Trial Outcomes & Findings for RISA Extension Study - Long Term Safety (NCT NCT00401986)
NCT ID: NCT00401986
Last Updated: 2021-02-01
Results Overview
The respiratory-related adverse event profile for the Alair group was analyzed on an annual basis in order to highlight trends in adverse occurrence.
Recruitment status
COMPLETED
Target enrollment
14 participants
Primary outcome timeframe
2-year, 3-year, 4-year and 5-year follow up post procedure
Results posted on
2021-02-01
Participant Flow
Participant milestones
| Measure |
Alair Group
A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RISA Extension Study - Long Term Safety
Baseline characteristics by cohort
| Measure |
Alair Group
n=14 Participants
Baseline Demographics are based on data collected at the time of entry into the PREDECESSOR STUDY (NCT00214539).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
38.64 years
STANDARD_DEVIATION 13.31 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=99 Participants
|
|
amPEF (Peak Expiratory Flow)
|
369.95 L/min (liters per minute)
STANDARD_DEVIATION 82.04 • n=99 Participants
|
|
Pre-Bronchodilator FEV1 (Forced Expiratory Volume in 1 second)
|
63.46 % predicted
STANDARD_DEVIATION 12.49 • n=99 Participants
|
|
Post-Bronchodilator FEV1
|
75.19 % predicted
STANDARD_DEVIATION 11.91 • n=99 Participants
|
|
ICS Dose (Inhaled Corticosteroid dose)
|
1179 µg/day (microgram/day)
STANDARD_DEVIATION 421 • n=99 Participants
|
|
LABA Dose (Long-acting Beta Agonists)
|
127 µg/day (microgram/day)
STANDARD_DEVIATION 62 • n=99 Participants
|
|
OCS Dose (Oral corticosteroids)
|
13.6 mg/day (milligrams/day)
STANDARD_DEVIATION 6.3 • n=99 Participants
|
|
Rescue Medication Use
|
60.9 Puffs/7 days
STANDARD_DEVIATION 60.9 • n=99 Participants
|
|
Asthma Control Questionnaire (ACQ) Score
|
2.76 scores on a scale
STANDARD_DEVIATION 1.02 • n=99 Participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) Score
|
4.11 scores on a scale
STANDARD_DEVIATION 1.27 • n=99 Participants
|
|
Symptom-Free Days
|
5.61 percentage of days
STANDARD_DEVIATION 14.06 • n=99 Participants
|
|
Total Symptom Score
|
5.35 scores on a scale
STANDARD_DEVIATION 2.92 • n=99 Participants
|
|
Unscheduled Physician Office Visits
|
8 Number of events
n=99 Participants
|
|
Emergency Room Visits
|
4 Number of events
n=99 Participants
|
|
Hospitalizations
|
10 Number of events
n=99 Participants
|
PRIMARY outcome
Timeframe: 2-year, 3-year, 4-year and 5-year follow up post procedurePopulation: A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment. All 14 subjects completed their Year 3 visit and 12 subjects have completed their Year 4 and 5 visits.
The respiratory-related adverse event profile for the Alair group was analyzed on an annual basis in order to highlight trends in adverse occurrence.
Outcome measures
| Measure |
Alair Group
n=14 Participants
A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment.
A total of 145 adverse events have been reported by the 14 subjects enrolled in the present study over Year 2 through 5. One hundred and three adverse events (71%) were respiratory-related.
The number of subjects reporting respiratory-related adverse events each year was consistent. Reporting were 11/14 subjects (78.6%) in Year 2, 12/14 subjects (85.7%) in Year 3, 10/12 subjects (83.3%) in Year 4, and 12/12 subjects (100%) in Year 5 reported respiratory adverse events.
|
|---|---|
|
Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments
Year 2, n=14
|
78.6 percentage subjects with respiratory AEs
|
|
Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments
Year 3, n=14
|
85.7 percentage subjects with respiratory AEs
|
|
Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments
Year 4, n=12
|
83.3 percentage subjects with respiratory AEs
|
|
Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments
Year 5, n=12
|
100 percentage subjects with respiratory AEs
|
PRIMARY outcome
Timeframe: 2-year, 3-year, 4-year and 5-year follow up post procedurePopulation: Subject attrition at years 4 \& 5
Pull down menu does not have a rate unit. Numbers reported represents Rate of Respiratory Adverse (number of Events/number of Subject/year).
Outcome measures
| Measure |
Alair Group
n=14 Participants
A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment.
A total of 145 adverse events have been reported by the 14 subjects enrolled in the present study over Year 2 through 5. One hundred and three adverse events (71%) were respiratory-related.
