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Table 3 Crude and PCR-adjusted ACPR by day: ITT analysis set

From: A randomised, double-blind clinical phase II trial of the efficacy, safety, tolerability and pharmacokinetics of a single dose combination treatment with artefenomel and piperaquine in adults and children with uncomplicated Plasmodium falciparum malaria

  

800:640 (N = 143)

800:960 (N = 148)

800:1440 (N = 146)

Total (N = 437)

Day 28

 Crude ACPR

n/r (%)

76/143 (53.1)

79/148 (53.4)

92/146 (63.0)

247/437 (56.5)

95% CIa

[44.63; 61.53]

[45.01; 61.61]

[54.64; 70.85]

[51.73; 61.23]

 PCR-adjusted ACPR

n/r (%)

77/143 (53.8)

82/148 (55.4)

95/146 (65.1)

254/437 (58.1)

95% CIa

[45.32; 62.21]

[47.02; 63.57]

[56.75; 72.76]

[53.34; 62.79]

Day 42

 Crude ACPR

n/r (%)

63/143 (44.1)

66/148 (44.6)

68/146 (46.6)

197/437 (45.1)

95% CIa

[35.77; 52.59]

[36.43; 52.98]

[38.29; 55.01]

[40.35; 49.88]

 PCR-adjusted ACPR

n/r (%)a

67/143 (46.9)

72/148 (48.6)

73/146 (50.0)

212/437 (48.5)

95% CIa

[38.47; 55.37]

[40.36; 56.99]

[41.62; 58.38]

[43.74; 53.31]

Day 63b

 Crude ACPR

n/r (%)a

50/136 (36.8)

49/140 (35.0)

58/135 (43.0)

157/411 (38.2)

95% CIa

[28.67; 45.45]

[27.14; 43.51]

[34.48; 51.76]

[33.48; 43.09]

PCR-adjusted ACPR

n/r (%)a

50/136 (36.8)

54/140 (38.6)

59/135 (43.7)

163/411 (39.7)

95% CIa

[28.67; 45.45]

[30.47; 47.16]

[35.19; 52.50]

[34.90; 44.57]

  1. n number of patients in each category achieving ACPR, r total number of patients in the relevant analysis set with a defined response of Cure or Failure, N total number of patients in relevant analysis set
  2. aClopper–Pearson
  3. bPatients followed up to day 63 consented separately from the patients followed up to day 42; hence, total patient population is lower for day 63