Safety population | QTcF population | Strict QTcF population | |
---|---|---|---|
N = 294 | N = 143 | N = 60 | |
Age (years) | |||
Mean (SD) | 39.8 (13.2) | 37.5 (12.4) | 37.7 (12.1) |
Range | 1.5; 74.0 | 12.0; 72.0 | 12.0; 72.0 |
Age category | |||
≤ 12 years old | 5 (1.7%) | 1 (0.7%) | 1 (1.7%) |
13–17 years old | 5 (1.7%) | 5 (3.5%) | 2 (3.3%) |
≥ 18 years old | 284 (96.6%) | 137 (95.8%) | 57 (95.0%) |
Gender | |||
Male | 205 (69.7%) | 98 (68.5%) | 42 (70.0%) |
Female | 89 (30.3%) | 45 (31.5%) | 18 (30.0%) |
Ethnicity | |||
Missing | 1 | ||
Oriental | 1 (0.3%) | ||
African | 248 (84.6%) | 118 (82.5%) | 51 (85.0%) |
Caucasian | 40 (13.7%) | 24 (16.8%) | 8 (13.3%) |
Hispanic | 1 (0.3%) | 1 (0.7%) | 1 (1.7%) |
Other | 3 (1.0%) | ||
Body Mass Index at visit 1 (kg/m2) | |||
Mean (SD) | 25.9 (4.7) | 25.6 (4.6) | 26.1 (5.2) |
Range | 15.7; 42.2 | 17.1; 13.9 | 18.2; 37.8 |
Smoking status | |||
Missing | 12 | 5 | 3 |
Never smoked | 205 (72.7%) | 101 (73.2%) | 40 (70.2%) |
Previous smoker | 39 (13.8%) | 16 (11.6%) | 9 (15.8%) |
Current smoker | 38 (13.5%) | 21 (15.2%) | 8 (14.0%) |
Alcohol consumption | |||
Missing | 14 | 5 | 3 |
Never/on special occasions (less than once a week) | 237 (84.6%) | 115 (83.3%) | 45 (78.9%) |
Ex-consumer | 5 (1.8%) | 3 (2.2%) | 2 (3.5%) |
Current consumer | 38 (13.6%) | 20 (14.5%) | 10 (17.5%) |
At least one illness history | |||
Yes (cf Additional file for details) | 124 (42.2%) | 55 (38.5%) | 26 (43.3%) |
No | 170 (57.8%) | 88 (61.5%) | 34 (56.7%) |
Clinical symptoms at enrolment | |||
Yes | 278 (94.6%) | 138 (96.5%) | 56 (93.3%) |
No | 16 (5.4%) | 5 (3.5%) | 4 (6.7%) |
Symptoms | |||
Fever | 261 (88.8%) | 128 (89.5%) | 50 (83.3%) |
Headache | 195 (66.3%) | 99 (69.2%) | 41 (68.3%) |
Shivering | 146 (49.7%) | 78 (54.5%) | 33 (55.0%) |
Arthralgia | 137 (46.6%) | 72 (50.3%) | 27 (45.0%) |
Sweating | 110 (37.4%) | 55 (38.5%) | 21 (35.0%) |
Vomiting | 107 (36.4%) | 49 (34.3%) | 15 (25.0%) |
Anemia | 26 (8.8%) | 11 (7.7%) | 7 (11.7%) |
Jaundice | 14 (4.8%) | 6 (4.2%) | 4 (6.7%) |
Splenomegaly | 14 (4.8%) | 8 (5.6%) | 1 (1.7%) |
Hepatomegaly | 3 (1.0%) | 3 (2.1%) | 3 (5.0%) |
Retinal damage | 0 | 0 | 0 |
Coma | 1 (0.3%) | 0 | 0 |
Other symptom | 103 (35.0%) | 51 (35.7%) | 23 (38.3%) |