Serum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemia
Serum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemia
Serum total bilirubin > 1.5 mg/dL or > 3 x ULN for patients with hereditary benign hyperbilirubinemia
Hepatic: < 2 x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
Bilirubin < 1.5 mg/dL (unless benign congenital hyperbilirubinemia).
Hepatic impairment, defined as total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible) or
Hepatic impairment, defined as total bilirubin > 1.5 x institutional ULN (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible) or
< 2.0 x ULN serum bilirubin, unless there is congenital benign hyperbilirubinemia
Total bilirubin =< 2 X ULN (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)
=< 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant (e.g. AML chloroma obstructing the biliary tree); patients with higher bilirubin levels due to causes other than active liver disease are also eligible with principal investigator (PI) approval e.g. patients with paroxysmal nocturnal hemoglobinuria (PNH), Gilbert's disease or other hemolytic disorders
Alanine aminotransferase (ALT) < 3 x upper limit of normal unless benign congenital hyperbilirubinemia
Obtained within 14 days (or as stipulated) prior to study drug (treatment) administration: total bilirubin ? 2.0 mg/dL or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinemia
Total bilirubin > 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible), within 21 days of initiation of protocol therapy
Bilirubin > 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert's syndrome] are eligible) or
Bilirubin > 1.5 x institutional upper limit of normal (ULN); patients with benign hyperbilirubinemia (e.g., Gilbert’s syndrome) are eligible
Total serum bilirubin < 1.5, unless there is congenital benign hyperbilirubinemia
Total bilirubin =< 2 x upper limit of normal (ULN) (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)
Total bilirubin =< 1.5 mg/dL (unless benign congenital elevated bilirubin)
Total bilirubin less than or equal to 2 x upper limit of normal (ULN) (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)
Hepatic: < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia
Total bilirubin =< 2.0 (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)
Hepatic: < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia
Bilirubin =< 2 mg/dL (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)
Total serum bilirubin < 1.5 x ULN, unless there is congenital benign hyperbilirubinemia
Serum total bilirubin ? 2.0 mg/dL (34.2 ?mol/L); or > 3.0 × upper limit of normal (ULN) for subjects with hereditary benign hyperbilirubinemia
Serum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemia
< 3 x ULN alanine aminotransferase (ALT), unless there is congenital benign hyperbilirubinemia
< 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia
Hepatic: < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia
Bilirubin less than 1.5 mg/dL (except for patients with Gilbert’s Syndrome of indirect hyperbilirubinemia)
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Bilirubin =< 1.5 x ULN (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL)
Total bilirubin (=< 1.5 mg/dl) normal unless history of Gilbert’s syndrome
Total bilirubin =< 2.0 mg/dL; in patients with Gilbert’s syndrome, total bilirubin >= 2.0 is permitted
Total bilirubin =< 1.5 x ULN (except in patients with Gilbert’s syndrome who may have total bilirubin < 3.0 mg/dL)
Serum direct bilirubin =< 2 mg/dL (unless history of Gilbert’s)
Total bilirubin =< 1.5 mg/dL (=< 2.0 in patients with known Gilberts syndrome)
Total bilirubin =< 1.5 mg/dl, except in subjects with Gilbert’s syndrome
Total bilirubin =< 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration by neoplastic disease or Gilbert’s syndrome
Total bilirubin =< 2.4 mg/dL unless related to Gilbert’s disease or patient’s lymphoma
Total bilirubin =< 1.5 mg/dL (=< 2.0 in participants with known Gilbert’s syndrome)
Total bilirubin =< 2.0 mg/dl unless due to underlying conjugation disease such as Gilbert’s
Bilirubin =< 2.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin less than or equal to 3 mg/dl
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin less than or equal to 3 mg/dl
Total bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin =< 3.0 mg/dl.
Total bilirubin within normal institutional limits; for patients with Gilbert’s syndrome, total bilirubin =< 3.0 mg/dL.
Total bilirubin within normal institutional limits; in patients with Gilbert’s, ? 3.0 mg/dL
Total bilirubin =< 2.0 mg/dl, except in patients with Gilbert’s Syndrome, who must have a total bilirubin < 3.0 mg/dl
Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin less than or equal to 3 mg/dl
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert’s syndrome, where bilirubin =< 5 mg/dL will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dL, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering study
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert’s syndrome, where bilirubin =< 5 mg/dL will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dL, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering study
COHORT 3: ENDOMETRIAL CANCER: Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert’s syndrome, where bilirubin =< 5 mg/dl will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dL, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering study
Direct bilirubin =< 2.0 mg/dL in the absence of suspected Gilbert’s disease (if Gilbert’s disease is suspected, the total bilirubin must be =< 3.0 mg/dL)
Bilirubin =< 1.5 mg/dL (OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0) (within 16 days before starting therapy)
Total bilirubin =< 2.0 mg/dL, except in patients with Gilbert’s syndrome, who must have a total bilirubin =< 3.0 mg/dL
Total bilirubin =< 2 mg/dL; for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Total bilirubin < 3.0 g/dl OR < 5.0 g/dl if Gilbert’s syndrome or disease infiltration of the liver is present
Total bilirubin =< 1.5 mg/dl, except in subjects with Gilbert’s syndrome
REP ELIGIBILITY: Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Total bilirubin within normal institutional limits except in patients with Gilbert’s syndrome who must have a total bilirubin < 3.0 mg/dL
Total bilirubin =< to 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Total bilirubin (except patients with Gilbert’s Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion) =< 2.0 mg/dl within 14 days prior to Step 2 registration and
Bilirubin =< 1.6 mg/dL (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL) obtained < 4 weeks prior to starting treatment
Total bilirubin =< 1.5 mg/dL, except in subjects with Gilbert’s Syndrome in whom total bilirubin must be =< 3.0 mg/dL
Total bilirubin < 2.0 mg/dl-exception permitted in patients with Gilbert’s syndrome
Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert‘s syndrome, where bilirubin =< 5 mg/dl will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dl, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering study
Total bilirubin =< 2.0 mg/dL unless due to known Gilbert’s disease obtained =< 14 days prior to registration\r\n* NOTE: If total bilirubin is > 2 mg/dL, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert’s to be diagnosed
Total bilirubin =< 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Total bilirubin less than or equal to 2 mg/dL (> 2 mg/dL permitted if the patient has evidence of Gilbert’s disease based upon prior bilirubin elevation or genetic testing)
Total bilirubin =< to 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Bilirubin =< 2 x ULN (except subjects with Gilbert’s syndrome, who must have total bilirubin < 3.0 mg/dL)
Bilirubin =< 1.5 mg/dL (excluding Gilbert’s syndrome)
Total bilirubin =< 1.5 mg/dL, unless hyperbilirubinemia is attributable solely to Gilbert’s syndrome
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s Syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< 1.5 x ULN, except subjects with Gilbert’s syndrome or liver metastases, who must have a baseline total bilirubin =< 3.0 mg/dL
Bilirubin < 1.5 mg/dL (except for Gilbert’s syndrome which will allow bilirubin =< 2.0 mg/dL)
Total bilirubin =< 2.0 mg/dL (unless previously diagnosed with Gilbert’s syndrome)
Bilirubin less than or equal to 1.5 mg/dl (unless due to Gilbert’s syndrome)
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 mg/dL or direct bilirubin =< 1.0 mg/dL for patients with Gilbert’s syndrome
Total bilirubin =< 1.5 x ULN except in patients with documented Gilbert’s syndrome or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dl
Bilirubin < 2.0 mg/dl, unless subject has Gilbert’s syndrome (=< 3.0 mg/dL)
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< 2.0 mg/dl (except for patients in whom hyperbilirubinemia is attributed to Gilbert’s syndrome)
Bilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert’s syndrome, who may have a total bilirubin above 1.5 mg/dL
Total bilirubin =< 2.5 mg% (unless from Gilbert’s disease or disease-related)
Total bilirubin =< 2.0 mg/dL; (does NOT apply to patients with Gilbert’s syndrome)
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< 2.0 mg/dL (=< 3.0 mg/dL for patients with known Gilbert’s syndrome), unless these are thought to be due to AML
Total serum bilirubin =< 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert’s syndrome)
Bilirubin < 2.0 mg/dL, unless subject has Gilbert’s Syndrome (=< 3.0 mg/dL)
Bilirubin =< 2.0 x ULN, (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl (Turnstile II)
Bilirubin equal or less than 1.5 mg/dl except for Gilbert’s disease
Total or direct bilirubin =< 1.5 mg/dL (if not due to the leukemia itself or known Gilbert’s syndrome) (as documented by treating physician)
Total bilirubin < 2.0 mg/dl, unless a diagnosis of Gilbert’s disease
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl (Turnstile II)
Bilirubin =< 1.5 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< 1.5 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin =< 3.0 mg/dl
Bilirubin < 1.5 mg/dL with the exception of patients thought to have Gilbert’s syndrome, who may have a total bilirubin above 1.5 mg/dL
Total bilirubin =< 1.5 mg/dL or direct bilirubin =< 1.0 mg/dL for patients with Gilberts syndrome
Total bilirubin must be less than 2 mg/dl (unless due to CLL involvement of liver or a known history of Gilbert’s disease)
Total bilirubin =< 1.5 mg/dL, except in subjects with Gilbert’s syndrome in whom total bilirubin must be =< 3.0 mg/dL
Total bilirubin =< 1.5 mg/dL, except in subjects with Gilbert’s syndrome in whom total bilirubin must be =< 3.0 mg/dL.
Total bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin </= 1.5 x ULN except in patients with documented Gilbert’s syndrome or liver metastasis, who must have a baseline total bilirubin 3.0 mg/dl within 3 weeks prior to initial treatment
Total serum bilirubin > 1.5 x ULN (patients with Gilbert’s disease may be included if their total bilirubin is =< 3.0 mg/dL).
Total bilirubin > 2 mg/dL (in the absence of Gilbert’s disease)
Total bilirubin < 2.0mg/dL unless due to Gilbert’s disease
Total bilirubin within =< 1.5 normal institutional limits (patients with Gilbert’s syndrome with total bilirubin up to 2.5 mg/dL is allowed)
Serum bilirubin =< 1.5 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Bilirubin =< 1.6 mg/dL (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< 2.5 mg% (unless from Gilbert’s disease or disease-related)
Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Bilirubin =< 2 x ULN (except subjects with Gilbert’s syndrome, who must have total bilirubin < 3.0 mg/dL)
Total bilirubin must be =< 1.5 mg/dL except in patients with Gilbert’s syndrome (as defined by > 80% unconjugated bilirubin) it must be < 5 mg/dl
Serum bilirubin =< 2.0 x ULN (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Bilirubin > 2 mg/dl (total) except > 5 mg/dl in patients with Gilbert’s syndrome as defined by > 80% unconjugated
Serum bilirubin < 2.0 mg/dL unless Gilberts disease
Bilirubin =< 2 x ULN (except subjects with Gilbert’s syndrome, who must have total bilirubin < 3.0 mg/dL)
Bilirubin =< 1.5 x ULN (except for patients with Gilbert’s syndrome, who must have a total bilirubin =< 3 mg/dL)
Total bilirubin (except patients with Gilbert’s syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion) =< 2.0 mg/dl
Bilirubin < 2.0 mg/dl, unless subject has Gilbert’s syndrome (=< 3.0 mg/dL)
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< 2.5 mg/dl (unless the patient has a history of Gilbert’s syndrome)
Total bilirubin =< 1.5 mg/dL (< 3 mg/dL for patients with Gilbert’s syndrome)
Total serum bilirubin =< 1.5 × the ULN; for subjects with known Gilbert’s disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< 3.0 mg/dL
Total bilirubin =< 2.0 mg/dL, unless due to Gilbert’s disease
Bilirubin =< 1.5 mg/dL (OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0) (within 16 days before starting therapy)
Total bilirubin =< 2.0. mg/dL or < 2.5 mg/dL if attributable to hepatic infiltration by neoplastic disease or Gilbert’s syndrome
In the case of Gilberts syndrome, or documented liver or pancreatic involvement by lymphoma, the requirement for total bilirubin is =< 5.0 mg/dL
Total bilirubin =< 1.5 x ULN; for participants with Gilbert’s disease =< 3.0 mg/dL
Total bilirubin < 2.0 mg/dl-exception permitted in patients with Gilbert’s syndrome
Total bilirubin =< 2.0 mg/dl-exception permitted in participants with Gilbert’s syndrome
Bilirubin =< 2.0 mg/dl within 21 days prior to study registration unless patient has Gilbert’s syndrome
