Table 1.

Demographic and clinical characteristics of 460 pediatric DILI cases.

Variable	Number	%	95% CI
Sex
Boys	259	56.3	[51.7-60.8]
Girls	201	43.7	[39.2-48.3]
Age (year)
Toddlers (≥30 days and <6 years old)	134	29.1	[25.2-33.4]
School-aged children (≥6 and <12 years old) years)	117	25.4	[21.7-29.6]
Adolescents (≥12 and <18 years old)	209	45.4	[40.9-50.0]
Clinical types
Hepatocellular injury (R ≥5)	258	62.6	[57.9-67.2]
Conform to Hy’s law	88	34.1	[28.6-40.1]
Others	170	65.9	[59.9-71.4]
Cholestatic injury (R ≤2)	44	10.7	[8.1-14.0]
Mixed injury (2<R <5)	110	26.7	[22.7-31.2]
Initial serum ALT (U/L)
≥5 × ULN	284	61.7	[57.2-66.1]
≥3 × ULN and <5 × ULN	54	11.7	[9.1-150.0]
<3 × ULN	122	26.5	[22.7-30.7]
Peak serum ALT (U/L)
≥5 × ULN	445	96.7	[84.7-98.0]
≥3 × ULN and <5 × ULN	12	2.6	[1.5-4.5]
<3 × ULN	3	0.7	[0.2-1.9]
Initial serum AST (U/L)
≥5 × ULN	135	29.3	[25.4-33.7]
≥3 × ULN and <5 × ULN	72	15.7	[12.6-19.3]
<3 × ULN	253	550.0	[50.4-59.5]
Peak serum AST (U/L)
≥5 × ULN	278	60.4	[55.9-64.8]
≥3 × ULN and <5 × ULN	90	19.6	[16.2-23.4]
<3 × ULN	92	20.0	[16.6-23.9]
Initial serum TBIL (μmol/L)
≥10 × ULN	39	8.7	[6.4-11.7]
≥5 × ULN and <10 × ULN	41	9.2	[6.8-12.2]
≥2 × ULN <5 × ULN	31	6.9	[4.9-9.7]
<2 × ULN	336	75.2	[71.0-78.9]
Peak serum TBIL (μmol/L)
≥10 × ULN	62	13.9	[11.0-17.4]
≥5 × ULN and <10 × ULN	45	10.1	[7.6-13.2]
≥2 × ULN <5 × ULN	44	9.8	[7.4-13.0]
<2 × ULN	296	66.2	[61.7-70.4]
Presentation of clinical jaundice
Yes	78	17.0	[13.8-20.7]
No	382	83.0	[79.3-86.2]
Fatal outcomes
Acute liver failure	8	1.7	[0.9-3.4]
Death	2	0.4	[0.1-1.6]
DILI had a primary role	1	50	[2.6-97.4]
DILI had no role	1	50	[2.6-97.4]

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; DILI, drug-induced liver injury; TBIL, total bilirubin; ULN, the upper limit of normal.

Data are presented as n (%) and corresponding 95% CIs, where n is the actual number with available data. Pearson chi-square test.