Trial Outcomes & Findings for AIR Extension Study - Long-Term Safety of Alair Treated Subjects (NCT NCT00448812)
NCT ID: NCT00448812
Last Updated: 2021-02-17
Results Overview
There is not one specific primary outcome measure. The primary objective of this study is to gather additional, longer-term safety data in subjects who participated in the AIR Trial (Protocol #0602-20), called the AIR PREDECESSOR STUDY in the AIR Extension Report (NCT00214526). The 'Percentage of Subjects with any Respiratory Adverse Event' was chosen to be the primary outcome measure because it is the first described in the final study report.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
12 Month periods out to 5 years
Results posted on
2021-02-17
Participant Flow
Participant milestones
| Measure |
Alair
Alair-treated subjects from AIR PREDECESSOR STUDY (NCT00214526).
|
Control
Control subjects from AIR PREDECESSOR STUDY (NCT00214526).
|
|---|---|---|
|
Year 1
STARTED
|
45
|
24
|
|
Year 1
COMPLETED
|
45
|
24
|
|
Year 1
NOT COMPLETED
|
0
|
0
|
|
Year 2
STARTED
|
45
|
24
|
|
Year 2
COMPLETED
|
41
|
23
|
|
Year 2
NOT COMPLETED
|
4
|
1
|
|
Year 3
STARTED
|
45
|
24
|
|
Year 3
COMPLETED
|
41
|
21
|
|
Year 3
NOT COMPLETED
|
4
|
3
|
|
Year 4
STARTED
|
43
|
0
|
|
Year 4
COMPLETED
|
43
|
0
|
|
Year 4
NOT COMPLETED
|
0
|
0
|
|
Year 5
STARTED
|
43
|
0
|
|
Year 5
COMPLETED
|
42
|
0
|
|
Year 5
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Alair
Alair-treated subjects from AIR PREDECESSOR STUDY (NCT00214526).
|
Control
Control subjects from AIR PREDECESSOR STUDY (NCT00214526).
|
|---|---|---|
|
Year 2
Missed visit but remained in study
|
4
|
1
|
|
Year 3
Withdrawal by Subject
|
1
|
3
|
|
Year 3
Lost to Follow-up
|
1
|
0
|
|
Year 3
Missed visit but remained in study
|
2
|
0
|
|
Year 5
Missed visit but remained in study
|
1
|
0
|
Baseline Characteristics
AIR Extension Study - Long-Term Safety of Alair Treated Subjects
Baseline characteristics by cohort
| Measure |
Alair Treatment
n=45 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY.
|
Control
n=24 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526).
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
40.88 years
STANDARD_DEVIATION 12.13 • n=7 Participants
|
40.30 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
41 participants
n=5 Participants
|
22 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Height (cm)
|
166.17 cm
STANDARD_DEVIATION 9.64 • n=5 Participants
|
164.83 cm
STANDARD_DEVIATION 7.72 • n=7 Participants
|
165.70 cm
STANDARD_DEVIATION 8.99 • n=5 Participants
|
|
Weight (kg)
|
76.37 kg
STANDARD_DEVIATION 23.31 • n=5 Participants
|
77.71 kg
STANDARD_DEVIATION 16.95 • n=7 Participants
|
76.84 kg
STANDARD_DEVIATION 21.20 • n=5 Participants
|
|
Inhaled Corticosteroid Dose
|
1291.11 mcg (micrograms)
STANDARD_DEVIATION 862.10 • n=5 Participants
|
1135.42 mcg (micrograms)
STANDARD_DEVIATION 1030.46 • n=7 Participants
|
1236.96 mcg (micrograms)
STANDARD_DEVIATION 919.58 • n=5 Participants
|
|
Long-acting Beta Agonists (LABA) Dose
|
108.89 mcg (micrograms)
STANDARD_DEVIATION 33.78 • n=5 Participants
|
100.00 mcg (micrograms)
STANDARD_DEVIATION 14.74 • n=7 Participants
|
105.80 mcg (micrograms)
STANDARD_DEVIATION 28.81 • n=5 Participants
|
|
Methacholine PC20
|
0.25 mg/ml
n=5 Participants
|
0.28 mg/ml
n=7 Participants
|
0.26 mg/ml
n=5 Participants
|
|
Asthma Control Questionnaire (ACQ) Overall Score
LABA Stable
|
1.39 Scores on a scale
STANDARD_DEVIATION 0.68 • n=5 Participants
|
1.29 Scores on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
1.36 Scores on a scale
STANDARD_DEVIATION 0.89 • n=5 Participants
|
|
Asthma Control Questionnaire (ACQ) Overall Score
LABA Withdrawal
|
2.50 Scores on a scale
STANDARD_DEVIATION 0.97 • n=5 Participants
|
2.08 Scores on a scale
STANDARD_DEVIATION 0.90 • n=7 Participants
|
2.35 Scores on a scale
STANDARD_DEVIATION 0.96 • n=5 Participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) Score
LABA Stable
|
5.65 Scores on a scale
STANDARD_DEVIATION 0.99 • n=5 Participants
|
5.62 Scores on a scale
STANDARD_DEVIATION 0.92 • n=7 Participants
|
5.64 Scores on a scale
STANDARD_DEVIATION 0.96 • n=5 Participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) Score
LABA Withdrawal
|
4.88 Scores on a scale
STANDARD_DEVIATION 1.30 • n=5 Participants
|
4.84 Scores on a scale
STANDARD_DEVIATION 1.40 • n=7 Participants
|
4.86 Scores on a scale
STANDARD_DEVIATION 1.33 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 Month periods out to 5 yearsThere is not one specific primary outcome measure. The primary objective of this study is to gather additional, longer-term safety data in subjects who participated in the AIR Trial (Protocol #0602-20), called the AIR PREDECESSOR STUDY in the AIR Extension Report (NCT00214526). The 'Percentage of Subjects with any Respiratory Adverse Event' was chosen to be the primary outcome measure because it is the first described in the final study report.
