TABLE 2.
Per-protocol analysis: efficacy by treatment at day 42
| Outcome | Value by treatment group: |
P value | ||
|---|---|---|---|---|
| AA | AL | DP | ||
| Total no. allocated to treatment | 228 | 228 | 228 | |
| No. withdrawn or lost to follow-up by day 42 | 16 | 10 | 16 | |
| No. of deaths | 1 | 0 | 0 | |
| No. of evaluable patients | 211 | 218 | 212 | |
| Results, PCR uncorrected, no. (%) | ||||
| Early treatment failure | 1 (0.47) | 1 (0.46) | 1 (0.47) | |
| Late clinical failure | 17 (8.1) | 12 (5.5) | 10 (4.7) | |
| Late parasitological failure | 39 (18.5) | 52 (23.9) | 18 (8.5) | |
| Adequate clinical and parasitological response | 154 (73.0) | 153 (70.2) | 183 (86.3) | 0.001 |
| PCR results on recurrent episodes, no. | ||||
| New infections with P. falciparum | 41 | 39 | 16 | |
| New infections with P. malariae/P. ovale | 2 | 10 | 1 | |
| Recrudescences of P. falciparum | 10 | 11 | 9 | |
| Undetermined PCR resulta | 3 | 4 | 2 | |
| Results, PCR corrected: adequate clinical and parasitological response, no. (%) | 197 (93.4) | 202 (92.7) | 200 (94.3) | 0.78 |
a
The samples were collected, but the PCR results were undetermined; cases were excluded from the PCR-corrected analysis.