Statistics.
EVENT
All null hypothesis significance tests were 2-tailed. Normality testing was performed on all data using the Shapiro-Wilk test (α = 0.05). In the event that data did not demonstrate normal Gaussian distribution, nonparametric tests were utilized as described. For tests using multiple comparisons, corrections for multiplicity were employed as described, and only the All patients who received acalabrutinib (Sample size was determined pretrial based on the primary outcome. It was estimated that 10 subjects allowed for 80% power to detect a 3-fold increase (1.1 natural log units; i.e. 1 food-dose escalation) in the threshold food dose using a paired Because most patients tolerated the highest cumulative amount of peanut during food challenge after acalabrutinib treatment, the primary outcome was analyzed as a censored variable after trial using a Wilcoxon matched-pairs signed rank test with For symptom scores, 2-way RM ANOVA with Geisser-Greenhouse correction was used to determine the interaction between treatment (baseline versus acalabrutinib), food challenge dose, and the patient on total symptom scores at each food challenge dose and an interaction effect of treatment by challenge dose. Once a patient displayed an objective clinical reaction, symptom scoring was ceased. For statistical analysis only, the final symptom score value was duplicated for the remainder of (unconsumed) food doses in order to perform ANOVA. This adjustment is not reflected in the graph in Due to nonnormal distribution of skin puncture testing data, the significant interaction effect between treatment and extract dilution, and that many skin tests showed no wheal response at lower concentrations of peanut extract, skin test size to undiluted peanut extract was analyzed separately using a Wilcoxon matched-pairs signed rank test. The highest nonreactive skin test was also analyzed using a Wilcoxon matched-pairs signed rank test (Because the interaction effect between treatment and extract dilution was significant, and at lower concentrations of extract many basophil activation responses were 0, peanut extract dilution responses were analyzed using the AUC. The mean response for each patient across all peanut extract dilutions was calculated and analyzed using Wilcoxon matched-pairs signed rank test to compare baseline to acalabrutinib treatment. This mean height was not multiplied by width given that the peanut extract has only relative units (w/v). Peanut response means were graphed as AUC. This test was also used to compare responses to anti-IgE and fMLP.To analyze peanut- and peanut component-specific IgE values, a 2-way RM ANOVA with Geisser-Greenhouse correction was used to determine interaction between treatment (baseline versus acalabrutinib), peanut (or component), and patient on the level of specific IgE. Multiplicity-Other laboratory values obtained for safety analysis were analyzed with 1-way ANOVA with the Geisser-Greenhouse correction when applicable (for serum chemistries and quantitative immunoglobulins), and otherwise were analyzed with a mixed-effects analysis (for complete blood counts).