Liver function tests (including ALT, AST, and total bilirubin), outside of the range of local laboratory normal at Screening
Total bilirubin < . X institutional upper limit of normal; for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range
Impaired liver function defined as a total bilirubin > . x normal range and AST or ALT > . x normal range unless secondary to Gilberts disease, hemolysis or leukemic involvement of the liver
Bilirubin =< . x ULN, (Patients with documented Gilberts syndrome and conjugated bilirubin within the normal range may be allowed into the study; in this event, it will be documented that the patient was eligible based on\r\nconjugated bilirubin levels)
Bilirubin level above the normal reference range
Direct bilirubin =< . x ULN except for i) patients with documented Gilberts syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range)
Serum total bilirubin within normal range (or =< . x upper limit of normal [ULN] if liver metastases are present; or total bilirubin =< . x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome), obtained =< days prior to registration
Serum bilirubin within (or under) normal limits (OR total bilirubin =< . x institutional upper limit of normal [IULN] with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Serum bilirubin within normal range (or =< . x upper limit normal [ULN] if liver metastases are present; or total bilirubin =< . x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Bilirubin level above the normal reference range
Total bilirubin within the reference range during screening evaluation
Serum bilirubin within normal range (or =< . x ULN if liver metastases are present; or total bilirubin =< . x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
Total bilirubin within institutional normal range
Total bilirubin up to . X institutional normal reference range
Within days of subject registration: Total bilirubin within normal range or =< . X institutional upper limit of normal (IULN) if liver metastases are present or total bilirubin =< . X IULN with direct bilirubin within normal range in subjects with well-documented Gilberts syndrome, which is defined as presence of unconjugated hyperbilirubinemia with normal results from complete blood count (CBC) (including normal reticulocyte count and blood smear), normal liver function test results and absence of other contributing disease processes at the time of diagnosis
Bilirubin < . x ULN of the institutional normal reference range
Total bilirubin ? times ULN \r\n* Patients with documented diagnosis of Gilbert syndrome resulting in elevated total bilirubin levels will be eligible, provided all other eligibility criteria are met\r\n* Patients with a total bilirubin of - mg/dL and direct (conjugated) bilirubin in the normal range will be eligible, provided all other eligibility criteria are met
Total bilirubin ? . upper limit of normal range except in cases of Gilbert's disease and liver metastases.
Performed within days of patient registration: Total bilirubin within normal range or =< . x institutional upper limit of normal (IULN) if liver metastases are present or total bilirubin =< . x IULN with direct bilirubin within normal range in patients with well documented Gilberts syndrome, which is defined as presence of several episodes of unconjugated hyperbilirubinemia with normal results from complete blood count (CBC) (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis
Total bilirubin =< . X ULN (institutional); for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range
Bilirubin* within normal range
Serum bilirubin =< upper limit of normal; or total bilirubin =< . x the ULN with direct bilirubin within the normal range in patients with well documented Gilbert syndrome
Serum bilirubin within normal range (or =< . x ULN if liver metastases are present; or total bilirubin =< . x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total bilirubin =< . mg/dL; for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range
Serum bilirubin within normal range (or =< . x ULN if liver metastases are present; or total bilirubin =< . x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Direct bilirubin ? . x ULN except for i) patient with documented Gilbert's syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range)
ARMs A, C, D: Total bilirubin within normal range (or =< . X upper limit of normal [ULN] if liver metastases are present); or total bilirubin =< . x ULN with direct bilirubin within normal range in patients with Gilbert syndrome
Serum bilirubin =< x the laboratory normal range (except for patients with Gilberts disease)
Serum bilirubin within normal range (or =< . x ULN if liver metastases are present; or total bilirubin =< . x ULN with direct bilirubin within normal range in patients with well-documented Gilbert Syndrome)
Serum bilirubin within normal range (or total bilirubin =< . x upper limit of normal [ULN] with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total bilirubin within the normal range at the screening visit
Direct bilirubin ? . x ULN except for i) patients with documented Gilbert's syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range).