The following is a summary of “Adverse Event Reporting in Randomized Clinical Trials for Multiple Myeloma,” published in the November 2023 issue of Hematology by Najjar et al.
The emphasis on treatment efficacy in clinical trial reports may lead to the underreporting of adverse events (AEs) or their description in subjective or minimizing terms, potentially affecting patients’ quality of life. Researchers performed a retrospective study to examine patterns of AE reporting in multiple myeloma (MM) randomized clinical trials (RCTs).
They searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials to evaluate the prevalence of minimizing terms in MM RCTs. Minimizing times, defined as subjective expressions favoring the intervention’s safety profile, encompassed words like convenient, manageable, acceptable, expected, well-tolerated, tolerable, favorable, and safe. The final data analysis occurred on July 21, 2023.
The results showed that 65 included RCTs, and 86% utilized minimizing terms when characterizing treatment-emergent adverse events. The most frequently employed minimizing terms were “well-tolerated” or “tolerable” in 45% of trials, “manageable” in 28%, and “acceptable” in 25%. The Grade 3 or 4 adverse events rate in the examined RCTs varied from 23% to 94%, with a median of 75% (IQR, 59%-82%). Univariate regression analysis indicated no correlation between the use of minimizing terms and Grade 3 or 4 adverse event rates (OR, 1.35 [95% CI, 0.88-2.10] per 10% AE rate increase; P=.17) or Grade 5 adverse event rates (OR, 3.16 [95% CI, 0.27-12.7] per 10% AE rate increase; P=.45).
They concluded that minimizing terms in MM trials enhanced transparency and patient-centered AE reporting.