Trial Outcomes & Findings for Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) Participants (NCT NCT04657211)
NCT ID: NCT04657211
Last Updated: 2025-08-17
Results Overview
Percentage of participants who continuously received triple therapy (SITT or MITT) for 6 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off.
Recruitment status
COMPLETED
Target enrollment
1212 participants
Primary outcome timeframe
From Day 1 (Month 1) up to 6 months
Results posted on
2025-08-17
Participant Flow
This was a non-interventional study, it did not include treatment interventions. Data was collected at participant's routine visits.
Total of 1212 participants were enrolled in this study,however 1196 participants were included in full analysis set(FAS)(as 16 participants were enrolled with incomplete documentation).FAS included all participants who signed Informed Consent Form\[ICF\],met all inclusion criteria and none of the exclusion criteria, and completed visit1. As pre-specified in protocol and SAP, a combined analysis across all cohorts was performed. Cohorts were used for representative sampling, not separate analyses.
Participant milestones
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Overall Study
STARTED
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1212
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Overall Study
Full Analysis Set Population
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1196
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Overall Study
Safety Analysis Set Population
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1196
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Overall Study
COMPLETED
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981
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Overall Study
NOT COMPLETED
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231
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Reasons for withdrawal
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Overall Study
Withdrawal by Subject
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21
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Overall Study
Lost to Follow-up
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113
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Overall Study
Death
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47
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Overall Study
Transfer to another institution
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21
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Overall Study
Other
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29
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Age, Continuous
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66.4 Years
STANDARD_DEVIATION 9.7 • n=1196 Participants
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Sex: Female, Male
Female
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634 Participants
n=1196 Participants
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Sex: Female, Male
Male
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562 Participants
n=1196 Participants
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Region of Enrollment
Germany
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1196 Participants
n=1196 Participants
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PRIMARY outcome
Timeframe: From Day 1 (Month 1) up to 6 monthsPopulation: Full Analysis Set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1.
Percentage of participants who continuously received triple therapy (SITT or MITT) for 6 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Percentage of Participants Who Continuously Received Triple Therapy for 6 Months
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92.5 Percentage of participants
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PRIMARY outcome
Timeframe: From Day 1 (Month 1) up to 12 monthsPopulation: Full Analysis Set.
Percentage of participants who continuously received triple therapy (SITT or MITT) for 12 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Percentage of Participants Who Continuously Received Triple Therapy for 12 Months
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84.4 Percentage of participants
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PRIMARY outcome
Timeframe: From Day 1 (Month 1) up to 24 monthsPopulation: Full Analysis Set.
Percentage of participants who continuously received triple therapy (SITT or MITT) for 24 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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Percentage of Participants Who Continuously Received Triple Therapy for 24 Months
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38.5 Percentage of participants
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PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set.
Time to stop triple therapy refers to the time duration from visit 1 at which a triple therapy (SITT or MITT) was safely and appropriately discontinued because its intended goals had been achieved, or no longer attainable, or risks outweighed the benefits. It was evaluated by Kaplan-Maier analysis.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Time to Stop Triple Therapy
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719 Days
Interval 651.0 to
Less than (\<) 75 percent (%) of participants experienced the event within the population. Hence, third-quartile could not be derived.
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SECONDARY outcome
Timeframe: Baseline (Day 1)Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Percentage of participants with diagnosis of asthma at the age of \<40 years have been presented. Data was collected at Baseline visit on Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=8 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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Percentage of Participants With Diagnosis of Asthma at the Age of <40 Years
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12.5 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline (Day 1)Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Percentage of participants with peripheral blood EOS count less than (\<) 100 cells per (/) micro liter (uL), 100 to \<200 cells/uL, 200 to greater than (\>) 300 cells/uL and greater than equal to (\>=) 300 cells/uL have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=94 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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Percentage of Participants With Peripheral Blood Eosinophils (EOS) Count <100 Cells/uL, 100 to <200 Cells/uL, 200 to <300 Cells/uL and >=300 Cells/uL at Baseline
<100 cells/uL
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23.4 Percentage of participants
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Percentage of Participants With Peripheral Blood Eosinophils (EOS) Count <100 Cells/uL, 100 to <200 Cells/uL, 200 to <300 Cells/uL and >=300 Cells/uL at Baseline
100 to <200 cells/uL
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26.6 Percentage of participants
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Percentage of Participants With Peripheral Blood Eosinophils (EOS) Count <100 Cells/uL, 100 to <200 Cells/uL, 200 to <300 Cells/uL and >=300 Cells/uL at Baseline
200 to <300 cells/uL
|
19.1 Percentage of participants
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Percentage of Participants With Peripheral Blood Eosinophils (EOS) Count <100 Cells/uL, 100 to <200 Cells/uL, 200 to <300 Cells/uL and >=300 Cells/uL at Baseline
>=300 cells/uL
|
30.9 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline (Day 1)Population: Full Analysis Set
Percentage of participants with a physician's diagnosis of COPD have been categorized according to the site localization i.e. East, North, South, and West Germany. Data was collected at Baseline visit on Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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Percentage of Participants With a Physician's Diagnosis of COPD by Site Localization
East Germany
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23.7 Percentage of participants
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Percentage of Participants With a Physician's Diagnosis of COPD by Site Localization
North Germany
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16.1 Percentage of participants
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Percentage of Participants With a Physician's Diagnosis of COPD by Site Localization
South Germany
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16.1 Percentage of participants
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Percentage of Participants With a Physician's Diagnosis of COPD by Site Localization
West Germany
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44.1 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline (Day 1)Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Percentage of participants with a physician's diagnosis of COPD categorized by pneumologists and general practitioners have been presented. Data was collected at Baseline visit on Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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Percentage of Participants With a Physician's Diagnosis of COPD by Physicians Group
General practitioners
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38.9 Percentage of participants
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Percentage of Participants With a Physician's Diagnosis of COPD by Physicians Group
Pneumologists
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61.1 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline (Day 1)Population: Full Analysis Set
COPD was classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. Participants were classified based on symptom and risk of exacerbation, where GOLD 1 (mild COPD), GOLD 2 (moderate COPD), GOLD 3 (severe COPD) and GOLD 4 (very severe COPD). Data for percentage of participants with COPD symptom and risk classes (GOLD 1, GOLD 2, GOLD 3, and GOLD 4) have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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Percentage of Participants With COPD Symptom and Risk Classes (GOLD 1 to 4) at Baseline
