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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