Table 1.
Baseline characteristics of patients
|
Pyronaridine-artesunate safety analysis |
Comparative efficacy analysis |
||||
|---|---|---|---|---|---|
| Safety population* (n=1015) | Safety re-treatment population† (n=316) | Pyronaridine-artesunate (n=673) | Artemether-lumefantrine (n=671) | ||
| Sex, female | 509 (50%) | 149 (47%) | 328 (49%) | 319 (48%) | |
| Age (years) | |||||
| Mean (SD, range) | 10·1 (8·6, 0–62) | 10·3 (8·5, 0–56) | 11·8 (9·4, 1–62) | 11·7 (9·7, 0–69) | |
| <5 | 236 (23%) | 78 (25%) | 116 (17%) | 130 (19%) | |
| ≥5 to <18 | 666 (66%) | 201 (64%) | 453 (67%) | 443 (66%) | |
| ≥18 years | 113 (11%) | 37 (12%) | 104 (15%) | 98 (15%) | |
| Bodyweight (kg) | |||||
| Mean (SD, range) | 28·7 (16·6, 6·7–84·2) | 29·5 (17·7, 7·0–82·0) | 32·0 (17·7, 8·3–84·2) | 31·8 (18·2, 7·8–100·6) | |
| <20 | 393 (39%) | 128 (41%) | 213 (32%) | 233 (35%) | |
| ≥20 | 622 (61%) | 188 (59%) | 460 (68%) | 438 (65%) | |
| Geometric mean parasite count (first episode) per μL (IQR) | 36 092 (1650–51 220) | 38 905 (3010–52 080) | 38 865 (4500–53 040) | 40 918 (4740–56 160) | |
Data are number (%), unless otherwise indicated.
*
Included all patients who received at least one dose of pyronaridine-artesunate for treatment of a first malaria episode.
†
Included all patients who received at least one dose of pyronaridine-artesunate for the first malaria episode plus at least one dose of pyronaridine-artesunate for a subsequent malaria episode.