Observational studyJournal of the National Cancer Institute2021
Underreporting of Symptomatic Adverse Events in Phase I Clinical Trials.
Observational study in Journal of the National Cancer Institute, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 1 of them a synthesis that pooled it.
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
41 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Patient-Reported Outcomes in Phase 3 Clinical Trials for Blood Cancers: A Systematic Review.JAMA network open · 2024Pooled it
- Patient Versus Clinician Reported Symptoms Agreement in Advanced Metastatic Bladder Cancer Patients.Cancer medicine · 2025Trial
- Measuring toxicity better: patient-reported outcome-informed calibration for CTCAE assessment.Translational cancer research · 2026Article
- Tutorial on Analyzing Patient-Reported Outcome Measures in Clinical Development.Clinical and translational science · 2026Review
- Review
- Illustrative Integration of Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Data in Dose-Cohort Review for a Phase I Clinical Trial.Research square · 2026Article
- Generalized Pairwise Comparisons in Dose Optimization Oncology Trials: Beyond Safety to Multi-outcome Dose Selection.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- 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
- Patient-Reported Outcomes in Early-Phase Oncology Clinical Trials: A Stepping Stone to a Patient-Centered Drug Development.The patient · 2026Review
- International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Article
- Impact of Reporter Type on Signal Detection of Cancer Therapy-Induced Alopecia: A Hypothesis-Generating Study Using the FDA Adverse Event Reporting System.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: A feasibility study.Clinical trials (London, England) · 2026Article
- Apatinib Plus PD-1 Blockade versus Chemotherapy After Prior Immunotherapy in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: A Retrospective Cohort Study.Biologics : targets & therapy · 2026Article
- Enhancing Adverse Event Identification and Management in Early-Phase Oncology Clinical Trials: The Emerging Role of Advanced Practice Providers.Journal of the advanced practitioner in oncology · 2025Review
- Review
- Totality of the Evidence: Optimizing Dosage Selection Strategies in Oncology.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Article
- Cancer Clinical Trial Patients' Perceptions of Reporting Adverse Events Via an Electronic Platform.Therapeutic innovation & regulatory science · 2025Article
- Incomplete Toxicity Reporting and Use of Toxicity-Minimizing Language in Phase III Oncology Trials.JCO oncology practice · 2025Article
- Evolving CAR T-Cell Therapy to Overcome the Barriers in Treating Pediatric Central Nervous System Tumors.Cancer discovery · 2025Review
- Receiving immunotherapy for the treatment of advanced renal cell carcinoma is associated with higher burden of illness, coagulopathy, cardiac arrhythmia, and disparities.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClinician reporting of symptomatic adverse events (AEs) in phase I trials uses the Common Terminology Criteria for Adverse Events (CTCAE). The utility of the patient-reported outcomes (PROs) version of the CTCAE (PRO-CTCAE) in this setting is unknown. This prospective, observational study compared patient- and clinician-reported symptomatic AEs in phase I patients.
methodsPhase I study-eligible patients at Princess Margaret were surveyed with the PRO-CTCAE full-item library (78 symptomatic AEs) at baseline (BL), mid-cycle 1, and mid-cycle 2 (C2). Patient and trial characteristics, best response, and survival data were collected. Presence or absence of patient- (PRO-CTCAE) or clinician-reported symptomatic AEs were compared (kappa) at defined timepoints and overall (BL+ mid-cycle 1 + C2).
resultsOf 292 patients approached from May 2017 to January 2019, a total of 265 (90.8%) were consented, with 243 (91.7%) evaluable and 552 PRO-CTCAE surveys (completion rate = 98.7%) included in analyses. Evaluation of overall patient-reported symptomatic AEs identified 50 PRO-CTCAE and 11 CTCAE items with 10% or greater reporting frequency. Nineteen CTCAE items were reported as 1% or less despite matched PRO-CTCAE items reporting as 10% or greater. Underreported categories included sexual health, bodily emissions, and cognition. Clinician- relative to patient-reporting frequency (ratio) demonstrated 9 symptomatic AEs with a 50-fold or more lower clinician reporting rate. Overall patient-clinician agreement for individual symptomatic AEs ranged from poor (κ = 0.00-0.19) to moderate (κ = 0.40-0.59), with discordance driven by lack of clinician reporting. Dyspnea (κ = 0.54) and peripheral neuropathy (κ = 0.63) at BL and limb edema (κ = 0.55) at C2 demonstrated the highest patient-clinician agreement.
conclusionsPoor to moderate patient-clinician agreement for symptomatic AEs suggests clinician underreporting in phase I trials. Analyses of severity and interference PRO categories are ongoing.
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