Center-level variation in accuracy of adverse event reporting in a clinical trial for pediatric acute myeloid leukemia: A report from the Children’s Oncology Group

Tamara P. Miller; Yimei Li; Marko Kavcic; Kelly D. Getz; Yuan Shun V. Huang; Lillian Sung; Todd A. Alonzo; Robert Gerbing; Marla H. Daves; Terzah M. Horton; Michael A. Pulsipher; Jessica Pollard; Rochelle Bagatell; Alix E. Seif; Brian T. Fisher; Selina Luger; Alan S. Gamis; Peter C. Adamson; Richard Aplenc

doi:10.3324/haematol.2017.168815

Center-level variation in accuracy of adverse event reporting in a clinical trial for pediatric acute myeloid leukemia: A report from the Children’s Oncology Group

Tamara P. Miller, Yimei Li, Marko Kavcic, Kelly D. Getz, Yuan Shun V. Huang, Lillian Sung, Todd A. Alonzo, Robert Gerbing, Marla H. Daves, Terzah M. Horton, Michael A. Pulsipher, Jessica Pollard, Rochelle Bagatell, Alix E. Seif, Brian T. Fisher, Selina Luger, Alan S. Gamis, Peter C. Adamson, Richard Aplenc

Research output: Contribution to journal › Letter › peer-review

3 Scopus citations

Original language	English
Pages (from-to)	340-343
Number of pages	4
Journal	Haematologica
Volume	102
Issue number	9
DOIs	https://doi.org/10.3324/haematol.2017.168815
State	Published - 31 Aug 2017
Externally published	Yes

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10.3324/haematol.2017.168815

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Miller, T. P., Li, Y., Kavcic, M., Getz, K. D., Huang, Y. S. V., Sung, L., Alonzo, T. A., Gerbing, R., Daves, M. H., Horton, T. M., Pulsipher, M. A., Pollard, J., Bagatell, R., Seif, A. E., Fisher, B. T., Luger, S., Gamis, A. S., Adamson, P. C., & Aplenc, R. (2017). Center-level variation in accuracy of adverse event reporting in a clinical trial for pediatric acute myeloid leukemia: A report from the Children’s Oncology Group. Haematologica, 102(9), 340-343. https://doi.org/10.3324/haematol.2017.168815

@article{fab906f9b12b46a9aa147d64988c020b,

title = "Center-level variation in accuracy of adverse event reporting in a clinical trial for pediatric acute myeloid leukemia: A report from the Children{\textquoteright}s Oncology Group",

author = "Miller, {Tamara P.} and Yimei Li and Marko Kavcic and Getz, {Kelly D.} and Huang, {Yuan Shun V.} and Lillian Sung and Alonzo, {Todd A.} and Robert Gerbing and Daves, {Marla H.} and Horton, {Terzah M.} and Pulsipher, {Michael A.} and Jessica Pollard and Rochelle Bagatell and Seif, {Alix E.} and Fisher, {Brian T.} and Selina Luger and Gamis, {Alan S.} and Adamson, {Peter C.} and Richard Aplenc",

note = "Funding Information: 1Divisions of Oncology, The Children{\textquoteright}s Hospital of Philadelphia, PA, USA;2Center for Pediatric Clinical Effectiveness, The Children{\textquoteright}s Hospital of Philadelphia, PA, USA;3Department of Biomedical and Health Informatics, The Children{\textquoteright}s Hospital of Philadelphia, PA, USA; 4Center for Clinical Epidemiology and Biostatistics Departments of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA;5Department of Haematology/Oncology, The Hospital for Sick Children, Toronto, Canada;6Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA;7Children{\textquoteright}s Oncology Group, Monrovia, CA, USA;8Department of Pediatrics, Section of Hematology-Oncology, Texas Children{\textquoteright}s Hospital, Houston, TX, USA;9Division of Hematology, Oncology and BMT, Children{\textquoteright}s Hospital of Los Angeles, USC Keck School of Medicine, CA, USA; 10Maine Children{\textquoteright}s Cancer Program, Maine Medical Center, Scarborough, ME, USA;11Departments of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA;12Infectious Diseases, The Children{\textquoteright}s Hospital of Philadelphia, PA, USA; 13Hematology/Bone Marrow Transplant, University of Pennsylvania School of Medicine, Philadelphia, PA, USA and 14Pediatric Hematology/Oncology, Children{\textquoteright}s Mercy Hospital, Kansas City, MO, USA Fundind: this work is supported by the National Institutes of Health R01 CA165277, K12 CA076931, Statistics and Data Center Grant U10CA098413, Chair's Grant U10CA098543, National Clinical Trials Network (NCTN) Operations Center Grant U10CA180886, NCTN Statistics & Data Center U10CA180899, the Pediatric Pharmacoepidemiology Training Grant 5T32HD064567-04, the Damon Runyon Cancer Research Foundation, and the St. Baldrick{\textquoteright}s Foundation. Staci Arnold, MD, MBA, Jessica Bokland, MD, James Feusner, MD, Samir Kahwash, MD, Michael Kelly, MD, PhD, Matthew Kutny, MD, William Roberts, MD, and Naomi Winick, MD also contributed data for this manuscript. Correspondence: aplenc@email.chop.edu doi:10.3324/haematol.2017.168815 Information on authorship, contributions, and financial & other disclosures was provided by the authors and is available with the online version of this article at www.haematologica.org.",

