Malaria Journal

Table 8 Hepatic safety measures in the integrated safety analysis

From: Safety and efficacy of pyronaridine–artesunate paediatric granules in the treatment of uncomplicated malaria in children: insights from randomized clinical trials and a real-world study

	PA (N = 667)		AL (N = 358)		P value^a
	N	% (95% CI)	N	% (95% CI)	P value^a
ALT	650		350
≤ 1×ULN	622	95.7 (93.8, 97.0)	337	96.3 (93.7, 97.8)	0.74
> 1.5×ULN to ≤ 3×ULN	19	2.9 (1.9, 4.5)	8	2.3 (1.2, 4.4)	0.68
> 3×ULN to ≤ 5×ULN	4	0.6 (0.2, 1.6)	2	0.6 (0.1, 2.1)	1.00
> 5×ULN to ≤ 10×ULN	1	0.2 (0.008, 0.9)	2	0.6 (0.1, 2.1)	0.28
> 10×ULN	4	0.6 (0.2, 1.6)	1	0.3 (0.015, 1.6)	0.66
AST	650		350
≤ 1×ULN	577	88.8 (86.1, 91.0)	319	91.1 (87.7. 93.7)	0.28
> 1.5×ULN to ≤ 3×ULN	61	9.4 (7.4, 11.9)	24	6.9 (4.7, 10.0)	0.19
> 3×ULN to ≤ 5×ULN	7	1.1 (0.5, 2.2)	3	0.9 (0.2, 2.5)	1.00
> 5×ULN to ≤ 10×ULN	0	0 (0, 0.6)	2	0.6 (0.1, 2.1)	0.12
> 10×ULN	5	0.8 (0.3, 1.8)	2	0.6 (0.1, 2.1)	1.00
Total bilirubin	650		349
≤ 1.5×ULN	636	97.8 (96.4, 98.7)	340	97.4 (95.2, 98.6)	0.66
> 1.5×ULN to ≤ 2×ULN	8	1.2 (0.6, 2.4)	3	0.9 (0.2, 2.5)	0.76
> 2×ULN to ≤ 3×ULN	5	0.8 (0.3, 1.8)	2	0.6 (0.1, 2.1)	1.00
> 3×ULN	1	0.2 (0.008. 0.9)	4	1.1 (0.4, 2.9)	0.053
Potential Hy’s Law^b	2	0.3 (0.1, 1.1)	3	0.9 (0.2, 2.5)	0.35

ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal
^aPyronaridine phosphate–artesunate (PA) versus artemether–lumefantrine (AL)
^bAlanine aminotransferase or aspartate aminotransferase > 3×ULN and total bilirubin > 2×ULN

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ISSN: 1475-2875

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