Table 6 Number (%) of On-treatment and post-treatment AEs and SAEs
FP/SAL 250/50 μg (N = 314) | SAL 50 μg (N = 325) | |
|---|---|---|
AEs (on-treatment) | 185 (59) | 205 (63) |
COPD | 47 (15) | 51 (16) |
Headache | 19 (6) | 19 (6) |
Upper respiratory tract infection | 15 (5) | 20 (6) |
Back pain | 10 (3) | 13 (4) |
Diarrhea | 11 (4) | 10 (3) |
Edema peripheral | 6 (2) | 14 (4) |
Nausea | 5 (2) | 13 (4) |
Treatment-related AEs (on-treatment) | 19 (6) | 22 (7) |
AEs leading to withdrawal from study | 29 (9) | 33 (10) |
SAEs (on-treatment) | 75 (24) | 82 (25) |
SAEs (post-treatment) | 16 (5) | 8 (2) |
Fatal SAEs (on-treatment) | 4 (1) | 3 (<1) |
Pneumonia AEs (all) | 13 (4) | 10 (3) |