Adverse Event Reporting in Randomized Clinical Trials for Multiple Myeloma

Area of Science:

• Oncology
• Clinical Trials
• Medical Writing

Background:

• Cancer treatments cause significant toxic effects impacting patient quality of life.
• Clinical trial reports may use subjective language to describe adverse events (AEs), potentially downplaying their severity.

Purpose of the Study:

• To evaluate the patterns of AE reporting in multiple myeloma (MM) randomized clinical trials (RCTs).
• To assess the prevalence of minimizing terms used to describe AEs in MM RCTs published between 2015 and early 2023.

Main Methods:

• A systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials was conducted.
• Minimizing terms (e.g., manageable, well-tolerated) were identified in MM RCTs published from January 1, 2015, to March 1, 2023.
• Univariate logistic regression analyzed the association between minimizing terms and the incidence of severe AEs (Grade 3-5).

Main Results:

• 86% of the 65 included MM RCTs utilized minimizing terms when describing treatment-emergent AEs.
• The most common minimizing terms were 'well-tolerated'/'tolerable' (45%), 'manageable' (28%), and 'acceptable' (25%).
• No significant association was found between the use of minimizing terms and the rates of Grade 3-4 or Grade 5 AEs.

Conclusions:

• Trial investigators and sponsors frequently employ minimizing terminology in MM trials, which may not accurately reflect the actual AE rates.
• This practice can hinder clinicians and patients from fully understanding the true tolerability of cancer treatments.
• Recommendations include emphasizing event rates and patient-reported outcomes for transparent AE reporting.