GOLD 1
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7.4 Percentage of participants
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Percentage of Participants With COPD Symptom and Risk Classes (GOLD 1 to 4) at Baseline
GOLD 2
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38.0 Percentage of participants
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Percentage of Participants With COPD Symptom and Risk Classes (GOLD 1 to 4) at Baseline
GOLD 3
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28.0 Percentage of participants
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Percentage of Participants With COPD Symptom and Risk Classes (GOLD 1 to 4) at Baseline
GOLD 4
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7.3 Percentage of participants
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Percentage of Participants With COPD Symptom and Risk Classes (GOLD 1 to 4) at Baseline
Missing
|
19.3 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline (Day 1)Population: Full Analysis Set
COPD was classified using the GOLD criteria. Participants are classified based on symptoms and risk of exacerbation, where GOLD A=Few symptoms low risk, GOLD B= More symptoms low risk, GOLD C= Few symptoms high risk and GOLD D= More symptoms high risk. Data for percentage of participants with COPD symptom and risk classes (GOLD A, GOLD B, GOLD C, and GOLD D) have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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Percentage of Participants With COPD Symptom and Risk Classes (GOLD A to D) at Baseline
GOLD A
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13.6 Percentage of participants
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Percentage of Participants With COPD Symptom and Risk Classes (GOLD A to D) at Baseline
GOLD B
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43.9 Percentage of participants
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Percentage of Participants With COPD Symptom and Risk Classes (GOLD A to D) at Baseline
GOLD C
|
13.4 Percentage of participants
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Percentage of Participants With COPD Symptom and Risk Classes (GOLD A to D) at Baseline
GOLD D
|
12.6 Percentage of participants
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Percentage of Participants With COPD Symptom and Risk Classes (GOLD A to D) at Baseline
Missing
|
16.5 Percentage of participants
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SECONDARY outcome
Timeframe: At Months 6, 12 and 24Population: Full Analysis Set. Participants may have provided multiple answers for this question, hence may have contributed to more than one category. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Percentage of participants with non-missing concomitant respiratory medication received during the study are presented. Percentage of participants were categorized by the substance class of concomitant respiratory medication received by them which included oral glucocorticosteroids, leukotriene receptor antagonist, oral betamimetics, immunotherapy, antibiotics for respiratory indications, and other substances with cardiac or respiratory effects. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=535 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 24: Leukotriene receptor antagonist
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1.2 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 24: Oral betamimetics
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25.6 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 24: Immunotherapy
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0.2 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 24: Antibiotics for respiratory indications
|
1.8 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 24: Other substances with cardiac or respiratory effects
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68.5 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 6: Oral glucocorticosteroids
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2.6 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 6: Leukotriene receptor antagonist
|
1.1 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 6: Oral betamimetics
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23.4 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 6: Immunotherapy
|
0.2 Percentage of participants
|
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 6: Antibiotics for respiratory indications
|
1.1 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 6: Other substances with cardiac or respiratory effects
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71.6 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 12: Oral glucocorticosteroids
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3.2 Percentage of participants
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 12: Leukotriene receptor antagonist
|
1.0 Percentage of participants
|
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 12: Oral betamimetics
|
24.0 Percentage of participants
|
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 12: Immunotherapy
|
0.2 Percentage of participants
|
|
Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 12: Antibiotics for respiratory indications
|
1.9 Percentage of participants
|
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 12: Other substances with cardiac or respiratory effects
|
69.7 Percentage of participants
|
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Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24
Month 24: Oral glucocorticosteroids
|
2.6 Percentage of participants
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SECONDARY outcome
Timeframe: Up to 48 weeks before study start (Day 1 of Month 1)Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Data for percentage of participants by their duration of triple therapy before study start have been presented. Data was categorized into following categories according to duration of triple therapy they received prior to study start: \<3 months, 3 to \<6 months, \>=6 months. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=116 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Percentage of Participants by Their Duration of Triple Therapy Before Study Start
3 to <6 months
|
27.6 Percentage of participants
|
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Percentage of Participants by Their Duration of Triple Therapy Before Study Start
>=6 months
|
40.5 Percentage of participants
|
|
Percentage of Participants by Their Duration of Triple Therapy Before Study Start
<3 months
|
31.9 Percentage of participants
|
SECONDARY outcome
Timeframe: At Months 6, 12 and 24Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Percentage of participants were categorized by their smoking status as Lifelong non-smoker, Current smoker and Previous smoker. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1091 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Percentage of Participants by Their Smoking Status at Months 6, 12 and 24
Month 6: Lifelong non-smoker
|
8.8 Percentage of participants
|
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Percentage of Participants by Their Smoking Status at Months 6, 12 and 24
Month 6: Current smoker
|
37.0 Percentage of participants
|
|
Percentage of Participants by Their Smoking Status at Months 6, 12 and 24
Month 6: Previous smoker
|
54.2 Percentage of participants
|
|
Percentage of Participants by Their Smoking Status at Months 6, 12 and 24
Month 12: Lifelong non-smoker
|
8.8 Percentage of participants
|
|
Percentage of Participants by Their Smoking Status at Months 6, 12 and 24
Month 12: Current smoker
|
36.8 Percentage of participants
|
|
Percentage of Participants by Their Smoking Status at Months 6, 12 and 24
Month 12: Previous smoker
|
54.3 Percentage of participants
|
|
Percentage of Participants by Their Smoking Status at Months 6, 12 and 24
Month 24: Lifelong non-smoker
|
8.9 Percentage of participants
|
|
Percentage of Participants by Their Smoking Status at Months 6, 12 and 24
Month 24: Current smoker
|
36.5 Percentage of participants
|
|
Percentage of Participants by Their Smoking Status at Months 6, 12 and 24
Month 24: Previous smoker
|
54.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At Baseline (Day 1)Population: Full Analysis Set
Percentage of participants with a lifelong non-smoking history at Baseline have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Percentage of Participants With a Lifelong Non-smoking History at Baseline
|
8.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Months 6, 12, and 24Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FEV1 and FVC was measured using spirometry. FEV1/FVC ratio was calculated as FEV1/FVC ratio=FEV1/FVC\*100. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage of participants with FEV1/FVC value \<0.7 have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Percentage of Participants With Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) Ratio (FEV1/FVC) of <0.7 at Study Enrollment and at 6, 12 and 24 Months
Baseline (Day 1)
|
50.4 Percentage of participants
|
|
Percentage of Participants With Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) Ratio (FEV1/FVC) of <0.7 at Study Enrollment and at 6, 12 and 24 Months
Month 6
|
41.5 Percentage of participants
|
|
Percentage of Participants With Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) Ratio (FEV1/FVC) of <0.7 at Study Enrollment and at 6, 12 and 24 Months
Month 12
|
42.8 Percentage of participants
|
|
Percentage of Participants With Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) Ratio (FEV1/FVC) of <0.7 at Study Enrollment and at 6, 12 and 24 Months
Month 24
|
42.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 months prior to Baseline (Day 1); Up to 3 months prior to Month 6; Up to 3 months prior to Month 12; Up to 3 months prior to Month 24Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage of participants with any moderate/severe exacerbation in the 24 months prior to Baseline or 3 months prior to each subsequent on-study visits at Months 6, 12 and 24 have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Percentage of Participants With Any Moderate/Severe Exacerbation in the 24 Months Prior to Baseline or 3 Months Prior to Each Subsequent On-study Visits at Months 6, 12 and 24
