Trial Outcomes & Findings for Asthma Intervention Research 2 (AIR2) Trial (NCT NCT00231114)
NCT ID: NCT00231114
Last Updated: 2017-07-27
Results Overview
Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the "Integrated AQLQ Score."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
297 participants
Primary outcome timeframe
Baseline, 12 Months
Results posted on
2017-07-27
Participant Flow
Participant milestones
| Measure |
Alair
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Randomized
STARTED
|
196
|
101
|
|
Randomized
COMPLETED
|
190
|
98
|
|
Randomized
NOT COMPLETED
|
6
|
3
|
|
Treatment Period
STARTED
|
190
|
98
|
|
Treatment Period
COMPLETED
|
189
|
98
|
|
Treatment Period
NOT COMPLETED
|
1
|
0
|
|
Post-Treatment Period
STARTED
|
189
|
98
|
|
Post-Treatment Period
COMPLETED
|
181
|
97
|
|
Post-Treatment Period
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
| Measure |
Alair
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Randomized
Withdrawal by Subject
|
6
|
3
|
|
Treatment Period
Death: Motor Vehicle Accident
|
1
|
0
|
|
Post-Treatment Period
Lost to Follow-up
|
6
|
1
|
|
Post-Treatment Period
Physician Decision
|
1
|
0
|
|
Post-Treatment Period
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Asthma Intervention Research 2 (AIR2) Trial
Baseline characteristics by cohort
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 11.89 • n=99 Participants
|
40.6 years
STANDARD_DEVIATION 11.85 • n=107 Participants
|
40.65 years
STANDARD_DEVIATION 11.86 • n=206 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=99 Participants
|
29 participants
n=107 Participants
|
88 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
36 participants
n=99 Participants
|
17 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
55 participants
n=99 Participants
|
29 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
28 participants
n=99 Participants
|
15 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the "Integrated AQLQ Score."
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
|
1.35 Units on a scale
Standard Deviation 1.10
|
1.16 Units on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Change between Baseline and 12-month Follow-Up Visit. Symptom-Free Days were defined as days when Subject reported no cough, wheeze, breathlessness, or sputum during the daytime, and no wheeze, cough, or awakenings due to asthma symptoms during nighttime.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Percent Symptom-Free Days (Change From Baseline)
|
24.4 Percent Change
Standard Deviation 36.16
|
21.0 Percent Change
Standard Deviation 35.48
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Change from Baseline and 12-month Follow-Up Visit. Total Symptom Score comprises the sum of these six asthma symptom measurements: wheeze during the night, cough during the night, wheeze during the day, cough during the day, breathlessness during the day, and sputum production during the day. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Total Symptom Score (Change From Baseline)
|
-1.7 Units on a scale
Standard Deviation 2.32
|
-1.6 Units on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Number of Puffs of Rescue Medication Used (Change From Baseline)
|
-6.0 Puffs/7 Days
Standard Deviation 16.67
|
-4.3 Puffs/7 Days
Standard Deviation 12.19
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Percent Days Rescue Medication Used (Change From Baseline)
|
-24.0 Percent Change
Standard Deviation 33.51
|
-22.0 Percent Change
Standard Deviation 36.14
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient's FEV1 value (% Predicted) that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
|
-0.82 Units on a scale
Standard Deviation 0.95
|
-0.77 Units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Morning Peak Expiratory Flow (amPEF) (Change From Baseline)
|
27.8 L/Min
Standard Deviation 49.78
|
22.3 L/Min
Standard Deviation 51.54
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
|
-1.4 Percent Change
Standard Deviation 14.71
|
-0.1 Percent Change
Standard Deviation 13.80
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
|
-2.8 Percent Change
Standard Deviation 10.74
|
-2.4 Percent Change
Standard Deviation 8.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Rate of occurrence of worsening of asthma requiring 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 Study entry.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Rate of Severe Exacerbations Requiring Systemic Corticosteroids
|
0.48 Events/Subject/Year
Standard Deviation 0.07
|
0.70 Events/Subject/Year
Standard Deviation 0.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Percent of subjects experiencing worsening of asthma requiring 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 Study entry.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids
|
26.3 Percent of Subjects
|
39.8 Percent of Subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Days Lost From Work/School/Other Activities Due to Asthma
|
1.32 Days/Subject/Year
Standard Deviation 0.36
|
3.9 Days/Subject/Year
Standard Deviation 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Unscheduled Physician Office Visits for Respiratory Symptoms
|
0.28 Events/Subject/Year
Standard Deviation 0.05
|
0.36 Events/Subject/Year
Standard Deviation 0.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsPopulation: Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Outcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Emergency Room Visits for Respiratory Symptoms
|
0.07 Events/Subject/Year
Standard Deviation 0.03
|
0.43 Events/Subject/Year
Standard Deviation 0.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Alair
n=190 Participants
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
Sham
n=98 Participants
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
|
|---|---|---|
|
Hospitalizations for Respiratory Symptoms
|
0.04 Events/Subject/Year
|
0.13 Events/Subject/Year
|
Adverse Events
Alair (Treatment Period)
Serious events: 19 serious events
Other events: 176 other events
Deaths: 0 deaths
Sham (Treatment Period)
Serious events: 4 serious events
Other events: 82 other events
Deaths: 0 deaths
Alair (Post-Treatment Period)
Serious events: 12 serious events
Other events: 157 other events
Deaths: 0 deaths
Sham (Post-Treatment Period)
Serious events: 10 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alair (Treatment Period)
n=190 participants at risk
Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Airways treated with the Alair System.
