Trial Outcomes & Findings for Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients. (NCT NCT00563381)
NCT ID: NCT00563381
Last Updated: 2013-12-24
Results Overview
First occurrence analysed by Cox regression as time to first exacerbation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
7376 participants
Primary outcome timeframe
52 weeks
Results posted on
2013-12-24
Participant Flow
There were 8 patients (4:4 on Tiotropium and Salmeterol respectively) randomized but not treated
Participant milestones
| Measure |
Tiotropium
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Overall Study
STARTED
|
3707
|
3669
|
|
Overall Study
COMPLETED
|
3122
|
3021
|
|
Overall Study
NOT COMPLETED
|
585
|
648
|
Reasons for withdrawal
| Measure |
Tiotropium
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
264
|
292
|
|
Overall Study
Protocol Violation
|
66
|
74
|
|
Overall Study
Lost to Follow-up
|
7
|
15
|
|
Overall Study
Withdrawal by Subject
|
192
|
209
|
|
Overall Study
Lack of Efficacy
|
32
|
24
|
|
Overall Study
Individual different reasons
|
24
|
34
|
Baseline Characteristics
Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients.
Baseline characteristics by cohort
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
Total
n=7376 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
62.8 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
62.9 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
948 Participants
n=5 Participants
|
922 Participants
n=7 Participants
|
1870 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2759 Participants
n=5 Participants
|
2747 Participants
n=7 Participants
|
5506 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3693 Participants
n=5 Participants
|
3657 Participants
n=7 Participants
|
7350 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
First occurrence analysed by Cox regression as time to first exacerbation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
First Occurrence of (Moderate or Severe) COPD Exacerbation
|
1277 number of first occurrences
|
1414 number of first occurrences
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
COPD Exacerbations Per Patient-year Leading to Hospitalisation
|
0.09 Hospitalizations per patient-year
Interval 0.09 to 0.1
|
0.13 Hospitalizations per patient-year
Interval 0.12 to 0.14
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Number of Participants With at Least One COPD Exacerbation
Participants with (at least one) event
|
1277 Participants
|
1414 Participants
|
|
Number of Participants With at Least One COPD Exacerbation
Participants with no event
|
2430 Participants
|
2255 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
COPD Exacerbations Per Patient-year
|
0.64 exacerbations per patient-year
Interval 0.61 to 0.67
|
0.72 exacerbations per patient-year
Interval 0.68 to 0.75
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
First occurrence analysed by Cox regression as time to first exacerbation leading to hospitalisation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
First Occurrence of COPD Exacerbation Leading to Hospitalization
|
262 number of first occurrences
|
336 number of first occurrences
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation
Participants with (at least one) event
|
262 Participants
|
336 Participants
|
|
Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation
Participants with no event
|
3445 Participants
|
3333 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Occurrence analysed by Cox regression as time to premature discontinuation of trial medication and reported as hazard ratio
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Occurrence of Premature Discontinuation of Trial Medication
|
585 number of first occurrences
|
648 number of first occurrences
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Number of Participants With Premature Discontinuation of Trial Medication
Participants with (at least one) event
|
585 Participants
|
648 Participants
|
|
Number of Participants With Premature Discontinuation of Trial Medication
Participants with no event
|
3122 Participants
|
3021 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
First occurrence analysed by Cox regression as time to first exacerbation or discontinuation of trial medication because of worsening of underlying disease, whichever comes first and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
First Occurrence of COPD Exacerbation or Discontinuation of Trial Medication Because of Worsening of Underlying Disease, Whichever Comes First
|
1316 number of first occurrences
|
1448 number of first occurrences
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
First Occurrence of COPD Exacerbations Treated With Systemic Steroids
|
715 number of first occurrences
|
852 number of first occurrences
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
First occurrence analysed by Cox regression as time to first exacerbation treated with antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
First Occurrence of COPD Exacerbations Treated With Antibiotics
|
1154 number of first occurrences
|
1259 number of first occurrences
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
First Occurrence of COPD Exacerbations Treated With Systemic Steroids and Antibiotics
|
562 number of first occurrences
|
671 number of first occurrences
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
COPD Exacerbations Treated With Systemic Steroids Per Patient-year
|
0.33 exacerbations per patient-year
Interval 0.31 to 0.36
|
0.41 exacerbations per patient-year
Interval 0.38 to 0.43
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
COPD Exacerbations Treated With Antibiotics Per Patient-year
|
0.53 exacerbations per patient-year
Interval 0.5 to 0.56
|
0.59 exacerbations per patient-year
Interval 0.56 to 0.62
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).
Outcome measures
| Measure |
Tiotropium
n=3707 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
COPD Exacerbations Treated With Systemic Steroids and Antibiotics Per Patient-year
|
0.23 exacerbations per patient-year
Interval 0.21 to 0.24
|
0.28 exacerbations per patient-year
Interval 0.27 to 0.3
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2446 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2434 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 1
|
222.85 liter per minute (L/min)
Standard Error 0.81
|
224.45 liter per minute (L/min)
Standard Error 0.81
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2413 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2377 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 2
|
225.15 liter per minute (L/min)
Standard Error 0.81
|
227.21 liter per minute (L/min)
Standard Error 0.81
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2394 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2357 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 3
|
226.31 liter per minute (L/min)
Standard Error 0.81
|
228.38 liter per minute (L/min)
Standard Error 0.81
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2380 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2349 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 4
|
227.37 liter per minute (L/min)
Standard Error 0.81
|
229.25 liter per minute (L/min)
Standard Error 0.81
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2360 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2335 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 5
|
228.27 liter per minute (L/min)
Standard Error 0.81
|
229.37 liter per minute (L/min)
Standard Error 0.81
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2351 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2319 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 6
|
228.80 liter per minute (L/min)
Standard Error 0.82
|
229.81 liter per minute (L/min)
Standard Error 0.81
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2339 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2306 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 7
|
229.35 liter per minute (L/min)
Standard Error 0.82
|
230.13 liter per minute (L/min)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2319 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2278 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 8
|
229.95 liter per minute (L/min)
Standard Error 0.82
|
230.43 liter per minute (L/min)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2279 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2234 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 9
|
229.72 liter per minute (L/min)
Standard Error 0.82
|
230.57 liter per minute (L/min)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2285 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2235 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 10
|
230.30 liter per minute (L/min)
Standard Error 0.82
|
231.27 liter per minute (L/min)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2289 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2228 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 11
|
230.61 liter per minute (L/min)
Standard Error 0.82
|
231.91 liter per minute (L/min)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2286 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2214 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 12
|
231.04 liter per minute (L/min)
Standard Error 0.82
|
232.04 liter per minute (L/min)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2278 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2212 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 13
|
231.23 liter per minute (L/min)
Standard Error 0.82
|
231.89 liter per minute (L/min)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2264 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2211 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 14
|
231.19 liter per minute (L/min)
Standard Error 0.82
|
232.42 liter per minute (L/min)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2256 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2193 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 15
|
231.64 liter per minute (L/min)
Standard Error 0.82
|
232.75 liter per minute (L/min)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples
PEFR means peak expiratory flow rate and is measured in liter per minute
Outcome measures
| Measure |
Tiotropium
n=2240 Participants
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=2174 Participants
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 16
|
232.06 liter per minute (L/min)
Standard Error 0.82
|
232.65 liter per minute (L/min)
Standard Error 0.82
|
Adverse Events
Tiotropium
Serious events: 545 serious events
Other events: 495 other events
Deaths: 0 deaths
Salmeterol
Serious events: 606 serious events
Other events: 581 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tiotropium
n=3707 participants at risk
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 participants at risk
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Cardiac disorders
Cardiomyopathy
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Blood and lymphatic system disorders
Splenitis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Angina pectoris
|
0.24%
9/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.14%
5/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Angina unstable
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Arrhythmia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
12/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.38%
14/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Atrial flutter
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cardiac arrest
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cardiac failure
|
0.46%
17/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.57%
21/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cardiac failure acute
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cardiac fibrillation
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cardiogenic shock
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cor pulmonale
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.14%
5/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Coronary artery disease
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.14%
5/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Dressler's syndrome
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Left ventricular failure
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Myocardial infarction
|
0.54%
20/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.35%
13/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.30%
11/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.16%
6/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Nodal rhythm
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Postinfarction angina
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Right ventricular failure
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.11%
4/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Sinus bradycardia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Tachycardia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Ear and labyrinth disorders
Tympanosclerosis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Ear and labyrinth disorders
Vestibular ataxia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Endocrine disorders
Hypoparathyroidism
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Endocrine disorders
Hypothyroidism
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Eye disorders
Cataract
|
0.16%
6/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Eye disorders
Eye disorder
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Eye disorders
Eyelid ptosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Eye disorders
Scleritis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Eye disorders
Visual impairment
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.11%
4/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Anal polyp
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Diverticulitis oesophageal
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Enamel anomaly
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Enteritis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Gastritis
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Peritonitis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Chest pain
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.16%
6/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Chills
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Death
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.19%
7/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Device dislocation
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Drowning
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Drug intolerance
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Gait disturbance
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Hernia
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Hypothermia
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Inflammation
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Malaise
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Multi-organ failure
|
0.13%
5/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Pyrexia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
General disorders
Sudden death
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Hepatobiliary disorders
Liver disorder
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Actinomycosis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Appendicitis
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Bronchiectasis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Bronchitis
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Bronchitis bacterial
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Bronchopneumonia
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Candidiasis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Cholangitis suppurative
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Dermatitis infected
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Empyema
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Gangrene
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Gastroenteritis
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
H1N1 influenza
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Hepatitis C
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Herpes zoster
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Infection
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.11%
4/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Influenza
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Kidney infection
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Laryngitis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Lobar pneumonia
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Lung abscess
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Lyme disease
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Oral candidiasis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Orchitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Pneumonia
|
1.5%
54/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
1.7%
64/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Pyelonephritis
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Pyothorax
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Respiratory tract infection
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.11%
4/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Rickettsiosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Sepsis
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Septic shock
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Subcutaneous abscess
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Superinfection bacterial
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Tracheobronchitis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Tuberculosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.11%
4/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Urinary tract infection
|
0.13%
5/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Infections and infestations
Wound sepsis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Cerebral haemorrhage traumatic
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Fall
|
0.24%
9/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.19%
7/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Frostbite
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Injury, poisoning and procedural complications
Wound
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Investigations
Arteriogram coronary
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Investigations
Investigation
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Investigations
Weight decreased
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.11%
4/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Metabolism and nutrition disorders
Tetany
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.11%
4/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Dental alveolar anomaly
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.14%
5/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.24%
9/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.19%
7/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to retroperitoneum
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoid tumour
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer stage unspecified
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Axonal neuropathy
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Brain oedema
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Cerebral circulatory failure
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.25%
9/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Cervical root pain
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Coma
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Diabetic ketoacidotic hyperglycaemic coma
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Dizziness
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Encephalopathy
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Epilepsy
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Headache
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Hypercapnic encephalopathy
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Ischaemic stroke
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Paresis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Postictal state
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Sciatica
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Syncope
|
0.13%
5/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Psychiatric disorders
Completed suicide
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Psychiatric disorders
Depression
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Psychiatric disorders
Drug abuse
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Renal and urinary disorders
Renal failure
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Renal and urinary disorders
Renal failure acute
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Renal and urinary disorders
Urinary retention
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.11%
4/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic granulomatous angiitis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.3%
270/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
9.1%
335/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.14%
5/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal swelling
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.14%
5/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.19%
7/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.16%
6/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.43%
16/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.55%
20/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Throat lesion
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Social circumstances
Social problem
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Surgical and medical procedures
Surgery
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Surgical and medical procedures
Vocal cord polypectomy
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Aortic aneurysm
|
0.05%
2/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.11%
4/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Aortic dissection
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Aortic stenosis
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Arteriosclerosis
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.08%
3/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Arteriovenous fistula
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Circulatory collapse
|
0.13%
5/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
5/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Embolism
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Haematoma
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Hypertension
|
0.24%
9/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.14%
5/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Hypertensive crisis
|
0.08%
3/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.11%
4/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Hypotension
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Iliac artery occlusion
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.11%
4/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.05%
2/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Peripheral ischaemia
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Superior vena caval occlusion
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Vascular occlusion
|
0.03%
1/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.00%
0/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
0.03%
1/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
Other adverse events
| Measure |
Tiotropium
n=3707 participants at risk
Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
|
Salmeterol
n=3669 participants at risk
Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
13.4%
495/3707 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
15.8%
581/3669 • 52 weeks (while on treatment with study drugs + 30 days)
The term "Chronic obstructive pulmonary disease" under "Other Adverse Events" contains number of patients with exacerbations which the investigator entered via AE reporting. They were consolidated with the exacerbation events used for efficacy analysis which were collected via separate designated case report form pages.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER