Demographics and parasite load
|
Sex (male), N (%)
|
246 (49.6)
|
248 (50)
|
86 (57.7)
|
89 (59.3)
|
Mean age (in years, Study-T; in months, Study-E) (SD)
|
17.3 (12.1)
|
16.5 (10.6)
|
37.2 (13.7)
|
37 (13.6)
|
Mean weight in kg (SD)
|
38.3 (15.5)
|
38.2 (15.5)
|
12.8 (2.5)
|
12.9 (2.6)
|
Geometric mean P. falciparum trophozoite density (/μl), (range)*
|
624
|
558
|
20,020
|
19,151
|
(16–355,623)
|
(16–285,011)
|
(2,016-415,082)
|
(2,000-194,127)
|
P. falciparum and P. malariae mixed infection, N (%)
|
7 (1.4)
|
9 (1.8)
|
-
|
-
|
Clinical- and laboratory signs, patients N (%) (any severity grade)
|
Fever / history of fever in past 48 hrs
|
491 (99.0)
|
497 (99.0)
|
149 (100)
|
150 (100)
|
Fatigue
|
75 (15.1)
|
76 (15.1)
|
16 (10.7)
|
12 (8.0)
|
Vomiting
|
48 (9.7)
|
49 (9.8)
|
29 (19.5)
|
21 (14.0)
|
Diarrhoea
|
8 (1.6)
|
11 (2.2)
|
14 (9.4)
|
13 (8.7)
|
Splenomegaly
|
24 (4.8)
|
20 (4.0)
|
21 (14.1)
|
19 (12.7)
|
Hepatomegaly
|
6 (1.2)
|
7 (1.4)
|
2 (1.3)
|
4 (2.7)
|
Anaemia total
|
82 (16.5)
|
80 (15.9)
|
25 (16.8)
|
20 (13.3)
|
Anaemia ≥ grade 3
|
2 (0.4)
|
2 (0.4)
|
10 (6.7)
|
12 (8.0)
|
Neutropaenia 1
|
78 (15.7)
|
81 (16.1)
|
21 (14.4)
|
16 (10.8)
|
Thrombocytopaenia 2
|
26 (5.2)
|
12 (2.4)
|
6 (4.0)
|
5 (3.3)
|
AST increased
|
38 (8.6)
|
35 (7.7)
|
9 (6.1)
|
10 (6.7)
|
ALT increased
|
21 (4.6)
|
22 (6.2)
|
3 (2.0)
|
5 (3.3)
|
Serum creatinine increased
|
8 (1.9)
|
15 (3.6)
|
1 (0.7)
|
1 (0.7)
|
Serum bilirubine (total) increased
|
12 (2.9)
|
17 (4.0)
|
11 (8.0)
|
13 (9.4)
|