Table 3.
Most frequent AEs (at least three patients in either treatment group) and discontinuations due to AEs (safety population), n (%)
| Preferred term | IND + GLY (N=226), n (%) | IND + PBO (N=221), n (%) |
|---|---|---|
| Any AE(s) | 85 (37.6) | 75 (33.9) |
| COPD worsening* | 33 (14.6) | 28 (12.7) |
| Nasopharyngitis | 10 (4.4) | 11 (5.0) |
| Lower respiratory tract infection | 7 (3.1) | 2 (0.9) |
| Cough | 6 (2.7) | 10 (4.5) |
| Back pain | 4 (1.8) | 3 (1.4) |
| Upper respiratory tract infection | 4 (1.8) | 5 (2.3) |
| Bacterial infection | 3 (1.3) | 0 |
| Headache | 3 (1.3) | 2 (0.9) |
| Influenza | 3 (1.3) | 1 (0.5) |
| Pain in extremity | 3 (1.3) | 1 (0.5) |
| Upper respiratory tract infection, bacterial | 3 (1.3) | 4 (1.8) |
| Viral upper respiratory tract infection | 3 (1.3) | 5 (2.3) |
| Oropharyngeal pain | 0 | 5 (2.3) |
| Discontinuation from study drug due to AE(s) | 3 (1.3) | 4 (1.8) |
Note:
*
Including COPD exacerbations.
Abbreviations: AE, adverse event; GLY, glycopyrronium 50 μg; IND, indacaterol 150 μg; PBO, placebo; COPD, chronic obstructive pulmonary disease.