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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