Trial Outcomes & Findings for AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness (NCT NCT01350414)
NCT ID: NCT01350414
Last Updated: 2016-09-26
Results Overview
The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment compared to subsequent 12-month periods out to 5 years. This objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).
Recruitment status
COMPLETED
Target enrollment
181 participants
Primary outcome timeframe
12 month periods out to 5 Years
Results posted on
2016-09-26
Participant Flow
Participant milestones
| Measure |
Alair Group
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02)
Bronchial Thermoplasty with the Alair System: Bronchial Thermoplasty with the Alair System
|
|---|---|
|
Overall Study
STARTED
|
181
|
|
Overall Study
Year 2
|
165
|
|
Overall Study
Year 3
|
162
|
|
Overall Study
Year 4
|
159
|
|
Overall Study
Year 5
|
162
|
|
Overall Study
COMPLETED
|
162
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Alair Group
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02)
Bronchial Thermoplasty with the Alair System: Bronchial Thermoplasty with the Alair System
|
|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness
Baseline characteristics by cohort
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02, NCT00231114).
|
|---|---|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
34 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
|
Height (cm)
|
166.8 cm
STANDARD_DEVIATION 8.94 • n=5 Participants
|
|
Weight (kg)
|
81.9 kg
STANDARD_DEVIATION 17.95 • n=5 Participants
|
|
ICS Dose (Inhaled Corticosteroid dose)
|
1943.9 mcg/day (micrograms/day)
STANDARD_DEVIATION 722.39 • n=5 Participants
|
|
LABA Dose (Long-acting Beta Agonists)
|
119.2 mcg/day
STANDARD_DEVIATION 45.64 • n=5 Participants
|
|
OCS Dose (Oral corticosteroids)
|
6.4 mg/day
STANDARD_DEVIATION 1.97 • n=5 Participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) Score
|
4.32 Scores on a scale
STANDARD_DEVIATION 1.15 • n=5 Participants
|
|
Pre-Bronchodilator FEV1 (Forced Expiratory Volume in 1 second)
|
77.8 % predicted
STANDARD_DEVIATION 15.67 • n=5 Participants
|
|
Post-Bronchodilator FEV1 (Forced Expiratory Volume in 1 second)
|
86 % predicted
STANDARD_DEVIATION 15.65 • n=5 Participants
|
|
amPEF (Peak Expiratory Flow)
|
383.4 L/min (liters per minute)
STANDARD_DEVIATION 104.65 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 month periods out to 5 YearsPopulation: Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.
The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment compared to subsequent 12-month periods out to 5 years. This objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).
Outcome measures
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
|
|---|---|
|
Severe Exacerbations
Year 1
|
30.9 Percentage subjects severe exacerbations
Interval 24.2 to 37.7
|
|
Severe Exacerbations
Year 2
|
23.6 Percentage subjects severe exacerbations
Interval 17.2 to 30.1
|
|
Severe Exacerbations
Year 3
|
34 Percentage subjects severe exacerbations
Interval 26.7 to 41.2
|
|
Severe Exacerbations
Year 4
|
36.5 Percentage subjects severe exacerbations
Interval 29.0 to 44.0
|
|
Severe Exacerbations
Year 5
|
21.6 Percentage subjects severe exacerbations
Interval 15.3 to 27.9
|
SECONDARY outcome
Timeframe: 12 Month periods out to 5 yearsPopulation: Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.
Number of severe exacerbations per subject per year. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).
Outcome measures
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
|
|---|---|
|
Severe Exacerbations
Year 1
|
0.486 Number of events/Number of subjects/Year
Interval 0.385 to 0.614
|
|
Severe Exacerbations
Year 2
|
0.406 Number of events/Number of subjects/Year
Interval 0.311 to 0.531
|
|
Severe Exacerbations
Year 3
|
0.549 Number of events/Number of subjects/Year
Interval 0.435 to 0.693
|
|
Severe Exacerbations
Year 4
|
0.560 Number of events/Number of subjects/Year
Interval 0.444 to 0.706
|
|
Severe Exacerbations
Year 5
|
0.309 Number of events/Number of subjects/Year
Interval 0.226 to 0.421
|
SECONDARY outcome
Timeframe: 12 Month periods out to 5 yearsPopulation: Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.
