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

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

		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)
Crude ACPR	95% CI^a	[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)
PCR-adjusted ACPR	95% CI^a	[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)
Crude ACPR	95% CI^a	[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)
PCR-adjusted ACPR	95% CI^a	[38.47; 55.37]	[40.36; 56.99]	[41.62; 58.38]	[43.74; 53.31]
Day 63^b
Crude ACPR	n/r (%)^a	50/136 (36.8)	49/140 (35.0)	58/135 (43.0)	157/411 (38.2)
Crude ACPR	95% CI^a	[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)
PCR-adjusted ACPR	95% CI^a	[28.67; 45.45]	[30.47; 47.16]	[35.19; 52.50]	[34.90; 44.57]

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
^aClopper–Pearson
^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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