Skip to main content

Statistically Significant and Insignificant Adverse Effects

  • Chapter
  • First Online:
Analysis of Safety Data of Drug Trials

Abstract

The current chapter reviews many statistical hypothesis tests, adequate for assessing prevalence (proportion of a population) and rate data (frequency of events per time unit) versus control or versus zero.

Only independent adverse effects are assessed here, and they are tested for statistically significant presence.

Both attention is given to paired and unpaired data, and particular attention is given to explicit time dependent Poisson methods, as well as log likelihood ratio tests, that provide better power than traditional tests for the purpose.

Bayesian crosstabs may be prone to overdispersion, but in the example given no adjustment was needed.

Methods for analyzing contingency tables larger than 2×2 are given, and longitudinal data like survival data and Cox regressions are used for addressing times to event and computing hazard ratios of adverse effects.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

Copyright information

© 2019 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Cleophas, T.J., Zwinderman, A.H. (2019). Statistically Significant and Insignificant Adverse Effects. In: Analysis of Safety Data of Drug Trials. Springer, Cham. https://doi.org/10.1007/978-3-030-05804-3_2

Download citation

Publish with us

Policies and ethics