Onset and duration of common IMP-related AEs
The most frequently reported IMP-related AEs had onset early during treatment. For the majority of IMP-related AEs, the median time of onset was within the first week of treatment (Figure 2). The local allergic reactions reported most frequently such as oral pruritus, throat irritation, tongue pruritus, oral paraesthesia and pharyngeal oedema all had median onset on day 1. Very few subjects had onset of new events after two weeks of treatment.
Median duration of the AEs was less than two weeks for most types of AEs, and for oral pruritus and throat irritation – the most common AEs – it was 11 days. In the group treated with 12 SQ-Bet, the longest median durations of most frequent IMP-related AEs was seen with dyspepsia (75 days), dry mouth (25 days), oral pain (21 days) and nasal pruritus (18 days).