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) | ||