scholarly journals BIRC5(survivin) splice variant expression correlates with refractory disease and poor outcome in pediatric acute myeloid leukemia: A report from the Children's Oncology Group

2013 ◽  
Vol 61 (4) ◽  
pp. 647-652 ◽  
Author(s):  
Andrew S. Moore ◽  
Todd A. Alonzo ◽  
Robert B. Gerbing ◽  
Beverly J. Lange ◽  
Nyla A. Heerema ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Splice Variant ◽  
Myeloid Leukemia ◽  
Refractory Disease ◽  
Oncology Group ◽  
Pediatric Acute Myeloid Leukemia ◽  
Poor Outcome ◽  
Acute Myeloid

scholarly journals Multimerin-1 (MMRN1) as Novel Adverse Marker in Pediatric Acute Myeloid Leukemia: A Report from the Children's Oncology Group

2015 ◽  
Vol 21 (14) ◽  
pp. 3187-3195 ◽  
Author(s):  
George S. Laszlo ◽  
Todd A. Alonzo ◽  
Chelsea J. Gudgeon ◽  
Kimberly H. Harrington ◽  
Robert B. Gerbing ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Oncology Group ◽  
Pediatric Acute Myeloid Leukemia ◽  
Acute Myeloid

scholarly journals Quality of life in pediatric acute myeloid leukemia: Report from the Children's Oncology Group

2019 ◽  
Vol 8 (9) ◽  
pp. 4454-4464 ◽  
Author(s):  
Rajaram Nagarajan ◽  
Robert Gerbing ◽  
Todd Alonzo ◽  
Donna L. Johnston ◽  
Richard Aplenc ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Oncology Group ◽  
Pediatric Acute Myeloid Leukemia ◽  
Acute Myeloid

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

2016 ◽  
Vol 34 (13) ◽  
pp. 1537-1543 ◽  
Author(s):  
Tamara P. Miller ◽  
Yimei Li ◽  
Marko Kavcic ◽  
Andrea B. Troxel ◽  
Yuan-Shun V. Huang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Current System ◽  
High Sensitivity ◽  
Oncology Group ◽  
Billing Data ◽  
Predictive Values ◽  
Pediatric Acute Myeloid Leukemia ◽  
Acute Myeloid

Purpose 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. Methods 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. Results 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 billing data had higher sensitivity (> 50% for nine AEs), but lower PPV (< 75% for 10 AEs). Viridans group streptococcal detection using PHIS microbiology data had high sensitivity (92.3%) and PPV (97.3%). 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.

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