Reporting rates for IBD in postmarketing experience from the secukinumab periodic safety update report
PSUR date | ||||||
26 December 2014–25 June 2015 | 26 June 2015–25 December 2015 | 25 December 2015–25 June 2016 | 25 June 2016–25 December 2016 | 25 December 2016–25 June 2017 | Cumulative rate | |
Cases (n) | 4 | 12 | 37 | 46 | 93 | 195 |
Exposure (PY) | 1838 | 7450 | 16 871 | 28 549 | 41 346 | 96 054 |
Reporting rate (per 100 PY) | 0.22 | 0.16 | 0.22 | 0.16 | 0.22 | 0.20 |
IBD, inflammatory bowel disease; PSUR, periodic safety update reports; PY, patient-years.