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Updated: Jan 28, 2026

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Published on: November 30, 2016
Clinician-reported symptomatic adverse events in cancer trials: are they concordant with patient-reported outcomes?
Francesco Sparano1, Neil K Aaronson2, Francesco Cottone1
1Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center & Health Outcomes Research Unit, Rome, Italy.
Aim:
We investigate the concordance, in terms of favoring the same treatment arm, between clinician-reported symptomatic adverse events (AEs) and information obtained via patient-reported outcomes (PRO) measures in cancer randomized controlled trials (RCTs).
Methods:
We conducted a systematic literature search to identify all RCTs conducted in breast, colorectal, lung and prostate cancer, published between 2004 and 2017.
Results:
We identified 207 RCTs. In the majority of RCTs (n=133, 64.2%) a discordance between PROs and AEs was found. In 104 studies (50.2%), PRO data favored the experimental arm when AEs did not, while the opposite situation was found in 29 trials (14.0%).
Conclusion:
Frequently, information obtained via PRO measures and clinician-reported AEs do not favor the same treatment arm in RCT settings.
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