Table 4.
SAEs (safety population), n (%)
| Primary system organ class Preferred term | IND + GLY (N=226), n (%) | IND + PBO (N=221), n (%) |
|---|---|---|
| Patients with any SAE(s) | 5 (2.2) | 5 (2.3) |
| Respiratory, thoracic and mediastinal disorders | 2 (0.9) | 2 (0.9) |
| COPD worsening* | 1 (0.4) | 2 (0.9) |
| Hemoptysis | 1 (0.4) | 0 |
| Gastrointestinal disorders | 1 (0.4) | 0 |
| Inguinal hernia | 1 (0.4) | 0 |
| Immune system disorders | 1 (0.4) | 0 |
| Hypersensitivity | 1 (0.4) | 0 |
| Infections and infestations | 1 (0.4) | 1 (0.5) |
| Bacterial infection | 1 (0.4) | 0 |
| Urinary tract infection | 0 | 1 (0.5) |
| Musculoskeletal and connective tissue disorders | 1 (0.4) | 0 |
| Osteitis | 1 (0.4) | 0 |
| Cardiac disorders | 0 | 1 (0.5) |
| Angina pectoris | 0 | 1 (0.5) |
| Injury, poisoning, and procedural complications | 0 | 1 (0.5) |
| Rib fracture | 0 | 1 (0.5) |
| Renal and urinary disorders | 0 | 1 (0.5) |
| Renal failure, acute | 0 | 1 (0.5) |
Notes:
*
Including COPD exacerbations; a patient with multiple occurrences of an SAE was counted only once in the SAE category.
Abbreviations: COPD, chronic obstructive pulmonary disease; GLY, glycopyrronium 50 μg; IND, indacaterol 150 μg; PBO, placebo; SAE, serious adverse event.