Table 3.
Adverse events
| UMEC/VI (N = 812) | UMEC (N = 804) | SAL (N = 809) | |
|---|---|---|---|
| AE, n (%) | |||
| AE | 315 (39) | 316 (39) | 314 (39) |
| Drug-related AE | 29 (4) | 37 (5) | 27 (3) |
| AE leading to study withdrawal | 32 (4) | 36 (4) | 26 (3) |
| SAE, n (%) | |||
| Non-fatal SAE | 46 (6) | 31 (4) | 38 (5) |
| Drug-related non-fatal SAE | 0 | 0 | 0 |
| Fatal SAEa | 4 (< 1) | 4 (< 1) | 0 |
| Drug-related fatal SAE | 0 | 0 | 0 |
| Most frequent AEsa, n (%) | |||
| Nasopharyngitis | 68 (8) | 87 (11) | 84 (10) |
| Upper respiratory tract infection | 19 (2) | 12 (1) | 20 (2) |
| Influenza | 20 (2) | 9 (1) | 18 (2) |
| Back pain | 10 (1) | 13 (2) | 15 (2) |
| Cough | 14 (2) | 11 (1) | 10 (1) |
| Headache | 10 (1) | 17 (2) | 6 (< 1) |
aThe incidence of fatal cardiovascular SAEs was < 1% in all treatment groups, with three cardiac disorders observed in the UMEC/VI arm and one in the UMEC arm (one acute myocardial infarction in each treatment group). bincludes all on-treatment AEs occurring in ≥2% of any treatment group
AE Adverse event, SAE Serious adverse event, SAL Salmeterol, UMEC Umeclidinium, VI Vilanterol