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. Author manuscript; available in PMC: 2020 Jun 1.
Published in final edited form as: J Allergy Clin Immunol. 2019 Jul 15;144(6):1584–1594.e2. doi: 10.1016/j.jaci.2019.06.038

Table I. Terms and their definitions.

Term Definition
Primary Outcome Peanut threshold or lowest observed adverse effect level (LOAEL) which is the lowest cumulative dose causing an objective allergic reaction.
Determined for each individual in mg peanut protein following each challenge
Primary Analysis Difference in log-threshold between non-intervention challenge and each intervention challenge also expressed as percentage change
Secondary outcome Eliciting dose (EDx) or population threshold cumulative eliciting dose (ED) predicted to provoke a reaction in a defined proportion of the population (x)

Full analysis population Individuals who received at least one post baseline intervention challenge
Extended analysis population All individuals who received a baseline peanut challenge

Baseline challenge Initial double-blind placebo-controlled challenge to confirm diagnosis of peanut allergy
Non-intervention challenge Open challenge to determine threshold when no intervention applied
Intervention challenge Open challenge to determine threshold with either exercise or sleep deprivation intervention