TABLE 2.

Reported treatment-emergent adverse events and serious adverse events based on safety populations

	Infants			Children*
	n (m)			n (m)
	Core study		Extension study (N = 2)	Core study (N = 8)	Extension study‡ (N = 7)
	SoC (n = 5)	Teduglutide† (n = 7)
Any TEAE	5 (29)	7 (125)	2 (12)	8 (93)	7 (101)
Severity
Mild	5 (23)	6 (62)	2 (9)	8 (76)	7 (86)
Moderate	2 (4)	5 (14)	1 (2)	4 (15)	3 (15)
Severe	2 (2)	1 (1)	1 (1)	2 (2)	0
Related to teduglutide	N/A	2 (9)	0	6 (20)	2 (2)
Led to treatment discontinuation	0	1 (5)	0	1 (1)	0
Led to death	0	0	0	0	0
Any TESAE	3 (6)	6 (14)	2 (4)	6 (15)	6 (18)
Related to teduglutide	N/A	0	0	1 (1)	0

m = number of events; n = number of patients experiencing the event; N/A = not applicable; SoC = standard of care; TEAE = treatment-emergent adverse event; TESAE = treatment-emergent serious adverse event.

^*For study NCT02980666 and its extension NCT03268811, 6 of 8 children were enrolled and received teduglutide treatment after protocol amendment, which included improved training for parents to administer doses of teduglutide to patients.

^†Data pooled from studies NCT03571516 (n = 5; patients randomized to receive teduglutide treatment compared with SoC group) and NCT02980666 (N = 2; patients only received teduglutide).

^‡Of the children enrolled in the extension study, 1 child did not receive teduglutide owing to ongoing enteral autonomy from the core study.