System Organ Class (MedDRA) Preferred Term (MedDRA) | Safety population | |
---|---|---|
Patientsa N = 294 | Events N = 11 | |
Blood and lymphatic system disorders | 3 (1.0%) | 3 |
Haemolysis | 2 (0.7%) | 2 |
Anaemia | 1 (0.3%) | 1 |
Gastrointestinal disorders | 2 (0.7%) | 3 |
Vomiting | 2 (0.7%) | 2 |
Nausea | 1 (0.3%) | 1 |
General disorders and administration site conditions | 1 (0.3%) | 1 |
Malaise | 1 (0.3%) | 1 |
Hepatobiliary disorders | 2 (0.7%) | 2 |
Hepatitis | 1 (0.3%) | 1 |
Hepatitis acute | 1 (0.3%) | 1 |
Infections and infestations | 2 (0.7%) | 2 |
Encephalitis brain stem | 1 (0.3%) | 1 |
Plasmodium falciparum infection | 1 (0.3%) | 1 |