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 |