[c09aa8]: / clusters / final9knumclusters / clust_379.txt

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Serum aspartate transaminase (aspartate aminotransferase [AST]) and serum alanine transaminase (alanine aminotransferase [ALT]) =< 2.5 x upper limit normal
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x upper limit of normal (ULN) or =< 5 x ULN with metastatic liver disease within 14 days prior to registration.
Alanine transaminase (ALT) < 3.0x the upper limit of normal (ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN (=< 5 x ULN if documented liver metastases are present)
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN.
Obtained =< 14 days prior to registration: Aspartate transaminase (AST) =< 3 x ULN (=< 5 x ULN for patients with liver involvement)
Aspartate transaminase (AST /SGOT) and alanine transaminase (ALT/SGPT) ? 3.0 x ULN.
aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ? 5 times the upper limit of normal (ULN)
Aspartate transaminase (AST), alanine transaminase (ALT) =< 3 × ULN
Hepatic: aspartate transaminase (AST)/alanine transaminase (ALT) ?2.5 x upper limit of normal (ULN); total or conjugated bilirubin ?1.5 x ULN
Aspartate transaminase (AST; SGOT), alanine transaminase (ALT; SGPT) ? 2.5 × ULN, (or ? 5 × ULN if tumor involvement (liver) is present).
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 5 x ULN
Aspartate transaminase (AST) or alanine transaminase (ALT) ? 3 x ULN, unless due to organ leukemic involvement
Alanine transaminase (ALT)/aspartate transaminase (AST) ?2.5 x upper limit of normal (ULN)
Serum aspartate transaminase (AST) or alanine transaminase (ALT) =< 2.5 x upper limit of normal (ULN); serum aspartate transaminase (AST) or alanine transaminase (ALT) =< 5 is permissible if due to disease
Adequate hepatic function (total bilirubin ? 1.5 × upper limit of normal [ULN] for the institution; aspartate transaminase (AST) and alanine transaminase (ALT) ? 2.5 × ULN.
Serum aspartate transaminase (AST) or alanine transaminase (ALT) =< 3.0 x upper limit of normal (ULN)
Alanine transaminase (ALT) ? 3 times the ULN, unless determined to be directly due to lymphoma.
Aspartate transaminase (AST) ? 3 times the ULN, unless determined to be directly due to lymphoma
Aspartate transaminase (AST) =< 3 x ULN, except for patients with liver metastasis, who are included if AST =< 5 x ULN, at the screening visit
Aspartate transaminase/alanine transaminase (AST/ALT) ? 2.5 x upper limit of normal (ULN)
Alanine transaminase (ALT) and aspartate transaminase (AST) within 1.5x upper limit of normal;
Aspartate transaminase (AST) =< 3 x ULN
Serum aspartate transaminase (AST) or alanine transaminase (ALT) =< 2.5 x upper limit of normal (ULN)
Serum alanine transaminase (ALT) and/or aspartate transaminase (AST) values < 3 x the upper limit of normal (ULN) of the local laboratory reference range
Aspartate aminotransferase (AST)/alanine transaminase (ALT) less than 2.5 X institutional ULN
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 upper limit of normal (ULN), or AST and ALT < 5 ULN if liver function abnormalities are due to underlying malignancy.
Aspartate transaminase (AST) and alanine transaminase (ALT) levels ? 2.5 × ULN or AST and ALT levels ? 5 x ULN (for subjects with documented metastatic disease to the liver)
Aspartic transaminase (AST) =< 1.5 x upper limit of normal (ULN).
Alanine transaminase (ALT) =< 1.5 x ULN.
Obtained =< 14 days prior to registration: Aspartate transaminase (AST) =< 2 x ULN (=< 5 x ULN for patients with liver involvement)
Aspartate aminotransferase (aspartate transaminase [AST]) and alanine aminotransferase (alanine transaminase [ALT]) =< 3.0 x ULN for the institution within 14 days of study registration
Aspartate transaminase (AST) or alanine transaminase (ALT) =< 3 x ULN
Aspartate transaminase (AST) and alanine aminotransferase (ALT) =< 5.0 x ULN
Alanine transaminase or aspartate transaminase ? 5 times the ULN
Alanine transaminase (ALT) =< 2.5 x upper normal limit (ULN) (=< 5 x ULN for subjects with documented metastatic disease to the liver).