Outcome measures
| Measure |
Alair Year 1
n=45 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 1.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 2
n=45 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 2.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 3
n=43 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 3.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 4
n=43 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 4.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 5
n=42 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 5.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Control Year 1
n=24 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 1.
|
Control Year 2
n=24 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 2.
|
Control Year 3
n=21 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 3.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Any Respiratory Adverse Event
|
38 Participants
|
24 Participants
|
24 Participants
|
23 Participants
|
22 Participants
|
18 Participants
|
13 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Month periods out to 5 yearsOutcome measures
| Measure |
Alair Year 1
n=45 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 1.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 2
n=45 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 2.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 3
n=43 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 3.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 4
n=43 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 4.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 5
n=42 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 5.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Control Year 1
n=24 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 1.
|
Control Year 2
n=24 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 2.
|
Control Year 3
n=21 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 3.
|
|---|---|---|---|---|---|---|---|---|
|
Health Care Usage
Hospitalizations for Respiratory Symptoms
|
0.07 Number events per subject
Standard Deviation 0.25
|
0.07 Number events per subject
Standard Deviation 0.25
|
0.07 Number events per subject
Standard Deviation 0.46
|
0.02 Number events per subject
Standard Deviation 0.15
|
0.02 Number events per subject
Standard Deviation 0.15
|
0.00 Number events per subject
Standard Deviation 0.00
|
0.00 Number events per subject
Standard Deviation 0.00
|
0.05 Number events per subject
Standard Deviation 0.22
|
|
Health Care Usage
Emergency Room (ER) Visits for Respiratory Symptoms
|
0.04 Number events per subject
Standard Deviation 0.21
|
0.07 Number events per subject
Standard Deviation 0.25
|
0.07 Number events per subject
Standard Deviation 0.34
|
0.14 Number events per subject
Standard Deviation 0.47
|
0.05 Number events per subject
Standard Deviation 0.22
|
0.00 Number events per subject
Standard Deviation 0.00
|
0.13 Number events per subject
Standard Deviation 0.34
|
0.14 Number events per subject
Standard Deviation 0.85
|
|
Health Care Usage
Unscheduled Physician Office Visits for Respiratory Symptoms
|
0.42 Number events per subject
Standard Deviation 0.72
|
0.18 Number events per subject
Standard Deviation 0.44
|
0.44 Number events per subject
Standard Deviation 0.70
|
0.70 Number events per subject
Standard Deviation 1.21
|
0.48 Number events per subject
Standard Deviation 0.94
|
0.42 Number events per subject
Standard Deviation 0.72
|
0.25 Number events per subject
Standard Deviation 0.74
|
0.29 Number events per subject
Standard Deviation 0.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Month periods out to 5 yearsNumber of respiratory adverse events per subject
Outcome measures
| Measure |
Alair Year 1
n=45 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 1.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 2
n=45 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 2.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 3
n=43 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 3.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 4
n=43 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 4.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 5
n=42 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 5.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Control Year 1
n=24 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 1.
