Hepatic Panel Data in Supplemental Data to Provide Additional Evidence of Safety and Efficacy for the Proposed Dosing Regimens of Fluconazole in Infants and Young Children

Includes all aspartate aminotransferase (AST), alanine transaminase (ALT) , total bilirubin (T Bili), direct bilirubin (D Bili), alkaline phosphatase (Alk phos) lab results from encounters in DEMOG dataset Study Description This was a multi-site retrospective data collection from the Pediatric Trials Network (PTN) Repository and Duke University Hospital electronic health records. The objective of this data collection was to provide supplemental data to support label change for fluconazole, and particularly evaluate adverse events associated with loading high-dose fluconazole compared to standard dose fluconazole in infants and children using real-world data. Hospitalized pediatric patients ages birth to 12 who received fluconazole.