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Table 3 Crude and PCR-adjusted ACPR at each time point in African patients aged ≤ 5 years (PP Set)

From: A randomized, double-blind, phase 2b study to investigate the efficacy, safety, tolerability and pharmacokinetics of a single-dose regimen of ferroquine with artefenomel in adults and children with uncomplicated Plasmodium falciparum malaria

  Artefenomel mg: Ferroquine mg
  800:400 800:600 800:900 800:1200 Total
Day 28
 N 69 67 63 62 261
 Crude ACPR, n/r (%) 34/69 (49.3) 48/67 (71.6) 48/63 (76.2) 54/62 (87.1) 184/261 (70.5)
 [95% CI] [37.0; 61.6] [59.3; 82.0] [63.8; 86.0] [76.1; 94.3] [64.6; 76.0]
 PCR-adjusted ACPR, n/r (%) 40/51 (78.4) 51/60 (85.0) 51/57 (89.5) 55/60 (91.7) 197/228 (86.4)
 [95% CI] [64.7; 88.7] [73.4; 92.9] [78.5; 96.0] [81.6; 97.2] [81.3; 90.6]
Day 42
 N 69 65 59 61 254
 Crude ACPR, n/r (%) 27/69 (39.1) 33/65 (50.8) 36/59 (61.0) 42/61 (68.9) 138/254 (54.3)
 [95% CI] [27.6; 51.6] [38.1; 63.4] [47.4; 73.5] [55.7; 80.1] [48.0; 60.6]
 PCR-adjusted ACPR, n/r (%) 30/43 (69.8) 45/55 (81.8) 42/50 (84.0) 50/57 (87.7) 167/205 (81.5)
 [95% CI] [53.9; 82.8] [69.1; 90.9] [70.9; 92.8] [76.3; 94.9] [75.5; 86.5]
Day 63
 N 68 65 59 60 252
 Crude ACPR, n/r (%) 24/68 (35.3) 30/65 (46.2) 34/59 (57.6) 35/60 (58.3) 123/252 (48.8)
 [95% CI] [24.1; 47.8] [33.7; 59.0] [44.1; 70.4] [44.9; 70.9] [42.5; 55.2]
 PCR-adjusted ACPR, n/r (%) 25/39 (64.1) 33/43 (76.7) 36/44 (81.8) 41/47 (87.2) 135/173 (78.0)
 [95% CI] [47.2; 78.8] [61.4; 88.2] [67.3; 91.8] [74.3; 95.2] [71.1; 84.0]
  1. N: total number of patients in the relevant analysis set. All doses of artefenomel and ferroquine are expressed as adult-equivalent doses
  2. n: number of patients in each category achieving ACPR
  3. r: total number of patients in the relevant analysis set with a defined response of Cure or Failure (i.e. patients evaluable for the outcome considered)