Category, n (%) | FF/UMEC/VI 100/62.5/25 μg | FF/VI 100/25 μg + UMEC 62.5 μg |
---|---|---|
(N = 527) | (N = 528) | |
On-treatment AEs | 255 (48) | 253 (48) |
On-treatment drug-related AEs | 27 (5) | 19 (4) |
On-treatment SAEs | 52 (10) | 57 (11) |
On-treatment non-fatal SAEs | 50 (9) | 54 (10) |
On-treatment fatal SAEs | 4 (< 1) | 4 (< 1) |
On-treatment AESIsa | ||
Adrenal suppression | 1 (< 1) | 0 |
Anticholinergic syndrome | 12 (2) | 5 (< 1) |
Cardiovascular events | 30 (6) | 28 (5) |
Cardiac arrhythmia | 6 (1) | 8 (2) |
Cardiac failure | 7 (1) | 7 (1) |
Ischemic heart disease | 6 (1) | 3 (< 1) |
Hypertension | 10 (2) | 13 (2) |
CNS hemorrhage/cerebrovascular conditions | 3 (< 1) | 1 (< 1) |
Decreased bone mineral density and associated fractures | 5 (< 1) | 6 (1) |
Hyperglycemia/new-onset diabetes mellitus | 7 (1) | 6 (1) |
Hypersensitivity | 7 (1) | 9 (2) |
LRTI excluding pneumonia | 16 (3) | 11 (2) |
Local steroid effects | 12 (2) | 14 (3) |
Ocular effects | 4 (< 1) | 5 (< 1) |
Pneumonia | 14 (3) | 21 (4) |
Tremor | 1 (< 1) | 0 |