Risk Factor Considerations in Statistical Signal Detection: Using Subgroup Disproportionality to Uncover Risk Groups for Adverse Drug Reactions in VigiBase.

This study reveals that it is possible to uncover signals of risk groups for adverse drug reactions through incorporation of broad risk factor screening into statistical signal detection in a global database of adverse event reports. Our findings suggest the potential to use such statistical methodologies for risk characterisation in subpopulations of concern.