Study-T (> 5 years) | Study-E (6-59 months) | |||
---|---|---|---|---|
ASAQ | AL | ASAQ | AL | |
N = 496 | N = 502 | N = 149 | N = 150 | |
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) |