Background/aim: The frequency of adverse events (AEs) in clinical trials without control arms is difficult to interpret.
Materials And Methods: This is a systematic literature review of AEs reported from the placebo arms of randomized cancer trials in PubMed between 2008 and 2020.
Results: We found 80 placebo patient cohorts in 73 publications, describing 17,968 subjects who received placebo. Headaches were reported in 35 patient cohorts with an average frequency of 12.3% (+/- SD=8.0, range=0.4-34.1), and were more common in cohorts with a median age between 45 and 50 years, with higher performance status, and breast cancer (average 29.8% +/- SD=6.1). AEs leading to discontinuation were reported in 5% of cohorts (+/- SD=5.1, range=0-22.7).
Conclusion: Considering covariates allows more accurate interpretation of the observed AE frequencies in cancer trials.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8286522 | PMC |
| http://dx.doi.org/10.21873/invivo.12460 | DOI Listing |
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