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Table 4 Re-emergence, crude and PCR-adjusted ACPR by day: PP 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 = 139)

800:960 (N = 140)

800:1440 (N = 139)

Total (N = 418)

Day 28

 Re-emergence

n/r (%)

48/129 (37.2)

56/136 (41.2)

39/133 (29.3)

143/398 (35.9)

 Recrudescence

n/r (%)

25/129 (19.4)

37/136 (27.2)

22/133 (16.5)

84/398 (21.1)

95% CIa

[12.95; 27.26]

[19.93; 35.50]

[10.67; 23.97]

[17.20; 25.45]

 New infection

n/r (%)

11/129 (8.5)

10/136 (7.4)

12/133 (9.0)

33/398 (8.3)

95% CIa

[4.33; 14.75]

[3.58; 13.11]

[4.75; 15.23]

[5.78; 11.45]

 Indeterminate

n/r (%)

3/129 (2.3)

0

0

3/398 (0.8)

 Negative

n/r (%)

2/129 (1.6)

1/136 (0.7)

0

3/398 (0.8)

 Missing

n/r (%)

7/129 (5.4)

8/136 (5.9)

5/133 (3.8)

20/398 (5.0)

 Crude ACPR

n/r (%)

74/129 (57.4)

77/136 (56.6)

89/133 (66.9)]

240/398 (60.3)

95% CIa

[48.36; 66.03]

[47.85; 65.09]

[58.23; 74.83

[55.31; 65.14]

 PCR-adjusted ACPR

n/r (%)

75/106 (70.8)

80/117 (68.4)

92/117 (78.6)

247/340 (72.6)

95% CIa

[61.13; 79.19]

[59.13; 76.66]

[70.09; 85.67]

[67.58; 77.32]

Day 42

 Re-emergence

n/r (%)

59/127 (46.5)

64/134 (47.8)

56/130 (43.1)

179/391 (45.8)

 Recrudescence

n/r (%)

29/127 (22.8)

37/134 (27.6)

25/130 (19.2)

91/391 (23.3)

95% CIa

[15.86; 31.12]

[20.24; 36.00]

[12.85; 27.07]

[19.17; 27.78]

 New infection

n/r (%)

16/127 (12.6)

17/134 (12.7)

18/130 (13.8)

51/391 (13.0)

95% CIa

[7.38; 19.65]

[7.57; 19.53]

[8.42; 21.00]

[9.87; 16.79]

 Indeterminate

n/r (%)

3/127 (2.4)

1/134 (0.7)

3/130 (2.3)

7/391 (1.8)

 Negative

n/r (%)

3/127 (2.4)

1/134 (0.7)

0

4/391 (1.0)

 Missing

n/r (%)

8/127 (6.3)

8/134 (6.0)

10/130 (7.7)

26/391 (6.6)

 Crude ACPR

n/r (%)

61/127 (48.0)

65/134 (48.5)

67/130 (51.5)

193/391 (49.4)

95% CIa

[39.09; 57.07]

[39.79; 57.29]

[42.62; 60.39]

[44.30; 54.43]

 PCR-adjusted ACPR

n/r (%)a

65/100 (65.0)

71/108 (65.7)

72/100 (72.0)

208/308 (67.5)

95% CIa

[54.82; 74.27]

[55.99; 74.60]

[62.13; 80.52]

[61.99; 72.73]

Day 63b

 Re-emergence

n/r (%)

59/114 (51.8)

70/122 (57.4)

53/116 (45.7)

182/352 (51.7)

 Recrudescence

n/r (%)

29/114 (25.4)

37/122 (30.3)

23/116 (19.8)

89/352 (25.3)

95% CIa

[17.75; 34.45]

[22.33; 39.30]

[13.00; 28.25]

[20.83; 30.16]

 New infection

n/r (%)

15/114 (13.2)

20/122 (16.4)

16/116 (13.8)

51/352 (14.5)

95% CIa

[7.56; 20.77]

[10.31; 24.18]

[8.09; 21.43]

[10.98; 18.61]

 Indeterminate

n/r (%)

4/114 (3.5)

3/122 (2.5)

4/116 (3.4)

11/352 (3.1)

 Negative

n/r (%)

3/114 (2.6)

1/122 (0.8)

0

4/352 (1.1)

 Missing

n/r (%)

8/114 (7.0)

9/122 (7.4)

10/116 (8.6)

27/352 (7.7)

 Crude ACPR

n/r (%)a

48/114 (42.1)

48/122 (39.3)

57/116 (49.1)

153/352 (43.5)

95% CIa

[32.92; 51.71]

[30.62; 48.59]

[39.74; 58.58]

[38.22; 48.82]

 PCR-adjusted ACPR

n/r (%)a

48/83 (57.8)

53/90 (58.9)

58/84 (69.0)

159/257 (61.9)

95% CIa

[46.49; 68.60]

[48.02; 69.16]

[58.02; 78.69]

[55.63; 67.83]

  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
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