Treatment-emergent AEs through week 120.
| Placebo (Week 0–24) | Placebo → Ustekinumab (Week 24–120) | Ustekinumab (Week 0–120) | All Ustekinumab | |
|---|---|---|---|---|
| Patients, n | 42 | 33 | 60 | 93 |
| Mean follow-up, wks | 23.8 | 59.8 | 81.1 | 73.6 |
| Patients with ≥ 1 AE | 29 (69.0) | 25 (75.8) | 55 (91.7) | 80 (86.0) |
| Patients with ≥ 1 infection | 20 (47.6) | 18 (54.5) | 44 (73.3) | 62 (66.7) |
| Patients with ≥ 1 opportunistic infection | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Patients with ≥ 1 SAE | 4 (9.5) | 5 (15.2) | 12 (20.0) | 17 (18.3) |
| Patients with ≥ 1 serious infection | 0 (0.0) | 2 (6.1) | 7 (11.7) | 9 (9.7) |
| Deaths | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Data presented as n (%) unless otherwise noted. AE; adverse event; SAE: serious adverse event.