Details
This analysis performed safety signal identification for risankizumab by monitoring non-pregnancy and non-cancer outcomes among new users of risankizumab in the Sentinel Distributed Database (SDD). We conducted this signal identification assessment using a self-controlled risk interval design, a supplemental analysis used an active comparator design. The study period includes data from April 23, 2019 through June 30, 2023. We distributed this request to 13 Sentinel Data Partners on February 12, 2024.
Statistical alerts generated by this analysis do not on their own represent safety signals. Alerts are triaged in consideration of the study design, existing drug knowledge, therapeutic context, treated population, and potential public health impact. Alerts determined to be newly identified safety signals (NISS) follow the FDA’s Center for Drug Evaluation and Research manual of policies and procedures for NISS (MAPP 4121.3).
The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.