Table 4 TEAEs reported for ≥3 % of patients in a treatment group (safety population)
n (%) | 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 | |||
Dry mouth | 2 (3.1) | 3 (4.7) | 3 (4.8) | 6 (9.4) | 3 (5.3) | 4 (6.8) | 3 (4.8) | 6 (9.7) |
Back pain | 0 | 2 (3.1) | 0 | 2 (3.1) | 2 (3.5) | 0 | 1 (1.6) | 0 |
Cough | 0 | 2 (3.1) | 0 | 1 (1.6) | 0 | 1 (1.7) | 3 (4.8) | 0 |
Hypertension | 1 (1.6) | 1 (1.6) | 1 (1.6) | 2 (3.1) | 1 (1.8) | 1 (1.7) | 1 (1.6) | 1 (1.6) |
Peripheral edema | 0 | 0 | 2 (3.2) | 0 | 0 | 1 (1.7) | 2 (3.2) | 0 |
Sinusitis | 1 (1.6) | 0 | 0 | 2 (3.1) | 1 (1.8) | 0 | 0 | 1 (1.6) |
Muscle spasm | 0 | 1 (1.6) | 0 | 1 (1.6) | 0 | 2 (3.4) | 0 | 0 |
Pain in extremity | 0 | 0 | 1 (1.6) | 0 | 0 | 2 (3.4) | 1 (1.6) | 0 |
Excoriation | 0 | 1 (1.6) | 2 (3.2) | 1 (1.6) | 0 | 0 | 0 | 0 |
Nasopharyngitis | 1 (1.6) | 0 | 0 | 0 | 0 | 0 | 2 (3.2) | 0 |