Impact of sex, race, or region/country on HSR risk
HSR risk* was analyzed in two separate, large databases to provide solid, statistically supported, results
Phase-IV-Analysis
Company´s global pharmacovigilance database
*In the Phase-IV-Analysis the HSR risk is called “incidence,” while in the GPV-Analysis the risk is called “reporting rate.” Both parameters describe the percentage of HSR cases in the respective cohort. Endrikat J. et al. BJR, 2024, DOI: 10.1093/bjr/tqae190
HSR risk varies with sex, not by race
Women showed a slightly higher risk for HSRs than men, an impact of race on HSR risk was not found
HSR risk* was significantly higher for women compared to men in both datasets (P ≤ .0001 for both)
No significant difference in HSR risk* (P = .3094) between white and Asian populations
*In the Phase-IV-Analysis the HSR risk is called “incidence,” while in the GPV-Analysis the risk is called “reporting rate.” Both parameters describe the percentage of HSR cases in the respective cohort. †Results only from the Phase-IV-Analysis as no exposure data available by race in Bayer’s global pharmacovigilance database. Endrikat J. et al. BJR, 2024, DOI: 10.1093/bjr/tqae190
HSR-reporting varied by region/country
Overall global HSR risk was 0.62% in the Phase-IV-Analysis and 0.015% in the global pharmacovigilance database*
HSR risk† by region and selected countries# in the Phase-IV-Analysis
HSR risk† by region and selected countries# in Company ́s global pharmacovigilance database
*The reason for the difference between the two analysis lies in the difference in data capture/study design*
†In the Phase-IV-Analysis the HSR risk is called “incidence,” while in the GPV-Analysis the risk is called “reporting rate.” Both parameters describe the percentage of HSR cases in the respective cohort. #Selected countries are the three countries with most participants in the Phase-IV-Analysis Endrikat J. et al. BJR, 2024, DOI: 10.1093/bjr/tqae190
