Table 4 Adverse events (including COPD exacerbations) overall and by primary system organ class (>3% in either treatment group; Safety population)
Indacaterol 150 μg o.d. N = 211 n (%) | Placebo N = 205 n (%) | |
|---|---|---|
Patients with any adverse event (s) | 104 (49.3) | 96 (46.8) |
Primary system organ class | ||
Respiratory, thoracic and mediastinal disorders | 40 (19.0) | 43 (21.0) |
Infections and infestations | 37 (17.5) | 28 (13.7) |
Gastrointestinal disorders | 19 (9.0) | 14 (6.8) |
Musculoskeletal and connective tissue disorders | 16 (7.6) | 17 (8.3) |
Nervous system disorders | 11 (5.2) | 11 (5.4) |
General disorders and administration site conditions | 9 (4.3) | 10 (4.9) |
Injury, poisoning and procedural complications | 9 (4.3) | 5 (2.4) |
Investigations | 7 (3.3) | 7 (3.4) |