Total bilirubin =< 1.5 mg/dL (exception: patients with documented Gilbert’s syndrome are allowed to participate despite elevated bilirubin)
Bilirubin < 1.5 mg/dl (OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0 mg/dL)
Bilirubin =< 2.5 x ULN (except for patients with Gilbert’s syndrome, who must have a total bilirubin =< 3 mg/dL)
Serum total bilirubin =< 2.5 mg/dL; Note, patients with Gilbert’s syndrome may have elevated bilirubin at baseline prior to diagnosis with AML or MDS; patients with Gilbert’s syndrome are included if their total bilirubin is =< 2 times their baseline total bilirubin
Serum total bilirubin > 2.5 mg/dL; Note, patients with Gilbert’s syndrome may have elevated bilirubin at baseline prior to diagnosis with AML or MDS; patients with Gilbert’s syndrome are excluded if their total bilirubin is > 2 times their baseline total bilirubin
Total bilirubin =< 1.5 x ULN, except subjects with Gilbert’s syndrome who can have total bilirubin =< 3.0 mg/dL
Total bilirubin =< 2.0 mg/dl, except in cases of Gilbert’s disease
Total bilirubin < 2 X ULN (except for subjects with documented Gilbert’s syndrome who can have total bilirubin < 3.0 mg/dl)
Bilirubin =< 1.5 ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< 2.0 mg/dL (unless MCL related or attributable to Gilbert’s disease)
Bilirubin =< 3.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver or pancreatic involvement by lymphoma
Bilirubin =< 2.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Bilirubin: ~ 2.0 x ULN (except for subjects with Gilbert’s syndrome, who must have a total bilirubin of less than 3.0 mg/dL)
Total bilirubin < 2.5 mg/dL (unless documented Gilbert’s syndrome)
Total bilirubin < 2.0 mg/dl except < 5 mg/dL in patients with Gilbert’s (as defined as > 80% unconjugated hyperbilirubinemia without other known cause); unless impairment due to organ involvement by lymphoma
Serum bilirubin > 2 mg/dl (unless due to Gilbert’s syndrome)
Total bilirubin =< 2 X ULN, except for patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl (part 1 & 2)
Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Bilirubin =< 1.5 mg/dl (total) except < 5 mg/dl in patients with Gilbert’s syndrome as defined by > 80% unconjugated
Total bilirubin =< 1.2 mg/dL (except patients with Gilbert’s syndrome)
Bilirubin: =< 2.0 x ULN (except for subjects with Gilbert’s syndrome, who must have a total bilirubin of less than 3.0 mg/dL)
Serum bilirubin levels =< 1.5 mg/dL except for patients with Gilbert’s syndrome
Bilirubin for Gilbert’s =< 3.0 mg/dl
Total bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Bilirubin < 1.5 mg/dl except for Gilbert’s disease
Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Bilirubin =< 1.5 ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< 1.5 times the upper normal limit (UNL), except patients with Gilbert’s syndrome in whom total bilirubin must be < 3.0 mg/dL
Total bilirubin < 2.0 mg/dL, except when the patient is known to have Gilbert’s syndrome, the total bilirubin can be =< 3.0 mg/dL
Total bilirubin =< to 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Serum bilirubin levels =< 1.5 mg/dL except for patients with Gilbert’s syndrome
Total bilirubin =< 2.0 mg/dL (excluding Gilbert’s syndrome), unless due to lymphoma
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3 mg/dl
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Bilirubin =< 2.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< 1.5 mg/dL unless due to Gilbert’s disease
Total bilirubin < 2.5 mg/dL unless the increase in bilirubin is attributable to Gilbert‘s syndrome
Bilirubin =< 1.5 x ULN (except subjects with Gilbert’s syndrome who must have total bilirubin =< 3.0 mg/dL), obtained within 14 days of the first dose of study drug
Total serum bilirubin =< 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert’s syndrome)
Total bilirubin < 2.0 mg/dl-exception permitted in participants with Gilbert’s syndrome
A bilirubin of up to 2.0 mg/dL, excluding patients with Gilbert’s disease
Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL for patients with Gilbert’s syndrome)
Total bilirubin =< 2.5 mg/dl (unless the patient has a history of Gilbert’s syndrome)
Total bilirubin >= 2 x the upper limits of normal or > 3.0 mg/dl in patients with Gilbert’s syndrome
Total bilirubin < 2 x normal institutional limits or > 3.0 mg/dl in patients with Gilbert’s syndrome
History of reversible posterior leukoencephalopathy syndrome (RPLS)
Trisomy 21 (Down syndrome)
Patients known to have one of the following concomitant genetic syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
Patients with Down syndrome
Patients with Down syndrome are not eligible
Down syndrome
Patients with down syndrome are excluded from this study
Patients with known symptomatic Fanconi anemia (FA), ataxia-telangiectasia (A-T) syndrome, Bloom syndrome (BS) and Nijmegen breakage syndrome (NBS) are not eligible (asymptomatic carriers are acceptable)
Mycosis fungoide/Sezary syndrome
History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
History of nephrotic syndrome
Patients with nevoid BCC syndrome (Gorlin syndrome) should not enroll in this study
Any history of serotonin syndrome (SS) after receiving 1 or more serotonergic drugs
Patients with Down’s syndrome
Patients with Down syndrome
Erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
History of multiple sclerosis or other demyelinating disease and/or Eaton-Lambert syndrome (para-neoplastic syndrome)
Any history of serotonin syndrome after receiving serotonergic drugs
Documented history of carcinoid syndrome
Subjects with history of or active symptoms of carcinoid syndrome
Any history of serotonin syndrome (SS) after receiving serotonergic drugs
Known reversible posterior leukoencephalopathy syndrome (RPLS)
History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
History of Gilbert’s syndrome
Any history of serotonin syndrome (SS) after receiving serotonergic drugs
Has any history of serotonin syndrome after receiving 1 or more serotonergic drugs
Has history of reversible posterior leukoencephalopathy syndrome
Has a paraneoplastic syndrome other than syndrome of inappropriate antidiuretic hormone secretion (SIADH) (hyponatremia)
Known Gilbert’s syndrome
history of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome;
Down syndrome
Individuals with Down syndrome
History of serotonergic syndrome
Any history of Stevens-Johnson syndrome
Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible
Patients with known Gilbert’s syndrome
Subjects with Gorlin syndrome
Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
No history of Steven’s Johnson’s syndrome, toxic epidermal necrolysis (TEN)s syndrome, or motor neuropathy
RANDOMIZED PHASE II (ARMS K AND L): No history of Steven’s Johnson’s syndrome, TENs syndrome, or motor neuropathy
History of Gilbert’s syndrome
Acute IA defined as duration of clinical syndrome of <30 days.
