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Table 3 Patient baseline characteristics

From: Safety and efficacy of pyronaridine-artesunate in uncomplicated acute malaria: an integrated analysis of individual patient data from six randomized clinical trials

Characteristic

PA safetya

PA efficacy (ITT)a

MQ + AS safety/efficacy

AL safety/efficacy

CQ safety

All comparators safetya

 

n = 2815

n = 2052

n = 423

n = 603

n=228

n = 1254

Female gender, n (%)

956 (34.0)

751 (36.6)

93 (22.0)

288 (47.8)

64 (28.1)

445 (35.5)

Mean age, years (SD) [range]

20.6 (12.9) [0.3–60.4]

18.6 (12.6) [0.3–60.4]

25.6 (12.5) [5.5–59.7]

14.6 (11.3) [0.3–57.0]

26.6 (10.9) [7.0–58.0]

20.5 (12.9) [0.3–59.7]

Age category, years, n (%)

      

  ≤1 year

9 (0.3)

9 (0.4)

0

3 (0.5)

0

3 (0.2)

  >1– <5

173 (6.1)

150 (7.3)

0

68 (11.3)

0

68 (5.4)

  5–12

704 (25.0)

656 (32.0)

61 (14.4)

274 (45.4)

9 (3.9)

344 (27.4)

  >12– <18

401 (14.2)

316 (15.4)

53 (12.5)

92 (15.3)

28 (12.3)

173 (13.8)

  ≥18

1528 (54.3)

921 (44.9)

309 (73.0)

166 (27.5)

191 (83.8)

666 (53.1)

Region, n (%)b

      

  Africa

1426 (50.7)

1223 (59.6)

79 (18.7)

531 (88.1)

0

610 (48.6)

  Asia

1389 (49.3)

829 (40.4)

344 (81.3)

72 (11.9)

228 (100)

644 (51.4)

Mean body weight, kg (SD) [range]

42.1 (16.5) [6.0–89.5]

39.5 (17.1) [6.0–89.5]

47.3 (12.1) [20.0–75.0]

34.6 (18.1) [7.2–86.0]

49.4 (10.2) [20.0–80.0]

41.6 (16.5) [7.2–86.0]

Malaria in last 12 months, n (%)

n = 2551

n = 2045

n = 423

n = 600

n = 228

n = 1251

  0

1431 (56.1)

1064 (52.0)

258 (61.0)

269 (44.8)

123 (53.9)

650 (52.0)

  1

498 (19.5)

444 (21.7)

92 (21.7)

116 (19.3)

58 (25.4)

266 (21.3)

  >1

622 (24.4)

537 (26.3)

73 (17.3)

215 (35.8)

47 (20.6)

335 (26.8)

P. falciparum parasitaemia, μL-1, n (%)c

      

  ≤5000

691 (26.8)

521 (25.4)

113 (26.7)

161 (26.7)

–

274 (26.7)

  >5000–10,000

394 (15.3)

293 (14.3)

72 (17.0)

81 (13.5)

–

153 (14.9)

  >10,000

1497 (58.0)

1238 (60.3)

238 (56.3)

360 (59.8)

–

598 (58.3)

P. vivax geometric mean asexual parasitaemia, μL–1 [range]

6914.8 [466–92500]

–

–

–

6145.8 [366–77035]

–

Mean haemoglobin, g/dL (SD)

11.9 (2.0)

11.8 (2.0)

12.1 (2.0)

11.5 (1.9)

12.3 (1.8)

11.9 (1.9)

  1. PA, pyronaridine-artesunate; MQ + AS, mefloquine plus artesunate; AL, artemether-lumefantrine; CQ, chloroquine.
  2. a The safety analysis included data from all Phase II and Phase III studies. The efficacy analysis included data from the Phase III P. falciparum trials. For comparators, MQ + AS, AL and CQ were included in the safety analysis; MQ + AS and AL in the efficacy analysis.
  3. b All subjects from African centres were of Black ethnicity except one in the AL group who was Asian/Oriental; all patients from Asian centres were of Asian/Oriental ethnicity.
  4. c Baseline P. falciparum parasite count was not available for five patients in the PA group and one patient in the AL group.
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Malaria Journal

ISSN: 1475-2875

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