Trial Outcomes & Findings for Immunization To Prevent Acute COPD Exacerbations (NCT NCT03276754)
NCT ID: NCT03276754
Last Updated: 2024-08-19
Results Overview
COPD exacerbations were defined as a complex of two or more respiratory symptoms (worsening dyspnea, cough, sputum production, chest tightness, or wheezing) related to the underlying COPD, with duration of 3 days or more, that required a change in treatment. Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. Adjusted rate of exacerbation was calculated as (Total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months.
Recruitment status
TERMINATED
Target enrollment
530 participants
Primary outcome timeframe
Baseline and Month 24
Results posted on
2024-08-19
Participant Flow
Participants diagnosed with Chronic Obstructive Pulmonary Disease (COPD) across 11 hospitals in Spain were followed up during their routine follow-up visits in this prospective observational study. Participants were prescribed therapies in line with routine clinical practice.
A total of 530 evaluable participants were included in the study.
Participant milestones
| Measure |
Participants With COPD
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Overall Study
STARTED
|
530
|
|
Overall Study
Without Pneumococcal Vaccination
|
126
|
|
Overall Study
With Pneumococcal Vaccination
|
404
|
|
Overall Study
13-Valent Pneumococcal Conjugate Vaccine (PCV13) Population
|
114
|
|
Overall Study
COMPLETED
|
421
|
|
Overall Study
NOT COMPLETED
|
109
|
Reasons for withdrawal
| Measure |
Participants With COPD
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Overall Study
Withdrawal of informed consent
|
4
|
|
Overall Study
Presence of any immunosuppressive condition
|
8
|
|
Overall Study
Lost to Follow-up
|
27
|
|
Overall Study
No data reported at Month 24
|
31
|
|
Overall Study
Death
|
39
|
Baseline Characteristics
Number Analyzed signifies number of participants evaluable for the specified rows.
Baseline characteristics by cohort
| Measure |
Participants With COPD
n=530 Participants
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Age, Continuous
Overall
|
70.2 Years
STANDARD_DEVIATION 7.9 • n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Age, Continuous
Without pneumococcal vaccination
|
68.2 Years
STANDARD_DEVIATION 8.4 • n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Age, Continuous
With pneumococcal vaccination
|
70.8 Years
STANDARD_DEVIATION 7.7 • n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Age, Continuous
PCV13 Population
|
69.2 Years
STANDARD_DEVIATION 7.9 • n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
Overall · Female
|
133 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
Overall · Male
|
397 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
Without pneumococcal vaccination · Female
|
42 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
Without pneumococcal vaccination · Male
|
84 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
With pneumococcal vaccination · Female
|
91 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
With pneumococcal vaccination · Male
|
313 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
PCV13 Population · Female
|
26 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
PCV13 Population · Male
|
88 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Weight
Overall
|
75.0 Kilogram
STANDARD_DEVIATION 16.1 • n=529 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Weight
Without pneumococcal vaccination
|
74.1 Kilogram
STANDARD_DEVIATION 18.9 • n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Weight
With pneumococcal vaccination
|
75.2 Kilogram
STANDARD_DEVIATION 15.1 • n=403 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Weight
PCV13 Population
|
75.2 Kilogram
STANDARD_DEVIATION 14.1 • n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Height
Overall
|
164.7 Centimeters
STANDARD_DEVIATION 8.4 • n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Height
Without pneumococcal vaccination
|
163.8 Centimeters
STANDARD_DEVIATION 9.2 • n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Height
With pneumococcal vaccination
|
164.9 Centimeters
STANDARD_DEVIATION 8.1 • n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Height
PCV13 Population
|
164.9 Centimeters
STANDARD_DEVIATION 7.9 • n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Body Mass Index
Overall
|
27.5 Kilograms per meter square
STANDARD_DEVIATION 5.1 • n=529 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Body Mass Index
Without pneumococcal vaccination
|
27.4 Kilograms per meter square
STANDARD_DEVIATION 5.8 • n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Body Mass Index
With pneumococcal vaccination
|
27.6 Kilograms per meter square
STANDARD_DEVIATION 4.8 • n=403 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Body Mass Index
PCV13 Population
|
27.7 Kilograms per meter square
STANDARD_DEVIATION 4.8 • n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Waist circumference
Overall
|
98.4 Centimeters
STANDARD_DEVIATION 16.4 • n=468 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Waist circumference
Without pneumococcal vaccination
|
99.1 Centimeters
STANDARD_DEVIATION 17.5 • n=110 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Waist circumference
With pneumococcal vaccination
|
98.2 Centimeters
STANDARD_DEVIATION 16.1 • n=358 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Waist circumference
PCV13 Population
|
100.1 Centimeters
STANDARD_DEVIATION 17.0 • n=104 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- No
|
39 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- Yes
|
491 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- Yes (Arterial hypertension)
|
279 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- Yes (Dyslipidemia)
|
241 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- Yes (Diabetes mellitus)
|
112 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- Yes (History of neoplasm)
|
78 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- Yes (Ischemic heart disease)
|
53 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- Yes (Cardiac failure)
|
37 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- Yes (Pneumonias in the last year)
|
36 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- Yes (Chronic renal failure)
