Table 3.

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.