Serious AEs occurred in nine patients and included myositis (n = 1), hepatitis (n = 2), increased ALT and AST (n = 1), oesophageal fistula (n = 1), hyperbilirubinemia (n = 1), rash (n = 1), pneumonitis (n = 1), and proteinuria (n = 1). This evidence concerns the gene GPT and pneumonitis.