Table 3. Sodium Stibogluconate (SSG) & Paromomycin (PM) versus SSG: Efficacy Data.
| Number of patients analyzeda | Number (%)cured | Treatment effectb (95% CI), p-valuec | Centre p-valued | Age p-valued | Period p-valued |
| Six months follow-up: | |||||
| ITT: Complete Case Analysise | |||||
| SSG: N = 359 | 337 (93.9) | 2.5 (−1.3–6.3) | 0.337 | 0.122 | 0.112 |
| SSG & PM: N = 359 | 328 (91.4) | p = 0.198 | |||
| PP: Complete Case Analysise | , | ||||
| SSG: N = 357 | 336 (94.1) | 2.8 (−1.1–6.6) | 0.286 | 0.080 | 0.064 |
| SSG & PM: N = 347 | 317 (91.4) | p = 0.157 | |||
| ITT: Worst Case Analysisf | |||||
| SSG: N = 386 | 337 (87.3) | 1.2 (−3.6–6.0) | <0.001 | 0.008 | <0.001 |
| SSG & PM: N = 381 | 328 (86.1) | p = 0.620 | |||
| PP: Worst Case Analysisf | |||||
| SSG: N = 383 | 336 (87.7) | 1.8 (−3.0–6.7) | <0.001 | 0.007 | <0.001 |
| SSG & PM: N = 369 | 317 (85.9) | p = 0.460 | |||
| End of Treatment: | |||||
| ITT: Complete Case Analysise | - | - | - | ||
| SSG: N = 385 | 366 (95.1) | 1.9 (−1.4–5.3) | |||
| SSG & PM: N = 378 | 352 (93.1) | p = 0.254 |
CI = confidence interval, ITT = Intention-to-Treat, PP = Per-Protocol.
a
381patients were originally recruited to the SSG&PM arm, 386 to the SSG arm.
b
Treatment effect: difference in efficacy between SSG and SSG & PM combination treatment, percent scale with exact binomial 95% CI.
c
p-value from likelihood ratio test comparing binomial regression models with and without treatment.
d
p-value from likelihood ratio test comparing binomial regression models with and without factor of interest, after adjustment for treatment allocation.
e
Complete-case analysis: patients with missing outcome data excluded from analysis.
f
Worst-case analysis: missing outcomes assumed to be treatment failures.