ArticlePediatric blood & cancer2019
Unintended consequences of evolution of the Common Terminology Criteria for Adverse Events.
Article in Pediatric blood & cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers.
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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.
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Who cites it
47 citing papers in PubMed.
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- Measuring toxicity better: patient-reported outcome-informed calibration for CTCAE assessment.Translational cancer research · 2026Article
- Efficacy of combined metformin plus progestin therapy versus progestin monotherapy in endometrial hyperplasia: a randomized clinical trial.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Diagnosis and treatment of cutaneous adverse effects of targeted therapy, antibody-drug conjugates, and immunotherapy in cancer patients: a national consensus statement by the Spanish Society of Medical Oncology and the Spanish Academy of Dermatology and Venereology.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- Exploring drug sensitivity guided individualized treatment in pediatric spindle cell/sclerosing rhabdomyosarcoma.Frontiers in pharmacology · 2026Article
- Assessing patient risk, benefit, and outcomes in drug development: a decade of vemurafenib clinical trials.Melanoma management · 2025Article
- A paradigm shift in neutrophil adverse event grading: What now?HemaSphere · 2025Article
- Health-Related Quality of Life and Social Outcomes in Adolescents and Young Adult Survivors of Childhood Cancer: A Single-Center Case-Control Study from Crete, Greece.Reports (MDPI) · 2025Article
- Treatment of refractory non-small cell lung cancer with combined infusion of modified CIK cells and PD1 antibody: safety and efficacy.Clinical and experimental medicine · 2025Article
- Skin Reactions and Other Underappreciated Dermatologic Side Effects of Cancer Therapies.Current treatment options in oncology · 2025Review
- Article
- Proton beam therapy and dentofacial development in paediatric cancer patients: A scoping review.International journal of particle therapy · 2024Article
- Apatinib beyond first progression is associated with prolonged overall survival in patients with advanced breast cancer: Results from an observational study.Experimental and therapeutic medicine · 2024Article
- Feasibility and Tolerability of Anlotinib Plus PD-1 Blockades for Patients with Treatment-Refractory Metastatic Colorectal Cancer: A Retrospective Exploratory Study.Cancer management and research · 2024Article
- High burden of clinically significant adverse events associated with contemporary therapy for pediatric T-cell acute lymphoblastic leukemia/lymphoma.Pediatric blood & cancer · 2023Article
- Effectiveness and Safety of Apatinib Plus Programmed Cell Death Protein 1 Blockades for Patients with Treatment-refractory Metastatic Colorectal Cancer: A Retrospective Exploratory Study.Journal of cancer prevention · 2023Article
- Long-term follow-up results of pediatric and adolescent patients with localized Ewing sarcoma treated based on stratified modalities.Cancer medicine · 2023Article
- Improving infectious adverse event reporting for children and adolescents enrolled in clinical trials for acute lymphoblastic leukemia: A report from the Children's Oncology Group.Pediatric blood & cancer · 2022Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
backgroundAdverse events (AEs) on Children's Oncology Group (COG) trials are reported manually by clinical research assistants (CRAs). The Common Terminology Criteria for Adverse Events (CTCAE) was developed to provide standardized definitions for identifying and grading AEs. The CTCAE has expanded significantly over its five versions, but the impact of CTCAE definitional changes has not been examined. PROCEDURE: This study compared AE number and ascertainment among the first four CTCAE versions using a case vignette. Each CTCAE version was used to create a list of AEs and grades by two separate CRAs.
resultsThe CTCAE expanded from 9 categories and 49 AEs in v1.0 to 26 categories and 790 AEs in v4.0. CRAs independently selected different approaches to AE ascertainment-comprehensive and parsimonious. The number of AEs identified in the parsimonious approach was stable with 10-14 in each CTC version. The comprehensive approach identified 9, 20, 29, and 37 AEs in CTC versions 1.0, 2.0, 3.0, and 4.0, respectively. Only approximately 65% of AEs were conclusively graded in versions 2.0 to 4.0 using the comprehensive approach.
conclusionsCTCAE has increased in complexity. Although this increased complexity allows for more granular AE reporting, these data demonstrate potential unintended negative consequences of increasing CTC AE complexity, including the risk of varying approaches to AE capture. A comprehensive evaluation of CTC AE definitions and CRA reporting practices across COG institutions and AEs are needed to improve the accuracy and efficiency of AE reporting.
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