Table 2.
Primary Efficacy Outcome of Definite Cure With Primary Imputation by Treatment Arm
| Analysis Set | Statistics | Arm 1, PM/MF 14 Days |
Arm 3, SSG/PM |
|---|---|---|---|
| Modified intention-to-treata | N | 170 | 170 |
| Number cured | 155 | 156 | |
| Efficacy, % | 91.2 | 91.8 | |
| Difference in efficacyb (97.5% CI) | 0.6 (−6.2 to 7.4) | … | |
| Per-protocolc | N | 162 | 169 |
| Number cured | 149 | 155 | |
| Efficacy, % | 92.0 | 91.7 | |
| Difference in efficacyb (97.5% CI) | −0.3 (−7.0 to 6.5) | … |
Abbreviations: CI, confidence interval; MF, miltefosine; PM, paromomycin; SSG, sodium stibogluconate.
Primary analysis.
Difference in efficacy from SSG/PM, that is, efficacy of SSG/PM minus efficacy of PM/MF 14 days.
Sensitivity analysis.