|
27 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Overall: Medical History- Yes (Metabolic syndrome)
|
2 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: No
|
12 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: Yes
|
114 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: Yes (Arterial hypertension)
|
60 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: Yes (Dyslipidemia)
|
53 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: Yes (Diabetes mellitus)
|
27 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: Yes (History of neoplasm)
|
10 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: Yes (Ischemic heart disease)
|
6 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: Yes (Cardiac failure)
|
11 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: Yes (Pneumonias in the last year)
|
9 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: Yes (Chronic renal failure)
|
1 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
Without Pneumococcal Vaccination: Yes (Metabolic syndrome)
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: No
|
27 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: Yes
|
377 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: Yes (Arterial hypertension)
|
219 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: Yes (Dyslipidemia)
|
188 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: Yes (Diabetes mellitus)
|
85 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: Yes (History of neoplasm)
|
68 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: Yes (Ischemic heart disease)
|
47 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: Yes (Cardiac failure)
|
26 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: Yes (Pneumonias in the last year)
|
27 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: (Chronic renal failure)
|
26 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
With Pneumococcal Vaccination: (Metabolic syndrome)
|
2 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
PCV 13 Population: No
|
13 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
PCV 13 Population: Yes
|
101 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
PCV 13 Population: Yes (Arterial hypertension)
|
56 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
PCV 13 Population: Yes (Dyslipidemia)
|
53 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
PCV 13 Population: Yes (Diabetes mellitus)
|
23 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
PCV 13 Population: Yes (History of neoplasm)
|
13 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
PCV 13 Population: Yes (Ischemic heart disease)
|
11 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
PCV 13 Population: Yes (Pneumonias in the last year)
|
9 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
PCV 13 Population: Yes (Cardiac failure)
|
2 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Relevant Medical History
PCV 13 Population: Yes (Chronic renal failure)
|
1 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
Overall · Regular smoker
|
98 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
Overall · Occasional smoker
|
18 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
Overall · Non-smoker
|
6 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
Overall · Former smoker
|
408 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
Without Pneumococcal Vaccination · Regular smoker
|
41 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
Without Pneumococcal Vaccination · Occasional smoker
|
7 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
Without Pneumococcal Vaccination · Non-smoker
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
Without Pneumococcal Vaccination · Former smoker
|
78 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
With Pneumococcal Vaccination · Regular smoker
|
57 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
With Pneumococcal Vaccination · Occasional smoker
|
11 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
With Pneumococcal Vaccination · Non-smoker
|
6 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
With Pneumococcal Vaccination · Former smoker
|
330 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
PCV13 Population · Regular smoker
|
25 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
PCV13 Population · Occasional smoker
|
3 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
PCV13 Population · Non-smoker
|
2 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Smoking habit
PCV13 Population · Former smoker
|
84 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Alcohol consumption
Overall · No
|
511 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Alcohol consumption
Overall · Yes
|
19 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Alcohol consumption
Without Pneumococcal Vaccination · No
|
118 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Alcohol consumption
Without Pneumococcal Vaccination · Yes
|
8 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Alcohol consumption
With Pneumococcal Vaccination · No
|
393 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Alcohol consumption
With Pneumococcal Vaccination · Yes
|
11 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Alcohol consumption
PCV13 Population · No
|
112 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Alcohol consumption
PCV13 Population · Yes
|
2 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Forced Expiratory Volume (FEV1)
Overall
|
53.4 Percentage
STANDARD_DEVIATION 18.6 • n=499 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Forced Expiratory Volume (FEV1)
Without Pneumococcal Vaccination
|
52.1 Percentage
STANDARD_DEVIATION 19.9 • n=113 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Forced Expiratory Volume (FEV1)
With Pneumococcal Vaccination
|
53.8 Percentage
STANDARD_DEVIATION 18.2 • n=386 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Forced Expiratory Volume (FEV1)
PCV13 Population
|
51.9 Percentage
STANDARD_DEVIATION 19.0 • n=99 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Forced Vital Capacity (FVC)
Overall
|
83.0 Percentage
STANDARD_DEVIATION 21.4 • n=499 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Forced Vital Capacity (FVC)
Without Pneumococcal Vaccination
|
82.3 Percentage
