Table 3.
Summary of adverse events in the treated set
|
n (%) |
Tiotropium Respimat® 5 μg
a
|
Tiotropium Respimat® 2.5 μg
a
|
Tiotropium Respimat® 1.25 μg
a
|
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 |
aAll patients in all groups on a background of maintenance treatment with stable medium-dose inhaled corticosteroids (400–800 μg budesonide or equivalent); bBoth patients experiencing serious adverse events required hospitalisation.