Table 2.
Summary of most common adverse events (≥ 20% of patients in any group) and serious adverse events, regardless of trial treatment relationship, by preferred term and treatment (Safety set)
| Cipargamin 10 mg single dose N = 10 n (%) |
Cipargamin 10 mg QD/3 days N = 10 n (%) |
Cipargamin 25 mg single dose N = 12 n (%) |
Cipargamin 25 mg QD/3 days N = 20 n (%) |
Cipargamin 50 mg single dose N = 21 n (%) |
Cipargamin 50 mg QD/3 days N = 19 n (%) |
Cipargamin 75 mg single dose N = 21 n (%) |
Cipargamin 150 mg single dose N = 22 n (%) |
Pooled artemether–lumefantrine N = 51 n (%) |
|
|---|---|---|---|---|---|---|---|---|---|
| Patients with adverse event(s) | 9 (90.0) | 8 (80.0) | 10 (83.3) | 14 (70.0) | 14 (66.7) | 16 (84.2) | 19 (90.5) | 13 (59.1) | 33 (64.7) |
| Most common adverse events | |||||||||
| Malaria | 1 (10.0) | 0 | 2 (16.7) | 4 (20.0) | 4 (19.0) | 5 (26.3) | 5 (23.8) | 9 (40.9) | 1 (2.0) |
| Headache | 3 (30.0) | 5 (50.0) | 1 (8.3) | 1 (5.0) | 2 (9.5) | 2 (10.5) | 5 (23.8) | 0 | 9 (17.6) |
| Treatment failure | 0 | 1 (10.0) | 3 (25.0) | 1 (5.0) | 0 | 1 (5.3) | 0 | 0 | 2 (3.9) |
| Patients with serious adverse events | 0 | 0 | 0 | 0 | 0 | 1 (5.3) | 2 (9.5) | 1 (4.5) | 1 (2.0) |
| Thrombocytopenia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4.8) | 0 | 0 |
| ALT increased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4.5) | 0 |
| Blood ALP increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4.8) | 0 | 0 |
| Blood bilirubin increased | 0 | 0 | 0 | 0 | 0 | 1 (5.3) | 1 (2.0) | ||
QD once daily, ALT alanine aminotransferase, ALP alkaline phosphatase