STANDARD_DEVIATION 22.4 • n=113 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Forced Vital Capacity (FVC)
With Pneumococcal Vaccination
|
83.2 Percentage
STANDARD_DEVIATION 21.2 • n=386 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Forced Vital Capacity (FVC)
PCV13 Population
|
84.5 Percentage
STANDARD_DEVIATION 22.1 • n=99 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
FEV1/FVC Ratio
Overall
|
49.3 Percentage
STANDARD_DEVIATION 11.3 • n=499 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
FEV1/FVC Ratio
Without Pneumococcal Vaccination
|
49.5 Percentage
STANDARD_DEVIATION 12.1 • n=113 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
FEV1/FVC Ratio
With Pneumococcal Vaccination
|
49.2 Percentage
STANDARD_DEVIATION 11.0 • n=386 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
FEV1/FVC Ratio
PCV13 Population
|
48.0 Percentage
STANDARD_DEVIATION 12.8 • n=99 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
Overall · Grade 1: Mild/unknown
|
55 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
Overall · Grade 2: Moderate
|
218 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
Overall · Grade 3: Severe
|
178 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
Overall · Grade 4: Very severe
|
79 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
Without Pneumococcal Vaccination · Grade 1: Mild/unknown
|
14 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
Without Pneumococcal Vaccination · Grade 2: Moderate
|
44 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
Without Pneumococcal Vaccination · Grade 3: Severe
|
50 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
Without Pneumococcal Vaccination · Grade 4: Very severe
|
18 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
With Pneumococcal Vaccination · Grade 1: Mild/unknown
|
41 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
With Pneumococcal Vaccination · Grade 2: Moderate
|
174 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
With Pneumococcal Vaccination · Grade 3: Severe
|
128 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
With Pneumococcal Vaccination · Grade 4: Very severe
|
61 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
PCV13 Population · Grade 1: Mild/unknown
|
12 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
PCV13 Population · Grade 2: Moderate
|
47 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
PCV13 Population · Grade 3: Severe
|
36 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
COPD severity (GOLD)
PCV13 Population · Grade 4: Very severe
|
19 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Number of moderate/severe exacerbations prior to study inclusion
Overall
|
3.3 Exacerbation per participant in 24 month
STANDARD_DEVIATION 3.2 • n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Number of moderate/severe exacerbations prior to study inclusion
Without Pneumococcal Vaccination
|
2.9 Exacerbation per participant in 24 month
STANDARD_DEVIATION 2.7 • n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Number of moderate/severe exacerbations prior to study inclusion
With Pneumococcal Vaccination
|
3.5 Exacerbation per participant in 24 month
STANDARD_DEVIATION 3.3 • n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Number of moderate/severe exacerbations prior to study inclusion
PCV13 Population
|
2.4 Exacerbation per participant in 24 month
STANDARD_DEVIATION 1.6 • n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
Overall: No
|
126 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
Overall: Yes
|
404 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
Overall: Yes, Polysaccharide only (PPSV23)
|
180 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
Overall: Yes, Polysaccharide (PPSV23) + Conjugate (PCV13)
|
142 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
Overall: Yes, Conjugate only (PCV13)
|
82 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
Without pneumococcal vaccination: No
|
126 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
Without pneumococcal vaccination: Yes
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
Without pneumococcal vaccination: Yes, Polysaccharide only (PPSV23)
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
Without pneumococcal vaccination: Yes, Polysaccharide (PPSV23) + Conjugate (PCV13)
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
Without pneumococcal vaccination: Yes, Conjugate only (PCV13)
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
With pneumococcal vaccination: No
|
0 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
With pneumococcal vaccination: Yes
|
404 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
With pneumococcal vaccination: Yes, Polysaccharide only (PPSV23)
|
180 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
With pneumococcal vaccination: Yes, Polysaccharide (PPSV23) + Conjugate (PCV13)
|
142 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Pneumococcal vaccination prior to study inclusion
With pneumococcal vaccination: Yes, Conjugate only (PCV13)
|
82 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
Overall: No
|
306 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
Overall: Yes
|
224 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
Overall: Yes (Not received influenza vaccine in the same year)
|
12 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
Overall: Yes (Received influenza vaccine in the same year)
|
212 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
Without pneumococcal vaccination: No
|
126 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
Without pneumococcal vaccination: Yes
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
Without pneumococcal vaccination: Yes (Not received influenza vaccine in the same year)
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
Without pneumococcal vaccination: Yes (Received influenza vaccine in the same year
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
With pneumococcal vaccination: No
|
180 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
With pneumococcal vaccination: Yes
|
224 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
With pneumococcal vaccination: Yes (Not received influenza vaccine in the same year)
|
12 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Conjugate pneumococcal vaccination (PCV13) prior to study inclusion