History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
Patients with HNPCC (Lynch Syndrome)
Has any history of serotonin syndrome after receiving serotonergic drugs
Down syndrome
Kostmann syndrome
Shwachman syndrome
No known Gilbert’s syndrome or known homozygosity for UGAT1A1*28 polymorphism
Patient has a history of Stevens-Johnson-Syndrome (SJS) or Toxic Epidermal Necroloysis (TEN)
Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
Documented Gilbert’s syndrome
Diagnosis of Down syndrome (Trisomy 21)
History of Gilbert’s syndrome
Patients with any of the following diagnoses:\r\n* Acute promyelocytic leukemia (APL)\r\n* Down syndrome\r\n* Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome\r\n* Wilson's disease and any other disorder of copper metabolism\r\n* Juvenile myelomonocytic leukemia (JMML)
Patients with Li Fraumeni syndrome are excluded from the study
Radiosensitivity syndrome (scleroderma, dermatomyositis, other genetic syndrome that predisposes to adverse radiotherapy complications)
Patients with a family history or Li-Fraumeni syndrome will not be eligible
History of posterior reversible encephalopathy syndrome
Patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other inherited bone marrow failure syndromes are not eligible
Patients who have experienced bowel perforation, neurologic involvement, Guillain Barré syndrome, Myasthenia Gravis, Steven Johnson syndrome and other intractable events or grade 4 non-laboratory toxicity
Patients with a history of toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome are excluded
Subject has Down syndrome.
Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.
Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
Subjects who have history of toxic epidermal necrolysis or Stevens-Johnson syndrome;
Had prior serotonin syndrome
Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
Patients must not have known Gilbert’s syndrome
Known history or presence of Sweet Syndrome at screening
History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
History of posterior reversible encephalopathy syndrome.
No history of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome
Any history of serotonin syndrome after receiving serotonergic drugs.
Have ongoing or recent (?6 months) hepatorenal syndrome.
Patients who have a known inherited syndrome as the cause for hormone over secretion.
History of Osler-Weber-Rendu syndrome or hereditary hemorrhagic telangiectasia
Known to have a hypercoagulability syndrome (e.g.: antithrombin III, deficiency, anticardiolipin syndrome etc)
Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes are not eligible
History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
Cushing’s syndrome
Li-Fraumeni Syndrome
History of reversible posterior leukoencephalopathy syndrome (RPLS)
History of Gilbert’s syndrome
Down Syndrome
History of Gilbert’s syndrome
History of Gilbert’s syndrome
Individuals with Down syndrome
History of Gilbert’s syndrome
Carcinoid Syndrome
Has a known history of, or active, neurologic paraneoplastic syndrome
Nephrotic syndrome
Down syndrome
Kostmann syndrome
Shwachman syndrome
Patients with Down syndrome and deoxyribonucleic acid (DNA) fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded
Concomitant genetic syndrome or other known bone marrow failure syndrome
Down syndrome
Patients with Down syndrome are excluded.
Patients with nevoid BCC syndrome (Gorlin syndrome) may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above
History of Gilbert’s syndrome
Known history of Gilbert’s syndrome
Patients with a known history of Gilbert’s syndrome
Sézary syndrome
Subjects with posterior leukoencephalopathy syndrome
History of neurological conditions that would confound assessment of treatment-emergent neuropathy other than =< grade 1 peripheral neuropathy including multiple sclerosis or other demyelinating disease and/or Eaton-Lambert syndrome (para-neoplastic syndrome); diabetes is allowed
Subjects who have Gorlin syndrome
History of hereditary hemorrhagic telangiectasia (HHT, Osler-Weber-Rendu syndrome)
Patients with a family history or Li-Fraumeni syndrome will not be eligible
Patient has Down syndrome
History of Gilbert’s syndrome
Nephrotic syndrome
Immediate family member with a known or suspected Familial Cancer Syndrome (including but not limited to hereditary breast and ovarian cancer syndrome, hereditary non-polyposis colorectal cancer syndrome and familial adenomatous polyposis).
Subject has acute chest syndrome
History of congenital platelet function defect (e.g., Bernard-Soulier syndrome, Chediak-Higashi syndrome, Glanzmann thrombasthenia, storage pool defect)
History of hepatic sinusoid obstructive syndrome (venoocculsive disease) within the prior 3 months.
Patients with a history of hereditary hemorrhagic telangiectasia (Osler-Weber-Rendu syndrome)
Patients with an immunodeficiency syndrome
Patients with any of the following diagnoses are not eligible:\r\n* Acute promyelocytic leukemia (APL)\r\n* Down syndrome\r\n* Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome\r\n* Wilson's disease and any other disorder of copper metabolism\r\n* Juvenile myelomonocytic leukemia (JMML)
History of Gilbert’s syndrome
Patients with Down syndrome
Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes are not eligible
Known Mirizzi syndrome.
History of irritable bowel syndrome (IBS)
Delayed gastric emptying syndrome
Patients with Sjogren's syndrome
Ongoing or recent hepatorenal syndrome.
Patients with diagnosis of chronic fatigue syndrome (CFS)
Patients with a diagnosis of obesity hypoventilation syndrome
History of irritable bowel syndrome (IBS)
Diagnosed or suspected vasospastic disease such as Raynaud’s syndrome;
Myelodysplatic Syndrome
History of Guillain-Barre syndrome
History of Guillain-Barre syndrome
Have a history of Guillain-Barre syndrome (GBS)
Patients with known or suspected Gilbert’s syndrome at the time of study enrollment
Down syndrome
Subjects who have Gorlins syndrome
Diagnosis of Down's Syndrome
History of Stevens-Johnson syndrome
History of Stevens-Johnson syndrome
History of Steven’s Johnson’s syndrome, toxic epidermal necrolysis syndrome (TENs) or motor neuropathy
History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.
