Common IMP-related AEs
The most frequently reported IMP-related AEs with 12 SQ Bet were oral pruritus (39% of subjects) and throat irritation (29%). This was the same for placebo but with a lower frequency: 7% (oral pruritus) and 4% (throat irritation) (Figure 1). Frequent IMP-related AEs outside the oral cavity related to treatment with 12 SQ-Bet were: ear pruritus (13% of subjects), cough (6%), and sensation of foreign body (2%). Severe IMP-related AEs reported by more than 1 subject treated with 12 SQ-Bet were oral hypoaesthesia, oral paraesthesia, tongue pruritus, mouth swelling, cough, oropharyngeal pain and lip swelling.