Table 5 Incidence of treatment-emergent AEs (all causality and treatment related; ≥1% in either treatment group) by decreasing cumulative frequency
MedDRA preferred term | All causality | Treatment related a | ||
|---|---|---|---|---|
Tiotropium | Placebo | Tiotropium | Placebo | |
Evaluable for AEs | 238 (100) | 219 (100) | 238 (100) | 219 (100) |
COPD (i.e., an exacerbation) b | 11 (4.6) | 24 (11.0) | 0 | 2 (0.9) |
Nasopharyngitis | 16 (6.7) | 11 (5.0) | 0 | 0 |
Upper RTI | 7 (2.9) | 5 (2.3) | 0 | 1 (0.5) |
Cough | 4 (1.7) | 8 (3.7) | 1 (0.4) | 3 (1.4) |
Bronchitis | 2 (0.8) | 8 (3.7) | 0 | 2 (0.9) |
Diarrhoea | 6 (2.5) | 3 (1.4) | 0 | 0 |
Headache | 2 (0.8) | 5 (2.3) | 1 (0.4) | 1 (0.5) |
Influenza | 4 (1.7) | 2 (0.9) | 0 | 0 |
RTI | 3 (1.3) | 3 (1.4) | 0 | 0 |
Rhinitis | 2 (0.8) | 4 (1.8) | 0 | 0 |
Dry mouth | 3 (1.3) | 2 (0.9) | 3 (1.3) | 1 (0.5) |
Viral RTI | 3 (1.3) | 2 (0.9) | 0 | 0 |
Hypertension | 3 (1.3) | 2 (0.9) | 1 (0.4) | 0 |
Arthralgia | 2 (0.8) | 3 (1.4) | 0 | 0 |
Dyspnoea | 0 | 5 (2.3) | 0 | 0 |
Nausea | 3 (1.3) | 1 (0.5) | 0 | 0 |
Herpes zoster | 3 (1.3) | 1 (0.5) | 0 | 0 |
Chronic bronchitis | 1 (0.4) | 3 (1.4) | 0 | 0 |
Back pain | 0 | 4 (1.8) | 0 | 0 |
Hyperglycaemia | 0 | 3 (1.4) | 0 | 1 (0.5) |
Epistaxis | 0 | 3 (1.4) | 0 | 2 (0.9) |
