Table 3.

Overview of TEAEs up to Week 52 [safety population].

Event	n [%] [n = 22]
TEAEs	20 [90.9]
Not related	18 [81.8]
Related	2 [9.1]
Mild	12 [54.5]
Moderate	6 [27.3]
Severe	2 [9.1]
Leading to study discontinuation	0
Serious TEAEs	4 [18.2]
Not related	3 [13.6]
Related	1 [4.5]
Leading to study discontinuation	0
Deaths	0
TEAEs in ≥ 5% patients
Proctalgia	6 [27.3]
Nasopharyngitis	5 [22.7]
Anal fistula	4 [18.2]
Crohn’s disease	2 [9.1]
Nausea	2 [9.1]
Acrochordon	2 [9.1]
Treatment-related AEs
Diarrhoea	1 [4.5]
Blood bilirubin increased	1 [4.5]
Treatment-related serious AE
Crohn’s disease	1 [4.5]

AE, adverse event; TEAE, treatment-emergent adverse event.