Table 3 Adverse events overall and by primary system organ class (safety population)
Indacaterol 150 μg N = 118 n (%) | Indacaterol 300 μg N = 122 n (%) | Tiotropium N = 120 n (%) | Placebo N = 123 n (%) | |
|---|---|---|---|---|
Patients with any AE(s) | 37 (31.4) | 36 (29.5) | 34 (28.3) | 35 (28.5) |
MedDRA primary system organ class | ||||
Respiratory, thoracic & mediastinal disorders | 17 (14.4) | 14 (11.5) | 15 (12.5) | 15 (12.2) |
Infections & infestations | 7 (5.9) | 14 (11.5) | 10 (8.3) | 10 (8.1) |
Musculoskeletal & connective tissue disorders | 6 (5.1) | 6 (4.9) | 2 (1.7) | 9 (7.3) |
Nervous system disorders | 4 (3.4) | 3 (2.5) | 5 (4.2) | 3 (2.4) |
Gastrointestinal disorders | 2 (1.7) | 3 (2.5) | 8 (6.7) | 3 (2.4) |
Injury, poisoning & procedural complications | 2 (1.7) | 0 | 1 (0.8) | 1 (0.8) |
Metabolism & nutrition disorders | 2 (1.7) | 2 (1.6) | 0 | 0 |
Blood & lymphatic system disorders | 1 (0.8) | 1 (0.8) | 1 (0.8) | 0 |
Cardiac disorders | 1 (0.8) | 1 (0.8) | 0 (0.0) | 2 (1.6) |
General disorders & administration site conditions | 1 (0.8) | 2 (1.6) | 3 (2.5) | 3 (2.4) |
Investigations | 1 (0.8) | 0 | 1 (0.8) | 0 |
Psychiatric disorders | 1 (0.8) | 0 | 1 (0.8) | 0 |
Ear & labyrinth disorders | 0 | 0 | 0 | 1 (0.8) |
Neoplasms benign, malignant & unspecified (including cysts and polyps) | 0 | 0 | 1 (0.8) | 0 |
Renal & urinary disorders | 0 | 2 (1.6) | 1 (0.8) | 0 |
Skin & subcutaneous tissue disorders | 0 | 2 (1.6) | 1 (0.8) | 0 |
Vascular disorders | 0 | 2 (1.6) | 1 (0.8) | 4 (3.3) |