Statistical analysis
Baseline characteristics were shown in continuous data presented as medians and categorical data were presented as numbers. Comparisons between groups were performed using Fisher’s exact test for categorical variables and Wilcoxon rank-sum test for continuous variables. The annualized rate of reactions was calculated by summing the number of reactions per patient and dividing it by the year. Logistic regression was used to perform univariate and multivariate analyses. The factors significantly associated with AAR were assessed for a crude odds ratio (OR) or an adjusted OR (aOR), with corresponding 95% confidence interval (CI) and associated p -values. Statistical significance was set at p < .05. All data were processed and summarized using GraphPad Prism 7 for Mac (La Jolla, CA, USA) and IBM SPSS Statistics for Windows (version 24.0; IBM Corp., Armonk, NY, USA).
Logistic regression analyses were performed to assess risk factors for AAR. In the univariate logistic regression analysis, all patient characteristic variables at baseline were used. In the multiple logistic regression analysis, variables with p <0.1 in the univariate analysis were adjusted.