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

Autor:	Caitlin W. Elgarten, Joel C. Thompson, Anne Angiolillo, Zhiguo Chen, Susan Conway, Meenakshi Devidas, Sumit Gupta, John A. Kairalla, Jennifer L. McNeer, Maureen M. O'Brien, Karen R. Rabin, Rachel E. Rau, Susan R. Rheingold, Cindy Wang, Charlotte Wood, Elizabeth A. Raetz, Mignon L. Loh, Sarah Alexander, Tamara P. Miller
Rok vydání:	2022
Předmět:	Oncology Adolescent Pediatrics Perinatology and Child Health Acute Disease Antineoplastic Combined Chemotherapy Protocols Humans Hematology Precursor Cell Lymphoblastic Leukemia-Lymphoma Child
Zdroj:	Pediatric bloodcancer. 69(11)
ISSN:	1545-5017
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::655907355adb42c9ecf304c62cbe73fb https://pubmed.ncbi.nlm.nih.gov/36083863 Zobrazit plný text záznamu Plný text