|
Control Year 2
n=24 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 2.
|
Control Year 3
n=21 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 3.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Respiratory Adverse Events
|
4.5 Number events per subject
Standard Deviation 4.2
|
1.2 Number events per subject
Standard Deviation 1.6
|
1.3 Number events per subject
Standard Deviation 1.9
|
1.2 Number events per subject
Standard Deviation 1.6
|
1.1 Number events per subject
Standard Deviation 2.2
|
3.1 Number events per subject
Standard Deviation 3.7
|
1.2 Number events per subject
Standard Deviation 1.1
|
1.3 Number events per subject
Standard Deviation 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Month periods out to 5 yearsOutcome measures
| Measure |
Alair Year 1
n=40 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 1.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 2
n=37 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 2.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 3
n=35 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 3.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 4
n=36 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 4.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Alair Year 5
n=35 Participants
Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 5.
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY
|
Control Year 1
n=19 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 1.
|
Control Year 2
n=23 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 2.
|
Control Year 3
n=21 Participants
Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 3.
|
|---|---|---|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) - % Predicted
Post-Bronchodilator Off-LABA
|
84.5 percentage predicted
Standard Deviation 13.3
|
85.0 percentage predicted
Standard Deviation 13.1
|
85.1 percentage predicted
Standard Deviation 11.6
|
84.6 percentage predicted
Standard Deviation 14.2
|
83.5 percentage predicted
Standard Deviation 13.5
|
82.2 percentage predicted
Standard Deviation 8.5
|
86.3 percentage predicted
Standard Deviation 9.7
|
80.7 percentage predicted
Standard Deviation 19.8
|
|
Forced Expiratory Volume in 1 Second (FEV1) - % Predicted
Pre-Bronchodilator Off-LABA
|
76.0 percentage predicted
Standard Deviation 14.0
|
73.5 percentage predicted
Standard Deviation 15.0
|
73.9 percentage predicted
Standard Deviation 12.6
|
74.3 percentage predicted
Standard Deviation 15.0
|
70.6 percentage predicted
Standard Deviation 14.6
|
71.6 percentage predicted
Standard Deviation 11.6
|
74.8 percentage predicted
Standard Deviation 10.6
|
70.1 percentage predicted
Standard Deviation 16.9
|
Adverse Events
Alair - Year 1
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Alair - Year 2
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Alair - Year 3
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Alair - Year 4
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Alair - Year 5
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Control - Year 1
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Control - Year 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Control - Year 3
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alair - Year 1
n=45 participants at risk
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Alair - Year 2
n=45 participants at risk
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Alair - Year 3
n=43 participants at risk
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Alair - Year 4
n=43 participants at risk
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Alair - Year 5
n=42 participants at risk
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Control - Year 1
n=24 participants at risk
Control treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Control - Year 2
n=23 participants at risk
Control treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Control - Year 3
n=21 participants at risk
Control treated subjects from PREDECESSOR STUDY (NCT00214526).
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.4%
2/45 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.2%
1/24 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Injury, poisoning and procedural complications
Left Leg Fracture
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.4%
2/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Infection
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.4%
1/42 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.4%
1/42 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Surgical and medical procedures
Knee surgery
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasosinusal polyps
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection pseudomonal
|
2.2%
1/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.4%
1/42 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Reproductive system and breast disorders
Tubal obstruction
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
General disorders
Pyrexia
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Infections and infestations
Sepsis
|
2.2%
1/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
2.2%
1/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.2%
1/24 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.4%
2/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.2%
1/24 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Renal and urinary disorders
Calculus urinary
|
2.2%
1/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Surgical and medical procedures
Laparotomy
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
1/21 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
Other adverse events
| Measure |
Alair - Year 1
n=45 participants at risk
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Alair - Year 2
n=45 participants at risk
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Alair - Year 3
n=43 participants at risk
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Alair - Year 4
n=43 participants at risk
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Alair - Year 5
n=42 participants at risk
Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Control - Year 1
n=24 participants at risk
Control treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Control - Year 2
n=23 participants at risk
Control treated subjects from PREDECESSOR STUDY (NCT00214526).
|
Control - Year 3
n=21 participants at risk
Control treated subjects from PREDECESSOR STUDY (NCT00214526).
