Total serum bilirubin ? ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.
Total bilirubin ? 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL). Direct bilirubin ? ULN for patients with total bilirubin levels >1.5 × ULN.
Serum bilirubin ? institutional 1.5 times upper limit of normal (ULN) (OR for patients with documented Gilbert syndrome, total bilirubin ? 3.0 times ULN with direct bilirubin ? ULN)
total bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN (except subject with Gilbert's Syndrome, who can have total bilirubin < 3.0 mg/dl)
Total serum bilirubin ?1.5 x ULN. In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ?1.5 × ULN, subject may be eligible)
Total serum bilirubin ? 1.5 × upper limit of normal for the study site (ULN) (in patients with known Gilbert Syndrome, total bilirubin ? 3 × ULN, with direct bilirubin ? 1.5 × ULN)
Total bilirubin ?1.5 times the upper limit of normal (ULN) (in patients with known Gilbert Syndrome, a total bilirubin ?3.0 x ULN, with direct bilirubin ?1.5 x ULN)
Total serum bilirubin ? 1.5 x ULN (in subjects with known Gilbert Syndrome, a total bilirubin ? 3.0 x ULN, with direct bilirubin ? 1.5 x ULN)
Total bilirubin ? 2x the institutional ULN with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ? 3.0x ULN and direct bilirubin is ? 2x ULN
Total bilirubin =< institutional upper limit of normal (ULN) (except in patients with Gilbert's syndrome; patients with Gilbert's syndrome may enroll if direct bilirubin is =< 1.5 x ULN
Total bilirubin level ? 1.5 x ULN, except for patients with known Gilbert's syndrome (confirmed by the UGT1A1 polymorphism analysis), who are excluded if total bilirubin>3.0 x ULN or direct bilirubin > 1.5 x ULN
Total bilirubin >1.5 times ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 x ULN or direct bilirubin >1.5 x ULN
Total serum bilirubin < ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome
Bilirubin > 1.5 x upper limit of normal (ULN), except for patients with known Gilbert syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Total bilirubin < 2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is >= 3.0 x upper limit of normal (ULN) and direct bilirubin =< 1.5 x ULN
Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN.
Total serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Total bilirubin < 2.5 x upper limit of normal (ULN); direct bilirubin < 2 x ULN for Gilbert's syndrome;
Serum total bilirubin within normal range (or =< 1.5 x upper limit of normal [ULN] if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome), obtained =< 14 days prior to registration
Serum bilirubin within normal range (or =< 1.5 x upper limit normal [ULN] if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total serum bilirubin >2.5 × upper limit of normal (ULN; except for subjects with Gilbert's Syndrome for whom direct bilirubin is <2.5 × ULN), or liver cirrhosis, or chronic liver disease Child-Pugh Class B or C.
Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Total bilirubin ?1.5 x the upper limit of the normal range (ULN) (except for Gilbert syndrome: direct bilirubin ?2 x ULN).
Total bilirubin > 2 mg/dL, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
At cycle 1 day 1 pre-dosing: Total bilirubin level >= 1.5 x ULN, (except for Gilbert syndrome: direct bilirubin >= 1.5 x ULN)
Total bilirubin > 1.5 × ULN; > 3 × ULN with direct bilirubin > 1.5 × ULN in presence of Gilbert's disease.
Total serum bilirubin >2.5 ULN (except for subjects with Gilbert's Syndrome for whom direct bilirubin is <2.5×ULN), or liver cirrhosis or chronic liver disease Child-Pugh Class B or C.
Total serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Bilirubin < 1.5 x upper limit of normal (ULN), for patients with Gilbert syndrome, direct bilirubin will be measured instead of total bilirubin
Serum bilirubin < 2 x ULN for patients with liver metastases and =< 1.5 x ULN for patients without liver metastases, (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)
Serum bilirubin =< 1.5 x ULN in patients with known Gilbert syndrome, total bilirubin =< 3 x ULN, with direct bilirubin =< 1.5 x ULN
Bilirubin ? 2.0 mg/dl with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ? 3.0 x ULN and direct bilirubin ? 1.5 x ULN
Total bilirubin =< 1.0 X ULN (institutional); for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range
Total bilirubin <upper limit of normal (ULN) except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin <=1.5*ULN of the direct bilirubin.
Serum bilirubin WNL or ?1.5 x the ULN in patients with liver metastases; or total bilirubin ?3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert's Syndrome.
Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Within 14 days prior to registration: total bilirubin =< 1.5 x institutional ULN (except participants with Gilbert syndrome, who can have total bilirubin =< 3.0 x institutional ULN with direct bilirubin that is within institutional ULN)
Serum bilirubin =< upper limit of normal; or total bilirubin =< 2.0 x the ULN with direct bilirubin within the normal range in patients with well documented Gilbert syndrome
Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total bilirubin =< upper limit of normal (ULN) except in patients with Gilbert's syndrome; patients with Gilbert's syndrome may enroll if direct bilirubin =< 1.5 x ULN of the direct bilirubin
Serum bilirubin within normal range (or =< 1.8 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Obtained within 2 weeks from study entry: Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Direct bilirubin ? 1.5 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 =< 1.5 X upper limit of normal [ULN] if liver metastases are present); or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with Gilbert syndrome
ARM B: Total bilirubin =< 1.5 X ULN (in patients with known Gilbert syndrome a total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 X ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN); in patients with known Gilbert's syndrome direct bilirubin =< 1.5 x ULN will be used as organ function criteria, instead of total bilirubin
Total serum bilirubin =< 1.5 x ULN (=< 3 x ULN with direct bilirubin within normal range in patients with documented hepatic involvement, well documented Gilbert's syndrome)
Total bilirubin ? 1.5× ULN (or ? 3× ULN, with direct bilirubin ?1.5 × ULN, in patients with known Gilbert syndrome).
Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well-documented Gilbert Syndrome)
Serum total bilirubin =< 1.5 x ULN OR total bilirubin =< 4.0 ULN with direct bilirubin =< 1.5 x ULN in patients with well documented Gilbert syndrome
Bilirubin =< 1.5 x upper limit of normal (ULN) (CTCAE v4.03 grade 1; in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Serum bilirubin within normal range (or total bilirubin =< 3.0 x upper limit of normal [ULN] with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total bilirubin ? 1.5 × ULN except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin ? 1.5 × ULN of the direct bilirubin.
Adequate hepatic function as evidenced by the following serum chemistry values: total bilirubin, ULN. If total bilirubin is greater than (>) ULN, measure indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, participant may be eligible) ALP 2.5 x ULN; Trabectedin: if the ALP is >2.5 x ULN, then an ALP liver fraction or 5-nucleotidase must be obtained and ULN, AST and ALT 2.5 ULN
Bilirubin > 1.5 x upper limit normal (ULN), except for patients with known Gilbert syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Serum total bilirubin =< ULN or 1.5 x ULN if liver metastases are present or total 3 x ULN with direct bilirubin =< ULN in patients with well documented Gilbert syndrome
Total bilirubin >1.5 × ULN; >3 × ULN with direct bilirubin, >1.5 × ULN in the presence of Gilbert's Disease
Direct bilirubin ? 1.5 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).