Table 5

Serious adverse events in 97 patients registered during the study

VariableFrom week 0 to week 24After week 24Total
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 disease183048
 Endoscopic dilation224
 Hospitalisation for Crohn's disease complication*9413
 Neurological disorder011
 Myelodysplasia†101
 Basal cell carcinoma112
 Lymphoma011
  • *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.