Evaluation of the value of attribution in the interpretation of adverse event data: A North Central Cancer Treatment Group and American College of Surgeons Oncology Group investigation Academic Article uri icon

Overview

MeSH Major

  • Adverse Drug Reaction Reporting Systems
  • Carcinoma, Non-Small-Cell Lung
  • Gastrointestinal Stromal Tumors
  • Lung Neoplasms
  • Piperazines
  • Pyrimidines
  • Triazoles

abstract

  • Nearly 50% of AEs were reported as attributed to study drug on the placebo arm of two randomized clinical trials. These data provide strong evidence that AE attribution is difficult to determine, unreliable, and of questionable value in interpreting AE data in randomized clinical trials.

publication date

  • June 20, 2010

Research

keywords

  • Academic Article

Identity

Language

  • eng

PubMed Central ID

  • PMC2903334

Digital Object Identifier (DOI)

  • 10.1200/JCO.2009.27.4282

PubMed ID

  • 20479400

Additional Document Info

start page

  • 3002

end page

  • 7

volume

  • 28

number

  • 18