Table 3.
ACPR (PCR-corrected) at Days 7, 14, 21, 28, 35, 42 (Cohort 2)
| Percentage of subjects with ACPR * (95% CI) † | MITT population | PP population | ||
|---|---|---|---|---|
| AZCQ N = 120 | AL N = 126 | AZCQ N = 114 | AL N = 124 | |
| Day 7 | 94.17 (89.55, 98.78) | 99.21 (97.25, 100.00) | 98.25 (95.39, 100.00) | 100.00 (−) |
| ACPR % difference‡, 95% CI† | -5.04 (-9.93, -0.15) | -1.75 (−) | ||
| Day 14 | 92.47 (87.30, 97.64) | 99.21 (97.24, 100.00) | 96.46 (92.59, 100.00) | 100.00 (−) |
| ACPR % difference‡, 95% CI† | -6.74 (-12.15, -1.32) | -3.54 (−) | ||
| Day 21 | 91.59 (86.04, 97.14) | 98.37 (95.65, 100.00) | 95.53 (91.10, 99.96) | 99.16 (97.03, 100.00) |
| ACPR % difference‡, 95% CI† | -6.78 (-12.82, -0.75) | -3.63 (-8.40, 1.14) | ||
| Day 28§ | 89.27 (82.77, 95.77) | 98.37 (95.59, 100.00) | 93.08 (87.32, 98.84) | 99.16 (96.97, 100.00) |
| ACPR % difference‡, 95% CI† | -9.10 (-16.02, -2.18) | -6.08 (-12.10, -0.05) | ||
| Day 35 | 89.27 (82.68, 95.86) | 96.19 (91.85, 100.00) | 93.08 (87.22, 98.95) | 96.96 (92.90, 100.00) |
| ACPR % difference‡, 95% CI† | -6.92 (-14.59, 0.76) | -3.87 (-10.79, 3.04) | ||
| Day 42 | 87.55 (80.08, 95.03) | 96.19 (91.79, 100.00) | 91.29 (84.31, 98.28) | 96.96 (92.84, 100.00) |
| ACPR % difference‡, 95% CI† | -8.63 (-17.08, -0.18) | -5.66 (-13.55, 2.22) | ||
ACPR = adequate clinical and parasitologic response, AL = artemether-lumefantrine, AZCQ = azithromycin-chloroquine fixed-dose combination, CI = confidence interval, MITT = modified intention-to-treat, PP = per protocol.
*Estimated from Kaplan-Meier curve.
†CI by large sample approximation to the binomial with continuity correction using the standard error estimated by the Greenwood formula.
‡Difference calculated from rates estimated from the Kaplan-Meier curves.
§Primary endpoint.
Note: Group-specific confidence intervals and the confidence interval for the difference between treatment groups were not calculated when all failures occurred in a single group.