Hepatic safety and tolerability of cipargamin (KAE609), in adult patients with Plasmodium falciparum malaria: a randomized, phase II, controlled, dose-escalation trial in sub-Saharan Africa

Table 1 Proportion of patients with at least 2 CTCAE grades increase from baseline in ALT or AST (Safety set)

Treatment group	At least 2 CTCAE grades increase in AST or ALT
Treatment group	m	n (%)	95% Pearson–Clopper CI (%)	2-sided p-value^a
Cipargamin 10 mg single dose (N = 10)	9	1 (11.1)	(0.3,48.2)	0.391
Cipargamin 10 mg QD 3 days (N = 10)	10	0 (0.0)	(0.0,30.8)	1
Cipargamin 25 mg single dose (N = 12)	12	0 (0.0)	(0.0,26.5)	1
Cipargamin 25 mg QD 3 days (N = 20)	20	0 (0.0)	(0.0,16.8)	1
Cipargamin 50 mg single dose (N = 21)	21	0 (0.0)	(0.0,16.1)	1
Cipargamin 50 mg QD 3 days (N = 19)	19	0 (0.0)	(0.0,17.6)	1
Cipargamin 75 mg single dose (N = 21)	21	0 (0.0)	(0.0,16.1)	1
Cipargamin 150 mg single dose (N = 22)	22	1 (4.5)	(0.1,22.8)	1
Pooled artemether–lumefantrine (N = 51)	51	2 (3.9)	(0.5,13.5)	–

N number of patients in the respective treatment group, m number of patients with baseline and at least one post-baseline assessment for either ALT or AST, n number of patients who meet the criterion. % 100*n/m, QD once daily
^a2-sided p-value results from Fisher exact test for each cipargamin treatment group compared to pooled artemether–lumefantrine

ISSN: 1475-2875