Table 2.
Treatment-emergent AEs and SAEs during the study period (safety set)
| Characteristics* | Tiotropium N=268 | SFC N=101 | IND/GLY N=373 |
|---|---|---|---|
|
| |||
| Patient with ≥1 AE (s) | 72 (26.9) | 34 (33.7) | 107 (28.7) |
| COPD | 8 (3.0) | 5 (5.0) | 13 (3.5) |
| Upper respiratory tract infection | 7 (2.6) | 3 (3.0) | 11 (2.9) |
| Cough | 9 (3.4) | 1 (1.0) | 10 (2.7) |
| Bronchitis | 7 (2.6) | 2 (2.0) | 9 (2.4) |
| Dyspnea | 5 (1.9) | 2 (2.0) | 7 (1.9) |
| Pneumonia | 2 (0.7) | 5 (5.0) | 7 (1.9) |
| Patient with ≥1 SAE(s) | 4 (1.5) | 8 (7.9) | 12 (3.2) |
| Pneumonia | 1 (0.4) | 3 (3.0) | 4 (1.1) |
| COPD | 0 (0) | 2 (2.0) | 2 (0.5) |
| SAEs requiring hospitalization or prolonged hospitalization | 2 (0.7) | 5 (5.0) | 7 (1.9) |
| Discontinuations due to AEs or SAEs | 15 (5.6) | 9 (8.9) | 24 (6.4) |
| Discontinuation due to SAEs | 2 (0.7) | 1 (1.0) | 3 (0.8) |
| Discontinuation due to non-SAEs | 13 (4.9) | 8 (7.9) | 21 (5.6) |
Notes:
*
Covers all AEs or SAEs experienced by ≥2% of overall study population (safety set). Data are presented as n (%).
Abbreviations: AE, adverse events; IND/GLY, indacaterol/glycopyrronium; SAE, serious AE.