Overall, hematological indices and

Overall, hematological indices and blood electrolyte levels were comparable between treatment arms in Study 3004. In regards to liver function, there were notable differences in AST and ALT values. For ALT, the mean change from baseline to maximum post-baseline values was 9 U/L (range, -66 – 1339) in the neratinib arm and 5 U/L (range, -63 -1646) in the placebo arm. For AST, the mean change from baseline to maximum post-baseline values was 6 U/L (range, -39 – 1727) in the neratinib arm and 4 U/L (range, -62 – 1953) in the placebo arm. LFT abnormalities are discussed in greater detail in section 7.4.5. Other laboratory parameters related to liver function (bilirubin, albumin, ALP, and LDH) were comparable between arms.