PMID- 36083863
OWN - NLM
STAT- MEDLINE
DCOM- 20220930
LR  - 20231102
IS  - 1545-5017 (Electronic)
IS  - 1545-5009 (Print)
IS  - 1545-5009 (Linking)
VI  - 69
IP  - 11
DP  - 2022 Nov
TI  - Improving infectious adverse event reporting for children and adolescents 
      enrolled in clinical trials for acute lymphoblastic leukemia: A report from the 
      Children's Oncology Group.
PG  - e29937
LID - 10.1002/pbc.29937 [doi]
AB  - Infections cause substantial morbidity for children with acute lymphoblastic 
      leukemia (ALL). Therefore, accurate characterization of infectious adverse events 
      (AEs) reported on clinical trials is imperative to defining, comparing, and 
      managing safety and toxicity. Here, we describe key processes implemented to 
      improve reporting of infectious AEs on two active phase III Children's Oncology 
      Group (COG) ALL trials. Processes include: (a) identifying infections as a 
      targeted toxicity, (b) incorporation of infection-specific case report form 
      questions, and (c) physician review of AEs with real-time data cleaning. 
      Preliminary assessment of these processes suggests improved reporting, as well as 
      opportunities for further improvement.
CI  - (c) 2022 Wiley Periodicals LLC.
FAU - Elgarten, Caitlin W
AU  - Elgarten CW
AUID- ORCID: 0000-0002-2474-3031
AD  - Department of Pediatrics, Division of Oncology, Children's Hospital of 
      Philadelphia, Philadelphia, Pennsylvania, USA.
FAU - Thompson, Joel C
AU  - Thompson JC
AUID- ORCID: 0000-0002-9609-7606
AD  - Department of Pediatrics, Division of Hematology/Oncology/Bone Marrow Transplant, 
      Children's Mercy Hospital, University of Missouri-Kansas City, Kansas City, 
      Missouri, USA.
FAU - Angiolillo, Anne
AU  - Angiolillo A
AD  - Center for Cancer and Blood Disorders, Children's National Medical Center, 
      Washington, District of Columbia, USA.
FAU - Chen, Zhiguo
AU  - Chen Z
AD  - Department of Biostatistics, University of Florida, Gainesville, Florida, USA.
FAU - Conway, Susan
AU  - Conway S
AD  - Department of Biostatistics, University of Florida, Gainesville, Florida, USA.
FAU - Devidas, Meenakshi
AU  - Devidas M
AD  - St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
FAU - Gupta, Sumit
AU  - Gupta S
AUID- ORCID: 0000-0003-1334-3670
AD  - Department of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, 
      Canada.
FAU - Kairalla, John A
AU  - Kairalla JA
AD  - Department of Biostatistics, University of Florida, Gainesville, Florida, USA.
FAU - McNeer, Jennifer L
AU  - McNeer JL
AD  - University of Chicago Comer Children's Hospital, Chicago, Illinois, USA.
FAU - O'Brien, Maureen M
AU  - O'Brien MM
AUID- ORCID: 0000-0002-9054-4321
AD  - Cincinnati Children's Hospital Medical Center, Pediatric Hematology/Oncology, 
      University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
FAU - Rabin, Karen R
AU  - Rabin KR
AD  - Pediatric Hematology/Oncology, Baylor College of Medicine, Houston, Texas, USA.
FAU - Rau, Rachel E
AU  - Rau RE
AD  - Pediatric Hematology/Oncology, Baylor College of Medicine, Houston, Texas, USA.
FAU - Rheingold, Susan R
AU  - Rheingold SR
AUID- ORCID: 0000-0001-8025-6767
AD  - Department of Pediatrics, Division of Oncology, Children's Hospital of 
      Philadelphia, Philadelphia, Pennsylvania, USA.
FAU - Wang, Cindy
AU  - Wang C
AD  - Department of Biostatistics, University of Florida, Gainesville, Florida, USA.
FAU - Wood, Charlotte
AU  - Wood C
AD  - Department of Biostatistics, University of Florida, Gainesville, Florida, USA.
FAU - Raetz, Elizabeth A
AU  - Raetz EA
AD  - Laura and Isaac Perlmutter Cancer Center, NYU Langone, New York, New York, USA.
FAU - Loh, Mignon L
AU  - Loh ML
AD  - Division of Hematology, Oncology, Bone Marrow Transplant, and Cellular Therapies, 
      Seattle Children's Hospital and the Ben Towne Center for Childhood Cancer 
      Research, University of Washington, Seattle, Washington, USA.
FAU - Alexander, Sarah
AU  - Alexander S
AUID- ORCID: 0000-0002-9695-1702
AD  - Department of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, 
      Canada.
FAU - Miller, Tamara P
AU  - Miller TP
AUID- ORCID: 0000-0003-4250-5376
AD  - Pediatric Hematology/Oncology, Children's Healthcare of Atlanta - Egleston, 
      Atlanta, Georgia, USA.
LA  - eng
GR  - U10 CA098413/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  - K07 CA211956/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20220909
PL  - United States
TA  - Pediatr Blood Cancer
JT  - Pediatric blood & cancer
JID - 101186624
SB  - IM
MH  - Acute Disease
MH  - Adolescent
MH  - *Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - Child
MH  - Humans
MH  - *Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy/etiology
PMC - PMC9529813
MID - NIHMS1828673
OTO - NOTNLM
OT  - acute lymphoblastic leukemia
OT  - adverse events
OT  - clinical trials
OT  - infections
EDAT- 2022/09/10 06:00
MHDA- 2022/10/01 06:00
PMCR- 2023/11/01
CRDT- 2022/09/09 13:52
PHST- 2022/07/28 00:00 [revised]
PHST- 2021/05/13 00:00 [received]
PHST- 2022/07/30 00:00 [accepted]
PHST- 2022/09/10 06:00 [pubmed]
PHST- 2022/10/01 06:00 [medline]
PHST- 2022/09/09 13:52 [entrez]
PHST- 2023/11/01 00:00 [pmc-release]
AID - 10.1002/pbc.29937 [doi]
PST - ppublish
SO  - Pediatr Blood Cancer. 2022 Nov;69(11):e29937. doi: 10.1002/pbc.29937. Epub 2022 
      Sep 9.