Number of respiratory adverse events per subject per year. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the "Respiratory System" that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.
Outcome measures
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
|
|---|---|
|
Respiratory Adverse Events
Year 1
|
2.022 Number of events/number of subject/Year
Interval 1.764 to 2.318
|
|
Respiratory Adverse Events
Year 2
|
1.218 Number of events/number of subject/Year
Interval 1.013 to 1.465
|
|
Respiratory Adverse Events
Year 3
|
1.247 Number of events/number of subject/Year
Interval 1.037 to 1.499
|
|
Respiratory Adverse Events
Year 4
|
1.176 Number of events/number of subject/Year
Interval 0.971 to 1.424
|
|
Respiratory Adverse Events
Year 5
|
0.778 Number of events/number of subject/Year
Interval 0.616 to 0.982
|
SECONDARY outcome
Timeframe: 12 Month periods out to 5 yearsPopulation: Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.
Proportion of subjects experiencing one or more respiratory adverse event in each of the years 1 through 5 following the Alair treatment. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the "Respiratory System" that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.
Outcome measures
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
|
|---|---|
|
Respiratory Adverse Events
Year 1
|
72.9 Percentage subjects with respiratory AE
Interval 66.5 to 79.4
|
|
Respiratory Adverse Events
Year 2
|
58.8 Percentage subjects with respiratory AE
Interval 51.3 to 66.3
|
|
Respiratory Adverse Events
Year 3
|
58 Percentage subjects with respiratory AE
Interval 50.4 to 65.6
|
|
Respiratory Adverse Events
Year 4
|
54.7 Percentage subjects with respiratory AE
Interval 47.0 to 62.5
|
|
Respiratory Adverse Events
Year 5
|
47.5 Percentage subjects with respiratory AE
Interval 39.8 to 55.2
|
SECONDARY outcome
Timeframe: 12 Month periods out to 5 yearsPopulation: Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.
Proportion of Subjects with Emergency Room Visits for Respiratory Symptoms
Outcome measures
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
|
|---|---|
|
Emergency Room Visits for Respiratory Symptoms
Year 1
|
5 Percentage subjects ER respir. symptoms
Interval 1.8 to 8.1
|
|
Emergency Room Visits for Respiratory Symptoms
Year 2
|
6.7 Percentage subjects ER respir. symptoms
Interval 2.9 to 10.5
|
|
Emergency Room Visits for Respiratory Symptoms
Year 3
|
8 Percentage subjects ER respir. symptoms
Interval 3.8 to 12.2
|
|
Emergency Room Visits for Respiratory Symptoms
Year 4
|
6.9 Percentage subjects ER respir. symptoms
Interval 3.0 to 10.9
|
|
Emergency Room Visits for Respiratory Symptoms
Year 5
|
5.6 Percentage subjects ER respir. symptoms
Interval 2.0 to 9.1
|
SECONDARY outcome
Timeframe: 12 Month periods out to 5 yearsPopulation: Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.
Number of Emergency Room Visits for Respiratory Symptoms per subject per year.
Outcome measures
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
|
|---|---|
|
Emergency Room (ER) Visits for Respiratory Symptoms
Year 1
|
0.072 Number of events/subject/year
Interval 0.048 to 0.107
|
|
Emergency Room (ER) Visits for Respiratory Symptoms
Year 2
|
0.085 Number of events/subject/year
Interval 0.058 to 0.124
|
|
Emergency Room (ER) Visits for Respiratory Symptoms
Year 3
|
0.136 Number of events/subject/year
Interval 0.1 to 0.184
|
|
Emergency Room (ER) Visits for Respiratory Symptoms
Year 4
|
0.094 Number of events/subject/year
Interval 0.065 to 0.136
|
|
Emergency Room (ER) Visits for Respiratory Symptoms
Year 5
|
0.068 Number of events/subject/year
Interval 0.044 to 0.104
|
SECONDARY outcome
Timeframe: 12 Month periods out to 5 YearsPopulation: Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.