With pneumococcal vaccination: Yes (Received influenza vaccine in the same year
|
212 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
History of influenza vaccination
Overall · No
|
57 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
History of influenza vaccination
Overall · Yes
|
473 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
History of influenza vaccination
Without Pneumococcal Vaccination · No
|
48 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
History of influenza vaccination
Without Pneumococcal Vaccination · Yes
|
78 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
History of influenza vaccination
With Pneumococcal Vaccination · No
|
9 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
History of influenza vaccination
With Pneumococcal Vaccination · Yes
|
395 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
History of influenza vaccination
PCV13 Population · No
|
19 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
History of influenza vaccination
PCV13 Population · Yes
|
95 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: No
|
3 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes
|
527 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (LABA + LAMA)
|
237 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (LAMA)
|
143 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (LABA)
|
10 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (IC + LABA + LAMA)
|
173 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (IC + LABA)
|
137 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (IC + LAMA)
|
2 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (IC+ Theophylline)
|
1 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (SABA)
|
221 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (SAMA)
|
35 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (Others)
|
57 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (PDE4 inhibitors-NAC)
|
13 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (PDE4 inhibitors + LABA + LAMA
|
12 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (PDE4 inhibitors + LAMA)
|
7 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (PDE4 inhibitors + LABA)
|
2 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (Antibiotics-macrolides)
|
18 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Overall: Yes (Theophylline + LABA + LAMA)
|
5 Participants
n=530 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: No
|
2 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes
|
124 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (LABA + LAMA)
|
63 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (LAMA)
|
46 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (LABA)
|
2 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (IC + LABA + LAMA)
|
30 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (IC + LABA)
|
42 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (IC + LAMA)
|
1 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (IC + Theophylline)
|
1 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (SABA)
|
58 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (SAMA)
|
15 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (Others)
|
21 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (PDE4 inhibitors-NAC)
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (PDE4 inhibitors + LABA + LAMA)
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (PDE4 inhibitors + LAMA)
|
1 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (PDE4 inhibitors + LABA)
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (Antibiotics-Macrolides)
|
3 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
Without Pneumococcal Vaccination: Yes (Theophylline + LABA + LAMA)
|
0 Participants
n=126 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: No
|
1 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes
|
403 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (LABA + LAMA)
|
174 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (LAMA)
|
97 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (LABA)
|
8 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (IC + LABA + LAMA)
|
143 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (IC + LABA)
|
95 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (IC + LAMA)
|
1 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (IC + Theophylline)
|
0 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (SABA)
|
163 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (SAMA)
|
20 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (Others)
|
36 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (PDE4 inhibitors-NAC)
|
13 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (PDE4 inhibitors + LABA + LAMA)
|
12 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (PDE4 inhibitors + LAMA)
|
6 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (PDE4 inhibitors + LABA)
|
2 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (Antibiotics-Macrolides)
|
15 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
With Pneumococcal Vaccination: Yes (Theophylline + LABA + LAMA)
|
5 Participants
n=404 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes
|
114 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (LABA + LAMA)
|
52 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (LAMA)
|
39 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (LABA)
|
2 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (IC + LABA + LAMA)
|
34 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (Inhaled corticosteroids - IC+ LABA)
|
29 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (IC+ LAMA)
|
1 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (SABA)
|
49 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (SAMA)
|
8 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (Others)
|
9 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (PDE4 inhibitors: NAC)
|
2 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (PDE4 inhibitors + LABA + LAMA)
|
1 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
|
Most frequent treatments for COPD at baseline
PCV13 Population: Yes (Antibiotics-macrolides)
|
1 Participants
n=114 Participants • Number Analyzed signifies number of participants evaluable for the specified rows.
