Selected Tolerability Consortium Publications

Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC. Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Clin Trials. 2021 Feb;18(1):104-114. doi: 10.1177/1740774520975120. Epub 2020 Dec 1. PMID: 33258687; PMCID: PMC7878323.

Basch E, Rogak LJ, Dueck AC. Methods for Implementing and Reporting Patient-reported Outcome (PRO) Measures of Symptomatic Adverse Events in Cancer Clinical Trials. Clin Ther. 2016 Apr;38(4):821-30. doi: 10.1016/j.clinthera.2016.03.011. Epub 2016 Apr 2. PMID: 27045992; PMCID: PMC4851916.

Diniz MA, Gresham G, Kim S, Luu M, Henry NL, Tighiouart M, Yothers G, Ganz PA, Rogatko A. Visualizing adverse events in clinical trials using correspondence analysis with R-package visae. BMC Med Res Methodol. 2021 Nov 9;21(1):244. doi: 10.1186/s12874-021-01368-w. PMID: 34753452; PMCID: PMC8579548.

Diniz M, Luu M. visae: Visualization of Adverse Events. R package version 0.1.0. 2021.

Dueck AC, Scher HI, Bennett AV, Mazza GL, Thanarajasingam G, Schwab G, Weitzman AL, Rogak LJ, Basch E. Assessment of Adverse Events From the Patient Perspective in a Phase 3 Metastatic Castration-Resistant Prostate Cancer Clinical Trial. JAMA Oncol. 2020 Feb 1;6(2):e193332. doi: 10.1001/jamaoncol.2019.3332. Epub 2020 Feb 13. PMID: 31556911; PMCID: PMC6764147.

Gresham G, Diniz MA, Razaee ZS, Luu M, Kim S, Hays RD, Piantadosi S, Tighiouart M, Yothers G, Ganz PA, Rogatko A. Evaluating Treatment Tolerability in Cancer Clinical Trials Using the Toxicity Index. J Natl Cancer Inst. 2020 Dec 14;112(12):1266-1274. doi: 10.1093/jnci/djaa028. PMID: 32091598; PMCID: PMC7735773.

Gresham G, Mazza GL, Langlais B, King-Kallimanis B, Rogak LR. Patient Tolerability Consortia Standardization Working Group, Graphical Representations of Patient Tolerability Data: Recommendations from the National Cancer Institute (NCI) Cancer Moonshot Standardization Working Group. J Clin Oncol 39, no. 15_suppl, May 28 2021

Hays R, Ganz PA, Spritzer KL, Rogatko A. Applying the Toxicity Index t Patient-Reported Symptom Data: An example using the European Organization for Research and Treatment of Cancer Colorectal Cancer-Specific Quality of Life Questionnaire. Clin Ther. 2021 Jun 25

Henry NL, Rogatko A, Ganz PA. Evaluating the Association of Adverse Events and Patient-Reported Symptoms to Endocrine Therapy Tolerability. J Clin Oncol. 2022 Feb 1;40(4):430-431. doi: 10.1200/JCO.21.02387. Epub 2021 Dec 9. PMID: 34882498; PMCID: PMC8797605

Langlais BT, et al. Evaluation of treatment tolerability utilizing a toxicity summary measure with Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) data. 2021 [UNDER REVIEW]

Langlais B, Dueck A. ProAE: Tools for PRO-CTCAE scoring, analysis, and graphical display. R package version 0.2.0. 2021.

Le-Rademacher JG, Hillman S, Storrick E, Mahoney MR, Thall PF, Jatoi A, Mandrekar SJ. Adverse Event Burden Score-A Versatile Summary Measure for Cancer Clinical Trials. Cancers (Basel). 2020 Nov 4;12(11):3251. doi: 10.3390/cancers12113251. PMID: 33158080; PMCID: PMC7694214.

Mazza GL, Petersen MM, Ginos B, Langlais BT, Heon N, Gounder MM, Mahoney MR, Zoroufy AJ, Schwartz GK, Rogak LJ, Thanarajasingam G. Missing data strategies for the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2. Qual Life Res. 2022 Apr;31(4):1069-80.

Rogatko A, Babb JS, Wang H, Slifker MJ, Hudes GR. Patient characteristics compete with dose as predictors of acute treatment toxicity in early phase clinical trials. Clin Cancer Res. 2004 Jul 15;10(14):4645-51. doi: 10.1158/1078-0432.CCR-03-0535. PMID: 15269136.

Razaee ZS, Amini AA, Diniz MA, Tighiouart M, Yothers G, Rogatko A. On the properties of the toxicity index and its statistical efficiency. Stat Med. 2021 Mar 15;40(6):1535-1552. doi: 10.1002/sim.8858. Epub 2020 Dec 20. PMID: 33345351; PMCID: PMC7953898.

Thanarajasingam G, Atherton PJ, Novotny PJ, Loprinzi CL, Sloan JA, Grothey A. Longitudinal adverse event assessment in oncology clinical trials: the Toxicity over Time (ToxT) analysis of Alliance trials NCCTG N9741 and 979254. Lancet Oncol. 2016 May;17(5):663-70. doi: 10.1016/S1470-2045(16)00038-3. Epub 2016 Apr 12. PMID: 27083333; PMCID: PMC4910515.

Thanarajasingam G, Leonard JP, Witzig TE, Habermann TM, Blum KA, Bartlett NL, Flowers CR, Pitcher BN, Jung SH, Atherton PJ, Tan A, Novotny PJ, Dueck AC. Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability: a case study of lenalidomide in the CALGB 50401 (Alliance) trial. Lancet Haematol. 2020 Jun;7(6):e490-e497. doi: 10.1016/S2352-3026(20)30067-3. PMID: 32470440; PMCID: PMC7457391.

Last Updated: November 3, 2022