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 | |||
|---|---|---|---|---|
| m | n (%) | 95% Pearson–Clopper CI (%) | 2-sided p-valuea | |
| 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