Table 3.
Adequate Clinical and Parasitological Response by Time Point: Intention-to-Treat Population
| Variable | Arterolane Maleate + Piperaquine Phosphate | Artemether–Lumefantrine | Difference: Wilson 95% Confidence Interval |
|---|---|---|---|
| Day 28 (N = 1072) | 714 | 358 | |
| PCR uncorrected ACPRa | 662 (92.72%; 90.56%–94.51%) | 321 (89.66%; 86.04%–92.62%) | 0.0305 (−.0043, .0701) |
| Total failure | 52 (7.28%) | 37 (10.34%) | |
| Missing (failure)b | 46 (6.44%) | 24 (6.70%) | |
| Late clinical failure | 4 (0.56%) | 5 (1.40%) | |
| Late parasitological failure | 2 (0.28%) | 8 (2.23%) | |
| Day 28 (N = 1072)$ | 714 | 358 | |
| PCR corrected ACPRa | 663 (92.86%; 90.72%–94.64%) | 331 (92.46%; 89.22%–94.97%) | 0.0040 (−.0274, .0402) |
| Total failure | 51 (7.14%) | 27 (7.54%) | |
| Missing (failure)b | 46 (6.44%) | 24 (6.70%) | |
| Late clinical failure | 4 (0.56%) | 1 (0.28%) | |
| Late parasitological failure | 1 (0.14%) | 2 (0.56%) | |
| $Recrudescence | 5 (0.70%) | 3 (0.84%) | |
| $Indeterminate PCR | 0 | 0 | |
| $Reinfection up to day 28c | 1 (0.14%) | 10 (2.79%) | |
| Day 42 (N = 1072) | 714 | 358 | |
| PCR uncorrected ACPRa | 638 (89.36%; 86.86%–91.52%) | 300 (83.80%; 79.57%–87.46%) | 0.0556 (.0131, .1021) |
| Total failure@ | 76 (10.64%) | 58 (16.20%) | |
| Missing (failure)b | 58 (8.12%) | 30 (8.37%) | |
| Late clinical failure | 10 (1.4%) | 9 (2.51%) | |
| Late parasitological failure | 8 (1.12%) | 19 (5.31%) | |
| Day 42 (N = 1072) | 714 | 358 | |
| PCR corrected ACPRa | 646 (90.48%; 88.08–92.53%) | 327 (91.34%; 87.93%–94.04%) | −0.0086 (−.0431, .0302) |
| Total failure | 68 (9.52%) | 31 (8.66%) | |
| Missing (failure)b | 57 (7.98%) | 4 (1.11%) | |
| Late clinical failure | 7 (0.98%) | 1 (0.28%) | |
| Late parasitological failure | 2 (0.28%) | 4 (1.12%) | |
| @Recrudescence | 9 (1.26%) | 5 (1.4%) | |
| @Indeterminate PCR | 2 (0.28%) | 0 | |
| @Reinfection up to day 42 | 7 (0.98%) | 22 (6.15%) |
$ signifies recrudescence, indeterminate PCR and Reinfection up to day 28 and @ signifies recrudescence, indeterminate PCR and Reinfection up to day 42.
Abbreviations: ACPR, Adequate Clinical and Parasitological Response; CI, confidence interval; PCR, polymerase chain reaction.
a Data presented includes (n: %, 95% CI). See “Methods” section for definition of outcomes.
b Patients with missing data were regarded as having treatment failure.
c Patients with reinfection were not included in the PCR-corrected ACPR.