Disproportionality Analysis

Screening of ICSR databases for statistical associations between products and events whereby the observed frequency is different than the expected frequency. For ADRs caused by one drug (called drug-event pairs), common measures of disproportionality are:

  1. Frequentist statistics
    • PRR (Proportional Reporting Ratio)
    • ROR (Reporting Odds Ratio)
  2. Bayesian statistics
    • IC (Information Component)
    • EGBM (Empirical Bayes Geometrical Mean).

For ADRs caused by the interaction of two drugs (called drug-drug-event triplets), the Omega (Ω) measure of disproportionality can be used.


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