Study-T (>5 years) | Study-E (6–59 months) | |||
---|---|---|---|---|
Patients N (%) | ASAQ | AL | ASAQ | AL |
N = 496 | N = 502 | N = 149 | N = 150 | |
AEs with severity grade ≥ 3 | ||||
Hepatitis | 1 (0.2) | 0 | - | - |
Stomatitis | - | - | 0 | 1 (0.7) |
Vomiting # | - | - | 0 | 1 (0.7) |
Malaria # | - | - | 1 (0.7) | 0 |
Pneumonia # | - | - | 1 (0.7) | 0 |
Splenomegaly | 7 (1.4) | 1 (0.2) | - | - |
Thrombocytopenia | 2 (0.4) | 0 | 4 (2.7) | 1 (0.7) |
Leukocytosis | 2 (0.4) | 4 (0.8) | - | - |
Neutropaenia | 2 (0.4) | 1 (0.2) | - | - |
Anaemia | 1 (0.2) | 0 | 3 (2.0) | 1 (0.7) |
AST increased | 3 (0.6) | 1 (0.2) | - | - |
ALT increased | 1 (0.2) | 0 | - | - |
Hepatomegaly | 0 | 1 (0.2) | - | - |