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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)