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%).