Table 3 Adverse events
High baseline SABA (≥1.5 puffs/day) | Low baseline SABA (< 1.5 puffs/day) | |||||
|---|---|---|---|---|---|---|
UMEC/VI | UMEC | SAL | UMEC/VI | UMEC | SAL | |
AE, n (%) | ||||||
AE | 157 (38) | 170 (42) | 156 (39) | 158 (40) | 146 (37) | 158 (38) |
Drug-related AE | 9 (2) | 16 (4) | 11 (3) | 20 (5) | 21 (5) | 16 (4) |
AE leading to study withdrawal | 12 (3) | 21 (5) | 14 (4) | 20 (5) | 15 (4) | 12 (3) |
SAE, n (%) | ||||||
Non-fatal SAE | 25 (6) | 17 (4) | 22 (6) | 21 (5) | 14 (4) | 16 (4) |
Drug-related non-fatal SAE | 0 | 0 | 0 | 0 | 0 | 0 |
Fatal SAE | 1 (< 1) | 2 (< 1) | 0 | 3 (< 1) | 2 (< 1) | 0 |
Drug-related fatal SAE | 0 | 0 | 0 | 0 | 0 | 0 |
Most frequent AEs,a n (%) | ||||||
Nasopharyngitis | 30 (7) | 40 (10) | 32 (8) | 38 (10) | 47 (12) | 52 (13) |
URTI | 9 (2) | 9 (2) | 12 (3) | 10 (3) | 3 (< 1) | 8 (2) |
Influenza | 12 (3) | 5 (1) | 9 (2) | 8 (2) | 4 (1) | 9 (2) |
Back pain | 8 (2) | 8 (2) | 10 (3) | 2 (< 1) | 5 (1) | 5 (1) |
Cough | 3 (< 1) | 3 (< 1) | 5 (1) | 11 (3) | 8 (2) | 5 (1) |
Bronchitis | 8 (2) | 7 (2) | 8 (2) | 3 (< 1) | 4 (1) | 4 (< 1) |
Headache | 4 (< 1) | 10 (2) | 4 (1) | 6 (2) | 7 (2) | 2 (< 1) |
Sinusitis | 2 (< 1) | 4 (< 1) | 5 (1) | 6 (2) | 3 (< 1) | 4 (< 1) |
Hypertension | 6 (1) | 4 (< 1) | 3 (< 1) | 2 (< 1) | 8 (2) | 2 (< 1) |
Nausea | 2 (< 1) | 7 (2) | 3 (< 1) | 2 (< 1) | 4 (1) | 3 (< 1) |
Worsening of COPD symptomsb | 6 (1) | 6 (1) | 6 (2) | 2 (< 1) | 4 (1) | 4 (< 1) |