System Organ Class (MedDRA) Preferred Term (MedDRA) | Safety population | |
---|---|---|
Patientsa N = 294 | Events N = 46 | |
Blood and lymphatic system disorders | 4 (1.4%) | 4 |
Haemolysis | 2 (0.7%) | 2 |
Anaemia | 1 (0.3%) | 1 |
Haemolytic anaemia | 1 (0.3%) | 1 |
Gastrointestinal disorders | 16 (5.4%) | 20 |
Vomiting | 9 (3.1%) | 9 |
Diarrhoea | 4 (1.4%) | 4 |
Abdominal pain | 3 (1.0%) | 3 |
Nausea | 2 (0.7%) | 2 |
Gastrointestinal pain | 1 (0.3%) | 2 |
General disorders and administration site conditions | 2 (0.7%) | 2 |
Asthenia | 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 | 3 (1.0%) | 3 |
Encephalitis brain stem | 1 (0.3%) | 1 |
Malaria | 1 (0.3%) | 1 |
Plasmodium falciparum infection | 1 (0.3%) | 1 |
Musculoskeletal and connective tissue disorders | 4 (1.4%) | 4 |
Back pain | 2 (0.7%) | 2 |
Myalgia | 1 (0.3%) | 1 |
Rhabdomyolysis | 1 (0.3%) | 1 |
Nervous system disorders | 4 (1.4%) | 7 |
Headache | 3 (1.0%) | 6 |
Insomnia | 1 (0.3%) | 1 |
Respiratory, thoracic and mediastinal disorders | 2 (0.7%) | 2 |
Dyspnoea | 2 (0.7%) | 2 |
Skin and subcutaneous tissue disorders | 2 (0.7%) | 2 |
Dry skin | 1 (0.3%) | 1 |
Pruritus | 1 (0.3%) | 1 |