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Clinician vs patient reporting of baseline and postbaseline symptoms for adverse event assessment in cancer clinical trials

JAMA Jan 06, 2020

Atkinson TM, Dueck AC, Satele DV, et al. - In this cancer clinical trials, clinician vs patient reporting of baseline and postbaseline symptoms for adverse event evaluations were done. Many individuals took part in cancer clinical trials with baseline symptoms. Significantly, the up to date clinician reporting mechanism for symptomatic adverse events (AEs) by the Common Terminology Criteria for Adverse Events (CTCAE) does not formally differentiate among symptoms present at baseline than those that develop during a trial. Hence, AE evaluation in clinical trials might involve symptoms that predate trial entry. This increases a concern that the cumulative incidence of individuals-reported AEs might be high, especially if preexisting symptoms correlated with other causes (eg, comorbidities, prior treatment) were attributed to study drugs.
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