PMID- 26884558
OWN - NLM
STAT- MEDLINE
DCOM- 20170703
LR  - 20200402
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 34
IP  - 13
DP  - 2016 May 1
TI  - Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute 
      Myeloid Leukemia.
PG  - 1537-43
LID - 10.1200/JCO.2015.65.5860 [doi]
AB  - 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.
CI  - (c) 2016 by American Society of Clinical Oncology.
FAU - Miller, Tamara P
AU  - Miller TP
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO. 
      millertp@e-mail.chop.edu.
FAU - Li, Yimei
AU  - Li Y
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Kavcic, Marko
AU  - Kavcic M
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Troxel, Andrea B
AU  - Troxel AB
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Huang, Yuan-Shun V
AU  - Huang YS
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Sung, Lillian
AU  - Sung L
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Alonzo, Todd A
AU  - Alonzo TA
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Gerbing, Robert
AU  - Gerbing R
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Hall, Matt
AU  - Hall M
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Daves, Marla H
AU  - Daves MH
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Horton, Terzah M
AU  - Horton TM
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Pulsipher, Michael A
AU  - Pulsipher MA
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Pollard, Jessica A
AU  - Pollard JA
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Bagatell, Rochelle
AU  - Bagatell R
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Seif, Alix E
AU  - Seif AE
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Fisher, Brian T
AU  - Fisher BT
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Luger, Selina
AU  - Luger S
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Gamis, Alan S
AU  - Gamis AS
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Adamson, Peter C
AU  - Adamson PC
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
FAU - Aplenc, Richard
AU  - Aplenc R
AD  - Tamara P. Miller, Yimei Li, Marko Kavcic, Yuan-Shun V. Huang, Rochelle Bagatell, 
      Alix E. Seif, Brian T. Fisher, Peter C. Adamson, and Richard Aplenc, The 
      Children's Hospital of Philadelphia; Yimei Li, Andrea B. Troxel, Rochelle 
      Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Peter C. Adamson, and 
      Richard Aplenc, University of Pennsylvania School of Medicine, Philadelphia, PA; 
      Lillian Sung, The Hospital for Sick Children, Toronto, Ontario, Canada; Todd A. 
      Alonzo and Michael A. Pulsipher, University of Southern California; Michael A. 
      Pulsipher, Children's Hospital of Los Angeles, Los Angeles; Todd A. Alonzo and 
      Robert Gerbing, Children's Oncology Group, Monrovia, CA; Matt Hall, Children's 
      Hospital Association, Overland Park, Kansas; Marla H. Daves, Children's 
      Healthcare of Atlanta, Atlanta, GA; Terzah M. Horton, Texas Children's Hospital, 
      Houston, TX; Jessica A. Pollard, Seattle Children's Hospital, Seattle, WA; and 
      Alan S. Gamis, Children's Mercy Hospital, Kansas City, MO.
LA  - eng
GR  - K12 CA076931/CA/NCI NIH HHS/United States
GR  - UG1 CA189955/CA/NCI NIH HHS/United States
GR  - U10 CA098543/CA/NCI NIH HHS/United States
GR  - U10 CA180899/CA/NCI NIH HHS/United States
GR  - U10 CA180886/CA/NCI NIH HHS/United States
GR  - T32 HD064567/HD/NICHD NIH HHS/United States
GR  - R01 CA165277/CA/NCI NIH HHS/United States
GR  - K12 CA090433/CA/NCI NIH HHS/United States
GR  - P30 CA016520/CA/NCI NIH HHS/United States
PT  - Journal Article
DEP - 20160216
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Aminoglycosides)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 93NS566KF7 (Gemtuzumab)
SB  - IM
CIN - J Clin Oncol. 2017 Apr 1;35(10):1135. PMID: 28165896
CIN - J Clin Oncol. 2017 Apr 1;35(10):1133-1134. PMID: 28165908
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Aminoglycosides/administration & dosage/*adverse effects
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/*adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
MH  - Child
MH  - Clinical Trials as Topic/*methods
MH  - Electronic Health Records
MH  - Female
MH  - Gemtuzumab
MH  - Humans
MH  - Leukemia, Myeloid, Acute/*drug therapy
MH  - Male
MH  - Randomized Controlled Trials as Topic/methods
PMC - PMC4872308
COIS- Authors' disclosures of potential conflicts of interest are found in the article 
      online at www.jco.org. Author contributions are found at the end of this article.
EDAT- 2016/02/18 06:00
MHDA- 2017/07/04 06:00
PMCR- 2017/04/01
CRDT- 2016/02/18 06:00
PHST- 2016/02/18 06:00 [entrez]
PHST- 2016/02/18 06:00 [pubmed]
PHST- 2017/07/04 06:00 [medline]
PHST- 2017/04/01 00:00 [pmc-release]
AID - JCO.2015.65.5860 [pii]
AID - 655860 [pii]
AID - 10.1200/JCO.2015.65.5860 [doi]
PST - ppublish
SO  - J Clin Oncol. 2016 May 1;34(13):1537-43. doi: 10.1200/JCO.2015.65.5860. Epub 2016 
      Feb 16.