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Incidence Ratios, Reporting Ratios, and Safety Signals Instead of Adverse Effects

  • Ton J. Cleophas
  • Aeilko H. Zwinderman
Chapter

Abstract

Proportional reporting ratios are statistics that compare (out of all patients with adverse effects) the proportion of patients with a specific adverse effect from a particular drug with that of the same in a much larger group of patients (using the same drug class).

Standardized Incidence Ratios are age-adjusted rates of adverse effects compared to similarly adjusted rates from larger populations like, cities, states, entire countries.

A safety signal is data information, suggesting a new causal association between a medicine and an adverse effect. In the past few years pharmacologists have worldwide been developing criteria for estimating the seriousness of adverse effects, other than or additional to the traditional statistical test criteria as reviewed in the Chap.  2. A problem with safety signals is their incomplete character.

Keywords

Proportional reporting ratios Standardized reporting ratios Large Chi-Square tables Safety signals Pharmacovigilance Spontaneous reporting systems Potential signals Signal detection 

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Ton J. Cleophas
    • 1
  • Aeilko H. Zwinderman
    • 2
  1. 1.Albert Schweitzer HospitalDepartment MedicineSliedrechtThe Netherlands
  2. 2.Department of Biostatistics and EpidemiologyAcademic Medical CenterAmsterdamThe Netherlands

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