PMID- 37948080 OWN - NLM STAT- MEDLINE DCOM- 20231113 LR - 20231113 IS - 2574-3805 (Electronic) IS - 2574-3805 (Linking) VI - 6 IP - 11 DP - 2023 Nov 1 TI - Adverse Event Reporting in Randomized Clinical Trials for Multiple Myeloma. PG - e2342195 LID - 10.1001/jamanetworkopen.2023.42195 [doi] LID - e2342195 AB - IMPORTANCE: Cancer treatment can result in burdensome toxic effects that profoundly affect patient quality of life. In seeking to emphasize the efficacy of tested treatments, clinical trial reports may use subjective or minimizing terms to describe adverse events (AEs). OBJECTIVE: To evaluate patterns of AE reporting in multiple myeloma (MM) randomized clinical trials (RCTs) published between 2015 and early 2023. DESIGN, SETTING, AND PARTICIPANTS: For this cohort study, the PubMed, Embase, and Cochrane Central Register of Controlled Trials databases were searched to assess the prevalence of minimizing terms in MM RCTs published between January 1, 2015, and March 1, 2023. Minimizing terms were defined as subjective terms used to favorably describe the safety profile of the intervention. The terms searched included convenient, manageable, acceptable, expected, well-tolerated, tolerable, favorable, and safe. Final data analysis was performed on July 21, 2023. MAIN OUTCOMES AND MEASURES: The primary outcome was the occurrence of at least 1 minimizing term in an article. Univariate logistic regression analyses were performed to evaluate the association between the presence of at least 1 minimizing term and the actual incidence of grade 3 or 4 AEs, serious AEs, or grade 5 AEs. RESULTS: Of the 65 RCTs included, 56 (86%) used minimizing terms when describing treatment-emergent AEs. The most frequently used minimizing terms were well-tolerated or tolerable in 29 trials (45%), manageable in 18 (28%), and acceptable in 16 (25%). Grade 3 or 4 AE rate in the examined RCTs ranged from 23% to 94%, with a median of 75% (IQR, 59%-82%). A univariate regression analysis demonstrated no association between the use of minimizing terms and grade 3 or 4 AE rates (odds ratio [OR], 1.35 [95% CI, 0.88-2.10] per 10% AE rate increase; P = .17) or grade 5 AE rates (OR, 3.16 [95% CI, 0.27-12.7] per 10% AE rate increase; P = .45). CONCLUSIONS AND RELEVANCE: These findings suggest that trial investigators and sponsors regularly use minimizing terms to describe toxic effects in MM trials, and use of this terminology may not reflect actual AE rates in these studies. Instead of using these terms, trial investigators should highlight event rates and patient-reported outcomes, to allow clinicians and patients to better evaluate the true tolerability of AEs. FAU - Najjar, Mimi AU - Najjar M AD - Department of Oncology, Johns Hopkins School of Medicine, Baltimore, Maryland. FAU - McCarron, John AU - McCarron J AD - Division of Hematology and Hematological Malignancies, Huntsman Cancer Institute, University of Utah, Salt Lake City. FAU - Cliff, Edward R Scheffer AU - Cliff ERS AD - Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. FAU - Berger, Katherine AU - Berger K AD - Independent Patient Advocate, Pawcatuck, Connecticut. FAU - Steensma, David P AU - Steensma DP AD - David P. Steensma LLC, Wellesley, Massachusetts. FAU - Al Hadidi, Samer AU - Al Hadidi S AD - Myeloma Center, Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences, Little Rock. FAU - Chakraborty, Rajshekhar AU - Chakraborty R AD - Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, New York. FAU - Goodman, Aaron AU - Goodman A AD - Division of Hematology, University of California, San Diego. FAU - Anto, Eric AU - Anto E AD - Division of Biostatistics, Department of Population Health Sciences, University of Utah, Salt Lake City. FAU - Greene, Tom AU - Greene T AD - Division of Biostatistics, Department of Population Health Sciences, University of Utah, Salt Lake City. FAU - Sborov, Douglas AU - Sborov D AD - Division of Hematology and Hematological Malignancies, Huntsman Cancer Institute, University of Utah, Salt Lake City. FAU - Mohyuddin, Ghulam Rehman AU - Mohyuddin GR AD - Division of Hematology and Hematological Malignancies, Huntsman Cancer Institute, University of Utah, Salt Lake City. LA - eng PT - Journal Article DEP - 20231101 PL - United States TA - JAMA Netw Open JT - JAMA network open JID - 101729235 SB - IM MH - Humans MH - *Multiple Myeloma/drug therapy MH - Randomized Controlled Trials as Topic MH - Cohort Studies PMC - PMC10638643 COIS- Conflict of Interest Disclosures: Dr Cliff reported receiving grants from Arnold Ventures outside the submitted work. Dr Steensma reported being formerly employed by Novartis outside the submitted work. Dr Al Hadidi reported receiving personal fees from Janssen, Sanofi, and Pfizer outside the submitted work. Dr Chakraborty reported receiving consulting fees, serving on advisory boards, and receiving honoraria from Janssen, Sanofi, and Adaptive Biotech; research grants from AbbVie and Genentech Inc; and honoraria from Guidepoint and Curio Science during the conduct of the study. Dr Goodman reported receiving consulting and speaker fees from Seattle Genetics outside the submitted work. Dr Greene reported receiving grants from AstraZeneca, Boehringer Ingelheim, CSL, and Vertex and personal fees from Janssen, Pfizer, Invokana, Novartis, and AstraZeneca outside the submitted work. Dr Sborov reported receiving personal fees from Bristol Myers Squibb, Janssen, Sanofi, Arcellx, Pfizer, AbbVie, AstraZeneca, and Bioline outside the submitted work. Dr Mohyuddin reported receiving payments from MashupMD for writing outside the submitted work. No other disclosures were reported. EDAT- 2023/11/10 12:46 MHDA- 2023/11/13 06:42 PMCR- 2023/11/10 CRDT- 2023/11/10 11:33 PHST- 2023/11/13 06:42 [medline] PHST- 2023/11/10 12:46 [pubmed] PHST- 2023/11/10 11:33 [entrez] PHST- 2023/11/10 00:00 [pmc-release] AID - 2811645 [pii] AID - zoi231220 [pii] AID - 10.1001/jamanetworkopen.2023.42195 [doi] PST - epublish SO - JAMA Netw Open. 2023 Nov 1;6(11):e2342195. doi: 10.1001/jamanetworkopen.2023.42195.