2022
DOI: 10.1002/pbc.29937
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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

Abstract: 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 infectio… Show more

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Cited by 3 publications
(2 citation statements)
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“…The source node “glucose”, a top ranked direct candidate returned by SemNet 2.0, is predominantly tied to hyperglycemia. Hyperglycemia is a relatively common event in pediatric cancer [ 63 , 64 ]. The extent of the role of hyperglycemia in modifying the infection risk is still debated in pediatric cancer.…”
Section: Resultsmentioning
confidence: 99%
“…The source node “glucose”, a top ranked direct candidate returned by SemNet 2.0, is predominantly tied to hyperglycemia. Hyperglycemia is a relatively common event in pediatric cancer [ 63 , 64 ]. The extent of the role of hyperglycemia in modifying the infection risk is still debated in pediatric cancer.…”
Section: Resultsmentioning
confidence: 99%
“…Patients with DS younger than 31 years old are eligible for this trial regardless of presenting white blood cell count, as are patients with B‐LLy. In March 2020, the protocol was amended to mandate reporting of all grades of SARS‐CoV‐2 infection, graded according to the CTCAE v5 grading schema for “infections and infestations‐other.” For all infectious adverse events (AEs) on the trial, there is a case report form (CRF) for additional data on the infectious pathogen, and real‐time review of infectious AEs by pediatric oncologists to resolve incomplete or ambiguous submissions [9].…”
Section: Methodsmentioning
confidence: 99%