AEs leading to discontinuation
The majority of AEs leading to discontinuations were IMP-related: 33
subjects (7%) discontinued due to IMP-related AEs after treatment with
12 SQ-Bet and 8 subjects (2%) after receiving placebo. The most
frequent IMP-related AEs leading to discontinuation after treatment with
12 SQ-Bet were throat irritation (10 subjects), oral pruritus (8
subjects), mouth swelling (8 subjects), swollen tongue (5 subjects),
pharyngeal oedema (5 subjects) and ear pruritus (5 subjects). The
majority of discontinuations due to IMP-related AEs occurred within the
first few weeks of treatment. A greater proportion of subjects with PFS
interrupted their treatment (19%) compared with no PFS (7%).