Table 4.
Adverse events in the intent-to-treat (safety) population
|
Outcome |
Pyronaridine-artesunate |
Artemether-lumefantrine |
|---|---|---|
| n = 355 | n = 180 | |
| Adverse event of any causea |
285 (80.3) |
143 (79.4) |
| Cough |
44 (12.4) |
28 (15.6) |
| Upper respiratory tract infection |
42 (11.8) |
19 (10.6) |
| Anemia |
34 (9.6) |
14 (7.8) |
| Platelets increased |
33 (9.3) |
19 (10.6) |
| Blood glucose decreased |
32 (9.0) |
19 (10.6) |
| Bronchitis |
28 (7.9) |
10 (5.6) |
| Vomiting |
25 (7.0) |
8 (4.4) |
| Pyrexia |
23 (6.5) |
8 (4.4) |
| Blood albumin decreased |
21 (5.9) |
16 (8.9) |
| Influenza-like illness |
19 (5.4) |
8 (4.4) |
| Drug-related adverse eventsb |
132 (37.2) |
80 (44.4) |
| Blood glucose decreased |
29 (8.2) |
15 (8.3) |
| Platelet count increased |
27 (7.6) |
14 (7.8) |
| Blood albumin decreased |
19 (5.4) |
16 (8.9) |
| Anemia |
15 (4.2) |
11 (6.1) |
| Blood potassium increased |
15 (4.2) |
6 (3.3) |
| Hemoglobin decreased |
15 (4.2) |
5 (2.8) |
| Upper respiratory tract infection |
14 (3.9) |
5 (2.8) |
| AST increased |
14 (3.9) |
7 (3.9) |
| Hematocrit decreased |
14 (3.9) |
5 (2.8) |
| Vomiting |
7 (2.0) |
6 (3.3) |
| Blood creatinine decreased | 7 (2.0) | 7 (3.9) |
All values are n (%). AST, aspartate aminotransferase.
a Experienced by ≥5% of patients in either treatment group.
b Experienced by ≥3% of patients in either treatment group.