Overview of patients reporting adverse events (AEs) in subgroups by asthma severity: treated set (treatment plus 30 days following treatment)
| Tiotropium 5 µg | Tiotropium 2.5 µg | Placebo | |
| Moderate asthma [18, 22] | |||
| Subjects | 269 | 260 | 269 |
| Any AEs | 166 (61.7) | 165 (63.5) | 171 (63.6) |
| Drug-related AEs | 4 (1.5) | 1 (0.4) | 3 (1.1) |
| AEs leading to discontinuation | 0 | 0 | 2 (0.7) |
| Serious AEs | 4 (1.5) | 5 (1.9) | 8 (3.0) |
| AEs reported in ≥5% and ≥10 patients# | |||
| Asthma exacerbation/worsening | 69 (25.7) | 76 (29.2) | 89 (33.1) |
| Decreased peak expiratory flow rate | 35 (13.0) | 40 (15.4) | 35 (13.0) |
| Nasopharyngitis/rhinopharyngitis | 31 (11.5) | 28 (10.8) | 30 (11.2) |
| Viral respiratory tract infection | 18 (6.7) | 19 (7.3) | 19 (7.1) |
| Respiratory tract infection | 15 (5.6) | 16 (6.2) | 21 (7.8) |
| Severe asthma [19, 21] | |||
| Subjects | 260 | 263 | 269 |
| Any AEs | 99 (38.1) | 101 (38.4) | 114 (42.4) |
| Drug-related AEs | 1 (0.4) | 0 | 3 (1.1) |
| AEs leading to discontinuation | 2 (0.8) | 0 | 3 (1.1) |
| Serious AEs | 6 (2.3) | 3 (1.1) | 2 (0.7) |
| AEs reported in ≥5% and ≥10 patients# | |||
| Asthma exacerbation/worsening | 39 (15.0) | 34 (12.9) | 44 (16.4) |
| Decreased peak expiratory flow rate | 20 (7.7) | 24 (9.1) | 33 (12.3) |
| Nasopharyngitis/rhinopharyngitis | 11 (4.2) | 11 (4.2) | 14 (5.2) |
Data are presented as n or n (%). Percentages are calculated using total number of patients per treatment as the denominator. #: in at least one treatment group.