Event (MedDRA Preferred Term)1 | DP n (%) | A + M n (%) |
---|---|---|
At least one AE | 60 (59.4%) | 33 (67.4%) |
Anaemia | 6 (5.9%) | 4 (8.2%) |
Asthenia | 10 (9.9%) | 9 (18.4%) |
Pyrexia | 18 (17.8%) | 10 (20.4%) |
Malaria2 | 5 (5.0%) | 7 (14.3%) |
Eosinophil count increased | 13 (12.9%) | 2 (4.1%) |
Haematocrit decreased | 11 (10.9%) | 5 (10.2%) |
Haemoglobin decreased | 13 (12.9%) | 7 (14.3%) |
Red blood cell count decreased | 11 (10.9%) | 10 (20.4%) |
At least one SAE | 5 (5.0%) | 1 (2.0%) |
At least one drug-related SAE | 4 (4.0%) | 1 (2.0%) |