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).