History of Guillain-Barre syndrome or Stevens-Johnson syndrome
Direct or total bilirubin < 1.5 x ULN (unless related to Gilbert’s or Meulengracht’s syndrome); the values must be obtained within 48 hours prior to randomization
Total bilirubin =< 1.5 x ULN; except subjects with known Gilbert’s syndrome
Total serum bilirubin =< 1.5 X ULN (except participants with Gilbert’s syndrome, who can have a total bilirubin [bili] < 5 X ULN), performed within 14 days of treatment initiation
Total bilirubin ? 1 X ULN (subjects with Gilbert’s disease can have bilirubin of up to 1.5 X ULN)
Total bilirubin: =< 1.5 x ULN (in case of known Gilbert’s syndrome, < 2 x ULN is allowed) within 8 weeks of pre-registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Total bilirubin: =< 1.5 x ULN (in case of known Gilbert’s syndrome, < 2 x ULN is allowed) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): Total bilirubin: =< 1.5 x ULN (in case of known Gilbert’s syndrome, < 2 x ULN is allowed) within 2 weeks of registration
Bilirubin =< 2.5 x ULN (=< 4 x ULN for subjects with Gilbert’s disease)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) except for previously documented Gilbert’s disease, defined as a mild unconjugated hyperbilirubinemia with no other identifiable cause and bilirubin values < 6 mg/dL; patients with hyperbilirubinemia secondary to presumed Gilbert’s disease who are being considered for enrollment in the study MUST have a fractionated bilirubin included in their screening labs when determining eligibility
Total bilirubin =< 2.0 x institutional ULN, unless documented Gilbert’s syndrome
Serum total bilirubin =< 2 x ULN (except for patients with Gilbert’s Syndrome)
Total bilirubin ? 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin ? 3.0 x ULN
Total bilirubin =<1.5 x ULN (excepting Gilbert’s syndrome)
Bilirubin =< 1.5 x ULN, (Patients with documented Gilbert’s 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 =< 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin =< 3.0 x ULN
Bilirubin: =< 1.5 x ULN (except for subjects with Gilbert’s Syndrome or of non-hepatic cause)
Total bilirubin < 2.5 ULN. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible.
Total bilirubin =< 1.5 x ULN (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 x ULN)
Total bilirubin ? ULN (except in patients who have Gilbert’s syndrome or patients with recently placed stents for biliary obstruction when bilirubin should be < 1.5 X ULN) obtained ? 14 days prior to randomization
Direct bilirubin (bili) =< 40% if total bili > ULN in patients with Gilbert’s syndrome
Known Gilbert’s disease
Patients with known Gilbert’s disease
Total bilirubin =< 1.5 x ULN (except if the patient has Gilbert’s syndrome who can have total bilirubin =< 2 x ULN) must be met during screening (within 21 days) and also prior to study drug administration on cycle 1 day 1
Total bilirubin =<1.5 X institutional ULN (or =< 3 X institutional ULN for patients with documented Gilberts syndrome) (unless dysfunction is secondary to lymphoma involvement)
Total bilirubin =< 1.5 x ULN (In the expansion cohort, subjects with Gilbert’s syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN).
Total bilirubin ? 1.5 x ULN (AST, ALT, and total bilirubin ? 3 × ULN in subjects with documented Gilbert’s syndrome or hyperbilirubinemia clearly attributed to lymphoma involvement of the liver)
ALT, AST > 2.5 ULN or total bilirubin > 1.5 ULN (not attributable to Gilbert’s)
Subjects with Gilbert’s syndrome, confirmed by genotyping or Invader UGTIA1 molecular assay prior to study entry, must have total bilirubin < 3.0 times ULN
Total bilirubin > or = 1.5 x ULN, unless due to Gilbert’s disease.
Total bilirubin =< 3 x ULN in patients with documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or in the presence of liver metastases
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)
Bilirubin =< 1.5 x ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 x ULN
Total serum bilirubin =< 2.0 x ULN (except if Gilbert’s disease)
Bilirubin =< 1.0 x ULN (exceptions for Gilbert’s syndrome)
Within 14 days prior to registration: Total bilirubin =< 1.5 x ULN (except in patients with Gilbert’s disease)
Total bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)
PHASE II SCLC: Total bilirubin =< 1.5 x ULN (unless Gilbert’s disease)
UROTHELIAL CARCINOMA EXPANSION COHORT: Total bilirubin =< 1.5 x ULN (=< 3 x ULN for subjects with Gilbert’s disease)
mCRPC EXPANSION COHORT: Total bilirubin =< 1.5 x ULN (=< 3 x ULN for subjects with Gilbert’s disease)
Total serum bilirubin ? 1.5 x ULN (? 3.0 x ULN if Gilbert’s disease)
Total bilirubin > 2 x institutional ULN (except for known Gilbert’s syndrome/familial non-hemolytic jaundice)
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nTotal bilirubin =< 1.5 X ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 X ULN
Total serum bilirubin =< 1.5 x ULN (=< 3 x ULN for Gilbert’s syndrome)
Bilirubin =< 1.5 x ULN or =< 3 x ULN for subjects with documented/suspected Gilbert’s disease
Total bilirubin =< 1.5 x ULN for the laboratory (total bilirubin criteria may be waived if a patient has documented Gilbert’s disease)
Total bilirubin ? 1.5 x ULN (excepting Gilbert’s syndrome)
Within 14 days of first dose of study drug: Bilirubin =< 1.5 x ULN (< 2 x ULN if hyperbilirubinemia is due to Gilbert’s syndrome)
Bilirubin must be =< 1.5 x ULN, except participants with Gilbert’s syndrome where bilirubin must be =< 2.0 x ULN
BLADDER: Clinical laboratory values at screening: bilirubin ? 1.5 x the ULN; for subjects with known Gilbert’s disease, bilirubin ? 3.0 mg/dL
Total bilirubin =< 1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert’s syndrome, then =< 2.5 x ULN
Total bilirubin =< 1.5 x ULN for the laboratory; Note: Patients with known Gilbert’s syndrome are not eligible for this study
Total bilirubin =< 1.5 x ULN unless if evidence of indirect hyperbilirubinemia due to for example Gilbert’s syndrome
