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

Conclusion
The current system of AE reporting for cooperative oncology group clinical trials in pediatric acute myeloid leukemia underestimates AE rates. The high sensitivity and PPV of PHIS microbiology data suggest that using external data sources may improve the accuracy of AE reporting.

Source: Journal of Clinical Oncology - April 19, 2016 Category: Cancer & Oncology Authors: Miller, Li, Kavcic, Troxel, Huang, Sung, Alonzo, Gerbing, Hall, Daves, Horton, Pulsipher, Pollard, Bagatell, Seif, Fisher, Luger, Gamis, Adamson, Aplenc Tags: Clinical Trials, Supportive Care, Epidemiology, Supportive Care, Acute Non-Lymphoblastic Leukemia/MDS/CML Pediatric Oncology Source Type: research