|
PRIMARY outcome
Timeframe: Baseline and Month 24Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row.
COPD exacerbations were defined as a complex of two or more respiratory symptoms (worsening dyspnea, cough, sputum production, chest tightness, or wheezing) related to the underlying COPD, with duration of 3 days or more, that required a change in treatment. Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. Adjusted rate of exacerbation was calculated as (Total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months.
Outcome measures
| Measure |
Participants With COPD
n=114 Participants
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population
|
-1.1 Exacerbation per participant in 24 month
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Baseline and Month 24Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" refers to the number of participants evaluable for the specified rows.
Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. COPD severity was graded as per GOLD criteria. Grade 1 mild/unknown: (FEV1 \>= 80 %, FEV1/ FVC \< 0.7 or no spirometry data). Grade 2: Moderate: (50% \<= FEV1\< 80%, FEV1/FVC \< 0.7), Grade 3: Severe (30% \<=FEV1 \< 50%, FEV1/FVC \< 0.7), Grade 4: Very severe (FEV1\< 30% or FEV1\< 50% plus respiratory failure, FEV1/FVC \< 0.7). Adjusted rate of exacerbation was calculated as (total no. of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months. Change in adjusted rate of moderate/severe exacerbations by COPD severity (Grade 1 and Grade \>1) at Month 24 is reported.
Outcome measures
| Measure |
Participants With COPD
n=114 Participants
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population
Grade 1: Mild/unknown
|
-1.5 Exacerbation per participant in 24 month
Standard Deviation 0.9
|
|
Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population
Grade >1: Moderate to Very Severe
|
-1.1 Exacerbation per participant in 24 month
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Month 24Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" refers to the number of participants evaluable for the specified rows.
Evaluate the impact of influenza and PCV13 vaccination on the reduction of COPD exacerbations. Adjusted rate of exacerbation was calculated as (total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months. Change in rate of moderate/severe exacerbations with and without history of influenza vaccination is presented in this outcome measure.
Outcome measures
| Measure |
Participants With COPD
n=114 Participants
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination
Influenza vaccination: No
|
-0.7 Exacerbation per participant in 24 month
Standard Deviation 2.2
|
|
Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination
Influenza vaccination: Yes
|
-1.2 Exacerbation per participant in 24 month
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, Month 12 and 24Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" refers to the number of participants evaluable for the specified rows.
To evaluate the impact of vaccination with PCV13 on patients quality of life SGRQ form was used. It is a self-administered questionnaire developed to measure health status (quality of life) in participants with chronic airflow limitation. The SGRQ consisted of 50 items, where 10 of them were multiple choice and 40 were true or false. Scores were calculated for three domains: Symptoms (eight items; including cough, sputum production, dyspnea or shortness of breath or breathlessness and wheezing, as well as duration, frequency and severity); Activity (16 true or false questions; refers to activities that are limited due to dyspnea);Impacts (26 items; referred to other situations or aspects related to social or psychological functioning affected by the respiratory problems that may alter the participants lifestyle). The total score and scores for each domain ranged from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status).
