Patients with adverse events | 96 (72.2) | 200 (76.0) |
Patients with serious adverse events | 18 (13.5) | 27 (10.3) |
Patients with adverse events leading to withdrawal | 26 (19.5) | 37 (14.1) |
Deaths | 0 (0) | 0 (0) |
Patients with severe adverse events | 22 (16.5) | 46 (17.5) |
Patients with probably drug related adverse events | 3 (2.3) | 17 (6.5) |
Patients with definitely drug related adverse events | 1 (0.8) | 8 (3.0) |
Adverse events occurring in ⩾5% of patients in at least one of the treatment groups | | |
Infections and infestations | 39 (29.3) | 77 (29.3) |
Headache | 20 (15.0) | 32 (12.2) |
Crohn’s disease aggravated | 14 (10.5) | 22 (8.4) |
Nausea | 8 (6.0) | 20 (7.6) |
Nasopharyngitis | 7 (5.3) | 19 (7.2) |
Abdominal pain | 6 (4.5) | 17 (6.5) |
Arthralgia | 8 (6.0) | 13 (4.9) |
Vomiting | 10 (7.5) | 10 (3.8) |
Pyrexia | 7 (5.3) | 10 (3.8) |
Cough | 8 (6.0) | 7 (2.7) |
Patients with adverse events occurring within 2 hours of the start of the infusion | | |
Any | 14 (10.5) | 54 (20.5) |
Hypersensitivity | 0 (0) | 7 (2.7) |
Dizziness | 1 (0.8) | 5 (1.9) |
Dermatitis | 0 (0) | 4 (1.5) |
Headache | 4 (3.0) | 2 (0.8) |