Frequency of AEs occurring in >2% of patients
| AEs occurring in >2% of patients, n (%)a | |||
| Tiotropium Respimat® 5 µg (n = 1256) | Tiotropium Respimat® 2.5 µg (n = 673) | Placebo Respimat® (n = 1260) | |
| Exposure, patient-years | 705.42 | 271.08 | 708.04 |
| Any AE | 732 (58.3) | 350 (52.0) | 772 (61.3) |
| Serious AEs | 51 (4.1) | 12 (1.8) | 56 (4.4) |
| AEs by preferred term | |||
| Asthma | 326 (26.0) | 106 (15.8) | 384 (30.5) |
| Decreased PEF rate | 158 (12.6) | 58 (8.6) | 207 (16.4) |
| Nasopharyngitis | 98 (7.8) | 51 (7.6) | 118 (9.4) |
| Upper respiratory tract infection | 49 (3.9) | 29 (4.3) | 67 (5.3) |
| Bronchitis | 43 (3.4) | 9 (1.3) | 27 (2.1) |
| Headache | 41 (3.3) | 19 (2.8) | 49 (3.9) |
| Sinusitis | 31 (2.5) | 17 (2.5) | 33 (2.6) |
| Influenza | 29 (2.3) | 1 (0.1) | 25 (2.0) |
↵aTreated set. PrimoTinA-asthma®: NCT00776984/NCT00772538; MezzoTinA-asthma®: NCT01172808/NCT01172821; GraziaTinA-asthma®: NCT01316380; Study 342: NCT00350207.