Table 2.
Adequate clinical and parasitological response (ACPR) in the per-protocol population
| Pyronaridine–artesunate | Artemether–lumefantrine | Difference (95% CI) | |
|---|---|---|---|
| Day 28 | |||
| PCR-corrected ACPR, n/Nb | 93/94 | 81/84 | |
| % (95% CI) | 98.9 (94.2 to 99.8) | 96.4 (90.0 to 98.8) | 2.5 (− 2.8 to 9.0)a |
| Total no. of failures | 1 (1.1) | 3 (3.6) | |
| No. with early treatment failure | 0 | 0 | |
| No. with late clinical failure | 0 | 0 | |
| No. with late parasitological failure | 1 (1.1) | 3c (3.6) | |
| No. with missing data | 7 (7.4) | 12 (14.3) | |
| Uncorrected ACPR, n/N | 87/95 | 75/85 | |
| % (95% CI) | 91.6 (84.3 to 95.7) | 88.2 (79.7 to 93.5) | 3.3 (− 5.7 to 12.8) |
| Total no. of failures | 8 (8.4) | 10 (11.8) | |
| No. with early treatment failure | 0 | 0 | |
| No. with late clinical failure | 1 (1.1) | 1 (1.2) | |
| No. with late parasitological failure | 7 (7.4) | 9 (10.6) | |
| No. with missing data | 6 (6.4) | 11 (12.9) | |
| Day 42 | |||
| PCR-corrected ACPR, n/Nb | 73/77 | 61/67 | |
| % (95% CI) | 94.8 (87.4 to 98.0) | 91.0 (81.8 to 95.8) | 3.8 (− 5.1 to 13.5) |
| Total no. of failures | 4 (5.2) | 6 (9.0) | |
| No. with early treatment failure | 0 | 0 | |
| No. with late clinical failure | 1 (1.3) | 0 | |
| No. with late parasitological failure | 3c (3.9) | 6d (9.0) | |
| No. with missing data | 24 (31.2) | 29 (43.3) | |
| Uncorrected ACPR, n/N | 67/86 | 56/77 | |
| % (95% CI) | 77.9 (68.1 to 85.4) | 72.7 (61.9 to 81.4) | 5.2 (− 8.0 to 18.4) |
| Total no. of failures | 19 (22.1) | 21 (27.3) | |
| No. with early treatment failure | 0 | 0 | |
| No. with late clinical failure | 5 (5.8) | 2 (2.6) | |
| No. with late parasitological failure | 14 (16.3) | 19 (24.7) | |
| No. with missing data | 15 (17.4) | 19 (24.7) | |
Data are n (%) unless otherwise indicated
Participants with a reinfection before day 28 were included in the day-28 per-protocol population for the uncorrected analysis. In the PCR-corrected analysis, however, patients with a reinfection before day 28 were excluded from the analysis because data were missing on day 28 (and there was no established recrudescence). On day 42, the per-protocol population was defined similarly
aNon-inferiority of pyronaridine–artesunate to artemether–lumefantrine is demonstrated if the lower limit of the 95% confidence interval (CI) of the difference in ACPR is > − 7%
bPCR-corrected for reinfection by msp1, msp2 and glurp genotyping
cOne of the late parasitological failures had indeterminate genotyping and was marked as recrudescence
dTwo of the late parasitological failures had indeterminate genotyping and were marked as recrudescence