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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