Total bilirubin =< . x normal institutional limits; this will not apply to patients with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia [predominantly unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician
Serum bilirubin =< . x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with the study sponsor
Should be performed within  days of treatment initiation: serum bilirubin ? . x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =<. x institutional upper limit of normal or =< . x upper limit of normal (ULN) for patients with liver metastases; this will not apply to patients with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Serum bilirubin =< . x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Within  days (+  day window) of enrollment: Serum bilirubin =< . x the institutional ULN, or =<  x ULN if confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology)
Serum bilirubin =< . x institutional upper limit of normal (ULN); (this will not apply to subjects with confirmed Gilbert's syndrome [persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology], who will be allowed only in consultation with their physician)
Serum bilirubin =< . x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
Serum bilirubin =< . x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Serum bilirubin =< . x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Serum bilirubin =< . x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only upon treating physician, principal investigators (PI) or co-PIs approval
Serum bilirubin =< . x institutional upper limit of normal (ULN). (This will not apply to subjects with confirmed Gilberts syndrome [persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology], who will be allowed only in consultation with their physician)
Serum bilirubin =< . x institutional upper limit of normal (ULN) within  days prior to study registration; this will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Total bilirubin =< . x the upper limit of normal (patients with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia in the absence of evidence of hemolysis or hepatic pathology) will be allowed to enroll after discussion with the principal investigator if total bilirubin is =<  x the upper limit of normal)
Serum bilirubin =< . x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Serum bilirubin =< . x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Serum bilirubin =< . x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Total bilirubin =< . x normal institutional limits; this last criterion will not apply to patients with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia [predominantly unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician
Serum bilirubin =< . x institutional upper limit of normal (ULN); (this will not apply to subjects with confirmed Gilberts syndrome [persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology], who will be allowed only in consultation with their physician)
Serum bilirubin =< . x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Serum bilirubin =< . x institutional upper limit of normal (ULN); this will not apply to patients with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology)
Serum bilirubin =< . x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician and the study principal investigator (PI)