Table 4.

Summary of TEAEs during the PEDFIC 2 treatment period.

	Cohort 1		Cohort 2 n = 16
Patients, n (%)	Cohort 1A n = 34	Cohort 1B n = 19
Any TEAE	28 (82)	14 (74)	8 (50)
Mild	17 (50)	6 (32)	2 (13)
Moderate	10 (29)	7 (37)	3 (19)
Severe	1 (3)	1 (5)	3 (19)
TEAEs of diarrhoea	7 (21)	1 (5)	0
Drug-related TEAEs	10 (29)	5 (26)	5 (31)
Serious TEAEs	0	3 (16)	1 (6)
TEAEs leading to discontinuation	0	1 (5)	2 (13)
Drug-related TEAEs occurring in ≥5% of patients overall, by preferred term
ALT increased	1 (3)	1 (5)	2 (13)
Blood bilirubin increased	3 (9)	2 (11)	2 (13)

All patients in PEDFIC 2 received odevixibat 120 μg/kg per day. Adverse events were untoward events that had worsened in a clinically significant manner from baseline, as assessed by investigators, and are presented by Standardized Medical Dictionary for Regulatory Activities preferred terms.

ALT, alanine aminotransferase; TEAE, treatment-emergent adverse event.