Total bilirubin =< 1.5 x ULN (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 ULN)
Total bilirubin =< 1.5 x ULN unless Gilbert’s syndrome of disease infiltration of the liver is present
Total bilirubin (TBil) and direct bilirubin (DBil) =< ULN with an exception of patients with confirmed Gilbert’s syndrome; for patients with confirmed Gilbert’s syndrome, the TBil should be =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN for the laboratory (total bilirubin criteria may be waived if a subject has documented Gilbert’s syndrome)
Total bilirubin within 1.5 x ULN, except those with Gilberts syndrome for whom this must be <3 x ULN
* Patients with a history of Gilbert’s syndrome may be eligible provided total bilirubin is less than or equal to 1.5 x ULN and the AST, ALT, and alkaline phosphatase meet the criteria detailed
Bilirubin =< 1.5 x ULN within 14 days prior to study registration; unless patient has Gilbert’s disease
Total bilirubin < 1.5 x ULN unless the patient has Gilbert’s syndrome, in which case total (T) bilirubin < 2.5 x ULN required
Total bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)
Bilirubin =< 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin =< 3.0 x ULN
Total-value bilirubin (TBil) and direct bilirubin (DBil) =< ULN with an exception of patients with confirmed Gilbert’s syndrome; for patients with confirmed Gilbert’s syndrome, the TBil should be =< 1.5 x ULN
Obtained =< 7 days prior to registration:\r\nTotal bilirubin =< 1.5 x ULN (does not apply to patients with isolated hyperbilirubinemia [e.g., Gilbert’s disease], in that case direct bilirubin should be =< 2 x ULN)
Serum bilirubin =< 1.5 x ULN (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total serum bilirubin =< 1.5 x ULN; patients with Gilbert’s syndrome with baseline serum bilirubin exceeding this limit are allowed to participate
Bilirubin < 2.0 x ULN, unless subject has Gilbert’s disease
Bilirubin must not be more than 1.5 x ULN (does not apply to patients with Gilbert’s disease)
Total bilirubin =< ULN (patient’s with Gilbert’s syndrome are eligible, even if total bilirubin is > ULN)
Bilirubin >= 3 x ULN (unless Gilbert’s syndrome)
Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 x ULN (does not apply to patients with isolated hyperbilirubinemia [e.g., Gilbert’s disease], in that case direct bilirubin should be =< 2 x ULN)
Total bilirubin =< 1.5 X ULN; patients with increased bilirubin due to Gilberts disease will not be excluded, if increased bilirubin is the only protocol exclusion criteria met
Total bilirubin =<1.5 x ULN unless increase is due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin
Total bilirubin =< 1.5 x ULN (< 3.0 x ULN in the presence of Gilbert’s disease)
Serum bilirubin =< 2 x the laboratory normal range (except for patients with Gilbert’s disease)
Bilirubin =< 1.5 x ULN, except in cases of patients with Gilbert’s disease, where =< 4 x ULN will be allowed
Total bilirubin =< 2.0 x ULN, unless elevated bilirubin is attributable to Gilbert’s syndrome or to HIV medications (e.g., indinavir, tenofovir, atazanavir)
Bilirubin =< 1.5 ULN (subjects with documented diagnosis of Gilbert’s syndrome are eligible provided total bilirubin < 3.0 x ULN)
Total bilirubin =< 2 x ULN, or < 5 ULN if Gilbert’s disease
Total bilirubin =< 2, unless due to Gilbert’s disease
Total bilirubin =< 2 x ULN (in the expansion cohort, patients with Gilbert’s syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN)
Bilirubin < 1.5 x ULN (unless Gilbert’s is suspected in which case total bilirubin < 3 x ULN)
Total serum bilirubin =< 1.5 x ULN (if documented Gilberts syndrome =< 3 x ULN) obtained =< 14 days prior to registration
Total bilirubin < 1.5 x ULN (if thought to be > 1.5 x ULN due to Gilbert’s disease or the patient’s AML, must discuss with the principal investigator [PI])
Serum bilirubin =< 4.0 x ULN or LLN (except for patients with Gilbert’s disease)
Greater than 3 x the ULN for total bilirubin (except for known cases of Gilbert’s syndrome, where the levels of conjugated bilirubin must be less than 3 x the ULN)
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin); bilirubin =< 3 x ULN is permissible if due to disease
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Bilirubin < 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome [as defined by > 80% unconjugated hyperbilirubinemia] or of non-hepatic origin)
Total bilirubin =< 1.5 times upper limit of normal (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Total bilirubin < 1.5 times upper limit of normal (ULN) unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (unless bilirubin rise is due to Gilbert’s syndrome or B-ALL or non-hepatic origin)
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin, in which case the total bilirubin should be < 3 x ULN)
Bilirubin: =< 1.5 x ULN (except for subjects with Gilbert’s syndrome or of non-hepatic origin)
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
Bilirubin =< 1.5 x institutional ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Bilirubin less than or equal to 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Serum bilirubin < 1.5 mg/dl unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin.
Bilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
Bilirubin < 1.5 x ULN unless bilirubin is due to Gilbert’s syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g/dL
Bilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
Total bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin); if considered related to ASM/MCL =< 3 x ULN
Bilirubin < 1.5 x ULN unless bilirubin is due to Gilbert’s syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g/dL
Bilirubin < 1.5 x ULN 9unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin)
Bilirubin > 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
Bilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).
