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) |