The number of subjects reporting respiratory-related adverse events each year was consistent. Reporting were 11/14 subjects (78.6%) in Year 2, 12/14 subjects (85.7%) in Year 3, 10/12 subjects (83.3%) in Year 4, and 12/12 subjects (100%) in Year 5 reported respiratory adverse events.
|
|---|---|
|
Respiratory Adverse Events
Year 2, n=14
|
1.4 Number of events/number of subject/Year
|
|
Respiratory Adverse Events
Year 3, n=14
|
2.4 Number of events/number of subject/Year
|
|
Respiratory Adverse Events
Year 4, n=12
|
1.7 Number of events/number of subject/Year
|
|
Respiratory Adverse Events
Year 5, n=12
|
2.4 Number of events/number of subject/Year
|
SECONDARY outcome
Timeframe: 2-year, 3-year, 4-year and 5-year follow up post procedurePopulation: Subject attrition at years 4 \& 5
Pull down menu does not have a rate unit. Rate of Hospitalizations for Respiratory Symptoms (number of Events/number of Subject/year)
Outcome measures
| Measure |
Alair Group
n=14 Participants
A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment.
A total of 145 adverse events have been reported by the 14 subjects enrolled in the present study over Year 2 through 5. One hundred and three adverse events (71%) were respiratory-related.
The number of subjects reporting respiratory-related adverse events each year was consistent. Reporting were 11/14 subjects (78.6%) in Year 2, 12/14 subjects (85.7%) in Year 3, 10/12 subjects (83.3%) in Year 4, and 12/12 subjects (100%) in Year 5 reported respiratory adverse events.
|
|---|---|
|
Hospitalizations for Respiratory Symptoms
Year 2, n=14
|
0.4 Number of events/number of subject/Year
|
|
Hospitalizations for Respiratory Symptoms
Year 3, n=14
|
0.2 Number of events/number of subject/Year
|
|
Hospitalizations for Respiratory Symptoms
Year 4, n=12
|
0.1 Number of events/number of subject/Year
|
|
Hospitalizations for Respiratory Symptoms
Year 5, n=12
|
0.1 Number of events/number of subject/Year
|
SECONDARY outcome
Timeframe: 2-year, 3-year, 4-year and 5-year follow up post procedurePopulation: Subject attrition at years 4 \& 5
Pull down menu does not have a rate unit. Rate of Emergency Room Visits for Respiratory Symptoms (number of Events/number of Subjects/year)
Outcome measures
| Measure |
Alair Group
n=14 Participants
A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment.
A total of 145 adverse events have been reported by the 14 subjects enrolled in the present study over Year 2 through 5. One hundred and three adverse events (71%) were respiratory-related.
The number of subjects reporting respiratory-related adverse events each year was consistent. Reporting were 11/14 subjects (78.6%) in Year 2, 12/14 subjects (85.7%) in Year 3, 10/12 subjects (83.3%) in Year 4, and 12/12 subjects (100%) in Year 5 reported respiratory adverse events.
|
|---|---|
|
Emergency Room Visits for Respiratory Symptoms
Year 2, n=14
|
0.3 Number of events/number of subject/Year
|
|
Emergency Room Visits for Respiratory Symptoms
Year 3, n=14
|
0 Number of events/number of subject/Year
|
|
Emergency Room Visits for Respiratory Symptoms
Year 4, n=12
|
0 Number of events/number of subject/Year
|
|
Emergency Room Visits for Respiratory Symptoms
Year 5, n=12
|
0.1 Number of events/number of subject/Year
|
Adverse Events
Year 2
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Year 3
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Year 4
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Year 5
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Year 2
n=14 participants at risk
Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
|
Year 3
n=14 participants at risk
Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
|
Year 4
n=12 participants at risk
Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
|
Year 5
n=12 participants at risk
Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
|
|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
General disorders
Pyrexia
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Injury, poisoning and procedural complications
Sudden Death
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
16.7%
2/12 • Number of events 3 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Renal and urinary disorders
Renal colic
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
21.4%
3/14 • Number of events 5 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exacerbated
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Surgical and medical procedures
Asthma exacerbation prophylaxis
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
Other adverse events
| Measure |
Year 2
n=14 participants at risk
Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
|
Year 3
n=14 participants at risk
Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
|
Year 4
n=12 participants at risk
Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
|
Year 5
n=12 participants at risk
Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
35.7%
5/14 • Number of events 11 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
50.0%
7/14 • Number of events 12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
16.7%
2/12 • Number of events 3 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
33.3%
4/12 • Number of events 4 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
14.3%
2/14 • Number of events 2 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
21.4%
3/14 • Number of events 4 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
14.3%
2/14 • Number of events 2 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 2 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
35.7%
5/14 • Number of events 5 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
28.6%
4/14 • Number of events 5 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
41.7%
5/12 • Number of events 8 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
58.3%
7/12 • Number of events 11 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 2 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
14.3%
2/14 • Number of events 2 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
16.7%
2/12 • Number of events 3 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
16.7%
2/12 • Number of events 3 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
14.3%
2/14 • Number of events 2 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 2 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
General disorders
Mass
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
General disorders
Venipuncture site thrombosis
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Infections and infestations
Ear infection
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Infections and infestations
Gastritis viral
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Injury, poisoning and procedural complications
Whiplash injury
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 2 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 2 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
16.7%
2/12 • Number of events 2 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Renal and urinary disorders
Renal colic
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
|
Surgical and medical procedures
Asthma exacerbation prophylaxis
|
0.00%
0/14 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
7.1%
1/14 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
8.3%
1/12 • Number of events 1 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
0.00%
0/12 • Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60