Up to 24 months prior to Baseline
|
5.1 Percentage of participants
|
|
Percentage of Participants With Any Moderate/Severe Exacerbation in the 24 Months Prior to Baseline or 3 Months Prior to Each Subsequent On-study Visits at Months 6, 12 and 24
Up to 3 months prior to Month 6
|
5.6 Percentage of participants
|
|
Percentage of Participants With Any Moderate/Severe Exacerbation in the 24 Months Prior to Baseline or 3 Months Prior to Each Subsequent On-study Visits at Months 6, 12 and 24
Up to 3 months prior to Month 12
|
8.5 Percentage of participants
|
|
Percentage of Participants With Any Moderate/Severe Exacerbation in the 24 Months Prior to Baseline or 3 Months Prior to Each Subsequent On-study Visits at Months 6, 12 and 24
Up to 3 months prior to Month 24
|
6.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Months 6, 12, and 24Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
The CAT is a validated measure of health status in COPD. The CAT is an 8-item, patient-completed instrument that covers symptoms such as cough, phlegm, chest tightness, breathlessness, and disease impacts including physical activity, confidence, sleep and energy. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A CAT sum score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. CAT sum score interpreted as \<=10: low impact level, 11-19: Medium impact level, \>=20: high impact level. Data for percentage of participants with CAT sum score of \<=10, 11-19, and \>=20 have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=935 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Baseline (Day 1): <=10
|
10.7 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Baseline (Day 1): 11-19
|
37.8 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Baseline (Day 1): >=20
|
51.6 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Month 6: <=10
|
14.5 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Month 6: 11-19
|
48.5 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Month 6: >=20
|
36.9 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Month 12: <=10
|
17.8 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Month 12: 11-19
|
44.9 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Month 12: >=20
|
37.3 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Month 24: <=10
|
20.6 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Month 24: 11-19
|
40.8 Percentage of participants
|
|
Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation
Month 24: >=20
|
38.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At Months 6, 12, and 24Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Percentage of participants with peripheral blood EOS count of \<300 cells/uL and \>=300 cells/uL have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1091 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months
Month 6: <300 cells/uL
|
3.8 Percentage of participants
|
|
Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months
Month 6: >=300 cells/uL
|
1.2 Percentage of participants
|
|
Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months
Month 6: Missing
|
95.0 Percentage of participants
|
|
Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months
Month 12: <300 cells/uL
|
3.5 Percentage of participants
|
|
Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months
Month 12: >=300 cells/uL
|
1.9 Percentage of participants
|
|
Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months
Month 12: Missing
|
94.6 Percentage of participants
|
|
Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months
Month 24: <300 cells/uL
|
2.9 Percentage of participants
|
|
Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months
Month 24: >=300 cells/uL
|
1.3 Percentage of participants
|
|
Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months
Month 24: Missing
|
95.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set
Chronic bronchitis phenotype is one of the 'treatable traits' in COPD participants, which - when modified - might lead to improved health outcomes. Percentage of participants with chronic bronchitis phenotype have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Chronic Bronchitis Phenotype
|
75.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Months 6 to 24Population: Full Analysis Set
Percentage of participants with at least one switch from triple therapy to LAMA/LABA from Months 6 to 24 have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With at Least One Switch From Triple Therapy to Long-acting Muscarinic Antagonist (LAMA)/Long-acting Beta Agonist (LABA) From Months 6 to 24
|
2.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Months 6 to 24Population: Full Analysis Set
Percentage of participants with at least one switch from triple therapy to ICS/LABA from Months 6 to 24 have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With at Least One Switch From Triple Therapy to Inhaled Corticosteroids (ICS)/LABA From Months 6 to 24
|
1.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. A participant may have \>1 reason to start triple therapy, hence total percentage of participants from different categories (reasons) may not yield 100%. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Percentage of participants with reasons to start COPD triple therapy in overall participants group have been presented. Reasons to start COPD triple therapy were documented in medical records by physicians. These reasons have been presented in separate categories. Also, data has been presented by type of physician (general practitioners \[GP\] and pneumologists) who documented these reasons. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Overall: Symptomatic despite previous dual therapy with ICS/LABA
|
23.4 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Overall: Symptomatic despite previous dual therapy with LAMA/LABA
|
52.4 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Overall: Deteriorating quality of life and/or lung function despite long-term therapy
|
32.4 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Overall: one or more exacerbations
|
15.1 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Overall: Acute exacerbation
|
6.7 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Overall: Hospitalization because of major exacerbation/other reason
|
3.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Overall: Exacerbation prophylaxis
|
21.2 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Overall: Participants wish to change medication or device
|
20.2 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Overall: Other
|
2.3 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Overall: Missing
|
0.1 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
General practitioners: Symptomatic despite previous dual therapy with ICS/LABA
|
24.7 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
General practitioners: Symptomatic despite previous dual therapy with LAMA/LABA
|
51.6 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
General practitioners: Deteriorating quality of life and/or lung function despite long-term therapy
|
26.2 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
General practitioners: one or more exacerbations
|
11.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
General practitioners: Acute exacerbation
|
5.8 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
General practitioners: Hospitalization because of major exacerbation/other reason
|
2.4 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
General practitioners: Exacerbation prophylaxis
|
31.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
General practitioners: Participants wish to change medication or device
|
38.1 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
General practitioners: Other
|
1.9 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
General practitioners: Missing
|
0.2 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Pneumologists: Symptomatic despite previous dual therapy with ICS/LABA
|
22.6 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Pneumologists: Symptomatic despite previous dual therapy with LAMA/LABA
|
52.9 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Pneumologists: Deteriorating quality of life and/or lung function despite long-term therapy
|
36.4 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Pneumologists: one or more exacerbations
|
17.8 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Pneumologists: Acute exacerbation
|
7.3 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Pneumologists: Hospitalization because of major exacerbation/other reason
|
3.4 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Pneumologists: Exacerbation prophylaxis
|
15.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Pneumologists: Participants wish to change medication or device
|
8.8 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Pneumologists: Other
|
2.5 Percentage of participants
|
|
Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group
Pneumologists: Missing
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Percentage of participants with change from triple to dual therapy and back to triple therapy (re-escalation) during a 24-month observation period after study enrollment have been presented. Data has been presented in categories split by the type of triple therapy (SITT and MITT) initiated by participants prior to change. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=13 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by SITT and MITT)
Re-escalation: MITT to dual therapy to MITT
|
7.7 Percentage of participants
|
|
Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by SITT and MITT)
Re-escalation: SITT to dual therapy to SITT
|
92.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set
Percentage of participants with change from triple to dual therapy and back to triple therapy (at least one re-escalation) during a 24-month observation period after study enrollment have been presented. Data has been presented in categories split by the type of dual therapy (LAMA/LABA, ICS/LABA and ICS/LAMA) received by participant after change from triple therapy. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by LAMA/LABA, ICS/LABA and ICS/LAMA)
