Statistical methodology
In addition to the pooled population, two other data pools were used in
order to investigate the difference between adults and adolescents: One
pool including adults (≥ 18 years) and one pool including adolescents
(12- < 18 years). The safety analyses were conducted according
to the actual treatment that subjects received regardless of
randomization.
Demographic (including age and gender) and baseline characteristics was
summarised by treatment group. Onset and duration in days were
summarised by treatment group and preferred term for most frequent
IMP-related AEs (≥ 1% of subjects in the 12 SQ-Bet treatment group).
Onset is the time from randomisation to the start of the AE. AEs were
summarised in terms of treatment emergent AEs and by causal relation to
IMP, severity, seriousness, and AEs leading to discontinuation
(treatment emergent AEs and AEs related to IMP respectively).
A graphical overview was presented for the frequencies of the most
frequent (≥ 5%) IMP-related AEs for subjects on active treatment in the
pooled population by preferred term and worst case severity (i.e. if a
subject had more than 1 event, only the highest intensity was used).
Likewise, IMP-related AEs in adults and adolescents with and without
asthma was presented by treatment group (pooled population) and by-worst
case severity (for subjects treated with 12 SQ-Bet only).
To evaluate safety across additional intrinsic factors, an analysis of
the differences between treatment groups in risk, calculated as hazard
ratio, of experiencing first moderate or severe treatment-related AEs in
specific subgroups (age (adolescents/adults), asthma status, IgE level
(class 2-3 or class 4-6), sensitisation (mono/poly) and PFS) were
performed for the pooled population. The results were presented in a
forest plot.