Serum aspartate transaminase or alanine transaminase =< 3.0 x upper limit of normal (ULN)
Obtained =< 28 days prior to registration: Aspartate transaminase (AST) AND alanine transaminase (ALT) =< 2.5 x ULN
Aspartate transaminase (AST) and alanine transaminase (ALT) ? 2 × ULN except for patients with known liver metastases, in which case aspartate transaminase or alanime transaminase may be ? 5.0 × ULN
Aspartate aminotransferase (aspartate transaminase [AST]) and alanine aminotransferase (alanine transaminase [ALT]) levels ? 2 x institutional upper limit of normal (ULN)
Aspartate transaminase (AST) =< 2.5 x ULN? alanine transaminase (ALT) =< 2.5 x ULN, except for patients with liver metastasis, who are only included if AST and ALT < 5 x ULN
Aspartate transaminase (AST) =< 2.5 x ULN obtained =< 7 days prior to registration
Serum aspartate transaminase (AST) or alanine transaminase (ALT) =< 2.5 x upper limit of normal (ULN)
Aspartate transaminase or alanine transaminase ?3 x ULN (?5x ULN in the presence of hepatic metastases)
Aspartate transaminase (AST) and alanine transaminase (ALT) ? 3.0 x ULN within 14 days prior to the first study treatment (cycle 1, day 1) with the following exception:\r\n* Patients with liver involvement: AST and/or ALT ? 5 x ULN
Serum aspartate transaminase (aspartate aminotransferase [AST]) or alanine transaminase (alanine aminotransferase [ALT]) less than or equal to 3 x ULN (unless due to B-ALL)
Serum aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 x upper limit of normal (ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 times the upper limit of normal (ULN); and
Serum aspartate transaminase (aspartate aminotransferase [AST]) or alanine transaminase (alanine aminotransferase [ALT]) =< 3.0 x upper limit of normal (ULN)
Serum aspartate transaminase (AST) and alanine transaminase (ALT) less than 1.5 times the upper limits of normal
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ? 2.5 × upper limit of the normal reference range (ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 times the upper limit of normal (ULN); and
Alanine transaminase (ALT) or aspartate transaminase (AST) >= 2.5 x the upper limit of normal (ULN)
Aspartate transaminase (AST) =< 3 x ULN, except with liver involvement by the lymphoma who are only included if AST =< 5 x ULN; alanine transaminase (ALT) < 3.0 x ULN, except with liver involvement by the lymphoma who are only included if AST =< 5 x ULN
Aspartate Transaminase (AST) and alanine transaminase (ALT) =< 2.5 x institutional upper limit of normal (ULN) unless liver metastases are present, in which case it must be =< 5 x ULN
Adequate renal and hepatic function (creatinine ? 2.0 mg/dl, bilirubin ? 2.0 mg/dl, aspartate transaminase (AST) and alanine transaminase (ALT) ? 4X upper limit of normal range).
Serum alanine transferase (ALT) and aspartate transaminase (AST) < 3 the upper limit of normal (ULN); < 5 ULN if there is liver involvement secondary to the tumor
Aspartate transaminase (aspartate aminotransferase [AST]) or alanine transaminase (alanine aminotransferase [ALT]) =< 2.5 x ULN
Liver enzymes: Aspartate transaminase (AST); Alanine transaminase (ALT) or Alkaline phosphatase (ALP) ?2.5 x ULN (or ?5.0 x ULN if liver involvement by primary disease);
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ? 1.5 x upper limit of normal (ULN) with alkaline phosphatase ? 2.5 x ULN, or AST and ALT ? 5 x ULN if liver function abnormalities are due to liver metastases
alanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 x ULN (< 5 x ULN if documented hepatic metastases)
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =< 3 x upper limit of normal (ULN)
Alanine aminotransferase and/or aspartate transaminase =< 3.0 x ULN or =< 5.0 x ULN if deemed to be elevated due to leukemia
Alanine transaminase =< 3 x ULN
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 times the upper limit of normal ([ULN]; or 5.0 times the ULN in the setting of liver metastases)
Aspartate transaminase (AST) < 2.0 x ULN, except for patients with liver metastasis, who are only included if AST < 3 x ULN; alanine transaminase (ALT) < 2.0 x ULN, except for patients with liver metastasis, who are only included if ALT < 3 x ULN
Aspartate transaminase (AST) =< 3.0 x ULN, except for patients with liver metastasis, who are only included if AST =< 5 x ULN; alanine transaminase (ALT) < 3.0 x ULN, except for patients with liver metastasis, who are only included if ALT < 5 x ULN
Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULN
alanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 x ULN (< 5 x ULN if documented hepatic metastases)
Aspartate transaminase (AST) or alanine transaminase (ALT) =< 2.5 x ULN
Alanine transaminase (ALT) =< 2 times the ULN or aspartate transaminase (AST) =< 2 times the ULN; this value must be obtained within two weeks before protocol entry
Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 upper limit of normal (ULN)
Serum aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 x institutional upper limit of normal (ULN)
Aspartate Transaminase (AST) / Alanine Transaminase (ALT) ? 3 times institutional upper limit of normal (except in patients with leukemic infiltration of liver)
Has the following laboratory parameters within 7 days before baseline (C1D1):Serum creatinine ?2 mg/dL; Total bilirubin ?2.0 mg/dL; Alanine transaminase (ALT) or aspartate transaminase (AST) <3.0×the upper limit of normal (ULN); Left ventricular ejection fraction (LVEF) >40%; Forced expiratory volume in 1 second (FEV1) >60% of predicted.
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ?3 x upper limit of normal (ULN)
Aspartate transaminase (AST) ? 2.5 x ULN
Hepatic: bilirubin < 1.5 times the upper limit of normal (ULN); alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) < 3.0 x ULN (AP, AST, and ALT < 5 x ULN is acceptable if the liver has tumor involvement).
Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 x upper limit of normal (ULN), and total bilirubin ? 1.5 x ULN except Gilbert's Syndrome where a direct bilirubin ? 1.5 ULN will be used.
Within 14 days of study drug(s) initiation: Alanine transaminase (ALT) and aspartate transaminase (AST) =< 2.5 x upper limit of normal (ULN) or =< 5 x ULN if known hepatic metastases.
Serum aspartate transaminase (AST) or alanine transaminase (ALT) less than or equal to 3.0 x upper limit of normal (ULN)
Obtained =< 21 days prior to registration: Aspartate transaminase (AST) =< 3 x ULN, =< 5.0 x ULN for patients with metastatic disease to the liver
Aspartate transaminase (AST) and alanine aminotransaminase (ALT) =< 3 x ULN
Aspartate transaminase (AST) =< 3 X ULN unless due to direct lymphoma involvement, and then =< 5 X ULN
Aspartate transaminase (AST) and/or alanine transaminase (ALT) < 2.5 x upper normal limit (ULN)
Serum aspartate transaminase (alanine aminotransferase [ALT]) and/or aspartate transaminase (aspartate aminotransferase [AST]) values < 3 x the upper limit of normal (ULN) of the local laboratory reference range; patients with elevated bilirubin due to Gilbert’s syndrome may be permitted with principal investigator (PI) approval
Aspartate transaminase (AST)/alanine transferase (ALT) < 3.0 ULN
Aspartate transaminase (AST) and/or alanine transaminase (ALT) =< 2.5 x ULN or =< 5 x ULN for patients with liver metastases, obtained =< 14 days prior to registration
Aspartate transaminase (AST) or alanine transaminase (ALT) ? 2.5 x institutional ULN. If liver function abnormalities are due to metastatic disease, patients are eligible provided the ALT and AST are < 5 x ULN
Alanine transaminase (ALT) or aspartate transaminase (AST) ? 2.5 x the upper limit of normal (ULN).
Aspartate transaminase (AST) =< 3 x ULN (obtained =< 14 days prior to registration)
Baseline alanine transaminase (ALT) or aspartate transaminase (AST) > 2 x upper limit of normal (ULN) without known complications of metastatic liver disease or primary hepatic disease (e.g. Cushing’s disease and acromegaly studies)
Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ?2.5×ULN.
Alanine transaminase (ALT) < 2.5 times the ULN
Aspartate transaminase (AST) < 2.5 times the ULN
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 times upper limit of normal (ULN) or =< 5.0 times the ULN in the setting of liver metastases
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x upper limit of normal (ULN) for the institution
Hepatic: Aspartate transaminase (AST) / Alanine transaminase (ALT) ? 2.5 x upper limit of normal (ULN) (if liver metastases are present, ? 5 x ULN); Total or conjugated bilirubin ? 1.5 x ULN
Aspartate transaminase (AST) < 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ? 2.5 × ULN.
Aspartate transaminase (AST) at least 2.5 ULN
Alanine transaminase (ALT) at least 2.5 ULN
Aspartate transaminase (AST) level ? 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ? 2.5 × upper limit of normal (ULN). For patients with liver metastases, AST ? 5 ULN, and AST ? 5 ULN may be enrolled if agreed upon by the investigator and medical monitor for the sponsor.
Alanine transaminase (ALT)/aspartate transaminase (AST) ? 2.5 x upper limit of normal (ULN).
Hepatic: aspartate transaminase (AST) / alanine transaminase (ALT) ? 2.5 x upper limit of normal (ULN) (if liver metastases are present, ? 5 x ULN); total or conjugated bilirubin ? 1.5 x ULN
Serum aspartate transaminase (AST) or alanine transaminase (ALT) < 3 x upper limit of normal (ULN)
Alanine transaminase (ALT) or aspartate transaminase (AST) =< 3 x ULN (if liver metastases are present, serum transaminases =< 5 x ULN are permitted)
Aspartate transaminase (AST) < 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ? 2.5 × upper limit of normal (ULN).
Serum aspartate transaminase (AST) or alanine transaminase (ALT) =< 3.0 x upper limit of normal (ULN); if considered related to ASM/MCL =< 5 x ULN
Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 times the ULN(or <= 5 times the ULN if liver metastases are present).
Participant has adequate hepatic function [bilirubin within normal limits (WNL), aspartate transaminase (AST) and alanine transaminase (ALT) ? 2.5 times the upper limit of normal (ULN), or ? 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase ? 5.0 times the ULN]
Within 14 days of enrollment: Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 x ULN for the institution\r\n* For patients in the metastatic cohort with documented liver or bone metastases: AST and/or ALT =< 5.0 x ULN
Serum aspartate transaminase (AST) or alanine transaminase (ALT) < 3 x upper limit of normal (ULN)
Within 14 days prior to the first study treatment (cycle 1, day 1): Aspartate aminotransferase (AST) and alanine transaminase (ALT) =< 3.0 x ULN
Aspartate transaminase (AST) =< 3 times ULN for age obtained =< 7 days prior to registration
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 2.0 x ULN
Aspartate transaminase (AST) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN in patients with liver metastasis)
Aspartate transaminase (AST) and alanine aminotransferase (ALT) < 3 x ULN
Aspartate transaminase (AST) =< 3 x ULN
Aspartate transaminase (AST) and alanine transaminase (ALT) ? 3 x the upper limit of the normal range (ULN) (? 5 x ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)
Alanine transaminase (ALT) and aspartate transaminase (AST) =< 2.5 times the ULN
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ? 3 x upper limit of normal (ULN)
Serum aspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x upper limit of normal (ULN)
Alanine aminotransferase and/or aspartate transaminase =< 2.5 x ULN
Aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 1.5 × upper limit of normal (ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) ?1.5 × upper limit of normal(ULN), or ? 2.5 × ULN with metastatic liver disease.
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 × the upper limit of normal (ULN), or =< 5 × the ULN in the presence of known liver metastases
Aspartate transaminase (AST) and alanine transaminase (ALT) ? 3 × ULN (? 5 x ULN for subjects with liver metastases)
Adequate clinical laboratory values (i.e., plasma creatinine <= 1.5 x upper limit of normal (ULN) for the institution, bilirubin <=1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 x ULN).
Alanine transaminase (ALT) and aspartate aminotransferase (AST) ? 2.5 × ULN.
serum aspartate transaminase or alanine transaminase > 3x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULN; unless elevated secondary to lymphoma involvement of the liver
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x upper limits of normal (ULN)
Serum aspartate transaminase (aspartate aminotransferase [AST]) or alanine transaminase (alanine aminotransferase [ALT]) >= 3.0 x upper limit of normal (ULN)
Adequate hepatic function (total bilirubin ? 1.5x ULN for the institution; AST [aspartate transaminase] and ALT [alanine transaminase] ? 3x ULN).
Adequate hepatic function (total bilirubin ? 1.5×ULN for the institution; aspartate transaminase and alanine transaminase ? 2.5×ULN, or ? 5×ULN if due to liver involvement by tumor; albumin ? 3 g/dL)
For Cohorts 1 and 2: serum aspartate transaminase (AST) or alanine transaminase (ALT) ?3.0 x upper limit of normal (ULN); for Cohort 3: ALT ?2.5 or AST ?2.5 ULN.
Hepatic: Total conjugated bilirubin ? 1.25 x upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x upper limit of normal (ULN) or < 5 x ULN in the setting of liver metastases
Hepatic: Total bilirubin < upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ? 3 x ULN
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =< 2.5 X upper limit of normal
Total bilirubin ? 1.25 x upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ? 3 x ULN
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x ULN for the institution
Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULN
14. Adequate hepatic function (total bilirubin ? 1.5 x ULN for the institution; aspartate transaminase [AST] and alanine transaminase [ALT] ? 2.5 x ULN).
Liver enzymes [aspartate transaminase (AST), alanine transaminase (ALT)] ?2 x ULN
Adequate hepatic function (total bilirubin ? 1.5x ULN (upper limit of normal) for the institution; AST [aspartate transaminase] and ALT [alanine transaminase] ? 3x ULN, or ? 5x ULN if due to liver involvement by tumor).
Serum aspartate transaminase (AST) >2.5x ULN
Serum alanine transaminase (ALT) >2.5x ULN
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) < 3.0 x upper limit of normal (ULN) unless due to disease.
Aspartate transaminase (AST) =< 3 x ULN
Serum aspartate transaminase (AST) or alanine transaminase (ALT) 2.5 x upper limit of normal (ULN) if no demonstrable liver metastases or 5 x ULN in the presence of liver metastases
Hepatic: Aspartate transaminase (AST) / Alanine transaminase (ALT) ? 2.5 x upper limit of normal (ULN) (if liver metastases are present, ? 5 x ULN); Total or conjugated bilirubin ? 1.5 x ULN
Part 1 only: plasma total bilirubin <= 1.5 mg/dL, alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 X ULN.
Serum aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x upper limit of normal (ULN)
Advanced liver disease, including persistent aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin value >3 × the upper limit of normal, liver biopsy demonstrating cirrhosis, extensive bridging fibrosis, or active hepatitis.
Alanine transaminase (ALT), Aspartate transaminase (AST), or Creatine kinase (CK) greater than 2 times the upper limit of normal
Alanine Transaminase (ALT) and Aspartate Transaminase (AST) ? 2.5 x ULN (if liver metastases are present, then ? 5 x ULN is allowed)
Aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ? 5 times the upper limit of normal (ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 × the upper limit of normal (ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) ?3 × ULN
Aspartate transaminase (AST) or alanine transaminase (ALT) ?3 x ULN, unless considered due to organ leukemic involvement
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =< 2.5 X upper limit of normal
The participant has adequate hepatic function as defined by a total bilirubin ? 1.5 x the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT) ? 3 x the ULN (or ? 5 x the ULN in the presence of known liver metastases)
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =< 2.5 x upper limit of normal (< 5 X upper limit of normal [ULN] for subjects with liver metastasis)
Hepatic: serum bilirubin less than 2x upper limit of normal for age as per local laboratory) (with the exception of isolated hyperbilirubinemia due to Gilbert's syndrome), alanine transaminase (ALT) and aspartate transaminase (AST) less than 4x upper limit of normal for age (as per local laboratory)
Aspartate transaminase (AST) =< 5 x ULN
Alanine aminotransferase and/or aspartate transaminase < 3.0 x ULN (or < 5.0 x ULN if deemed to be elevated due to leukemia)
Aspartate transaminase (AST) > 3.0 x ULN, except for patients with liver metastasis who are excluded if AST > 5.0 x ULN
Aspartate transaminase (AST) =< 3 x ULN unless due to direct lymphoma involvement, and then =< 5x ULN
Aspartate transaminase (AST) and alanine transaminase (ALT) levels =< 5 x upper limit of normal (ULN)
Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULN
Obtained =< 30 days prior to randomization: Alanine aminotransferase (ALT) or aspartate transaminase (AST) =< 3 x upper limit of normal (ULN)
Serum alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 × ULN;
Serum aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 x upper limit of normal (ULN)
Serum aspartate transaminase (AST) and alanine transaminase (ALT) =< 4.0 x upper limit of normal (ULN)
Total bilirubin ?1.5 times upper limit of normal value (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ?5 × ULN.
Alanine transaminase (ALT) < 5.0 x ULN
Alanine transaminase (ALT) =< 3 x ULN
Significant liver disease as defined as aspartate transaminase (AST) or alanine transferase (ALT) twice than normal
Aspartate transaminase (AST) and alanine transaminase (ALT) £1.5 × upper limit of normal (ULN), or ? 2.5 × ULN with metastatic liver disease
Aspartate transaminase (AST) and alanine transaminase (ALT) ? 2.5 x ULN for age
Baseline safety laboratory abnormalities: ANC (absolute neutrophil Count) < 1000 cells/mm3, platelet count < 25,000 cells/mm3, hemoglobin < 8.0 g/dL, AST (aspartate transaminase) or ALT (alanine transaminase) > 5 x ULN (upper Limit of normal), bilirubin > 2.5 x ULN
c. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ? 3.0 x ULN
Aspartate transaminase (AST) =< 3 x upper limit of normal (ULN) (=< 5 x ULN acceptable for pancreatic subjects with known liver metastasis only)
The participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).
The participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.0 x ULN or ? 5 X ULN for subjects with liver metastases.