year = "2017",

month = aug,

day = "31",

doi = "10.3324/haematol.2017.168815",

language = "English",

volume = "102",

pages = "340--343",

journal = "Haematologica",

issn = "0390-6078",

publisher = "Ferrata Storti Foundation",

number = "9",

}

Miller, TP, Li, Y, Kavcic, M, Getz, KD, Huang, YSV, Sung, L, Alonzo, TA, Gerbing, R, Daves, MH, Horton, TM, Pulsipher, MA, Pollard, J, Bagatell, R, Seif, AE, Fisher, BT, Luger, S, Gamis, AS, Adamson, PC & Aplenc, R 2017, 'Center-level variation in accuracy of adverse event reporting in a clinical trial for pediatric acute myeloid leukemia: A report from the Children’s Oncology Group', Haematologica, vol. 102, no. 9, pp. 340-343. https://doi.org/10.3324/haematol.2017.168815

TY - JOUR

T1 - Center-level variation in accuracy of adverse event reporting in a clinical trial for pediatric acute myeloid leukemia

T2 - A report from the Children’s Oncology Group

AU - Miller, Tamara P.

AU - Li, Yimei

AU - Kavcic, Marko

AU - Getz, Kelly D.

AU - Huang, Yuan Shun V.

AU - Sung, Lillian

AU - Alonzo, Todd A.

AU - Gerbing, Robert

AU - Daves, Marla H.

AU - Horton, Terzah M.

AU - Pulsipher, Michael A.

AU - Pollard, Jessica

AU - Bagatell, Rochelle

AU - Seif, Alix E.

AU - Fisher, Brian T.

AU - Luger, Selina

AU - Gamis, Alan S.

AU - Adamson, Peter C.

AU - Aplenc, Richard

N1 - Funding Information: 1Divisions of Oncology, The Children’s Hospital of Philadelphia, PA, USA;2Center for Pediatric Clinical Effectiveness, The Children’s Hospital of Philadelphia, PA, USA;3Department of Biomedical and Health Informatics, The Children’s Hospital of Philadelphia, PA, USA; 4Center for Clinical Epidemiology and Biostatistics Departments of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA;5Department of Haematology/Oncology, The Hospital for Sick Children, Toronto, Canada;6Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA;7Children’s Oncology Group, Monrovia, CA, USA;8Department of Pediatrics, Section of Hematology-Oncology, Texas Children’s Hospital, Houston, TX, USA;9Division of Hematology, Oncology and BMT, Children’s Hospital of Los Angeles, USC Keck School of Medicine, CA, USA; 10Maine Children’s Cancer Program, Maine Medical Center, Scarborough, ME, USA;11Departments of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA;12Infectious Diseases, The Children’s Hospital of Philadelphia, PA, USA; 13Hematology/Bone Marrow Transplant, University of Pennsylvania School of Medicine, Philadelphia, PA, USA and 14Pediatric Hematology/Oncology, Children’s Mercy Hospital, Kansas City, MO, USA Fundind: this work is supported by the National Institutes of Health R01 CA165277, K12 CA076931, Statistics and Data Center Grant U10CA098413, Chair's Grant U10CA098543, National Clinical Trials Network (NCTN) Operations Center Grant U10CA180886, NCTN Statistics & Data Center U10CA180899, the Pediatric Pharmacoepidemiology Training Grant 5T32HD064567-04, the Damon Runyon Cancer Research Foundation, and the St. Baldrick’s Foundation. Staci Arnold, MD, MBA, Jessica Bokland, MD, James Feusner, MD, Samir Kahwash, MD, Michael Kelly, MD, PhD, Matthew Kutny, MD, William Roberts, MD, and Naomi Winick, MD also contributed data for this manuscript. Correspondence: aplenc@email.chop.edu doi:10.3324/haematol.2017.168815 Information on authorship, contributions, and financial & other disclosures was provided by the authors and is available with the online version of this article at www.haematologica.org.

PY - 2017/8/31

Y1 - 2017/8/31

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U2 - 10.3324/haematol.2017.168815

DO - 10.3324/haematol.2017.168815

M3 - Letter

C2 - 28642300

AN - SCOPUS:85029581914

SN - 0390-6078

VL - 102

SP - 340

EP - 343

JO - Haematologica

JF - Haematologica

IS - 9

ER -