title: Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia.
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 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%).
  
  
  
  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.
authors.affiliation: 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.
authors.forename: Tamara P
authors.initials: TP
authors.lastname: Miller
authors.affiliation: 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.
authors.forename: Yimei
authors.initials: Y
authors.lastname: Li
authors.affiliation: 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.
authors.forename: Marko
authors.initials: M
authors.lastname: Kavcic
authors.affiliation: 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.
authors.forename: Andrea B
authors.initials: AB
authors.lastname: Troxel
authors.affiliation: 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.
authors.forename: Yuan-Shun V
authors.initials: YS
authors.lastname: Huang
authors.affiliation: 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.
authors.forename: Lillian
authors.initials: L
authors.lastname: Sung
authors.affiliation: 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.
authors.forename: Todd A
authors.initials: TA
authors.lastname: Alonzo
authors.affiliation: 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.
authors.forename: Robert
authors.initials: R
authors.lastname: Gerbing
authors.affiliation: 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.
authors.forename: Matt
authors.initials: M
authors.lastname: Hall
authors.affiliation: 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.
authors.forename: Marla H
authors.initials: MH
authors.lastname: Daves
authors.affiliation: 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.
authors.forename: Terzah M
authors.initials: TM
authors.lastname: Horton
authors.affiliation: 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.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Pulsipher
authors.affiliation: 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.
authors.forename: Jessica A
authors.initials: JA
authors.lastname: Pollard
authors.affiliation: 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.
authors.forename: Rochelle
authors.initials: R
authors.lastname: Bagatell
authors.affiliation: 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.
authors.forename: Alix E
authors.initials: AE
authors.lastname: Seif
authors.affiliation: 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.
authors.forename: Brian T
authors.initials: BT
authors.lastname: Fisher
authors.affiliation: 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.
authors.forename: Selina
authors.initials: S
authors.lastname: Luger
authors.affiliation: 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.
authors.forename: Alan S
authors.initials: AS
authors.lastname: Gamis
authors.affiliation: 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.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Adamson
authors.affiliation: 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.
authors.forename: Richard
authors.initials: R
authors.lastname: Aplenc
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000617:Aminoglycosides / Q000008:administration & dosage / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods*; D057286:Electronic Health Records; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D016032:Randomized Controlled Trials as Topic / Q000379:methods
chemical_list: D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D000079982:Gemtuzumab