Treatment emergent adverse events (TEAE)
A TEAE was any untoward medical occurrence following commencement of
treatment, which did not necessarily have a relationship with the study
treatment. TEAE were graded according to criteria developed by National
Institute of Health (NIH) Consortium for Food Allergy Research (CoFAR)
and the Food and Drug Administration (FDA, USA) (supporting
information). TEAE are summarized by relationship to treatment and
severity, and presented according to medical dictionary for regulatory
activities (MedDRA) terms (system organ class and preferred term), and
tabulated with descriptive statistics.