Table 3. Frequency of adverse events with incidence ≥4% in any treatment group (treated set).
| n (%) | Tiotropium Respimat 5 μg (n = 114) a | Tiotropium Respimat 2.5 μg (n = 114) a | Placebo Respimat (n = 57) a |
|---|---|---|---|
| Infections and infestations | 81 (71.1) | 81 (71.1) | 33 (57.9) |
| Nasopharyngitis | 55 (48.2) | 51 (44.7) | 24 (42.1) |
| Bronchitis | 11 (9.6) | 15 (13.2) | 4 (7.0) |
| Pharyngitis | 9 (7.9) | 15 (13.2) | 2 (3.5) |
| Gastroenteritis | 12 (10.5) | 4 (3.5) | 3 (5.3) |
| Upper respiratory tract infection | 5 (4.4) | 8 (7.0) | 2 (3.5) |
| Influenza | 5 (4.4) | 7 (6.1) | 2 (3.5) |
| Cystitis | 5 (4.4) | 3 (2.6) | 1 (1.8) |
| Respiratory, thoracic and mediastinal disorders | 47 (41.2) | 46 (40.4) | 28 (49.1) |
| Asthma worsening b | 33 (28.9) | 34 (29.8) | 22 (38.6) |
| Upper respiratory tract inflammation | 7 (6.1) | 7 (6.1) | 4 (7.0) |
| Dysphonia | 7 (6.1) | 2 (1.8) | 0 |
| Allergic rhinitis | 2 (1.8) | 3 (2.6) | 4 (7.0) |
| Investigations | 23 (20.2) | 12 (10.5) | 16 (28.1) |
| Decreased peak expiratory flow rate | 18 (15.8) | 9 (7.9) | 12 (21.1) |
| Gastrointestinal disorders | 26 (22.8) | 18 (15.8) | 13 (22.8) |
| Gastritis | 6 (5.3) | 3 (2.6) | 4 (7.0) |
| Constipation | 1 (0.9) | 0 | 3 (5.3) |
| Gastro-oesophageal reflux disease | 6 (5.3) | 1 (0.9) | 1 (1.8) |
| Diarrhoea | 5 (4.4) | 5 (4.4) | 0 |
| Musculoskeletal and connective tissue disorders | 15 (13.2) | 9 (7.9) | 9 (15.8) |
| Back pain | 4 (3.5) | 4 (3.5) | 3 (5.3) |
| Injury, poisoning and procedural complications | 12 (10.5) | 8 (7.0) | 7 (12.3) |
| Ligament sprain | 3 (2.6) | 2 (1.8) | 3 (5.3) |
| Nervous system disorders | 10 (8.8) | 12 (10.5) | 3 (5.3) |
| Headache | 4 (3.5) | 7 (6.1) | 1 (1.8) |
| Eye disorders | 6 (5.3) | 7 (6.1) | 5 (8.8) |
| Allergic conjunctivitis | 2 (1.8) | 5 (4.4) | 1 (1.8) |
| Vascular disorders | 5 (4.4) | 1 (0.9) | 2 (3.5) |
| Hypertension | 5 (4.4) | 1 (0.9) | 0 |
aPatients were randomised 2:2:1 to the tiotropium Respimat 5 μg, tiotropium Respimat 2.5 μg and placebo Respimat groups, respectively.
bThe preferred term ‘asthma’ summarises several lowest level terms.