Re-escalation: Triple to LABA/LAMA to Triple
|
0.8 Percentage of participants
|
|
Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by LAMA/LABA, ICS/LABA and ICS/LAMA)
Re-escalation: Triple to LABA/ICS to Triple
|
0.3 Percentage of participants
|
|
Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by LAMA/LABA, ICS/LABA and ICS/LAMA)
Re-escalation: Triple to LAMA/ICS to Triple
|
0.0 Percentage of participants
|
|
Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by LAMA/LABA, ICS/LABA and ICS/LAMA)
No re-escalation
|
98.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set
Percentage of participants with at least one change in their triple therapy from MITT to SITT or SITT to MITT during a 24-month observation period have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With at Least One Change From MITT to SITT or SITT to MITT During a 24-month Observation Period
SITT to MITT
|
3.9 Percentage of participants
|
|
Percentage of Participants With at Least One Change From MITT to SITT or SITT to MITT During a 24-month Observation Period
MITT to SITT
|
3.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set
Percentage of participants with at least one change within their type of triple therapy - from SITT to SITT or MITT to MITT during a 24-month observation period have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With at Least One Change From SITT to SITT or MITT to MITT During a 24-month Observation Period
SITT to SITT
|
2.8 Percentage of participants
|
|
Percentage of Participants With at Least One Change From SITT to SITT or MITT to MITT During a 24-month Observation Period
MITT to MITT
|
1.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set
Percentage of participants with change from once daily to twice daily or twice daily to once daily medication has been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Change From Once Daily to Twice Daily or Twice Daily to Once Daily Medication
Once daily to twice daily
|
3.9 Percentage of participants
|
|
Percentage of Participants With Change From Once Daily to Twice Daily or Twice Daily to Once Daily Medication
Twice daily to once daily
|
3.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set
Percentage of participants with a change between different inhaler types have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With a Change Between Different Inhaler Types
|
7.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. A participant may have \>1 reason, hence total percentage of participants from different categories (reasons) may not yield 100%. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Percentage of participants with prespecified reasons to change a triple therapy (TT) (either MITT or SITT) by type of physician group have been presented. Reasons to change a triple therapy were documented in medical records by physicians. These reasons are included in separate categories. Also, data has been presented by type of physician (general practitioners \[GP\] and pneumologists). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=72 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Symptomatic despite previous dual therapy with ICS/LABA
|
2.6 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Symptomatic despite previous dual therapy with LAMA/LABA
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Deteriorating quality of life (QoL) and/or lung function despite long-term therapy
|
2.6 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: One or more exacerbations
|
5.1 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Acute exacerbation
|
2.6 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Hospitalization because of major exacerbation/other reason
|
5.1 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Exacerbation prophylaxis
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Participants wish to change medication or device
|
56.4 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Switching from open TT (MITT, various inhalers) to closed TT (SITT, one inhaler)
|
2.6 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Change from twice daily to once daily
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Switching to a different type of inhaler
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Insufficient effectiveness of the previous medication
|
5.1 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Recommendation of guideline (e.g. discontinuation of ICS)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Recommendation from a referring pulmonologist or acute care clinic
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Adverse Event
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Symptomatic under existing triple therapy
|
35.9 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Other
|
7.7 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
GP: Missing
|
17.9 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Symptomatic despite previous dual therapy with ICS/LABA
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Symptomatic despite previous dual therapy with LAMA/LABA
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Deteriorating QoL and/or lung function despite long-term therapy
|
12.1 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: One or more exacerbations
|
6.1 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Acute exacerbation
|
6.1 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Hospitalization because of major exacerbation/other reason
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Exacerbation prophylaxis
|
3.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Participants wish to change medication or device
|
21.2 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists:Switching from open TT(MITT, various inhalers) to closed TT(SITT, 1 inhaler)
|
6.1 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Change from twice daily to once daily
|
3.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Switching to a different type of inhaler
|
9.1 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Insufficient effectiveness of the previous medication
|
6.1 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Recommendation of guideline (e.g. discontinuation of ICS)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Recommendation from a referring pulmonologist or acute care clinic
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Adverse Event
|
3.0 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Symptomatic under existing triple therapy
|
24.2 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Other
|
9.1 Percentage of participants
|
|
Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group
Pneumologists: Missing
|
24.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. A participant may have \>1 reason, hence total percentage of participants from different categories (reasons) may not yield 100%. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Percentage of participants with reasons for change in their triple therapy to another triple therapy in overall participants group have been presented. Reasons for change in triple therapy to another triple therapy were documented in medical records by physician. These reasons are included in separate categories. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=72 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Symptomatic despite previous dual therapy with ICS/LABA
|
1.4 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Symptomatic despite previous dual therapy with LAMA/LABA
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Deteriorating quality of life (QoL) and/or lung function despite long-term therapy
|
6.9 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
One or more exacerbations
|
5.6 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Acute exacerbation
|
4.2 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Hospitalization because of major exacerbation/other reason
|
2.8 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Exacerbation prophylaxis
|
1.4 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Participants wish to change medication or device
|
40.3 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Switching from open TT (MITT, various inhalers) to closed TT (SITT, one inhaler)
|
4.2 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Change from twice daily to once daily
|
1.4 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Switching to a different type of inhaler
|
4.2 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Insufficient effectiveness of the previous medication
|
5.6 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Recommendation of guideline (e.g. discontinuation of ICS)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Recommendation from a referring pulmonologist or acute care clinic
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Adverse Event
|
1.4 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Symptomatic under existing triple therapy
|
30.6 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Other
|
8.3 Percentage of participants
|
|
Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants
Missing
|
20.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. A participant may have \>1 reason, hence total percentage of participants from different categories (reasons) may not yield 100%. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Percentage of participants with reasons for change from triple therapy to therapy de-escalation in overall participants group have been presented. A participant was classified as de-escalation, if there was at least one change from triple therapy to a therapy with just two components within the first 365 days of observation. Reasons for change from triple therapy to therapy de-escalation were documented in medical records by physicians. These reasons are included in separate categories. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=27 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Symptomatic despite previous dual therapy with ICS/LABA
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Symptomatic despite previous dual therapy with LAMA/LABA
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Deteriorating quality of life (QoL) and/or lung function despite long-term therapy
|
