Laboratory testing and toxicity monitoring.
toxicity, Hepatitis, Toxicity
ADVERSE EVENT, ALLERGY, HEPATITIS
All patients underwent medical interview, physical exam, and laboratory testing at all visits to monitor for safety. Laboratory testing for toxicity monitoring (complete blood counts, serum chemistries, and quantitative immunoglobulins) was performed at each visit prior to OFC by the Johns Hopkins Core Pathology Laboratory. Adverse event determinations were made using the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Hepatitis serologies were also performed at visit 1. Before the start of the food challenges, laboratory quantification of total IgE and specific IgE to peanut and peanut components were performed using the Phadia ImmunoCAP platform by the Johns Hopkins Dermatology, Allergy, and Clinical Immunology Reference Laboratory. The lower limit of detection for the Phadia system is 0.1 KUA/L for all specific IgEs.