Details
In this analysis, we performed signal identification for subcutaneous semaglutide by monitoring non-pregnancy and non-cancer outcomes among new users of subcutaneous semaglutide in the Sentinel Distributed Database (SDD). We conducted this signal identification assessment using a self-controlled risk interval (SCRI) 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 subcutaneous semaglutide.
The study period includes data from December 1, 2017 to August 31, 2024. We distributed this request to 13 Sentinel Data Partners: 11 Data Partners on April 17, 2025 and two Data Partners on April 18, 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.