Table 5. Outcomes and events during treatment: Efficacy.
| AmBisome + SSG | AmBisome + Miltefosine | Miltefosine | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Interim analysis (D28: ITT) | N | Cured, n | Decision | N | Cured, n | Decision | N | Cured, n | Decision |
| 1 | 14 | 13 | Continue | 15 | 14 | Continue | 14 | 14 | Continue |
| 2 | 29 | 26 | Continue | 31 | 28 | Continue | 30 | 25 | Continue |
| 3 | 44 | 41 | Stop | 44 | 41 | Stop | 47 | 42 | Stop |
| Cumulative analysis (D28) | N | Cured, n | % (95% CI*) | N | Cured, n | % (95% CI*) | N | Cured, n | % (95% CI*) |
| ITT | 51 | 47 | 85% (73–92) | 49 | 46 | 85% (73–92) | 51 | 45 | 85% (73–92) |
| Cumulative analysis (D210) | N | Cured, n | % (95% CI*) | N | Cured, n | % (95% CI*) | N | Cured, n | % (95% CI*) |
| ITT | 51 | 47 | 87% (77–97) | 49 | 40 | 77% (64–90) | 51 | 38 | 72% (60–85) |
* Efficacy and corresponding 95% CI estimated taking into account sequential design