Table 2.
Summary of adverse events through 1 year
| 20 watt cohort n=12 |
15 watt cohort n=10 |
All n=22 |
||||
|---|---|---|---|---|---|---|
| RF dosage, watt Adverse event |
Adverse event frequency n=60 (%) |
Subject * frequency (%) |
Adverse event frequency n=39 (%) |
Subject* frequency (%) |
Adverse event frequency n=99 (%) |
Subject* frequency (%) |
| Device-related non-serious | ||||||
| Bronchial perforation (carina) | 2 (3) | 2 (17) | – | – | 2 (2) | 2 (9) |
| Bronchial stenosis | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| Bronchial ulceration | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| COPD Exacerbation | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
| Granulomas | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| Worsening of FEV1† | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
| Device related-serious | ||||||
| Gastroparesis | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
| Procedural related-non-serious (related or reported within 2 days of either procedure) | ||||||
| Broken tooth | 1 (2) | 1 (8) | 1 (1) | 1 (5) | ||
| Cough | 2 (3) | 2 (17) | – | – | 2 (2) | 2 (9) |
| Dyspnoea | 2 (3) | 2 (17) | 1 (3) | 1 (10) | 3 (3) | 3 (14) |
| Eczema | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
| Headache | 2 (3) | 2 (17) | – | – | 2 (2) | 2 (9) |
| Mucus | 3 (5) | 3 (25) | – | – | 3 (3) | 3 (14) |
| Sore throat | 3 (5) | 3 (25) | 1 (3) | 1 (10) | 4 (4) | 4 (18) |
| Tracheal injury (due to rigid bronchoscope) | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| Procedural related-serious (related or reported within 2 days of either procedure) | ||||||
| Anaphylactic reaction | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| COPD exacerbation | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
| Other non-serious | ||||||
| Abscess (skin) | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
| Back ache | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| Bronchitis | – | – | 5 (13) | 2 (20) | 5 (5) | 2 (9) |
| Candida | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
| Chest pain | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| Common cold | 2 (3) | 2 (17) | – | – | 2 (2) | 2 (9) |
| COPD exacerbation | 12 (20) | 7 (58) | 13 (33) | 6 (60) | 25 (25) | 13 (59) |
| Cough | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| Diarrhoea | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| Difficulty swallowing | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| Dizziness | 2 (3) | 2 (17) | 1 (3) | 1 (10) | 3 (3) | 3 (14) |
| Dyspnoea | 3 (5) | 2 (17) | 1 (3) | 1 (10) | 4 (4) | 3 (14) |
| Flu | 3 (5) | 3 (25) | 1 (3) | 1 (10) | 4 (4) | 4 (18) |
| Gastritis | 2 (3) | 2 (17) | 1 (3) | 1 (10) | 3 (3) | 3 (14) |
| Gastroparesis | 1 (2) | 1 (8) | – | – | 1 (1) | 1 (5) |
| Pneumonia | 1 (1) | 1 (8) | – | – | 1 (1) | 1 (5) |
| Respiratory inflammation | 4 (7) | 4 (33) | – | – | 4 (4) | 4 (18) |
| Sinusitis | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
| Other serious | ||||||
| Chest pain | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
| COPD exacerbation | 2 (3) | 2 (17) | 5 (13) | 3 (30) | 7 (7) | 5 (23) |
| Coronary artery disease/CABG | 1 (2) | – | – | – | 1 (1) | 1 (5) |
| Flu | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
| Lung infection | 2 (3) | 2 (17) | – | – | 2 (2) | 2 (9) |
| Stomach cancer (stage 3) | – | – | 1 (3) | 1 (10) | 1 (1) | 1 (5) |
A total of 99 adverse events were reported in 22 (100%) subjects.
Serious/non-serious defined per ISO 14155.
All adverse events were independently adjudicated.
*Count reflects number of subjects with event reported one or more times.
†Adverse event included based on primary endpoint definition.
CABG, coronary artery bypass surgery; COPD, chronic obstructive pulmonary disease; RF, radiofrequency; SGRQ, St. George's Respiratory Questionnaire.