Table 3.
Clinical characteristics at inclusion in the safety population.
| ASAQ1 group (N = 313) |
ASAQ2 group (N = 315) |
AL group (N = 312) |
|
| Axillary temperature (°C) | 37.94 ± 1.09 | 38.04 ± 1.04 | 37.92 ± 1.07 |
| Asthenia | 272 (86.9%) | 277 (87.9%) | 270 (86.5%) |
| Anorexia | 260 (83.1%) | 253 (80.3%) | 250 (80.1%) |
| Headache* | 172/212 (81.1%) | 191/231 82.7%) | 181/219 (82.6%) |
| Chills | 150 (47.9%) | 156 (49.5%) | 147 (47.1%) |
| Perspiration | 146 (46.6%) | 153 180 (57.1%) | 147 183 (58.7%) |
| Dizziness* | 53/165 (32.1%) | 50/185 (27.0%) | 48/165 (28.9%) |
| Pain* | 96/313 (31.2%) | 89/314 (28.3%) | 87/312 (28.3%) |
| Jaundice | 10 (3.2%) | 2 (0.6%) | 2 (0.6%) |
| Pruritus | 1 (0.3%) | 3 (1.0%) | 3 (0.9%) |
| Skinfold | None | 3 (0.9%) | 1 (0.3%) |
| Skin rash | None | 1 (0.3%) | None |
| Vomiting | 143 (45.8%) | 153 (48.6%) | 164 (52.7%) |
| Diarrhoea | 9 (2.9%) | 3 (1.0%) | 8 (2.6% |
| Hepatomegaly | 3 (0.9%) | 5 (1.6%) | 1 (0.3%) |
| Splenomegaly | 31 (9.9%) | 34 (10.8%) | 32 (10.3%) |
Data are presented as mean ± SD for quantitative variables and as patient numbers (%) for categorical variables.
*Information on these self-reported symptoms was not available for young children; the number of patients for whom data was available is thus indicated and used to calculate percentage values.