Table 4 Summary of adverse events (safety population)
GFF MDI | GP MDI 36 μg (N = 41) | Open-label tiotropium 18 μg (N = 58) | FF MDI | Placebo MDI (N = 52) | Open-label FFa DPI 12 μg (N = 55) | |||
|---|---|---|---|---|---|---|---|---|
72/9.6 μg (N = 41) | 36/9.6 μg (N = 43) | 9.6 μg (N = 64) | 7.2 μg (N = 64) | |||||
Patients with at least one AE, n (%) | 17 (41.5) | 18 (41.9) | 11 (26.8) | 22 (37.9) | 24 (37.5) | 16 (25.0) | 9 (17.3) | 17 (30.9) |
Patients with AE related to study treatment, n (%) | 13 (31.7) | 12 (27.9) | 7 (17.1) | 7 (12.1) | 7 (10.9) | 4 (6.3) | 2 (3.8) | 7 (12.7) |
Patients with SAE, n (%) | 0 | 1 (2.3) | 0 | 2 (3.4) | 1 (1.6) | 2 (3.1) | 0 | 0 |
Patients with SAE related to study treatment, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Patients with AE leading to early withdrawal, n (%) | 1 (2.4) | 0 | 1 (2.4) | 1 (1.7) | 4 (6.3) | 3 (4.7) | 1 (1.9) | 0 |
Patients with SAE leading to early withdrawal, n (%) | 0 | 0 | 0 | 0 | 0 | 2 (3.1) | 0 | 0 |
TEAEs reported in ≥2 patients in any treatment group | ||||||||
Dry mouth | 8 (19.5) | 3 (7.0) | 5 (12.2) | 4 (6.9) | 3 (4.7) | 2 (3.1) | 1 (1.9) | 2 (3.6) |
Headache | 3 (7.3) | 4 (9.3) | 1 (2.4) | 1 (1.7) | 1 (1.6) | 0 | 1 (1.9) | 2 (3.6) |
Tremor | 1 (2.4) | 5 (11.6) | 0 | 0 | 0 | 0 | 0 | 0 |
Cough | 0 | 2 (4.7) | 0 | 1 (1.7) | 0 | 0 | 0 | 0 |
Dysphonia | 1 (2.4) | 2 (4.7) | 0 | 0 | 0 | 0 | 0 | 0 |