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Research Letter
December 26, 2019

Clinician vs Patient Reporting of Baseline and Postbaseline Symptoms for Adverse Event Assessment in Cancer Clinical Trials

Author Affiliations
  • 1Memorial Sloan Kettering Cancer Center, New York, New York
  • 2Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona
  • 3Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota
  • 4Mayo Clinic, Rochester, Minnesota
  • 5University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
JAMA Oncol. Published online December 26, 2019. doi:10.1001/jamaoncol.2019.5566

Many patients enter cancer clinical trials with baseline symptoms.1 Notably, the current clinician reporting mechanism for symptomatic adverse events (AEs) via the Common Terminology Criteria for Adverse Events (CTCAE)2 does not formally distinguish between symptoms present at baseline vs those that develop during a trial. Therefore, AE estimation in clinical trials may include symptoms that predate trial entry. This raises concern that the cumulative incidence of patient-reported AEs may be high, particularly if preexisting symptoms related to other causes (eg, comorbidities, prior treatment) are attributed to study drugs.

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