TABLE 2.
Primary and secondary endpoints
| Endpoint | n (%) | 95% CI |
|---|---|---|
| Primary (n = 240) | ||
| Adequate clinical and parasitological response (KMa) | 224 (96.55) | 93.67–98.15 |
| Cumulative incidence of treatment failures (KM) | 8 (3.45) | 1.85–6.33 |
| Late clinical failure (day 21) | 1 | |
| Late parasitological failure (n = 7) at day: | ||
| 14 | 2 | |
| 28 | 5 | |
| Patients with asexual parasitemia at day: | ||
| 1 | 139 (57.92) | 51.44–64.13 |
| 2 | 17 (7.08) | 4.39–11.23 |
| 3 | 0 | |
| Secondary | ||
| Fever clearance (n = 139 = 100% at day 0) at day: | ||
| 1 | 34 (24.46) | 18.7–31.32 |
| 2 | 5 (3.59) | 1.49–8.41 |
| 3 | 0 | |
| Gametocyte clearance (n = 207 = 100% at day 0) at day: | ||
| 1 | 83 (40.1) | 33.96–46.56 |
| 2 | 11 (5.31) | 3.0–9.23 |
| 3 | 0 | |
| CQ blood concn at day of failure > 100 ng/ml at day: | 3/3 | |
| 14 (LPF) | 114.66 | |
| 21 (LCF) | 133.09 | |
| 28 (LPF) | 125.87 | |
| Hemoglobin recovery, median individual Hb change from day 0–28, g/dl (IQR) for patients: | ||
| All (n = 224) | +0.7 (−0.2–+1.6) | |
| Anemic at day 0 (n = 78) | +1.7 (+0.7–+3.2) | |
| Nonanemic at day 0 (n = 146) | +0.25 (−0.4–+1.0) | |
a
KM, Kaplan-Meier estimate.