Table 1

Definition of inflammatory bowel disease in the phase 3 study of brodalumab in patients with axial spondyloarthritis

EOI labelIdentified risks/ potential risks of brodalumabSearch strategySearch list for PT for sponsor-defined EOI
Inflammatory bowel diseasePotential risksSponsor-defined EOI, gastrointestinal ulceration (SMQ) and ischaemic colitis (SMQs)Colonic abscess, Crohn’s disease, enteritis, inflammatory bowel disease, large intestinal ulcer perforation, metastatic cutaneous Crohn’s disease and small intestinal ulcer perforation
  • EOI, event of interest; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SMQ, standardised MedDRA query.