Table A2.

Summary of the Incidence Rates (IR) and Relative Rates (RR) that are significantly decreased among regimen initiators (N = 114,035)^a,b in a risk period compared to a post-vaccination self-comparison period for combined potential hospital only general safety outcomes by analysis category^c.

Abbreviations: ER, emergency room; HCUP, Healthcare Cost and Utilization Project; IR, incidence rate; RR, relative rate; CI, confidence interval.

^aPatient Accrual 16-OCT-2009 through 31-DEC-2016.

^bRegimen Initiators include males any age with at least one dose of Gardasil.

^cOnly HCUP categories with at least one decreased RR (lower confidence limit > 1.0) are presented. Results for all HCUP categories are located in Table Sets 16-19.

^dIncidence rates per 1,000 person-years.

^eBolded RR and CI indicates the interval excludes 1.00. Bolded and highlighted RR and CI indicates the double false-discovery rate adjusted p-value remains significant. DFDR adjustment was at level 1 and 2.

^fMales with codes for the same HCUP category up to 12 months prior to and including the day of first vaccination in any healthcare setting (ER, hospitalization or physician office/outpatient) were excluded from the analysis for that HCUP category.