Table 4 Number (%) of study patients reporting AEs (safety population)
Preferred term | PBO MDI | GP MDI | GP MDI | GP MDI | GP MDI | TIO |
|---|---|---|---|---|---|---|
n = 21 | 14.4 μg | 28.8 μg | 57.6 μg | 115.2 μg | 18 μg | |
n (%) | n = 21 | n = 23 | n = 21 | n = 21 | n = 22 | |
n (%) | n (%) | n (%) | n (%) | n (%) | ||
One or more AEs | 4 (19.0) | 3 (14.3) | 3 (13.0) | 5 (23.8) | 3 (14.3) | 4 (18.2) |
Dry mouth | 2 (9.5) | 1 (4.8) | 0 | 3 (14.3) | 1 (4.8) | 2 (9.1) |
Oropharyngeal pain | 0 | 1 (4.8) | 0 | 0 | 1 (4.8) | 0 |
Bronchospasm paradoxical | 0 | 0 | 0 | 0 | 1 (4.8) | 0 |
Nasopharyngitis | 0 | 0 | 0 | 1 (4.8) | 0 | 0 |
Urinary tract infection | 0 | 0 | 0 | 1 (4.8) | 0 | 0 |
Vessel puncture site hematoma | 0 | 0 | 1 (4.3) | 0 | 0 | 1 (4.5) |
Sinusitis | 0 | 0 | 1 (4.3) | 0 | 0 | 0 |
Headache | 0 | 0 | 1 (4.3) | 0 | 0 | 0 |
Insomnia | 0 | 0 | 1 (4.3) | 0 | 0 | 0 |
Dyspnea | 0 | 0 | 1 (4.3) | 0 | 0 | 0 |
Hypertension | 0 | 0 | 1 (4.3) | 0 | 0 | 0 |
Dizziness | 0 | 1 (4.8) | 0 | 0 | 0 | 0 |
Cough | 0 | 1 (4.8) | 0 | 0 | 0 | 0 |
Diarrhea | 0 | 0 | 0 | 0 | 0 | 1 (4.5) |
Umbilical hernia | 1 (4.8) | 0 | 0 | 0 | 0 | 0 |
Gastroenteritis | 1 (4.8) | 0 | 0 | 0 | 0 | 0 |
Gastrointestinal viral infection | 1 (4.8) | 0 | 0 | 0 | 0 | 0 |