Table 3.

Hepatic and renal abnormalities

	Study 2101						Study 2102
		3 mg/kg*		4.5 mg/kg*			4.5 mg/kg
Parameter	Criteria	6–11 years (n = 13)	12–16 years (n = 12)	2–5 years (n = 31)	6–11 years (n = 20)	Total (n = 78)	4 months–<2 years (n = 9)
AST†	>3× ULN	0	0	3 (10)	1 (5)	4 (5)	1 (11)
ALT†	>3× ULN	0	0	4 (13)	1 (5)	5 (6)	2 (22)
AST or ALT	>3× ULN	0	0	5 (16)	1 (5)	6 (8)	2 (22)
Total bilirubin‡	>2× ULN	1 (8)	2 (17)	0	0	3 (4)	1 (11)
Creatinine	>2× ULN	0	1 (8)	1 (3)	0	2 (3)	0

ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.

ULNs: 75 U/L (AST); 45 U/L (ALT); 2 mg/dL (total bilirubin); 0.4 mg/dL (creatinine; 4 months–<2 years), 0.7 mg/dL (2–11 years), and 1.0 mg/dL (12–16 years).

^*Not shown: one child aged 2–5 years in the 3 mg/kg dose group and one child aged 12–16 years in the 4.5 mg/kg dose group experienced no abnormal liver function tests.

^†No children experienced elevated AST or ALT >5x ULN.

^‡One child in Study 2102 experienced elevated AST and/or ALT >3x ULN and total bilirubin >2x ULN.