Eight patients (2.1%), all Africans ≤ 5 years, experienced treatment-emergent SAEs: 2 in the artefenomel + ferroquine 600 mg arm (malaria and pharyngitis), 4 in the artefenomel + ferroquine 900 mg arm (malaria, drug-induced liver injury and 2 cases of ALT increase), and 2 in the artefenomel + ferroquine 1200 mg arm (hepatitis A, pneumonia aspiration). This evidence concerns the gene GPT and hepatitis A virus infection.