Table 3 Incidence of adverse events by post bronchodilator % predicted FEV1*
Variable | Placebo (n = 1544) | SAL (n = 1542) | FP (n = 1552) | SFC (n = 1546) |
|---|---|---|---|---|
FEV 1 < 30% predicted | ||||
n | 215 | 261 | 223 | 246 |
any AE, n (%) | 198 (92) | 241 (92) | 212 (95) | 230 (93) |
serious AEs, n (%) | 108 (50) | 142 (54) | 129 (58) | 134 (54) |
fatal AEs, n (%) | 26 (12) | 35 (13) | 35 (16) | 25 (10) |
FEV 1 30% to < 50% predicted | ||||
n | 786 | 750 | 785 | 735 |
any AE, n (%) | 717 (91) | 669 (89) | 702 (89) | 664 (90) |
serious AEs, n (%) | 322 (41) | 306 (41) | 357 (45) | 327 (44) |
fatal AEs, n (%) | 70 (9) | 62 (8) | 87 (11) | 62 (8) |
FEV 1 ≥ 50% predicted | ||||
n | 543 | 531 | 544 | 565 |
any AE, n (%) | 470 (87) | 471 (89) | 481 (88) | 487 (86) |
serious AEs, n (%) | 197 (36) | 174 (33) | 169 (31) | 198 (35) |
fatal AEs, n (%) | 37 (7) | 29 (5) | 38 (7) | 27 (5) |