Variable | From week 0 to week 24 | After week 24 | Total |
---|---|---|---|
Patients with at least one serious adverse event, n (%) | 31 (32) | 39 (40) | 70 (72) |
Patients with serious adverse events, n | |||
Surgery for Crohn's disease | 18 | 30 | 48 |
Endoscopic dilation | 2 | 2 | 4 |
Hospitalisation for Crohn's disease complication* | 9 | 4 | 13 |
Neurological disorder | 0 | 1 | 1 |
Myelodysplasia† | 1 | 0 | 1 |
Basal cell carcinoma | 1 | 1 | 2 |
Lymphoma | 0 | 1 | 1 |
*Occlusive syndrome (seven), severe abdominal pain (three), fever and nausea (one), severe acute diarrhoea (one) and subacute folliculitis (one).
†The patient died at the age of 82 years, 12 months later of myelodysplasia, diagnosed 1 month after adalimumab initiation in combotherapy with azathioprine, initiated 12 months before.