TABLE 3.
Overall summary of adverse events (AEs)
| Tiotropium Respimat 5 µg once daily | Tiotropium Respimat 2.5 µg once daily | Placebo Respimat once daily | Total | |
| Patients n | 130 | 127 | 135 | 392 |
| Patients with any AE | 43 (33.1) | 42 (33.1) | 48 (35.6) | 133 (33.9) |
| Patients with severe AEs | 3 (2.3) | 0 | 0 | 3 (0.8) |
| Patients with investigator-defined drug-related AEs | 0 | 0 | 1 (0.7) | 1 (0.3) |
| Patients with AEs leading to discontinuation of trial medication | 0 | 0 | 1 (0.7) | 1 (0.3) |
| Patients with serious AEs | 2 (1.5) | 1 (0.8) | 0 | 3 (0.8) |
| AEs in >2% patients, by preferred term# | ||||
| Asthma¶ | 15 (11.5) | 14 (11.0) | 14 (10.4) | 43 (11.0) |
| Decreased peak expiratory flow rate | 5 (3.8) | 9 (7.1) | 13 (9.6) | 27 (6.9) |
| Nasopharyngitis | 5 (3.8) | 6 (4.7) | 4 (3.0) | 15 (3.8) |
| Rhinitis | 1 (0.8) | 3 (2.4) | 3 (2.2) | 7 (1.8) |
| Upper respiratory tract infection | 3 (2.3) | 1 (0.8) | 3 (2.2) | 7 (1.8) |
| Viral infection | 0 | 1 (0.8) | 4 (3.0) | 5 (1.3) |
| Allergic rhinitis | 0 | 2 (1.6) | 3 (2.2) | 5 (1.3) |
| Tonsillitis | 3 (2.3) | 0 | 1 (0.7) | 4 (1.0) |
| Viral respiratory tract infection | 1 (0.8) | 0 | 3 (2.2) | 4 (1.0) |
Data are presented as n or n (%). Treated set. Patients may be counted in more than one category. #: Medical Dictionary for Regulatory Activities version 16.1, www.meddra.org/sites/default/files/guidance/file/intguide_16_1_english.pdf; ¶: includes asthma worsening and asthma exacerbations.