Table 5 Frequency of AEs (pooled analysis)
Pooled analysis | |||||
|---|---|---|---|---|---|
Placebo | Olodaterol 5 μg | Olodaterol 10 μg | Formoterol 18 μg | Total | |
(n = 190) | (n = 188) | (n = 187) | (n = 186) | (n = 199) | |
Patients with any AE | 60 (31.6) | 61 (32.4) | 64 (34.2) | 49 (26.3) | 129 (64.8) |
Patients with severe AEs | 11 (5.8) | 9 (4.8) | 6 (3.2) | 10 (5.4) | 28 (14.1) |
Discontinuations due to AEs | 4 (2.1) | 4 (2.1) | 3 (1.6) | 3 (1.6) | 14 (7.0) |
COPD | 12 (6.3) | 10 (5.3) | 9 (4.8) | 8 (4.3) | 35 (17.6) |
Upper respiratory tract infection | 4 (2.1) | 5 (2.7) | 7 (3.7) | 7 (3.8) | 19 (9.5) |
Bronchitis | 3 (1.6) | 7 (3.7) | 4 (2.1) | 4 (2.2) | 14 (7.0) |
Cough | 1 (0.5) | 6 (3.2) | 1 (0.5) | 4 (2.2) | 12 (6.0) |
Headache | 2 (1.1) | 2 (1.1) | 5 (2.7) | 2 (1.1) | 9 (4.5) |
Sinusitis | 3 (1.6) | 1 (0.5) | 3 (1.6) | 3 (1.6) | 9 (4.5) |
Urinary tract infection | 4 (2.1) | 0 | 4 (2.1) | 2 (1.1) | 9 (4.5) |
Diarrhea | 1 (0.5) | 0 | 2 (1.1) | 2 (1.1) | 5 (2.5) |
Nausea | 3 (1.6) | 1 (0.5) | 0 | 1 (0.5) | 5 (2.5) |
Muscle spasms | 1 (0.5) | 1 (0.5) | 1 (0.5) | 2 (1.1) | 5 (2.5) |
Chest pain | 2 (1.1) | 1 (0.5) | 2 (1.1) | 0 | 5 (2.5) |
Pneumonia | 1 (0.5) | 0 | 2 (1.1) | 1 (0.5) | 4 (2.0) |
Respiratory tract congestion | 3 (1.6) | 0 | 1 (0.5) | 0 | 4 (2.0) |