Population
The study populations in the phase-II and phase-III trials comprised adolescents and adults (12-65 years) with persistent moderate-to-severe allergic rhinitis and/or conjunctivitis induced by birch pollen despite having received symptom-relieving medication during the 2 previous tree pollen seasons. Subjects had to have a positive skin prick test response (wheal diameter, >3mm) to birch, a positive Bet v 1–specific IgE level (IgE class 2 or greater, >0.7 kU/L), and affected quality-of-life items (sleep disturbance; impairment of daily activities, leisure, and/or sport; impairment of school or work; or troublesome symptoms) because of allergic rhinitis and/or conjunctivitis during the previous birch pollen season. Subjects with uncontrolled asthma or severe asthma exacerbations were excluded from the trial.
The subjects in the pooled safety analysis data set (hereafter called ‘pooled population’) comprised
subjects from the mentioned phase-II and phase-III trials who were randomized to a daily dose of 12 SQ-Bet or placebo and received at least one dose of treatment.