Details
This analysis performed signal identification for faricimab by monitoring non-pregnancy and non-cancer outcomes among new users of faricimab in the Sentinel Distributed Database (SDD). We conducted this signal identification assessment using a self-controlled risk interval design with Tree-Only Scan and Tree-Temporal Scan analyses to identify incident outcomes, and temporal clusters of incident outcomes following initiation of treatment with faricimab.
The study period includes data from January 1, 2022 to April 30, 2025. We distributed this request to 13 Sentinel Data Partners on August 19, 2025.
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.