Table 1.

Demographic and laboratory data in the overall PALF cohort (n=1144) and the 10-site sub-cohort (N=658).

Characteristic	All Sites (n = 1144)		Sites in all 3 phases Total (n=658)		Phase 1 & 2 12/99–12/10 (n=515)		Phase 3 5/12 – 12/14 (n=143)		Phase comparison p-value
Age(yrs),									0.03
median,	4.5,		4.5,		5.0,		2.9,
Q1–Q3	0.8 – 13.4		1.0 – 13.9		1.2 – 14.1		0.3 – 13.7
Age at enrollment, n %
≤ 28 days	156	13.6	79	12.0	50	9.7	29	20.3	0.003
29–90 days	64	5.6	34	5.2	28	5.4	6	4.2
91 days to < 1 year	99	8.7	54	8.2	44	8.5	10	7.0
1–3 years	224	19.6	144	21.9	108	21.0	36	25.2
4–12 years	297	26.0	153	23.3	132	25.6	21	14.7
13–17 years	304	26.6	194	29.5	153	29.7	41	28.7
Male, n %	585	51.1	332	50.5	249	48.4	83	58.0	0.04
Race, n %
White	812	72.6	463	72.7	368	73.5	95	69.9	0.40
Non-White	307	27.4	174	27.3	133	26.5	41	30.1
Unknown, n % of total	25	2.2	21	3.2	14	2.7	7	4.9
Study Entry Labs (includes values up to 3 days before study entry)
INR,									0.02
Median	2.6,		2.6,		2.5,		2.7,
Q1–Q3	2.1 – 3.8		2.1 – 3.7		2.0 – 3.7		2.2 – 3.9
Missing, n % of total	97	8.5	30	4.6	30	11.3	0	0.0
Total Bilirubin (mg/dL),									0.11
median,	9.1,		7.9,		8.7,		6.1,
Q1–Q3	2.8 – 17.0		2.7 – 16.3		2.7 – 16.6		2.5 – 14.2
Missing, n % of total	103	9.0	81	12.3	58	11.3	23	16.1
ALT (IU/L)									0.45
median,	1545,		1735,		1693,		1858,
Q1–Q3	386 – 3393		509 – 3932		513 – 3754		490 – 4708
Missing, n % of total	94	8.2	12	1.8	10	1.9	2	1.4
Creatinine (mg/dL)									0.0001
median,	0.5,		0.5,		0.5,		0.4
Q1–Q3	0.3 – 0.8		0.3 – 0.7		0.3 – 0.8		0.2 – 0.7
Missing, n % of total	18	1.6	12	1.8	11	2.1	1	0.7
Encephalopathy Grade peak up to 7 days past enrollment, n %									0.03
0	435	39.9	242	38.7	184	36.8	58	46.0
1	238	21.9	133	21.3	100	20.0	33	26.2
2	172	15.8	105	16.8	88	17.6	17	13.5
3	134	12.3	73	11.7	64	12.8	9	7.1
4	110	10.1	73	11.7	64	12.8	9	7.1
Not assessable, n % of total	53	4.6	30	4.6	15	2.9	15	10.5
Not done, n % of total	2	0.2	2	0.3	0	0.0	2	1.4