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Table 2 Demographics and patient characteristics by region (randomized patients)

From: A randomized, double-blind, phase 2b study to investigate the efficacy, safety, tolerability and pharmacokinetics of a single-dose regimen of ferroquine with artefenomel in adults and children with uncomplicated Plasmodium falciparum malaria

  Artefenomel mg: Ferroquine mg
  800:400 800:600 800:900 800:1200 Total
African patients > 6 months and ≤ 5 years
 N 73 74 73 72 292
 Males, n (%) 43 (58.9) 35 (47.3) 41 (56.2) 27 (37.5) 146 (50.0)
 Age (months), median (range) 40.74
(9.0; 59.6)
41.10
(8.7; 59.9)
40.05
(10.3; 59.9)
40.89
(7.6; 59.2)
40.30
(7.6; 59.9)
 > 6 months to ≤ 2 years, n (%)a 7 (9.6) 8 (10.8) 6 (8.2) 7 (9.7) 28 (9.6)
 > 2 years to ≤ 5 years, n (%) 66 (90.4) 66 (89.2) 67 (91.8) 65 (90.3) 264 (90.4)
 Body weight (kg), median (range) 13.10
(8.2; 20.0)
13.85
(8.0; 19.0)
13.10
(7.7; 19.0)
13.75
(8.1; 21.5)
13.50
(7.7; 21.5)
 Baseline parasitaemia (/µL), median (range)b 34,400
(18; 182,719)
38,153.5
(1060; 177,867)
31,164.5
(599; 145,053)
22,793
(920; 119,804)
31,219
(18; 182,719)
African patients > 5 years
 N 16 15 18 15 64
 Males, n (%) 9 (56.3) 9 (60.0) 8 (44.4) 5 (33.3) 31 (48.4)
 Age (years), median (range) 14.58
(6.2; 56.0)
15.90
(7.2; 32.9)
15.71
(6.1; 43.7)
16.28
(5.2; 48.3)
15.24
(5.2; 56.0)
 > 5 years to ≤ 14 years, n (%) 6 (37.5) 5 (33.3) 6 (33.3) 5 (33.3) 22 (34.4)
 > 14 years to ≤ 18 years, n (%) 5 (31.3) 5 (33.3) 5 (27.8) 4 (26.7) 19 (29.7)
 > 18 years 5 (31.3) 5 (33.3) 7 (38.9) 6 (40.0) 23 (35.9)
 Body weight (kg), median (range) 47.20
(18.8; 70.2)
47.60
(19.9; 77.3)
44.85
(19.3; 89.0)
50.70
(15.0; 75.0)
47.00
(15.0; 89.0)
 Baseline parasitaemia (/µL), median (range)b 4693.0
(885; 72,317)
21,968.0
(550; 162,303)
4280.0
(684; 85,130)
5321.0
(1060; 103,947)
5962.0
(550; 162,303)
Asian patients
 N 4 5 6 6 21
 Males, n (%) 4 (100) 4 (80.0) 5 (83.3) 5 (83.3) 18 (85.7)
 Age (years), median (range) 28.39
(15.4; 32.9)
24.96
(19.8; 61.9)
28.12
(14.7; 55.8)
28.91
(21.2; 53.4)
27.38
(14.7; 61.9)
 > 6 months to ≤ 2 years, n (%) 0 0 0 0 0
 > 2 years to ≤ 5 years, n (%) 0 0 0 0 0
 > 5 years to ≤ 14 years, n (%) 0 0 0 0 0
 > 14 years to ≤ 18 years, n (%) 1 (25.0) 0 2 (33.3) 0 3 (14.3)
 > 18 years 3 (75.0) 5 (100) 4 (66.7) 6 (100) 18 (85.7)
 Body weight (kg), median (range) 52.50
(46.0; 55.0)
55.00
(47.0; 63.0)
55.50
(44.0; 62.0)
55.50
(50.0; 63.0)
55.00
(44.0; 63.0)
B aseline parasitaemia (/µL), median (range)b 19,681.5
(1280; 44,951)
2698.0
(1562; 26,190)
24,274.5
(7512; 95,251)
15,702.0
(1592; 63,985)
19,627.0
(1280; 95,251)
  1. N: total number of patients in the relevant analysis set. All doses of artefenomel and ferroquine are expressed as adult-equivalent doses
  2. aIncluding 11 patients (3.8%) aged < 12 months (2 with the artefenomel + 400 mg ferroquine dose, 2 with the 600 mg dose, 4 with the 900 mg dose and 3 with the 1200 mg dose)
  3. bBaseline parasitaemia corresponds to the baseline/post-dose measurement and was summarized for all treated patients (i.e. Safety Set, including 289 African patients ≤ 5 years, 64 African patients > 5 years and 20 Asian patients). Baseline parasitaemia is missing for 3 African patients > 5 years