Skip to main content

Table 3 Kaplan–Meier estimates of primary and main secondary outcomes by nutritional status

From: Efficacy of artemether-lumefantrine in relation to drug exposure in children with and without severe acute malnutrition: an open comparative intervention study in Mali and Niger

  SAM Non-SAM  
  n/Na Kaplan–Meier estimate (95 % CI) n/Na Kaplan–Meier estimate (95 % CI) P
Day 28 PCR-corrected ACPRb
 mITT 131/131 100 % (NA) 263/266 98.9 % (96.5–99.6) 0.232
 PP 118/118 100 % (NA) 241/244 98.9 % (96.2–99.6) 0.227
Day 42 PCR-corrected ACPR
 mITT 131/131 100 % (NA) 262/266 98.3 % (95.6–99.4) 0.168
 PP 118/118 100 % (NA) 240/244 98.2 % (95.3–99.3) 0.162
Day 28 uncorrected ACPR
 mITT 108/131 81.3 % (73.3–87.2) 223/266 83.5 % (78.4–87.5) 0.611
 PP 96/118 81.3 % (73.0–87.3) 203/244 83.2 % (77.9–87.3) 0.668
Day 42 uncorrected ACPR
 mITT 102/131 76.4 % (67.9–83.0) 196/266 73.0 % (67.2–78.0) 0.552
 PP 91/118 77.1 % (68.4–83.7) 176/244 72.1 % (66.0–77.3) 0.377
Day 28 reinfection
 mITT 23/131 18.7 % (12.8–26.8) 39/266 15.2 % (11.3–20.1) 0.374
 PP 22/118 18.6 % (12.7–26.9) 37/244 15.3 % (11.4–20.5) 0.412
Day 42 reinfection
 mITT 29/131 23.6 % (17.0–32.1) 65/266 25.4 % (20.5–31.2) 0.811
 PP 27/118 22.9 % (16.3–31.6) 63/244 26.2 % (21.1–32.3) 0.600
  1. P values were calculated with log-rank test
  2. aN, total number; n, number with event (adequate response or reinfection)
  3. bPrimary endpoint
  4. SAM severe acute malnutrition, ACPR adequate clinical and parasitological response, mITT modified intent-to-treat population (N = 397), PP per protocol population (N = 362), CI Wald confidence interval, NA not assessable