Proportion of subjects with hospitalizations for respiratory symptoms.
Outcome measures
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
|
|---|---|
|
Hospitalizations for Respiratory Symptoms
Year 1
|
3.3 Percentage of subjects hospitalized
Interval 0.7 to 5.9
|
|
Hospitalizations for Respiratory Symptoms
Year 2
|
4.2 Percentage of subjects hospitalized
Interval 1.2 to 7.3
|
|
Hospitalizations for Respiratory Symptoms
Year 3
|
6.2 Percentage of subjects hospitalized
Interval 2.5 to 9.9
|
|
Hospitalizations for Respiratory Symptoms
Year 4
|
5.7 Percentage of subjects hospitalized
Interval 2.1 to 9.3
|
|
Hospitalizations for Respiratory Symptoms
Year 5
|
1.9 Percentage of subjects hospitalized
Interval 0.0 to 3.9
|
SECONDARY outcome
Timeframe: 12 Month periods out to 5 yearsPopulation: Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.
Number of Hospitalizations for Respiratory Symptoms per subject per year.
Outcome measures
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
|
|---|---|
|
Hospitalizations for Respiratory Symptoms
Year 1
|
0.039 Number of events/subjects/year
Interval 0.025 to 0.06
|
|
Hospitalizations for Respiratory Symptoms
Year 2
|
0.061 Number of events/subjects/year
Interval 0.042 to 0.087
|
|
Hospitalizations for Respiratory Symptoms
Year 3
|
0.068 Number of events/subjects/year
Interval 0.048 to 0.096
|
|
Hospitalizations for Respiratory Symptoms
Year 4
|
0.075 Number of events/subjects/year
Interval 0.054 to 0.105
|
|
Hospitalizations for Respiratory Symptoms
Year 5
|
0.025 Number of events/subjects/year
Interval 0.014 to 0.044
|
SECONDARY outcome
Timeframe: 12 Month periods out to 5 yearsPopulation: Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.
Pre-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.
Outcome measures
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
|
|---|---|
|
Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Year 1
|
-1.4 Percentage of change from Baseline
Standard Deviation 14.82
|
|
Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Year 2
|
-4.6 Percentage of change from Baseline
Standard Deviation 15.36
|
|
Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Year 3
|
-2.7 Percentage of change from Baseline
Standard Deviation 15.33
|
|
Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Year 4
|
-1.2 Percentage of change from Baseline
Standard Deviation 14.60
|
|
Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Year 5
|
-1.2 Percentage of change from Baseline
Standard Deviation 16.33
|
SECONDARY outcome
Timeframe: 12 Month periods out to 5 yearsPopulation: Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.
Post-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.
Outcome measures
| Measure |
Alair Group
n=181 Participants
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
|
|---|---|
|
Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Year 1
|
-2.8 Percentage of change from Baseline
Standard Deviation 10.67
|
|
Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Year 2
|
-5.4 Percentage of change from Baseline
Standard Deviation 11.51
|
|
Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Year 3
|
-4 Percentage of change from Baseline
Standard Deviation 12.88
|
|
Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Year 4
|
-3.7 Percentage of change from Baseline
Standard Deviation 11.65
|
|
Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Year 5
|
-3.8 Percentage of change from Baseline
Standard Deviation 11.95
|
Adverse Events
Year 1
Serious events: 5 serious events
Other events: 112 other events
Deaths: 0 deaths
Year 2
Serious events: 8 serious events
Other events: 89 other events
Deaths: 0 deaths
Year 3
Serious events: 10 serious events
Other events: 81 other events
Deaths: 0 deaths
Year 4
Serious events: 9 serious events
Other events: 77 other events
Deaths: 0 deaths
Year 5
Serious events: 3 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Year 1
n=187 participants at risk
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 1 is defined as 365 days from the treatment period (6 weeks after the last bronchoscopy). All subjects were considered in the analysis regardless of whether they have completed the Year 1 annual visit or not.
|
Year 2
n=168 participants at risk
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 2 is defined as 366 to 730 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 2 annual visit or not.
|
Year 3
n=163 participants at risk
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 3 is defined as 731 to 1095 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 3 annual visit or not.
|
Year 4
n=163 participants at risk
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 4 is defined as 1096 to 1460 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 4 annual visit or not.
|
Year 5
n=162 participants at risk
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 5 is defined as 1461 days to 1826 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 5 annual visit or not.
