Table 3. Miltefosine treatment outcomes.
Day 28 | ||||||
Overall N = 66a,b |
Boru Meda N = 50 |
Gondar N = 16 |
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Outcome | n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI |
Cure | 12 (13.6) | 12 (24.0) | 14.0–37.9 | 0 (0) | 0–22.3 | |
Good improvement | 46 (66.0) | 2.2–38.5 | 35 (70.0) | 60.0–83.9 | 11 (68.8) | 50.0–91.0 |
Partial improvement | 8 (20.4) | 17.6–95.9 | 3 (6.0) | 0–19.9 | 5 (31.2) | 12.5–53.5 |
No improvement | 0 (0) | 0 (0) | 0–13.9 | 0 (0) | 0–2.3 | |
Day 90 | ||||||
Overall N = 60a |
Boru Meda N = 44 |
Gondar N = 16 |
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n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI | |
Cure | 34 (35.7) | 13.1–62.1 | 34 (72.7) | 61.4–85.9 | 2 (12.5) | 0–40.8 |
Good improvement | 17 (40.9) | 10.9–78.0 | 8 (20.5) | 9.1–33.6 | 8 (50.0) | 31.3–78.3 |
Partial improvement | 0 | - | 0 (0) | 0–13.2 | 0 (0) | 0–28.3 |
No improvement | 0 | - | 0 (0) | 0–13.2 | 0 (0) | 0–28.3 |
Relapse | 9 (23.4) | 3.3–60.2 | 3 (6.8) | 0–20.0 | 6 (37.5) | 18.8–65.8 |
Day 180 | ||||||
Overall N = 63a |
Boru Meda N = 48 |
Gondar N = 15 |
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n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI | |
Cure | 39 (48.7) | 25.2–72.6 | 35 (72.9) | 62.5–85.8 | 4 (26.7) | 6.7–52.7 |
Good improvement | 9 (19.0) | 3.1–54.1 | 7 (14.6) | 4.2–27.5 | 2 (13.3) | 0–39.4 |
Partial improvement | 0 | - | 0 (0) | 0–12.9 | 0 (0) | 0–26.1 |
No improvement | 0 | - | 0 (0) | 0–12.9 | 0 (0) | 0–26.1 |
Relapse | 15 (32.3) | 11.8–61.0 | 6 (12.5) | 2.0–25.4 | 9 (60.0) | 40.0–86.1 |
CI: Confidence interval. This table shows the per protocol analysis.
aProportions and 95% confidence intervals shown here are adjusted by site.
bAdjusted proportions and confidence intervals were calculated for day 28 by adding one cured, one good improvement and one partial improvement dummy patient to Gondar to obtain estimates which could otherwise not be obtained due to sparse data.