Table 2.

Incidence of hepatotoxicity events at any post-dosing timepoint after treatment with pyronaridine-artesunate for a first malaria episode (episode 1) versus re-treatment (episode 2+)

	All patients		Age ≥6 months to <5 years		Age ≥5years to <18 years		Age ≥18 years
	Episode 1	Episode 2+	Episode 1	Episode 2+	Episode 1	Episode 2+	Episode 1	Episode 2+
Patients dosed	1015	316	236	78	666	201	113	37
Total number of post-day 0 liver function tests	2894	1215	652	276	1922	789	320	150
Number of hepatotoxicity events*	16 (1%)	2 (<1%)	5 (1%)	0 (0%)	6 (<1%)	1 (<1%)	5 (2%)	1 (1%)
Patients with any post day 0 liver function test	996	311	224	78	660	197	112	36
Patients with hepatotoxicity events	13 (1%)	2 (1%)	3 (1%)	0	6 (<1%)	1 (1%)	4 (4%)	1 (3)
Potential Hy's law event†	1 (<1%)	0 (0%)	1 (<1%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)

Data are number or number (%).

^*Denominator for the calculation of the percentages was total number of post-day 0 liver function tests.

^†Denominator for the calculation of the percentages was the number of patients dosed.