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.4%
2/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.7%
2/43 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Gastrointestinal disorders
Nausea
|
8.9%
4/45 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Infections and infestations
Ear infection
|
6.7%
3/45 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.2%
1/24 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Infections and infestations
Influenza
|
6.7%
3/45 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
7.1%
3/42 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.2%
1/24 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Infections and infestations
Sinusitis
|
4.4%
2/45 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
8.3%
2/24 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Infections and infestations
Tonsillitis
|
6.7%
3/45 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.4%
1/42 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.4%
2/45 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.7%
2/43 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.2%
1/24 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Nervous system disorders
Headache
|
28.9%
13/45 • Number of events 36 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.7%
2/43 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.4%
1/42 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
16.7%
4/24 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
8.9%
4/45 • Number of events 5 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
16.3%
7/43 • Number of events 8 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
16.3%
7/43 • Number of events 8 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
14.3%
6/42 • Number of events 8 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
8.7%
2/23 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
1/21 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
15.6%
7/45 • Number of events 9 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.4%
2/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
7.0%
3/43 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
2/42 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
12.5%
3/24 • Number of events 5 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.3%
1/23 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
1/21 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.8%
17/45 • Number of events 29 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
8.9%
4/45 • Number of events 5 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.7%
2/43 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
7.0%
3/43 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
2/42 • Number of events 6 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
33.3%
8/24 • Number of events 9 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
14.3%
3/21 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
44.4%
20/45 • Number of events 40 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
8.9%
4/45 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
9.3%
4/43 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
9.3%
4/43 • Number of events 5 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
9.5%
4/42 • Number of events 7 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
50.0%
12/24 • Number of events 22 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
8.7%
2/23 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
14.3%
3/21 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.7%
2/43 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
2/42 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
13.0%
3/23 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
1/21 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
28.9%
13/45 • Number of events 21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.4%
2/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.4%
1/42 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
20.8%
5/24 • Number of events 6 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
13.3%
6/45 • Number of events 7 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.4%
1/42 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
13.3%
6/45 • Number of events 7 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
8.3%
2/24 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
5/45 • Number of events 7 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
16.7%
4/24 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
9/45 • Number of events 14 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.4%
2/45 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.7%
2/43 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.4%
1/42 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
25.0%
6/24 • Number of events 6 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
8.9%
4/45 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
8.3%
2/24 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
8.9%
4/45 • Number of events 5 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
6.7%
3/45 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
11.6%
5/43 • Number of events 6 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
7.0%
3/43 • Number of events 6 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
2/42 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
20.8%
5/24 • Number of events 6 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
8.7%
2/23 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
1/21 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
2/42 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.2%
1/45 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.7%
2/43 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.7%
2/43 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
2/42 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.3%
1/23 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
8.9%
4/45 • Number of events 5 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
6.7%
3/45 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/43 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/42 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/24 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/21 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheobronchitis
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/45 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.3%
1/43 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
2.4%
1/42 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.2%
1/24 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
0.00%
0/23 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
9.5%
2/21 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
22.2%
10/45 • Number of events 15 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
24.4%
11/45 • Number of events 17 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
18.6%
8/43 • Number of events 13 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
18.6%
8/43 • Number of events 13 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
9.5%
4/42 • Number of events 5 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
8.3%
2/24 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
13.0%
3/23 • Number of events 5 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
19.0%
4/21 • Number of events 7 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
31.1%
14/45 • Number of events 19 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.4%
2/45 • Number of events 3 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
7.0%
3/43 • Number of events 5 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
7.0%
3/43 • Number of events 4 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
2/42 • Number of events 2 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
16.7%
4/24 • Number of events 6 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.3%
1/23 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
4.8%
1/21 • Number of events 1 • Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60