Table 6 Common adverse eventsa (treated setb)
Study 1222.37, n (%) | Study 1222.38, n (%) | |||||
|---|---|---|---|---|---|---|
Placebo | Olodaterol 5 μg | Olodaterol 10 μg | Placebo | Olodaterol 5 μg | Olodaterol 10 μg | |
(n = 143) | (n = 147) | (n = 143) | (n = 149) | (n = 150) | (n = 147) | |
Any adverse event | 38 (26.6) | 49 (33.3) | 42 (29.4) | 34 (22.8) | 42 (28.0) | 31 (21.1) |
Serious adverse event | 3 (2.1) | 3 (2.0) | 3 (2.1) | 3 (2.0) | 8 (5.3) | 3 (2.0) |
Adverse event leading to discontinuation | 4 (2.8) | 4 (2.7) | 2 (1.4) | 1 (0.7) | 2 (1.3) | 0 (0.0) |
Most common adverse events | ||||||
COPD exacerbation Nasopharyngitis Insomnia Headache Dyspnoea Cough Oropharyngeal pain | 10 (7.0) 4 (2.8) 0 (0.0) 1 (0.7) 3 (2.1) 2 (1.4) 1 (0.7) | 11 (7.5) 3 (2.0) 2 (1.4) 4 (2.7) 4 (2.7) 1 (0.7) 0 (0.0) | 7 (4.9) 1 (0.7) 3 (2.1) 2 (1.4) 2 (1.4) 3 (2.1) 3 (2.1) | 10 (6.7) 3 (2.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (1.3) 0 (0.0) | 9 (6.0) 2 (1.3) 0 (0.0) 2 (1.3) 1 (0.7) 1 (0.7) 0 (0.0) | 4 (2.7) 7 (4.8) 0 (0.0) 2 (1.4) 2 (1.4) 0 (0.0) 0 (0.0) |