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Disproportionality Analysis

Meaning

Disproportionality Analysis is a specific statistical method employed in pharmacovigilance to screen large databases of adverse event reports for potential drug-event associations. The analysis identifies when the reporting frequency of a particular adverse event for a single drug is significantly higher than the frequency of that same event reported for all other drugs. This technique functions as an early warning signal, flagging a potentially unexpected safety issue that requires in-depth clinical investigation.