Table 1.
Demographic and clinical characteristics of the intent-to-treat population at screening
|
Characteristic |
Pyronaridine-artesunate |
Artemether-lumefantrine |
|---|---|---|
| n = 355 | n = 180 | |
| Male, n (%) |
177 (49.9) |
84 (46.7) |
| Mean age, years (SD) [range] |
4.9 (2.5) [0.3–11] |
5.3 (2.5) [0.3–12] |
| <1 year, n (%) |
12 (3.4) |
3 (1.7) |
| 1– < 5 years, n (%) |
148 (41.7) |
69 (38.3) |
| 5–12 years, n (%) |
195 (54.9) |
108 (60.0) |
| Ethnicity, n (%) | ||
| Black |
342 (96.3) |
172 (95.6) |
| Asian/Oriental |
13 (3.7) |
8 (4.4) |
| Mean weight, kg (SD) [range] |
16.3 (4.1) [6.0–24.8] |
17.1 (4.4) [7.2–24.9] |
| Mean body mass index, kg/m2 (SD) [range] |
15.0 (2.2) [6.0–24.5] |
15.1 (2.3) [10.7–25.0] |
| Geometric mean asexual parasites per μL |
18565.9 |
18798.3 |
| (95% CI) |
(16005.9, 21535.4) |
(15243.1, 23182.7) |
| Patients with gametocytes, n (%) |
43 (12.1) |
25 (13.9) |
| Temperature, °C |
38.0 (1.1) [35.9–41.5] |
37.8 (1.1) [35.4–41.0] |
| Fever at screening, n (%) |
230 (65.0) |
107 (59.4) |
| No previous malaria infection, n (%) |
130 (36.7) |
59 (32.8) |
| Malaria in last 12 months, n (%)a | ||
| None |
143 (41.1) |
65 (36.7) |
| 1 |
65 (18.7) |
34 (19.2) |
| 2 |
56 (16.1) |
35 (19.8) |
| >2 | 84 (24.1) | 43 (24.3) |
a Malaria in last 12 months; status was unknown for 10 patients.