Details
Report 1: Seizure Following Ranolazine Use
Request ID: cder_mpl1r_wp033_nsdp_v01
This report contains the estimated rates of seizures among indiviuals exposed to ranolazine alone, as well as individuals with concomitant use of ranolazine and either beta blockers, selected oral calcium channel blockers, or non-injectable nitrates. This request was distributed to 16 Data Partners on August 4, 2016.
Report 2: Seizure Following Ranolazine Use: A Self-Controlled Risk Interval Analysis
Request ID: cder_mpl2p_wp002_nsdp_v01
This report utilized a self-controlled risk interval study design to estimate the number of individuals exposed to ranolazine, or ranolazine and non-injectable nitrates, and among them, the number who had a seizure that occurred during specified risk and control windows. This request was distributed to 12 Data Partners on November 18, 2016. These data were presented at the 2017 ICPE Symposium: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year. View more information here.
Report 3: Seizure Following Ranolazine Use: A Self-Controlled Risk Interval Analysis (an update to cder_mpl2p_wp002)
Request ID: cder_mpl2p_wp006_nsdp_v01
This report had two goals: 1) to compare the baseline characteristics of ranolazine and beta blockers users and 2) to utilize a self-controlled risk interval study design to estimate the risk of seizure events within specified risk and control windows for ranolazine users, and those with concomitant use of ranolazine and CYP3 inhibitors. This request was distributed to 14 Data Partners on November 9, 2017.
The analytic packages associated with these reports can be found externally in Sentinel's Git Repository located here: Package 1, Package 2. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.