7.4 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
One or more exacerbations
|
3.7 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Acute exacerbation
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Hospitalization because of major exacerbation/other reason
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Exacerbation prophylaxis
|
3.7 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Participants wish to change medication or device
|
63.0 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Switching from open TT (MITT, various inhalers) to closed TT (SITT, one inhaler)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Change from twice daily to once daily
|
3.7 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Switching to a different type of inhaler
|
3.7 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Insufficient effectiveness of the previous medication
|
3.7 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Recommendation of guideline (e.g. discontinuation of ICS)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Recommendation from a referring pulmonologist or acute care clinic
|
3.7 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Adverse Event
|
3.7 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Symptomatic under existing triple therapy
|
3.7 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Other
|
7.4 Percentage of participants
|
|
Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation
Missing
|
22.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Percentage of participants with reasons to change de-escalated therapy back to triple therapy in overall participants group have been presented. A participant was classified as de-escalation, if there was at least one change from triple therapy to a therapy with just two components within the first 365 days of observation. Reasons to change de-escalated therapy back to triple therapy were documented in medical records by physicians. These reasons are included in separate categories. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=10 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Symptomatic despite previous dual therapy with ICS/LABA
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Symptomatic despite previous dual therapy with LAMA/LABA
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Deteriorating quality of life (QoL) and/or lung function despite long-term therapy
|
10.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
One or more exacerbations
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Acute exacerbation
|
10.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Hospitalization because of major exacerbation/other reason
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Exacerbation prophylaxis
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Participants wish to change medication or device
|
20.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Switching from open TT (MITT, various inhalers) to closed TT (SITT, one inhaler)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Change from twice daily to once daily
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Switching to a different type of inhaler
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Insufficient effectiveness of the previous medication
|
10.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Recommendation of guideline (e.g. discontinuation of ICS)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Recommendation from a referring pulmonologist or acute care clinic
|
20.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Adverse Event
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Symptomatic under existing triple therapy
|
0.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Other
|
10.0 Percentage of participants
|
|
Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy
Missing
|
20.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the study period (per participant per year) was assessed. Annualized rate of moderate and severe exacerbations was calculated as Annual exacerbation rate = total number of moderate or severe exacerbation/total person years. Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Data for mean annual rate of moderate and/or severe exacerbations is presented for overall participants, and by their peripheral EOS count (missing, \<300 and \>=300 cells/uL), smoking status (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown).
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Overall
|
0.156 Exacerbations per participant per year
Standard Deviation 0.465
|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Smoking status: Lifelong non-smoker
|
0.128 Exacerbations per participant per year
Standard Deviation 0.458
|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Smoking status: Current smoker
|
0.102 Exacerbations per participant per year
Standard Deviation 0.296
|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Smoking status: Previous smoker
|
0.199 Exacerbations per participant per year
Standard Deviation 0.553
|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Eosinophil count: <300 cells/uL
|
0.445 Exacerbations per participant per year
Standard Deviation 0.923
|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Eosinophil count: >=300 cells/uL
|
0.238 Exacerbations per participant per year
Standard Deviation 0.671
|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Eosinophil count: Missing
|
0.145 Exacerbations per participant per year
Standard Deviation 0.433
|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Asthma history: No
|
0.152 Exacerbations per participant per year
Standard Deviation 0.446
|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Asthma history: Yes
|
0.162 Exacerbations per participant per year
Standard Deviation 0.439
|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Asthma history: Missing
|
0.176 Exacerbations per participant per year
Standard Deviation 0.523
|
|
Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Asthma history: Unknown
|
0.161 Exacerbations per participant per year
Standard Deviation 0.568
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set
Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Annualized rate of hospitalization due to severe exacerbations was calculated as Annual hospitalization rate equal to (=) number of hospitalizations due to severe exacerbations divided by (/) total person years.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Mean Annual Rate of Hospitalizations Due to Severe Exacerbations
|
0.058 Hospitalization per participant per year
Standard Deviation 0.303
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Month 6Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 6 minus the value at Baseline. Data for change from Baseline in FEV1 is presented for overall participants, and by their peripheral blood eosinophil count (missing, \<300 and \>=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown).
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=717 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Overall
|
0.01 Liter
Standard Deviation 0.38
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Peripheral blood EOS: <300 cells/uL
|
-0.04 Liter
Standard Deviation 0.46
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Peripheral blood EOS: >=300 cells/uL
|
0.00 Liter
Standard Deviation 0.28
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Peripheral blood EOS: Missing
|
0.02 Liter
Standard Deviation 0.37
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Smoking history: Lifelong non-smoker
|
-0.04 Liter
Standard Deviation 0.39
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Smoking history: Current smoker
|
0.02 Liter
Standard Deviation 0.39
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Smoking history: Previous smoker
|
0.02 Liter
Standard Deviation 0.36
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Asthma history: No
|
0.00 Liter
Standard Deviation 0.37
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Asthma history: Yes
|
0.08 Liter
Standard Deviation 0.28
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Asthma history: Unknown
|
0.37 Liter
Standard Deviation 0.53
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Asthma history: Missing
|
0.05 Liter
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Month 12Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 12 minus the value at Baseline. Data for change from Baseline in FEV1 is presented for overall participants, and by their peripheral blood eosinophil count (missing, \<300 and \>=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown).
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=709 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Overall
|
0.02 Liter
Standard Deviation 0.48
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Peripheral blood EOS: <300 cells/uL
|
-0.07 Liter
Standard Deviation 0.52
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Peripheral blood EOS: >=300 cells/uL
|
-0.16 Liter
Standard Deviation 0.36
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Peripheral blood EOS: Missing
|
0.03 Liter
Standard Deviation 0.48
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Smoking history: Lifelong non-smoker
|
-0.01 Liter
Standard Deviation 0.47
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Smoking history: Current smoker
|
0.04 Liter
Standard Deviation 0.55
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Smoking history: Previous smoker
|
0.01 Liter
Standard Deviation 0.44
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Asthma history: No
|
-0.02 Liter
Standard Deviation 0.42
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Asthma history: Yes
|
0.23 Liter
Standard Deviation 0.81
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Asthma history: Unknown
|
0.78 Liter
Standard Deviation 0.87
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Asthma history: Missing
|
0.08 Liter
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Month 24Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 24 minus the value at Baseline. Data for change from Baseline in FEV1 is presented for overall participants, and by their peripheral blood eosinophil count (missing, \<300 and \>=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown).
