Table 2.
Summary of AEs and SAEs by preferred terms in the Japanese subgroup
| IND/GLY (n=42) | IND (n=41) | GLY (n=40) | TIO (n=40) | Placebo (n=19) | |
|---|---|---|---|---|---|
| Total AEs | 21 (50.0) | 27 (65.9) | 24 (60.0) | 31 (77.5) | 12 (63.2) |
| AEs ≥2 incidences in any group | |||||
| COPDa | 5 (11.9) | 7 (17.1) | 6 (15.0) | 10 (25.0) | 6 (31.6) |
| Nasopharyngitis | 4 (9.5) | 10 (24.4) | 9 (22.5) | 9 (22.5) | 5 (26.3) |
| Cough | 2 (4.8) | 2 (4.9) | 0 | 0 | 0 |
| Productive cough | 2 (4.8) | 0 | 0 | 0 | 0 |
| Constipation | 2 (4.8) | 2 (4.9) | 3 (7.5) | 0 | 0 |
| Bronchitis | 1 (2.4) | 0 | 0 | 3 (7.5) | 1 (5.3) |
| Upper respiratory tract infection | 1 (2.4) | 1 (2.4) | 0 | 2 (5.0) | 1 (5.3) |
| GERD | 0 | 2 (4.9) | 1 (2.5) | 0 | 0 |
| Back pain | 0 | 0 | 3 (7.5) | 0 | 0 |
| Drug-related AEs | 7 (16.7) | 5 (12.2) | 4 (10.0) | 5 (12.5) | 0 |
| AEs leading to permanent discontinuation of study drugs | |||||
| Total SAEs | 1 (2.4) | 5 (12.2) | 2 (5.0) | 1 (2.5) | 2 (10.5) |
Notes: Data are presented as number of patients (percentage).
a
Includes COPD exacerbation or COPD worsening.
Abbreviations: AEs, adverse events; SAEs, serious adverse events; IND, indacaterol; GLY, glycopyrronium; TIO, tiotropium; GERD, gastroesophageal reflux disease.