Table 3.

Effects of odevixibat on markers of cholestasis through Week 24 of PEDFIC 2.

	Week 12			Week 24
	n	Mean (SE)	Mean (SE) change from baseline to Week 12	n	Mean (SE)	Mean (SE) change from baseline to Week 24
Serum ALT, U/L†
Cohort 1A	26	54 (8)	-22 (13)	21	54 (16)	-27 (23)
Cohort 1B	16	83 (23)	12 (18)	9	99 (33)	16 (21)
Cohort 2	12	116 (33)	37 (27)	4	44 (28)	-10 (31)
Serum AST, U/L‡
Cohort 1A	27	57 (6)	-13 (7)	20	54 (8)	-15 (10)
Cohort 1B	16	92 (18)	6 (11)	9	86 (15)	-1.7 (6)
Cohort 2	11	120 (34)	30 (23)	4	54 (21)	-7.8 (16)
Total bilirubin, mg/dl§
Cohort 1A	26	1.3 (0.5)	0.0 (0.1)	21	0.9 (0.3)	-0.2 (0.1)
Cohort 1B	16	2.7 (0.7)	-0.6 (0.7)	9	2.3 (0.8)	-1.6 (1.3)
Cohort 2	12	2.9 (1.0)	0.8 (0.9)	4	1.3 (0.4)	-0.2 (0.5)

^†Normal reference range varies by age and sex, but typical values are ≤55 U/L.

^‡Normal reference range varies by age and sex, but typical values are <79 U/L.

^§Normal reference range: ≤1.2 mg/dL. ALT, alanine aminotransferase; AST, aspartate aminotransferase.