Skip to main content

Table 1 Demographic and baseline clinical characteristics

From: Comparison of the safety and efficacy of fixed-dose combination of arterolane maleate and piperaquine phosphate with chloroquine in acute, uncomplicated Plasmodium vivax malaria: a phase III, multicentric, open-label study

 

AM + PQP

N = 159

Chloroquine

N = 158

Total

N = 317

Gender N (%)

 Male

137 (86.2 %)

145 (91.8 %)

282 (89.0 %)

 Female

2 2 (13.8 %)

13 (8.2 %)

35 (11.0 %)

Race

 Asian

159 (100.0 %)

158 (100.0 %)

317 (100.0 %)

Age (years)

 Mean ± std

33.2 ± 11.81

33.7 ± 13.45

33.5 ± 12.64

 Median

32

30

30

 Min, max

13.0, 65.0

15.0, 65.0

13.0, 65.0

Height (cm)

 Mean ± std

163.6 ± 7.83

163.6 ± 8.67

163.6 ± 8.24

 Median

164

164

164

 Min, max

130.0, 179.0

131.0, 182.0

130.0, 182.0

Weight (kg)

 Mean ± std

57.6 ± 8.76

58.8 ± 11.55

58.2 ± 10.25

 Median

57

56.4

57

 Min, max

42.0, 81.0

41.2, 128.9

41.2, 128.9

No. of subjects having P. vivax asexual parasites (/µL) at screening

 Mean ± std

6458.9 ± 11,439.07

5943.6 ± 10,401.49

6202.9 ± 10,921.57

 Median

2704

2880

2750.5

 GM

2749.7

2706.5

2728.2

 Min, max

250.0, 90,049.0

280.0, 80,000.0

250.0, 90,049.0

Body temperature (degree celsius)

 Mean ± std

38.5 ± 0.62

38.5 ± 0.61

38.5 ± 0.61

 Median

38.6

38.6

38.6

 Min, max

36.1, 40.2

36.8, 40.4

36.1, 40.4

Fever >(38.0 degree celsius)

122 (76.7 %)

118 (74.7 %)

240 (75.7 %)

No. of subjects having normal temperature (<37.5 degree celsius) at screening

6 (3.8 %)

3 (1.9 %)

9 (2.8 %)

Hepatomegaly

10 (6.3 %)

12 (7.6 %)

22 (6.9 %)

Splenomegaly

10 (6.3 %)

14 (8.9 %)

24 (7.6 %)

Anemia <30 % at screening

12 (7.55 %)

11 (6.96 %)

23 (7.26 %)

Hematocrit at screening

 Mean ± SD

37.14 ± 5.35

37.75 ± 5.30

37.45 ± 5.33

 Median

37.4

37.75

37.5

 Min, max

19.8, 50

2254.7

19.8, 54.7

G6PD deficiency

0

0

0

P. vivax infections in prior 12 months

9 (5.66 %)

8 (5.03 %)

17 (5.36 %)

  1. AM + PQP: FDC of arterolane maleate and PQP