This Article Full Text Full Text (PDF) [Publisher's Note] Erratum (v24,p1015) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Mahoney, M. R. Articles by Buckner, J. C. Search for Related Content PubMed PubMed Citation Articles by Mahoney, M. R. Articles by Buckner, J. C.

Dealing With a Deluge of Data: An Assessment of Adverse Event Data on North Central Cancer Treatment Group Trials

From the Mayo Clinic and Mayo Foundation, Rochester, MN; Allegheny Cancer Center, Pittsburgh, PA; The University of North Carolina at Chapel Hill, Chapel Hill, NC; and Toledo Community Hospital Oncology Program CCOP, Toledo, OH

Address reprint requests to Michelle Mahoney, MS, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: mahoneym{at}mayo.edu

PURPOSE: Adverse events (AEs) are monitored in clinical trials for patient safety, to satisfy reporting requirements, and develop safety profiles. Recently, much attention has been placed on the reporting of serious AEs (SAEs) that are either life threatening or lethal in clinical trials. However, SAEs comprise a small subset of all AE data collected for trials; the majority of AE data collected are routine AEs (RAEs) regarding non–life-threatening events. We assessed the utility of the RAE data collected, relative to the volume.

PATIENTS AND METHODS: We surveyed the RAE data from 26 North Central Cancer Treatment Group coordinated trials.

RESULTS: A total of 8,318 (11%) of 75,598 of RAEs required queries. Of these, 86% were protocol-required RAEs, 83% of RAEs required per protocol were within normal limits (eg, platelets) or not present, and 61% of extra AEs were mild. One fifth of RAEs were considered unlikely to be related or unrelated to treatment. Overall, 3% of events were severe, life threatening, or caused death. Only 1% of RAE data reported required expedited reporting (eg, via Adverse Event Expedited Reporting System). Results indicate that 72% of RAEs would be eliminated if only the maximum severity per patient and type were required. These results were validated in a large phase III trial.

CONCLUSION: The majority of RAEs identified, transcribed, and entered are not clinically important. Our data suggest that reducing the number of AEs monitored will affect substantially neither overall patient safety nor compromise evaluation of regimens undergoing testing. We present several considerations for such a reduction in data collection, as well as a policy that we have used to address the deluge of RAE data.

Supported in part by Public Health Service Grants No. CA-25224, CA-37404, and CA-35103 and conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

This article has been cited by other articles:

				M. Reddy, S. S. Gill, S. R. Kalkar, W. Wu, P. J. Anderson, and P. A. Rochon Treatment for Lymphatic Filariasis and Elephantiasis--Reply JAMA, February 13, 2008; 299(6): 633 - 633. [Full Text] [PDF]

				E. Atallah, J. Cortes, S. O'Brien, S. Pierce, M. B. Rios, E. Estey, M. Markman, M. Keating, E. J. Freireich, and H. Kantarjian Establishment of baseline toxicity expectations with standard frontline chemotherapy in acute myelogenous leukemia Blood, November 15, 2007; 110(10): 3547 - 3551. [Abstract] [Full Text] [PDF]

				A. Trotti, A. D. Colevas, A. Setser, and E. Basch Patient-Reported Outcomes and the Evolution of Adverse Event Reporting in Oncology J. Clin. Oncol., November 10, 2007; 25(32): 5121 - 5127. [Abstract] [Full Text] [PDF]

				S. M. Bentzen and A. Trotti Evaluation of Early and Late Toxicities in Chemoradiation Trials J. Clin. Oncol., September 10, 2007; 25(26): 4096 - 4103. [Abstract] [Full Text] [PDF]

				S. J. Anderson Some Thoughts on the Reporting of Adverse Events in Phase II Cancer Clinical Trials J. Clin. Oncol., August 20, 2006; 24(24): 3821 - 3822. [Full Text] [PDF]