Equivalence, Inferiority and Superiority Testing of Adverse Effects

  • Ton J. Cleophas
  • Aeilko H. Zwinderman


Instead of testing a null hypothesis of no adverse effect, the presence of adverse effect can also be assessed with confidence intervals, and confirmed if a priori defined boundaries meet those confidence intervals. Boundaries commonly set are those of.
  • equivalencce,

  • inferiority,

  • superiority.

This chapter assesses how testing works and why and when it is particularly relevant.

If, in a controlled trial a new treatment is compared to a standard treatment instead of placebo, there is a big risk of finding small differences, and testing against prior boundaries is particularly helpful.


Null hypothesis Adverse effect Confidence intervals Priori defined boundaries Equivalencce Inferiority Superiority Comparison versus placebo 

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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