Table 4.

Treatment-emergent adverse events ≥ 5% overall, n (%)

	Adults (n = 21)		Pediatric (n = 24)
	All TEAE	Severe TEAE	All TEAE	Severe TEAE
Infections and infestations
Device related infection	0 (0)	0 (0)	2 (8.3)	1 (4.1)
Upper respiratory tract infection	0 (0)	0 (0)	2 (8.3)	0 (0)
Gastrointestinal disorders
Abdominal pain	1 (4.7)	0 (0)	4 (16.6)	0 (0)
Abdominal distension	2 (9.5)	0 (0)	0 (0)	0 (0)
General disorders and administration site conditions
Injection site pain or erythema1	0 (0)	0 (0)	2 (8.3)	0 (0)
Injury, poisoning and procedural complications
Stoma complications	1 (4.7)	0 (0)	2 (8.3)	1 (4.1)

¹Considered adverse event of special interest (AESI).

Treatment-emergent adverse event with incidence ≥ 5% in the overall study population (n = 45); one in adults and one in pediatric considered AESI. TEAE: Treatment-emergent adverse event.