Outcome measures
| Measure |
Participants With COPD
n=112 Participants
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Baseline: QOL
|
45.7 Units on a scale
Standard Deviation 15.4
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Change at Month 12: QOL
|
-5.6 Units on a scale
Standard Deviation 17.4
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Change at Month 24: QOL
|
-6.0 Units on a scale
Standard Deviation 13.8
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Baseline: Symptoms
|
47.4 Units on a scale
Standard Deviation 18.9
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Change at Month 12: Symptoms
|
-9.0 Units on a scale
Standard Deviation 26.2
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Change at Month 24: Symptoms
|
-16.3 Units on a scale
Standard Deviation 23.4
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Baseline: Activity
|
56.3 Units on a scale
Standard Deviation 21.2
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Change at Month 12: Activity
|
-4.6 Units on a scale
Standard Deviation 19.9
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Change at Month 24: Activity
|
-4.2 Units on a scale
Standard Deviation 17.3
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Baseline: Impacts
|
39.7 Units on a scale
Standard Deviation 15.4
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Change at Month 12: Impacts
|
-5.6 Units on a scale
Standard Deviation 19.1
|
|
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Change at Month 24: Impacts
|
-6.5 Units on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: Baseline, Month 12 and 24Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" refers to the number of participants evaluable for the specified rows.
To evaluate the impact of vaccination with PCV13 on patients quality of life ,CAT questionnaire is used. It is used to measure the impact COPD on the participant's wellbeing and daily life and severity of symptoms. The CAT has 8 questions, with score ranging from 0 to 5 for each question, where 0 = no impairment and 5=severe impairment. Total score was calculated as the sum of scores of individual questions and ranged from 0 to 40 with higher scores indicating more severe disease.
Outcome measures
| Measure |
Participants With COPD
n=109 Participants
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population
Baseline
|
15.5 Units on a scale
Standard Deviation 7.5
|
|
Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population
Change at Month 12
|
-1.7 Units on a scale
Standard Deviation 6.3
|
|
Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population
Change at Month 24
|
-1.8 Units on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row.
To evaluate the impact of vaccination with PCV13 on the decrease of FEV1 was evaluated. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Outcome measures
| Measure |
Participants With COPD
n=114 Participants
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population
Baseline
|
51.9 Percentage
Standard Deviation 19.0
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population
Change at Month 24
|
-1.7 Percentage
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Up to Month 24Population: Evaluable Population according to inclusion criteria (at least 2 years of clinical history available that includes records of previous moderate/severe exacerbations, influenza and pneumococcal vaccination history comorbidities and previous treatments). The participants were administered PCV13 at least 2 years before or after giving informed consent
Percentage of evaluable study participants vaccinated with PCV13 prior or after inclusion in the study.
Outcome measures
| Measure |
Participants With COPD
n=530 Participants
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Percentage of Participants With COPD Vaccinated With PCV13
|
46.8 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Month 24Population: PCV13 population included evaluable participants that were administered PCV13 at least 1 month prior providing informed consent to participate in the study and that did not subsequently received PPSV23.
Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization or Intensive care unit and treatment received were planned to be analyzed in this outcome measure.
Outcome measures
| Measure |
Participants With COPD
n=114 Participants
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Mean Cost Saving Per COPD Participant With PCV13
|
NA Euro per participant per year
Cost saving could not be calculated as unitary cost was not reported.
|
Adverse Events
Participants With COPD
Serious events: 78 serious events
Other events: 10 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Participants With COPD
n=530 participants at risk
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
Infections and infestations
Pneumonia
|
3.2%
17/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.9%
10/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
COVID-19
|
0.57%
3/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Abdominal sepsis
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Appendicitis perforated
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cellulitis
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Osteomyelitis
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Peritonitis bacterial
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Respiratory tract infection
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Sepsis
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.1%
6/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Cardiac failure
|
0.75%
4/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.57%
3/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
7/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.57%
3/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Death
|
1.7%
9/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Sudden death
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Encephalopathy
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Ischaemic stroke
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Syncope
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal failure
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal impairment
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Peripheral ischaemia
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Shock
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Lung operation
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Participants With COPD
n=530 participants at risk
Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice.
|
|---|---|
|
General disorders
Chest pain
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Local reaction
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Vaccination site reaction
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
COVID-19
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Immunosuppression
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Pulmonary resection
|
0.19%
1/530 • Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER