. Therefore, AEs were not analysed for the run-in period.
|
Additional Information
Clinical Trial Transparency
Chiesi Farmaceutici S.p.A.
Phone: + 39 0521 2791
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Results of this study may be published or presented at scientific meetings. If a publication is presented by the Investigator, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor to Chiesi before submission.
- Publication restrictions are in place
Restriction type: OTHER