Table 2 Incidence of adverse events per treatment arm
IC43 100 μg (n = 393)No. (%) | Placebo (n = 403)No. (%) | P value | Total (N = 796)No. (%) | |
|---|---|---|---|---|
Patients with ≥ 1 AE | 366 (93.1) | 389 (96.5) | .0365 | 755 (94.8) |
Most frequently reported AEs by preferred term (> 10%)a | ||||
Diarrhea | 57 (14.5) | 52 (12.9) | .5371 | 109 (13.7) |
Pyrexia | 43 (10.9) | 62 (15.4) | .0747 | 105 (13.2) |
Urinary tract infection | 53 (13.5) | 52 (12.9) | .8346 | 105 (13.2) |
Decubitus ulcer | 53 (13.5) | 49 (12.2) | .5971 | 102 (12.8) |
Pneumonia | 47 (12.0) | 50 (12.4) | .9138 | 97 (12.2) |
Treatment-related AEs | 27 (6.9) | 23 (5.7) | .5599 | 50 (6.3) |
Severe AEs | 236 (60.1) | 235 (58.3) | .6653 | 471 (59.2) |
Treatment-related severe AEs | 2 (0.5) | 2 (0.5) | 1.0000 | 4 (0.5) |
Serious AEs | 227 (57.8) | 232 (57.6) | 1.0000 | 459 (57.7) |
Treatment-related serious AEs | 0 (0.0) | 1 (0.2) | 1.0000 | 1 (0.1) |
Medically attended AEs | 347 (88.3) | 356 (88.3) | 1.0000 | 703 (88.3) |
AEs occurring within 1 h after first vaccination | 5 (1.3) | 8 (2.0) | .5783 | 13 (1.6) |
AEs occurring within 1 h after second vaccination | 3 (0.8) | 3 (0.7) | 1.0000 | 6 (0.8) |