Assessment of medication-associated inflammatory bowel disease using large spontaneous-report datasets and multiple disproportionality methods to identify safety signals.
Key Takeaways
- Reports labeled as IBD indications or drugs approved solely for IBD were excluded
- Signal detection required simultaneous positivity across ROR, PRR, IC, and EBGM algorithms
- Positivity criteria included ROR lower 95% CI>1, PRR≥2, IC025>0, EBGM05>2