ArticleJournal of pain and symptom management2022
Evaluating Treatment Tolerability Using the Toxicity Index With Patient-Reported Outcomes Data.
Article in Journal of pain and symptom management, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 23 citations in OpenAlex.
- Patient Versus Clinician Reported Symptoms Agreement in Advanced Metastatic Bladder Cancer Patients.Cancer medicine · 2025Trial
- Improving real-world evaluation of patient- and physician-reported tolerability: niraparib for recurrent ovarian cancer (NiQoLe).JNCI cancer spectrum · 2025Trial
- Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Article
- PRO-ADD: Patient-empowered dose-finding trials integrating safety, preliminary efficacy and patient-reported outcomes for optimal dose selection.Statistical methods in medical research · 2026Article
- ProAE: an R package for graphical tools and standardized analysis of patient-reported outcomes and adverse events data.BMC medical informatics and decision making · 2025Article
- Article
- Review
- Review
- Analyses of adverse events and patient-reported outcomes with the toxicity index in cancer clinical trials.Cancer · 2025Review
- Article
- Toxicity-benefit analysis of advanced prostate cancer trials using weighted toxicity scoring.The oncologist · 2025Article
- Assessing Quality of Life and Symptoms in Transplantation and CAR-T Recipients: Expert Panel Recommendations from the Survivorship Special Interest Group of ASTCT.Transplantation and cellular therapy · 2025Review
- Incorporation of patient-reported outcomes in pediatric cancer clinical trials: design, implementation, and dissemination.Journal of the National Cancer Institute · 2025Article
- Under the radar-frequency, timing, duration, and trajectory of lower-grade adverse events in clinical trials of anti-cancer therapies.The oncologist · 2025Article
- Comparison of patient-reported symptoms with multi-item patient-reported outcome measures of fatigue, anxiety, and depression in the clinical care of women undergoing chemotherapy for early breast cancer.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Article
- Combining Response and Toxicity Data to Implement Project Optimus.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Article
- The Weighted Toxicity Score: Confirmation of a Simple Metric to Communicate Toxicity in Randomized Trials of Systemic Cancer Therapy.The oncologist · 2024Article
- A toolbox of different approaches to analyze and present PRO-CTCAE data in oncology studies.Journal of the National Cancer Institute · 2023Article
- Simulation study comparing analytical methods for single-item longitudinal patient-reported outcomes data.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
Corrections and comments
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Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
contextSummarizing longitudinal symptomatic adverse events during clinical trials is necessary for understanding treatment tolerability. The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) provides insight for capturing treatment tolerability within trials. Tolerability summary measures, such as the maximum score, are often used to communicate the potential negative symptoms both in the medical literature and directly to patients. Commonly, the proportions of present and severe symptomatic adverse events are used and reported between treatment arms among adverse event types. The toxicity index is also a summary measure previously applied to clinician-reported CTCAE data.
objectivesApply the toxicity index to PRO-CTCAE data from the COMET-2 trial alongside the maximum score, then present and discuss considerations for using the toxicity index as a summary measure for communicating tolerability to patients and clinicians.
methodsProportions of maximum PRO-CTCAE severity levels and median toxicity index were computed by arm using all trial data and adjusting for baseline symptoms.
resultsGroup-wise statistical differences were similar whether using severity level proportions or the toxicity index. The impact of adjusting for baseline symptoms was equivalently seen when comparing arms using severity rates or the toxicity index.
conclusionThe toxicity index is a useful method when ranking patients from those with the least to most symptomatic adverse event burden. This study showed the toxicity index can be applied to PRO-CTCAE data. Though as a tolerability summary measure, further study is needed to provide a clear clinical or patient-facing interpretation of the toxicity index.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.