Table 4 Summary of AEs
Placebo, n (%) | Olodaterol 2.5 μg BID, n (%) | Olodaterol 5 μg QD, n (%) | Olodaterol 5 μg BID, n (%) | Olodaterol 10 μg QD, n (%) | Total, n (%) | |
|---|---|---|---|---|---|---|
All AEs | 33 (16.4) | 15 (14.9) | 15 (14.9) | 19 (18.8) | 13 (12.7) | 73 (35.4) |
Treatment-related AEs | 2 (1.0) | 0 | 1 (1.0) | 3 (3.0) | 1 (1.0) | 7 (3.4) |
AEs leading to discontinuation | 0 | 1 (1.0) | 0 | 1 (1.0) | 0 | 2 (1.0) |
Serious AEs | 2 (1.0) | 1 (1.0) | 0 | 1 (1.0) | 0 | 4 (1.9) |
Specific AEs with an incidence >1 % | ||||||
Asthma | 4 (2.0) | 1 (1.0) | 1 (1.0) | 2 (2.0) | 1 (1.0) | 9 (4.4) |
Injury, poisoning and procedural complications | 2 (1.0) | 3 (3.0) | 0 | 3 (3.0) | 1 (1.0) | 9 (4.4) |
Headache | 5 (2.5) | 1 (1.0) | 2 (2.0) | 0 | 3 (2.9) | 9 (4.4) |
Sinusitis | 1 (0.5) | 0 | 0 | 0 | 4 (3.9) | 5 (2.4) |
Nasopharyngitis | 3 (1.5) | 0 | 0 | 1 (1.0) | 0 | 4 (1.9) |
Musculoskeletal and connective tissue disorders | 0 | 2 (2.0) | 1 (1.0) | 1 (1.0) | 0 | 4 (1.9) |
Upper respiratory tract infection | 3 (1.5) | 1 (1.0) | 0 | 1 (1.0) | 0 | 4 (1.9) |
Cystitis | 1 (0.5) | 0 | 0 | 2 (2.0) | 0 | 2 (1.0) |
Eye disorders | 1 (0.5) | 0 | 0 | 2 (2.0) | 0 | 2 (1.0) |
Rhinitis allergic | 0 | 2 (2.0) | 0 | 0 | 0 | 2 (1.0) |
Skin and cutaneous tissue disorders | 0 | 0 | 2 (2.0) | 0 | 0 | 2 (1.0) |