ALB and lymphopenia: Fifteen grade 4 related AEs were reported across nine patients; these included three cases of decreased lymphocyte count, and ascites, decreased appetite, edema, “general physical health deterioration,” decreased blood albumin, hepatic failure (this case was conservatively added to the nine cases of grade 3 or higher hyperbilirubinemia for primary endpoint analysis), hepatic cirrhosis, lymphopenia, dyspnoea, encephalopathy, peritonitis, sepsis, one case each.