|
Sham (Treatment Period)
n=98 participants at risk
Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Sham treatment.
|
Alair (Post-Treatment Period)
n=187 participants at risk
Six weeks after the last bronchoscopy session until 12 Months. Airways treated with the Alair System.
|
Sham (Post-Treatment Period)
n=98 participants at risk
Six weeks after the last bronchoscopy session until 12 Months. Sham treatment.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.53%
1/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma (Multiple Symptoms)
|
4.7%
9/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.0%
2/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.7%
5/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
4.1%
4/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.1%
2/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.53%
1/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.53%
1/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Stage II
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.53%
1/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.53%
1/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis Pyrophosphate
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.53%
1/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Psychiatric disorders
Depression
|
0.53%
1/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
General disorders
Fatigue
|
0.53%
1/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Investigations
Forced Expiratory Volume Decreased
|
0.53%
1/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Foreign Body Aspiration
|
0.53%
1/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Surgical and medical procedures
Haematoma Evacuation
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.53%
1/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Nervous system disorders
Headache
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Infection
|
1.1%
2/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Nervous system disorders
Migraine
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.53%
1/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.53%
1/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.53%
1/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.53%
1/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
Other adverse events
| Measure |
Alair (Treatment Period)
n=190 participants at risk
Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Airways treated with the Alair System.
|
Sham (Treatment Period)
n=98 participants at risk
Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Sham treatment.
|
Alair (Post-Treatment Period)
n=187 participants at risk
Six weeks after the last bronchoscopy session until 12 Months. Airways treated with the Alair System.
|
Sham (Post-Treatment Period)
n=98 participants at risk
Six weeks after the last bronchoscopy session until 12 Months. Sham treatment.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Sinusitis
|
2.6%
5/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.0%
2/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
3.7%
7/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
8.2%
8/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma (Multiple Symptoms)
|
52.1%
99/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
38.8%
38/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
27.3%
51/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
42.9%
42/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.7%
9/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
6.1%
6/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
3.2%
6/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
5.1%
5/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
3.7%
7/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.0%
2/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
7.0%
13/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
5.1%
5/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Discomfort
|
8.9%
17/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
10.2%
10/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.6%
3/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
13.7%
26/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
13.3%
13/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.7%
5/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
23/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
14.3%
14/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.7%
5/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
5.1%
5/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
21/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
6.1%
6/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.1%
4/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.0%
1/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Nervous system disorders
Headache
|
14.2%
27/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
9.2%
9/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
4.8%
9/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
3.1%
3/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Infections and infestations
Influenza
|
4.2%
8/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.0%
2/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
4.3%
8/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
12.2%
12/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Infection
|
7.9%
15/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.0%
2/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
3.2%
6/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
6.1%
6/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
4.7%
9/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
7.1%
7/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
10.7%
20/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
5.1%
5/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
3.2%
6/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
5.1%
5/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.53%
1/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.0%
2/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
7.4%
14/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
9.2%
9/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.7%
5/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
4.1%
4/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
1.6%
3/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
0.00%
0/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
4.3%
8/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
6.1%
6/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
3.2%
6/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
5.1%
5/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
6.4%
12/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
7.1%
7/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
4.7%
9/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
12.2%
12/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
1.1%
2/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
3.1%
3/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
20.0%
38/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
11.2%
11/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
29.9%
56/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
25.5%
25/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Viral Upper Respiratory Tract Infection
|
4.2%
8/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
2.0%
2/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
5.9%
11/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
7.1%
7/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
15.3%
29/190
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
6.1%
6/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
4.3%
8/187
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
3.1%
3/98
Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
|
Additional Information
Narinder S Shargill, PhD
Asthmatx, Inc.
Phone: 408-419-0100
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60