Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Tamara P MillerRichard Aplenc

Abstract

Reporting of adverse events (AEs) in clinical trials is critical to understanding treatment safety, but data on AE accuracy are limited. This study sought to determine the accuracy of AE reporting for pediatric acute myeloid leukemia clinical trials and to test whether an external electronic data source can improve reporting. Reported AEs were evaluated on two trials, Children's Oncology Group AAML03P1 and AAML0531 arm B, with identical chemotherapy regimens but with different toxicity reporting requirements. Chart review for 12 AEs for patients enrolled in AAML0531 at 14 hospitals was the gold standard. The sensitivity and positive predictive values (PPV) of the AAML0531 AE report and AEs detected by review of Pediatric Health Information System (PHIS) billing and microbiology data were compared with chart data. Select AE rates from AAML03P1 and AAML0531 arm B differed significantly and correlated with the targeted toxicities of each trial. Chart abstraction was performed on 204 patients (758 courses) on AAML0531. AE report sensitivity was < 50% for eight AEs, but PPV was > 75% for six AEs. AE reports for viridans group streptococcal bacteremia, a targeted toxicity on AAML0531, had a sensitivity of 78.3% and PPV of 98.1%. PHIS...Continue Reading

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Citations

Oct 22, 2016·British Journal of Haematology·Henrik Hasle, Gertjan J L Kaspers
Oct 25, 2016·Leukemia Research·Bruno C Medeiros, Robert Peter Gale
Feb 2, 2017·British Journal of Haematology·Tamara P MillerRichard Aplenc
Feb 7, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Heather S L Jim, Howard L McLeod
Apr 12, 2018·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Daniel ShepshelovichEitan Amir
Apr 11, 2019·Pediatric Blood & Cancer·Tamara P MillerRichard Aplenc
Mar 12, 2020·British Journal of Haematology·William R Otto, Abby M Green
Apr 1, 2021·Current Hematologic Malignancy Reports·Tamara P Miller, Richard Aplenc
May 7, 2020·International Journal of Radiation Oncology, Biology, Physics·Andrew T FairchildJulian C Hong

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