Evaluation of the patient experience of symptomatic adverse events on Phase I clinical trials using PRO-CTCAE

[1]  L. Minasian,et al.  Underreporting of symptomatic adverse events in phase I clinical trials. , 2021, Journal of the National Cancer Institute.

[2]  M. Bertagnolli,et al.  Composite grading algorithm for the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) , 2020, Clinical trials.

[3]  C. Yap,et al.  585P Trends in patient-reported outcome (PRO) use in early phase oncology trials , 2020 .

[4]  Thomas J. Smith,et al.  Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials , 2020, JNCI cancer spectrum.

[5]  Zahra S. Razaee,et al.  Evaluating Treatment Tolerability in Cancer Clinical Trials Using the Toxicity Index , 2020, Journal of the National Cancer Institute.

[6]  Versione,et al.  Common Terminology Criteria for Adverse Events , 2020, Definitions.

[7]  E. Basch,et al.  Clinician vs Patient Reporting of Baseline and Postbaseline Symptoms for Adverse Event Assessment in Cancer Clinical Trials. , 2019, JAMA oncology.

[8]  F. Fiteni,et al.  Health-related quality of life as an endpoint in oncology phase I trials: a systematic review , 2019, BMC Cancer.

[9]  Arlene E. Chung,et al.  Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) , 2019, J. Am. Medical Informatics Assoc..

[10]  L. Minasian,et al.  What Do "None," "Mild," "Moderate," "Severe," and "Very Severe" Mean to Patients With Cancer? Content Validity of PRO-CTCAE™ Response Scales. , 2017, Journal of pain and symptom management.

[11]  M. Socinski,et al.  Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials , 2017, JAMA oncology.

[12]  Sarah T. Jewell,et al.  The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review , 2016, Supportive Care in Cancer.

[13]  E. Basch,et al.  Methods for Implementing and Reporting Patient-reported Outcome (PRO) Measures of Symptomatic Adverse Events in Cancer Clinical Trials. , 2016, Clinical therapeutics.

[14]  Jay K. Harness,et al.  Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) , 2016, Health and Quality of Life Outcomes.

[15]  Amy P Abernethy,et al.  Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). , 2015, JAMA oncology.

[16]  Philippe Ravaud,et al.  Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles , 2015, BMC Medicine.

[17]  Natalie Cook,et al.  Early phase clinical trials to identify optimal dosing and safety , 2015, Molecular oncology.

[18]  Amy P Abernethy,et al.  Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). , 2014, Journal of the National Cancer Institute.

[19]  O. Bortolami,et al.  Clinician versus nurse symptom reporting using the National Cancer Institute-Common Terminology Criteria for Adverse Events during chemotherapy: results of a comparison based on patient's self-reported questionnaire. , 2009, Annals of oncology : official journal of the European Society for Medical Oncology.

[20]  A. Colevas,et al.  Adverse event reporting in publications compared with sponsor database for cancer clinical trials. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[21]  D. Sargent,et al.  Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. , 2002, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[22]  J. Ioannidis,et al.  Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. , 2001, JAMA.