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=657 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Overall
|
0.00 Liter
Standard Deviation 0.52
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Peripheral blood EOS: <300 cells/uL
|
0.04 Liter
Standard Deviation 0.56
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Peripheral blood EOS: >=300 cells/uL
|
-0.13 Liter
Standard Deviation 0.59
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Peripheral blood EOS: Missing
|
0.00 Liter
Standard Deviation 0.51
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Smoking history: Lifelong non-smoker
|
-0.04 Liter
Standard Deviation 0.52
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Smoking history: Current smoker
|
0.03 Liter
Standard Deviation 0.59
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Smoking history: Previous smoker
|
-0.01 Liter
Standard Deviation 0.46
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Asthma history: No
|
-0.04 Liter
Standard Deviation 0.47
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Asthma history: Yes
|
0.15 Liter
Standard Deviation 0.82
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Asthma history: Unknown
|
0.85 Liter
Standard Deviation 0.74
|
|
Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Asthma history: Missing
|
0.02 Liter
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Month 6Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FVC was measured using spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 6 minus the value at Baseline. Data for change from Baseline in FVC is presented for overall participants, and by their peripheral blood eosinophil count (missing, \<300 and \>=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown).
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=591 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Overall
|
0.02 Liter
Standard Deviation 0.46
|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Peripheral blood EOS: <300 cells/uL
|
-0.03 Liter
Standard Deviation 0.58
|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Peripheral blood EOS: >=300 cells/uL
|
-0.06 Liter
Standard Deviation 0.29
|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Peripheral blood EOS: Missing
|
0.02 Liter
Standard Deviation 0.45
|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Smoking history: Lifelong non-smoker
|
0.02 Liter
Standard Deviation 0.39
|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Smoking history: Current smoker
|
0.01 Liter
Standard Deviation 0.46
|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Smoking history: Previous smoker
|
0.02 Liter
Standard Deviation 0.46
|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Asthma history: No
|
0.02 Liter
Standard Deviation 0.44
|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Asthma history: Yes
|
0.00 Liter
Standard Deviation 0.45
|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Asthma history: Unknown
|
0.17 Liter
Standard Deviation 0.35
|
|
Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6
Asthma history: Missing
|
0.01 Liter
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Month 12Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FVC was measured using spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 12 minus the value at Baseline. Data for change from Baseline in FVC is presented for overall participants, and by their peripheral blood eosinophil count (missing, \<300 and \>=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown).
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=577 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Overall
|
-0.02 Liter
Standard Deviation 0.53
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Peripheral blood EOS: <300 cells/uL
|
-0.05 Liter
Standard Deviation 0.70
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Peripheral blood EOS: >=300 cells/uL
|
-0.24 Liter
Standard Deviation 0.46
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Peripheral blood EOS: Missing
|
-0.01 Liter
Standard Deviation 0.52
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Smoking history: Lifelong non-smoker
|
0.22 Liter
Standard Deviation 0.41
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Smoking history: Current smoker
|
-0.05 Liter
Standard Deviation 0.49
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Smoking history: Previous smoker
|
-0.03 Liter
Standard Deviation 0.55
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Asthma history: No
|
-0.03 Liter
Standard Deviation 0.52
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Asthma history: Yes
|
-0.12 Liter
Standard Deviation 0.62
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Asthma history: Unknown
|
0.07 Liter
Standard Deviation 0.58
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12
Asthma history: Missing
|
0.00 Liter
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Month 24Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FVC was measured using spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 24 minus the value at Baseline. Data for change from Baseline in FVC is presented for overall participants, and by their peripheral blood eosinophil count (missing, \<300 and \>=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown).
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=529 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Overall
|
-0.06 Liter
Standard Deviation 0.56
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Peripheral blood EOS: <300 cells/uL
|
0.02 Liter
Standard Deviation 0.72
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Peripheral blood EOS: >=300 cells/uL
|
-0.13 Liter
Standard Deviation 0.63
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Peripheral blood EOS: Missing
|
-0.06 Liter
Standard Deviation 0.54
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Smoking history: Lifelong non-smoker
|
0.08 Liter
Standard Deviation 0.55
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Smoking history: Current smoker
|
-0.06 Liter
Standard Deviation 0.59
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Smoking history: Previous smoker
|
-0.08 Liter
Standard Deviation 0.53
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Asthma history: No
|
-0.06 Liter
Standard Deviation 0.56
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Asthma history: Yes
|
0.07 Liter
Standard Deviation 0.79
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Asthma history: Unknown
|
0.26 Liter
Standard Deviation 0.52
|
|
Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24
Asthma history: Missing
|
-0.11 Liter
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Months 6, 12 and 24Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Change in COPD symptoms were evaluated through COPD Assessment Test (CAT) and were categorized as stable symptoms, less symptoms, and more symptoms by comparing with Baseline. Percentage of participants with change in COPD symptoms at Months 6, 12 and 24 from Baseline have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1088 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline
Month 6: Stable symptoms
|
77.3 Percentage of participants
|
|
Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline
Month 6: Less symptoms
|
15.6 Percentage of participants
|
|
Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline
Month 6: More symptoms
|
7.1 Percentage of participants
|
|
Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline
Month 12: Stable symptoms
|
81.3 Percentage of participants
|
|
Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline
Month 12: Less symptoms
|
10.8 Percentage of participants
|
|
Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline
Month 12: More symptoms
|
7.9 Percentage of participants
|
|
Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline
Month 24: Stable symptoms
|
82.6 Percentage of participants
|
|
Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline
Month 24: Less symptoms
|
11.0 Percentage of participants
|
|
Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline
Month 24: More symptoms
|
6.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Months 12 and 24Population: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
EQ-5D-5L is self-assessment questionnaire,consisting of 5 items covering 5 dimensions (mobility,self care,usual activities,pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health state). Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=621 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Change From Baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Months 12 and 24
Month 12
|
-0.006 Scores on a scale
Standard Deviation 0.222
|
|
Change From Baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Months 12 and 24
Month 24
|
0.003 Scores on a scale
Standard Deviation 0.219
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set
Clinically important deterioration was defined as if at least one of the following conditions exists at any point of time during the observational period: decrease (\>=100 milliliter \[mL\]) of FEV1 from Baseline (missing values are treated as no decrease); increase (\>2 units) of CAT from Baseline (missing values are treated as no increase); any documented exacerbation; and all-cause mortality. Percentage of participants experiencing a clinically important deterioration during 24 months observation period have been presented. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants Experiencing a Clinically Important Deterioration
|
53.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set.
The time to first moderate or severe exacerbation was defined as the duration between onset of first moderate or severe acute exacerbation of COPD from Day 1. Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. It was evaluated by Kaplan-Maier analysis.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Time to First Moderate or Severe Exacerbation
|
NA Days
\<25% of participants experienced the event within the population. Hence, median and inter-quartiles could not be derived.
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set.
Time to first hospitalization is calculated as the time interval between date of study enrollment (Day 1) and the date of the first hospital admission for a relevant cause. Time to first hospitalization was analyzed using Kaplan-Meier methods.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Time to First Hospitalization
|
NA Days
\<25% of participants experienced the event within the population. Hence, median and inter-quartiles could not be derived.
