Table 2. Overall summary of adverse events (treated set).
| n (%) | Tiotropium Respimat 5 μg (n = 114) a | Tiotropium Respimat 2.5 μg (n = 114) a | Placebo Respimat (n = 57) a |
|---|---|---|---|
| Any AE | 101 (88.6) | 99 (86.8) | 51 (89.5) |
| Severe AEs | 2 (1.8) | 1 (0.9) | 3 (5.3) |
| Drug-related AEs b | 10 (8.8) | 6 (5.3) | 3 (5.3) |
| AEs leading to discontinuation | 2 (1.8) | 1 (0.9) | 1 (1.8) |
| Significant (pre-specified) AEs c | 0 | 0 | 0 |
| Serious AEs | 4 (3.5) | 4 (3.5) | 9 (15.8) |
| Requiring hospitalisation | 4 (3.5) | 4 (3.5) | 7 (12.3) |
| Drug-related | 0 | 0 | 1 (1.8) d |
| Fatal | 0 | 0 | 0 |
| Other | 0 | 0 | 2 (3.5) |
aPatients were randomised 2:2:1 to the tiotropium Respimat 5 μg, tiotropium Respimat 2.5 μg and placebo Respimat groups, respectively.
bAs determined by the investigator.
cElevation of aspartate aminotransferase and/or alanine aminotransferase ≥3 × upper limit of normal combined with elevated total bilirubin ≥2 × upper limit of normal at the same visit.
dAsthma worsening.
AE, adverse event.