Treatment-emergent adverse events during the 12-week induction trial
| Placebo (n=69) | 10 mg (n=67) | 50 mg (n=71) | 200 mg (n=40) | |
| Any adverse events, n (%) | 63 (91.3) | 60 (89.6) | 58 (81.7) | 33 (82.5) |
| Severe adverse events, n (%) | 5 (7.2) | 12 (17.9) | 12 (16.9) | 5 (12.5) |
| Serious adverse events, n (%) | 9 (13.0) | 7 (10.4) | 9 (12.7) | 11 (27.5) |
| GI disorders* | 5 (7.2) | 3 (4.5) | 7 (9.9) | 8 (20.0) |
| Serious infections and infestations | ||||
| Sepsis | 1 (1.4) | – | – | – |
| Anal abscess | – | 1 (1.5) | 2 (2.8) | – |
| Groin abscess | – | – | – | 1 (2.5) |
| Intestinal abscess | – | 1 (1.5) | – | – |
| Pneumonia | – | – | – | 1 (2.5) |
| Deaths | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) |
| Discontinuations due to adverse events, n (%) | 7 (10.1) | 6 (9.0) | 6 (8.5) | 8 (20.0) |
| Temporary discontinuation due to adverse events, n (%) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) |
| Common adverse events (≥5% in any treatment group), n (%) | ||||
| Crohn’s disease† | 8 (11.6) | 3 (4.5) | 10 (14.1) | 8 (20.0) |
| Abdominal pain | 8 (11.6) | 6 (9.0) | 8 (11.3) | 6 (15.0) |
| Headache | 6 (8.7) | 5 (7.5) | 8 (11.3) | 2 (5.0) |
| Nasopharyngitis | 3 (4.3) | 10 (14.9) | 7 (9.9) | 3 (7.5) |
| Nausea | 1 (1.4) | 7 (10.4) | 7 (9.9) | 1 (2.5) |
| Rash | 1 (1.4) | 2 (3.0) | 7 (9.9) | 1 (2.5) |
| Arthralgia | 8 (11.6) | 5 (7.5) | 5 (7.0) | 0 (0.0) |
| Erythema | 0 (0.0) | 1 (1.5) | 4 (5.6) | 1 (2.5) |
| Fatigue | 0 (0.0) | 2 (3.0) | 4 (5.6) | 0 (0.0) |
| Proctalgia | 0 (0.0) | 2 (3.0) | 4 (5.6) | 0 (0.0) |
| Pyrexia | 8 (11.6) | 5 (7.5) | 4 (5.6) | 1 (2.5) |
| Upper respiratory tract infection | 2 (2.9) | 0 (0.0) | 4 (5.6) | 0 (0.0) |
| Back pain | 4 (5.8) | 4 (6.0) | 3 (4.2) | 1 (2.5) |
| Peripheral oedema | 2 (2.9) | 2 (3.0) | 3 (4.2) | 2 (5.0) |
| Urinary tract infection | 3 (4.3) | 2 (3.0) | 3 (4.2) | 5 (12.5) |
| Vomiting | 2 (2.9) | 3 (4.5) | 3 (4.2) | 2 (5.0) |
| Gastroenteritis | 1 (1.4) | 0 (0.0) | 1 (1.4) | 2 (5.0) |
| Constipation | 2 (2.9) | 2 (3.0) | 0 (0.0) | 2 (5.0) |
| Upper abdominal pain | 0 (0.0) | 1 (1.5) | 0 (0.0) | 3 (7.5) |
*GI disorders include Crohn’s disease, abdominal pain, anal fistula, intestinal perforation, intestinal stenosis, colitis, hematochezia and acute pancreatitis.
†Includes worsening, exacerbation and flare of Crohn’s disease.