Table 4 Common adverse events reported by participants who completed all study visits
Adverse Event (AE) | Study Visits | |||
|---|---|---|---|---|
4-week | 8-week | 12-week | 24-week | |
no. pts reporting AEs/total no. pts (%) | no. pts reporting AEs/total no. pts (%) | no. pts reporting AEs/total no. pts (%) | no. pts reporting AEs/total no. pts (%) | |
Throat/mouth irritation* | 16/45 (35.6%) | 9/43 (20.9%) | 7/41 (17.1%) | 4/38 (10.5%) |
Dry throat/mouth | 13/45 (28.9%) | 10/43 (23.3%) | 9/41 (22.0%) | 7/38 (18.4%) |
Headache | 12/45 (26.7%) | 9/43 (20.9%) | 8/41 (19.5%) | 8/38 (21.1%) |
Dry cough | 10/45 (22.2%) | 7/43 (16.3%) | 5/41 (12.2%) | 2/38 (5.3%) |
Dizziness§ | 7/45 (15.6%) | 7/43 (16.3%) | 5/41 (12.2%) | 3/38 (7.9%) |
Nausea | 6/45 (13.3%) | 5/43 (11.6%) | 5/41 (12.2%) | 5/38 (13.2%) |
Sore throat | 4/45 (8.9%) | 3/43 (7.0%) | 1/41 (2.4%) | 1/38 (2.6%) |
Palpitations | 3/45 (6.7%) | 3/43 (7.0%) | 0/41 (0%) | 0/38 (0%) |
Choking sensation | 2/45 (4.4%) | 1/43 (2.3%) | 0/41 (0%) | 0/38 (0%) |