Summary of subjects with treatment-emergent adverse events (TEAEs) (safety population)
| GB50 once daily+FDC FF12/FP250 twice daily | FDC GB12.5/FF12/FP250 twice daily | Total | |
| Subjects n | 197 | 198 | 395 |
| TEAE | 49 (24.9) | 50 (25.3) | 99 (25.1) |
| SAE | 1 (0.5) | 3 (1.5) | 4 (1.0) |
| AE leading to death | 1 (0.5) | 0 | 1 (0.3) |
| AE leading to permanent discontinuation of IP | 5 (2.5) | 5 (2.5) | 10 (2.5) |
| AE leading to early termination | 5 (2.5) | 5 (2.5) | 10 (2.5) |
| AE by relationship | |||
| Yes | 12 (6.1) | 20 (10.1) | 32 (8.1) |
| No | 37 (18.8) | 30 (15.2) | 67 (17.0) |
| SAE by relationship | |||
| Yes | 0 | 1 (0.5) | 1 (0.3) |
| No | 1 (0.5) | 2 (1.0) | 3 (0.8) |
| AE by severity | |||
| Mild | 38 (19.3) | 37 (18.7) | 75 (19.0) |
| Moderate | 10 (5.1) | 10 (5.1) | 20 (5.1) |
| Severe | 1 (0.5) | 3 (1.5) | 4 (1.0) |
Data are presented as n (%), unless otherwise stated. Percentages are based on the number of subjects in the safety population in the respective treatment groups. Study drug-related AE is defined as an AE with a relationship considered and reported as “Related” by the investigator. Subjects with more than one AE were counted only once. AE: adverse event; FDC: fixed-dose combination; FF12: 12 μg formoterol fumarate; FP250: 250 μg fluticasone propionate; GB12.5: 12.5 μg glycopyrronium; GB50: 50 μg glycopyrronium; IP: investigational product; SAE: serious adverse event.