Serum bilirubin 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
Bilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome or of non-hepatic origin
Total bilirubin =< 1.5 mg/dL X ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Bilirubin =< 2.0 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Bilirubin =< 1.5 x upper limit of normal (unless elevated bilirubin is due to Gilbert’s syndrome or of non-hepatic origin)
Total bilirubin =< 1.5 times upper limit of normal (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Total bilirubin =< 1.5 x normal institutional limits; this will not apply to patients with confirmed Gilbert’s 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 less than two times the institutional upper limits of normal (ULN); higher levels are acceptable if these can be attributed to active hemolysis, ineffective erythropoiesis, or Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN); NOTE: exceptions can be granted from principal investigator (PI) for instances of Gilbert’s disease, and/or primarily indirect bilirubinemia, if due to recent transfusion and/or hemolysis
NOTE: exceptions can be granted from PI for instances of Gilbert’s disease, and/or primarily indirect bilirubinemia, if due to recent transfusion and/or hemolysis
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Total bilirubin =< 2.0 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesis
Bilirubin =< 2.0 mg/dl, unless due to Gilbert’s, hemolysis or leukemic infiltration
Serum bilirubin =< 1.5 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 the study sponsor
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis) for patients receiving MAC, RIC or RIC-MMF and bilirubin =< 5.0 mg/dL for patients receiving IOC (unless due to Gilbert’s syndrome or hemolysis)
Should be performed within 10 days of treatment initiation: serum bilirubin ? 1.5 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
Total serum bilirubin < 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome, hemolysis or the underlying leukemia approved by the principal investigator (PI)
Direct bilirubin ? 2 X institutional upper limit of normal (ULN) (unless due to known Gilbert’s syndrome or compensated hemolysis directly attributable to CLL)
Serum bilirubin =< 1.5 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
Within 7 days (+ 3 day window) of enrollment: Serum bilirubin =< 1.5 x the institutional ULN, or =< 3 x ULN if confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology)
Serum bilirubin =< 1.5 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 =< 1.5 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.
Total bilirubin (T bili) =< 1.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Serum bilirubin =< 1.5 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 =< 1.5 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 =< 1.5 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 upon treating physician, principal investigators (PI) or co-PIs approval
Serum bilirubin =< 1.5 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 =< 1.5 x institutional upper limit of normal (ULN) within 28 days prior to study registration; 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
Direct bilirubin =< 2 X institutional upper limit of normal (ULN) (unless due to known Gilbert’s syndrome or compensated hemolysis directly attributable to CLL)
Total bilirubin =< 1.5 x the upper limit of normal (patients with confirmed Gilbert’s 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 =< 3 x the upper limit of normal)
Transaminases < 5 x upper limit of normal (ULN) and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Serum bilirubin =< 1.5 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
Bilirubin =< 2.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 14 days prior to registration)
Serum bilirubin =< 1.5 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
Total bilirubin within normal institutional limits unless thought due to hemolysis or to Gilbert’s syndrome
Patients with Gilbert’s syndrome will be eligible for the study; a diagnosis of Gilbert’s syndrome will be based on the exclusion of other diseases based on the following criteria:\r\n* Unconjugated hyperbilirubinemia noted on several occasions\r\n* No evidence of hemolysis (normal hemoglobin, reticulocyte count, and lactate dehydrogenase [LDH])\r\n* Normal liver function tests\r\n* Absence of other diseases associated with unconjugated hyperbilirubinemia
Total bilirubin =< 3 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesis
Direct bilirubin >= 2.0 mg/dL not related to hemolysis or Gilbert’s disease
Bilirubin =< 2 times institutional upper limit of normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 10 days prior to study day 0)
Transaminases =< 5 x upper limit of normal (ULN) and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Serum bilirubin =< 1.5 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
Total bilirubin =< 1.5 mg/dL (except Gilbert’s syndrome or known hemolysis or leukemic infiltration) obtained =< 7 days prior to registration
Total bilirubin above 2.5 ULN in the absence of hemolysis or diagnosis of Gilbert’s syndrome
Direct bilirubin < 1.5 mg/dl, unless due to Gilbert’s or secondary to hemolysis
Bilirubin =< 1.5 x ULN unless known to have Gilbert’s syndrome or elevated bilirubin resulting from hemolysis
Bilirubin =< 1 .5 x upper limit of normal (ULN) unless elevation is thought to be due to Gilbert’s syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
Patients with active hemolysis should be excluded
Total bilirubin =< 1.5 mg/dl, unless increase is due to hemolysis or congenital disorder
Total bilirubin =< 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder
PART 2: Total serum bilirubin must be < 3 mg/dL unless the elevation is thought to be due to Gilbert’s disease or hemolysis
Serum bilirubin > 2.0 mg/dl that is not due to Gilbert’s syndrome or hemolysis
Total bilirubin of < 2 mg/dl unless due to hemolysis, leukemia organ infiltration, or Gilbert’s syndrome
Total serum bilirubin < 2 x upper limit normal (unless due to hemolysis, Gilbert’s syndrome, or ineffective erythropoiesis)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless considered due to Gilbert’s syndrome or hemolysis)
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Total bilirubin =< 2 mg/dL unless hemolysis or Gilbert’s disease
Total bilirubin =< 1.5 x normal institutional limits; this last criterion will not apply to patients with confirmed Gilbert’s 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
Bilirubin ? 2.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 14 days prior to study day 0)
Total bilirubin =< institutional upper limit of normal (ULN) (unless due to known Gilbert’s syndrome or compensated hemolysis directly attributable to CLL); patients with Gilbert’s syndrome may enroll if direct bilirubin =< 1.5 x ULN of the direct bilirubin; elevated indirect bilirubin due to post-transfusion hemolysis is allowed
Total serum bilirubin must be < 3mg/dL unless the elevation is thought to be due to Gilbert’s disease or hemolysis
Serum bilirubin =< 1.5 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)
Direct bilirubin ?2 X institutional ULN (unless due to known Gilbert's syndrome or compensated hemolysis directly attributable to CLL)
Patients with uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis is not an exclusion)
Indirect hyperbilirubinemia due to Gilbert’s disease or hemolysis is permitted
Poor liver function defined as bilirubin >= 2 mg/dl (not due to hemolysis, Gilbert’s or primary malignancy) or
Bilirubin < 2.0 x ULN unless subject has Gilbert’s disease, low-grade hemolysis, or liver involvement with lymphoma
Patients must have a total bilirubin =< 2.0 x institutional upper limit of normal (IULN) within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert’s syndrome or hemolysis and not to liver dysfunction
Total bilirubin =< 2.0 x IULN within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert’s syndrome or hemolysis and not to liver dysfunction
Bilirubin =< 2.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 14 days prior to study day 0)
Bilirubin =< 1.5 x upper limits of normal (unless due to liver involvement, hemolysis, or Gilbert’s disease)
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Total bilirubin < 2 X institutional upper limit of normal (ULN) unless predominantly indirect and therefore likely due to hemolysis or Gilbert’s syndrome
Direct bilirubin > 1.5 x ULN unless due to hemolysis or Gilbert’s syndrome
Total bilirubin =< 1.5 mg/dL (except Gilbert’s syndrome or known hemolysis or leukemic infiltration)
Total bilirubin < 2.0 mg/dL unless due to Gilbert’s disease, hemolysis or leukemia
Serum bilirubin =< 1.5 x ULN (unless Gilbert’s syndrome and evidence of hemolysis)
< 2.0 total serum bilirubin (unless secondary to hemolysis)
Serum bilirubin =< 1.5 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 =< 1.5 x institutional upper limit of normal (ULN); this will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology)
Patients must have a total bilirubin =< 2.1 mg/dL within 72 hours of initiating the induction cycle, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert’s syndrome or hemolysis or non-hepatic origin, and not to liver dysfunction
Serum bilirubin =< 2.0 (unless hemolysis or Gilbert disease)
Serum direct bilirubin less than 1 mg/dl (unless due to Gilbert’s syndrome or hemolysis)
Total bilirubin =< 1.5 × upper limit of normal (ULN) for the laboratory unless resulting from hemolysis
Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is considered to be secondary to Gilbert’s syndrome, hemolysis, or hepatic infiltration by AML
Bilirubin greater than 1.5 mg/dl (>26 µmol/L) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert syndrome, or hemolysis.
