Definition of inflammatory bowel disease in the phase 3 study of brodalumab in patients with axial spondyloarthritis
| EOI label | Identified risks/ potential risks of brodalumab | Search strategy | Search list for PT for sponsor-defined EOI |
| Inflammatory bowel disease | Potential risks | Sponsor-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.