Table 3 Overview of TEAEs (safety population)
GP MDI | Placebo n = 62 | Open-label tiotropium n = 62 | ||||||
|---|---|---|---|---|---|---|---|---|
18 μg n = 64 | 9 μg n = 64 | 4.6 μg n = 62 | 2.4 μg n = 64 | 1.2 μg n = 57 | 0.6 μg n = 59 | |||
At least one TEAE | ||||||||
n (%) | 17 (26.6) | 18 (28.1) | 14 (22.6) | 19 (29.7) | 14 (24.6) | 13 (22.0) | 15 (24.2) | 16 (25.8) |
TEAEs related to study treatment | ||||||||
n (%) | 5 (7.8) | 4 (6.3) | 4 (6.5) | 6 (9.4) | 4 (7.0) | 2 (3.4) | 5 (8.1) | 3 (4.8) |
Serious AEs | ||||||||
n (%) | 0 | 1 (1.6) | 0 | 1 (1.6) | 0 | 1 (1.7) | 1 (1.6) | 1 (1.6) |
TEAEs leading to study withdrawal | ||||||||
n (%) | 3 (4.7) | 2 (3.1) | 0 | 1 (1.6) | 1 (1.8) | 1 (1.7) | 1 (1.6) | 1 (1.6) |