Table 3.
Failure rates overall and per site on day 28 and 42 using the ITT and mITT populations
| P. falciparum (PCR corrected) | P. vivax | |||||||
|---|---|---|---|---|---|---|---|---|
| Pf-noPQ | Pf-PQ1 | p value | Hazards ratio | Pv-noPQ | Pv-PQ14 | p value | Hazards ratio | |
| ITT | ||||||||
| D28 | ||||||||
| Overall (95% CI) | 2.35 (0.59–9.08) | 0.86 (0.12–5.96) | 0.419 | 0.385 (0.035–4.241) | 9.93 (3.31–27.76) | 0.00 | 0.046 | – |
| New Halfa (95% CI) | 2.90 (0.73–11.10) | 1.03 (0.15–7.09) | 0.406 | 0.374 (0.034–4.129) | 20.0 (3.08–79.62) | 0.00 | 0.157 | _ |
| Gezira Slanj (95% CI) | 0.00 | 0.00 | 1.000 | – | 8.17 (2.11–28.92) | 0.00 | 0.120 | _ |
| p valueb | 0.493 | 0.658 | – | – | 0.487 | 1.000 | – | – |
| D42 | ||||||||
| Overall (95% CI) | 3.75 (1.22–11.22) | 0.86 (0.12–5.96) | 0.189 | 0.247 (0.026–2.378) | 13.39 (5.24–31.91) | 5.26 (1.34–19.44) | 0.212 | 0.358 (0.066–1.956) |
| New Halfa (95% CI | 4.66 (1.52–13.85) | 1.03 (0.15–7.09) | 0.176 | 0.238 (0.025–2.293) | 20.0 (3.08–79.62) | 0.00 | 0.157 | – |
| Gezira Slanj (95% CI) | 0.00 | 0.00 | 1.000 | – | 12.35 (4.15–33.59) | 7.14 (1.84–25.65) | 0.480 | 0.535 (0.089–3.200) |
| p valueb | 0.389 | 0.658 | – | – | 0.392 | 0.684 | – | – |
| mITTa | ||||||||
| D28 | ||||||||
| Overall (95% CI) | 2.00 (0.28–13.36) | 0.00 | 0.282 | – | 0.00 | 0.00 | 1.000 | – |
| New Halfa (95% CI) | 2.86 (0.41–18.60) | 0.00 | 0.237 | – | 0.00 | 0.00 | 1.000 | – |
| Gezira Slanj (95% CI) | 0.00 | 0.00 | 1.000 | – | 0.00 | 0.00 | 1.000 | – |
| p valueb | 0.513 | 1.000 | – | – | 1.000 | 1.000 | – | – |
| D42 | ||||||||
| Overall (95% CI) | 4.28 (1.08–16.10) | 0.00 | 0.117 | – | 0.00 | 6.90 (1.77–24.86) | 0.247 | – |
| New Halfa (95% CI) | 6.21 (1.58–22.73) | 0.00 | 0.083 | – | 0.00 | 0.00 | 1.000 | – |
| Gezira Slanj (95% CI) | 0.00 | 0.00 | 1.000 | – | 0.00 | 10.00 (2.60–34.40) | 0.186 | – |
| p valueb | 0.340 | 1.000 | – | – | 1.00 | 0.334 | 0.334 | – |
Significant values are in italics (p < 0.05)
amITT population excluded 132 (42.7%) with incomplete or suboptimal dosing of study drugs
bThis p value refers to site specific differences and does not consider overall results