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.53%
1/187 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.53%
1/187 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Nervous system disorders
Headache
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.1%
4/187 • Number of events 4 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
3.6%
6/168 • Number of events 8 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
4.3%
7/163 • Number of events 8 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
3.7%
6/163 • Number of events 9 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
1.2%
2/162 • Number of events 3 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.62%
1/162 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.53%
1/187 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Lobar pneumonia
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.1%
2/187 • Number of events 2 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
1.8%
3/163 • Number of events 3 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.62%
1/162 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
1/187 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.53%
1/187 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
General disorders
Pyrexia
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.53%
1/187 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
1.2%
2/163 • Number of events 2 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.62%
1/162 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.62%
1/162 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Infections and infestations
Osteomyelitis
|
0.53%
1/187 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Infections and infestations
Viral labyrinthitis
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.53%
1/187 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.53%
1/187 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/168 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.62%
1/162 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/187 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.60%
1/168 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/163 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.00%
0/162 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
Other adverse events
| Measure |
Year 1
n=187 participants at risk
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 1 is defined as 365 days from the treatment period (6 weeks after the last bronchoscopy). All subjects were considered in the analysis regardless of whether they have completed the Year 1 annual visit or not.
|
Year 2
n=168 participants at risk
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 2 is defined as 366 to 730 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 2 annual visit or not.
|
Year 3
n=163 participants at risk
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 3 is defined as 731 to 1095 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 3 annual visit or not.
|
Year 4
n=163 participants at risk
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 4 is defined as 1096 to 1460 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 4 annual visit or not.
|
Year 5
n=162 participants at risk
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 5 is defined as 1461 days to 1826 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 5 annual visit or not.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
27.8%
52/187 • Number of events 87 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
28.0%
47/168 • Number of events 77 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
29.4%
48/163 • Number of events 82 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
31.3%
51/163 • Number of events 81 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
24.7%
40/162 • Number of events 52 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
7.5%
14/187 • Number of events 18 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
7.1%
12/168 • Number of events 14 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
4.9%
8/163 • Number of events 11 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
3.7%
6/163 • Number of events 7 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
3.1%
5/162 • Number of events 6 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
3.7%
7/187 • Number of events 9 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
5.4%
9/168 • Number of events 15 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
6.7%
11/163 • Number of events 14 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
9.2%
15/163 • Number of events 20 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
3.7%
6/162 • Number of events 7 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
11.2%
21/187 • Number of events 27 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
5.4%
9/168 • Number of events 10 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
3.7%
6/163 • Number of events 7 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
3.7%
6/163 • Number of events 6 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.62%
1/162 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
6.4%
12/187 • Number of events 16 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
9.5%
16/168 • Number of events 17 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
6.7%
11/163 • Number of events 14 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
5.5%
9/163 • Number of events 10 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
3.7%
6/162 • Number of events 7 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
30.5%
57/187 • Number of events 81 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
14.3%
24/168 • Number of events 29 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
14.7%
24/163 • Number of events 25 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
14.1%
23/163 • Number of events 28 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
11.1%
18/162 • Number of events 23 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
5.9%
11/187 • Number of events 12 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
3.6%
6/168 • Number of events 6 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
0.61%
1/163 • Number of events 1 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
1.9%
3/162 • Number of events 3 • 12 months out to 5 years
In previous outcome analysis and in the participant flow, the denominator was based on the number of subjects that completed the corresponding annual visit. For Adverse Events the denominator was based on all the subjects that entered that period regardless of whether they completed the annual visit or not for that period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60