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set
Time to death is calculated as the duration between date of study enrollment (Day 1) and the date of death of a participant. Time to death was analyzed using Kaplan-Meier methods.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Time to Death
|
NA Days
\<25% of participants experienced the event within the population. Hence, median and inter-quartiles could not be derived.
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Number of COPD related visits made by participants have been presented and categorized by type of physician (general practitioners and pneumologists).
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Number of COPD Related Visits
General practitioners
|
5.8 Number of visits
Standard Deviation 0.89
|
|
Number of COPD Related Visits
Pneumologists
|
3.7 Number of visits
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
The annual rate of exacerbations during the observation period (per participant per year) was assessed. Annualized rate of exacerbations was calculated as Annual exacerbation rate = total number of exacerbation/total person years. Data for mean annual rate of exacerbations categorized by general practitioners and pneumologists have been presented.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Physician
General practitioners
|
0.182 Exacerbations per participant per year
Standard Deviation 0.479
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Physician
Pneumologists
|
0.140 Exacerbations per participant per year
Standard Deviation 0.456
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Annualized rate of hospitalization due to severe exacerbations was calculated as Annual hospitalization rate=number of hospitalizations due to severe exacerbations/total person years. Severe exacerbations are defined as COPD exacerbations requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Data for mean annual rate of hospitalization due to severe exacerbation categorized by general practitioners and pneumologists have been presented.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Mean Annual Rate of Hospitalization Due to Severe Exacerbation Over a 24-month Observation Period Categorized by Physician
General practitioners
|
0.027 Hospitalization per participant per year
Standard Deviation 0.142
|
|
Mean Annual Rate of Hospitalization Due to Severe Exacerbation Over a 24-month Observation Period Categorized by Physician
Pneumologists
|
0.078 Hospitalization per participant per year
Standard Deviation 0.369
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Percentage of participants have been categorized according to the site localization (East, North, South, and West Germany) of physician and type of physician (general practitioners and pneumologists). Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician
General practitioners: East Germany
|
9.2 Percentage of participants
|
|
Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician
General practitioners: North Germany
|
29.2 Percentage of participants
|
|
Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician
General practitioners: South Germany
|
29.5 Percentage of participants
|
|
Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician
General practitioners: West Germany
|
32.0 Percentage of participants
|
|
Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician
Pneumologists: East Germany
|
33.0 Percentage of participants
|
|
Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician
Pneumologists: North Germany
|
7.8 Percentage of participants
|
|
Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician
Pneumologists: South Germany
|
7.5 Percentage of participants
|
|
Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician
Pneumologists: West Germany
|
51.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
The annual rate of exacerbations during the observation period (per participant per year) was assessed. Annualized rate of exacerbations was calculated as Annual exacerbation rate = total number of exacerbation/total person years. Data for mean annual rate of exacerbations is presented by smoking status (Lifelong non-smoker, Current and previous smoker), peripheral blood eosinophil count (missing, \<300 and \>=300 cells/uL), and asthma history (missing, yes, no and unknown). Data was also categorized by the type of physician (general practitioners and pneumologists).
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
General practitioners: Smoking status- Lifelong non-smoker
|
0.158 Exacerbations per participant per year
Standard Deviation 0.559
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
General practitioners: Smoking status- Current smoker
|
0.143 Exacerbations per participant per year
Standard Deviation 0.336
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
General practitioners: Smoking status- Previous smoker
|
0.211 Exacerbations per participant per year
Standard Deviation 0.535
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
General practitioners: Eosinophil count- Missing
|
0.187 Exacerbations per participant per year
Standard Deviation 0.493
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
General practitioners: Eosinophil count- <300 cells/uL
|
0.072 Exacerbations per participant per year
Standard Deviation 0.189
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
General practitioners: Eosinophil count- >=300 cells/uL
|
0.119 Exacerbations per participant per year
Standard Deviation 0.216
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
General practitioners: Asthma history- Missing
|
0.252 Exacerbations per participant per year
Standard Deviation 0.637
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
General practitioners: Asthma history- No
|
0.159 Exacerbations per participant per year
Standard Deviation 0.433
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
General practitioners: Asthma history- Yes
|
0.439 Exacerbations per participant per year
Standard Deviation 0.732
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
General practitioners: Asthma history- Unknown
|
0.386 Exacerbations per participant per year
Standard Deviation 0.711
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Pneumologists: Smoking status- Lifelong non-smoker
|
0.099 Exacerbations per participant per year
Standard Deviation 0.331
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Pneumologists: Smoking status- Current smoker
|
0.080 Exacerbations per participant per year
Standard Deviation 0.270
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Pneumologists: Smoking status- Previous smoker
|
0.191 Exacerbations per participant per year
Standard Deviation 0.565
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Pneumologists: Eosinophil count- Missing
|
0.118 Exacerbations per participant per year
Standard Deviation 0.387
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Pneumologists: Eosinophil count- <300 cells/uL
|
0.619 Exacerbations per participant per year
Standard Deviation 1.077
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Pneumologists: Eosinophil count- >=300 cells/uL
|
0.302 Exacerbations per participant per year
Standard Deviation 0.812
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Pneumologists: Asthma history- Missing
|
0.137 Exacerbations per participant per year
Standard Deviation 0.454
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Pneumologists: Asthma history- No
|
0.146 Exacerbations per participant per year
Standard Deviation 0.456
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Pneumologists: Asthma history- Yes
|
0.048 Exacerbations per participant per year
Standard Deviation 0.156
|
|
Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History
Pneumologists: Asthma history- Unknown
|
0.116 Exacerbations per participant per year
Standard Deviation 0.532
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Analysis Set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Number of participants who had pneumonia and cardiovascular events have been presented.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Number of Participants Who Had Pneumonia and Cardiovascular Events
Pneumonia events
|
22 Participants
|
|
Number of Participants Who Had Pneumonia and Cardiovascular Events
Cardiovascular events
|
23 Participants
|
SECONDARY outcome
Timeframe: Days 90 and 365Population: Full Analysis Set.
NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants on SIIT compared to non SITT. A participant is classified as SITT, if the treatment is SITT continuously for the first 365 days of observation.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Number Needed to Treat for Benefit (NNTB) for SITT Participants Compared to Non SITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 90: NNTB with respect to Exacerbations
|
58 Participants
|
|
Number Needed to Treat for Benefit (NNTB) for SITT Participants Compared to Non SITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 365: NNTB with respect to Exacerbations
|
15 Participants
|
|
Number Needed to Treat for Benefit (NNTB) for SITT Participants Compared to Non SITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 90: NNTB with respect to Pneumonia
|
NA Participants
Data could not be derived because there was a harm and no benefit of treatment.
|
|
Number Needed to Treat for Benefit (NNTB) for SITT Participants Compared to Non SITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 365: NNTB with respect to Pneumonia
|
NA Participants
Data could not be derived because there was a harm and no benefit of treatment.
|
|
Number Needed to Treat for Benefit (NNTB) for SITT Participants Compared to Non SITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 90: NNTB with respect to Cardiovascular events
|
1042 Participants
|
|
Number Needed to Treat for Benefit (NNTB) for SITT Participants Compared to Non SITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 365: NNTB with respect to Cardiovascular events
|
NA Participants
Data could not be derived because there was a harm and no benefit of treatment.
|
SECONDARY outcome
Timeframe: Days 90 and 365Population: Full Analysis Set
NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants on MITT compared to non MITT. A participant is classified as MITT, if the treatment is MITT continuously for the first 365 days of observation.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Number Needed to Treat for Benefit (NNTB) for MITT Participants Compared to Non MITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 90: NNTB with respect to Exacerbations
|
131 Participants
|
|
Number Needed to Treat for Benefit (NNTB) for MITT Participants Compared to Non MITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 365: NNTB with respect to Exacerbations
|
25 Participants
|
|
Number Needed to Treat for Benefit (NNTB) for MITT Participants Compared to Non MITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 90: NNTB with respect to Pneumonia
|
146 Participants
|
|
Number Needed to Treat for Benefit (NNTB) for MITT Participants Compared to Non MITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 365: NNTB with respect to Pneumonia
|
91 Participants
|
|
Number Needed to Treat for Benefit (NNTB) for MITT Participants Compared to Non MITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 90: NNTB with respect to Cardiovascular events
|
203 Participants
|
|
Number Needed to Treat for Benefit (NNTB) for MITT Participants Compared to Non MITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events
Day 365: NNTB with respect to Cardiovascular events
|
98 Participants
|
SECONDARY outcome
Timeframe: Days 90 and 365Population: Full Analysis Set
NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants whose triple therapies were interrupted by ICS and/or LAMA "off/on" periods compared to other triple therapies.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants Whose Triple Therapies Interrupted by ICS and/or LAMA "Off/on" Periods Compared to Other Triple Therapies
Day 90: NNTB with respect to Exacerbations
|
NA Participants
Data could not be derived because there was a harm and no benefit of treatment.
|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants Whose Triple Therapies Interrupted by ICS and/or LAMA "Off/on" Periods Compared to Other Triple Therapies
Day 365: NNTB with respect to Exacerbations
|
NA Participants
Data could not be derived because there was a harm and no benefit of treatment.
|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants Whose Triple Therapies Interrupted by ICS and/or LAMA "Off/on" Periods Compared to Other Triple Therapies
Day 90: NNTB with respect to Pneumonia
|
163 Participants
|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants Whose Triple Therapies Interrupted by ICS and/or LAMA "Off/on" Periods Compared to Other Triple Therapies
Day 365: NNTB with respect to Pneumonia
|
41 Participants
|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants Whose Triple Therapies Interrupted by ICS and/or LAMA "Off/on" Periods Compared to Other Triple Therapies
Day 90: NNTB with respect to Cardiovascular events
|
226 Participants
|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants Whose Triple Therapies Interrupted by ICS and/or LAMA "Off/on" Periods Compared to Other Triple Therapies
Day 365: NNTB with respect to Cardiovascular events
|
61 Participants
|
SECONDARY outcome
Timeframe: Days 90 and 365Population: Full Analysis Set
NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants whose triple therapies were switched between SITT and MITT compared to no switch. A participants is classified as switch, if there is no de-escalation of therapy, but at least one switch between SITT and MITT within the first 365 days of observation.
Outcome measures
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 Participants
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants With Switch of Triple Therapies Between SITT and MITT Compared to no Switch
Day 90: NNTB with respect to Exacerbations
|
NA Participants
Data could not be derived because there was a harm and no benefit of treatment.
|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants With Switch of Triple Therapies Between SITT and MITT Compared to no Switch
Day 365: NNTB with respect to Exacerbations
|
NA Participants
Data could not be derived because there was a harm and no benefit of treatment.
|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants With Switch of Triple Therapies Between SITT and MITT Compared to no Switch
Day 90: NNTB with respect to Pneumonia
|
159 Participants
|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants With Switch of Triple Therapies Between SITT and MITT Compared to no Switch
Day 365: NNTB with respect to Pneumonia
|
40 Participants
|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants With Switch of Triple Therapies Between SITT and MITT Compared to no Switch
Day 90: NNTB with respect to Cardiovascular events
|
NA Participants
Data could not be derived because there was a harm and no benefit of treatment.
|
|
Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants With Switch of Triple Therapies Between SITT and MITT Compared to no Switch
Day 365: NNTB with respect to Cardiovascular events
|
NA Participants
Data could not be derived because there was a harm and no benefit of treatment.
|
Adverse Events
Participants With Chronic Obstructive Pulmonary Disease (COPD)
Serious events: 142 serious events
Other events: 16 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 participants at risk
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
18/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.33%
4/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.25%
3/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Pneumonia
|
1.6%
19/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.25%
3/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
COVID-19
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Diverticulitis
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Influenza
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Bronchitis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Pneumonia aspiration
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Sepsis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Septic shock
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Tick-borne viral encephalitis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Tooth infection
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
General disorders
Death
|
1.7%
20/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
General disorders
Chest pain
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
General disorders
Gait disturbance
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
General disorders
Impaired healing
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Cardiac failure
|
0.84%
10/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
6/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Angina pectoris
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Atrial flutter
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Cardiac disorder
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Coronary artery disease
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Myocardial infarction
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Tachycardia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.33%
4/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Elastofibroma
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal neoplasm
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancoast's tumour
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.42%
5/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.42%
5/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Nervous system disorders
Aphasia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Nervous system disorders
Senile dementia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Nervous system disorders
Syncope
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Colitis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Constipation
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Gastritis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Ileus
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Vascular disorders
Aortic aneurysm
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Vascular disorders
Thrombosis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Psychiatric disorders
Panic attack
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Psychiatric disorders
Psychotic disorder
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Eye disorders
Diplopia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
Other adverse events
| Measure |
Participants With Chronic Obstructive Pulmonary Disease (COPD)
n=1196 participants at risk
Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.25%
3/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.17%
2/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Glossodynia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Oral candidiasis
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Infections and infestations
Pneumonia
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Cardiac disorders
Palpitations
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
General disorders
Oedema peripheral
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Investigations
C-reactive protein abnormal
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Investigations
International normalised ratio abnormal
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
|
Investigations
Weight decreased
|
0.08%
1/1196 • All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER