Table A1.

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 potential combined ER/Hospital 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 increased RR (lower confidence limit >1.0) are presented. Results for all HCUP categories are located in Table Sets 12-15.

^dIncidence rates per 1,000 person-years

^eBolded relative rate and confidence interval indicates the interval excludes 1.00. Bolded and highlighted relative rate and confidence interval indicates the double false discovery rate adjusted p-value remains significant.Multiplicity adjustment limited to HCUP levels 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 health care setting (ER, hospitalization or physician office/outpatient) were excluded from the analysis for that HCUP category.