n (%) | Tiotropium Respimat® 5 μga | Tiotropium Respimat® 2.5 μga | Tiotropium Respimat® 1.25 μga | Placebo Respimat®a |
---|---|---|---|---|
(n = 146) | (n = 147) | (n = 146) | (n = 144) | |
Patients with any adverse event | 23 (15.8) | 20 (13.6) | 14 (9.6) | 21 (14.6) |
Patients with severe adverse events | 2 (1.4) | 0 | 0 | 0 |
Patients with serious adverse eventsb | 2 (1.4) | 0 | 0 | 0 |
Patients with investigator-defined drug-related adverse events | 3 (2.1) | 0 | 2 (1.4) | 2 (1.4) |
Patients with adverse events leading to discontinuation of study medication | 1 (0.7) | 0 | 0 | 0 |
Most frequently reported adverse events (>1 patient on any treatment per treatment period) | ||||
Infections and infestations | 9 (6.2) | 4 (2.7) | 6 (4.1) | 7 (4.9) |
Nasopharyngitis | 5 (3.4) | 1 (0.7) | 2 (1.4) | 2 (1.4) |
Bronchitis | 2 (1.4) | 0 | 0 | 0 |
Oral candidiasis | 0 | 0 | 1 (0.7) | 2 (1.4) |
Influenza | 1 (0.7) | 0 | 1 (0.7) | 0 |
Rhinitis | 0 | 0 | 1 (0.7) | 1 (0.7) |
Respiratory, thoracic and mediastinal disorders | 5 (3.4) | 8 (5.4) | 4 (2.7) | 7 (4.9) |
Asthma exacerbation | 4 (2.7) | 3 (2.0) | 1 (0.7) | 5 (3.5) |
Dyspnoea | 0 | 3 (2.0) | 0 | 1 (0.7) |
Cough | 0 | 1 (0.7) | 2 (1.4) | 0 |