Total bilirubin < 3 x ULN, exception is elevated indirect bilirubin attributed to Gilbert’s syndrome or hemolysis
Total bilirubin =< 2.0 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesis
Bilirubin =< 2 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 7 days prior to study day 1)
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Serum bilirubin levels =< 1.5 mg/dL; higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis
Serum bilirubin =< 1.5 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 and the study principal investigator (PI)
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Bilirubin =< 2.5 mg/dL, except for patients with Gilbert’s syndrome or hemolysis
Total bilirubin < 2.0 mg/dl, unless hepatic dysfunction is a manifestation of cGVHD; for patients in whom a diagnosis of hemolysis or Gilbert’s is made, the total bilirubin is allowed to be elevated
Known history of hemolysis and/or methemoglobinemia
Iron (Fe) phosphatase =< 5 x upper limit of normal and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Subjects must have a serum direct bilirubin < 2.0 mg/dL unless related to Gilbert’s syndrome of hemolysis; if the total bilirubin =< 2.0, direct bilirubin does not need to be drawn
Total serum bilirubin ? 1.5 x ULN regardless of liver involvement secondary to tumor. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin: =<1.5 × institutional upper limit of normal (ULN), or =< 3 x ULN for participants with Gilbert’s disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without AST or ALT elevation, and must have a total bilirubin less than 3.0 mg/dL), within 2 weeks prior to enrollment
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 30 days of day 1 of study; NOTE: patients with elevated bilirubin secondary to Gilbert’s disease are eligible to participate in the study
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert‘s syndrome who must have total bilirubin =< 3.0 x ULN)
Bilirubin =< 1.5 x institutional upper limits of normal (ULN); if patient has documented Gilbert’s syndrome bilirubin must be < 3 x institutional ULN
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which bilirubin =< 3 x institutional ULN is permitted)
Within 6 weeks prior to randomization: Total bilirubin must be =< upper limit of normal (ULN) for the laboratory (lab) unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin
Bilirubin =< 1.5 x ULN upper limit of normal (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL), must be obtained within 8 weeks prior to screening for protocol therapy
Total bilirubin < 1.5 x institutional upper limit of normal (=< 3 mg/dL in case of Gilbert’s syndrome)
Total bilirubin =< ULN (institutional upper limit of normal) except elevated total bilirubin < 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin, measured within 28 days prior to randomization
Obtained within 28 days prior randomization: total bilirubin must be =< 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > 1.5 x ULN to 3 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin; and
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless isolated hyperbilirubinemia attributed to Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) except subjects with documented Gilbert’s syndrome (> 5 x ULN) or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s Syndrome must have bilirubin =< 3 x ULN (for treatment phase)
Measured within 28 days prior to registration: total bilirubin =< 1.5 x institutional upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (< 2 × ULN) is allowed.
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Total Bilirubin ? 1.5 x upper limit of normal (ULN), or patients diagnosed with Gilberts syndrome, that have been reviewed and approved by the medical monitor.
Total bilirubin within normal institutional limits (unless patient has Gilbert’s syndrome in which total bilirubin should be =< 2 x upper limit of normal [ULN])
Total bilirubin < 1.5 X upper limit of normal unless known diagnosis of Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) except patients with documented Gilbert’s syndrome (=< 3 x ULN)
Total bilirubin within normal institutional limits (or < 2 X the upper limit of normal in those with Gilbert’s disease)
Total bilirubin =< 1.5 x institutional upper limit of normal, unless due to Gilbert’s syndrome
Total bilirubin =< 1.25 x institutional upper limit of normal (ULN), with the exception of < 2.9 mg/dL for patients with Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) (or =< 2.5 x ULN for subjects with asymptomatic Gilbert’s syndrome)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome
Bilirubin =< 1.5 x the upper limit of normal (ULN) within 7 days before the first dose of cabozantinib. For subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Serum bilirubin ? 1.5 × upper limit of normal (ULN) or ? 2 x ULN if patient is known to have Gilbert’s disease as the only underlying hepatic disorder
Serum total bilirubin =< 1.5 x upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (< 2 x ULN) is allowed.
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or 2.0 x ULN in patients with documented Gilbert’s syndrome)
Total bilirubin=< 1.5 x upper limit of normal (ULN) (if, however, the participant has Gilbert’s disease or unconjugated hyperbilirubinemia that is considered to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome or hemolysis, in which case =< 3.0 x ULN is allowed
Total bilirubin (except for Gilbert’s syndrome) =< 2.5 x upper limit of normal (ULN)
Total bilirubin ? 1.5 x institutional upper limit of normal (ULN) (or ? 2.5 x ULN with Gilbert’s disease) within 28 days prior to registration
Serum bilirubin < 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert’s disease)
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s disease; if total bilirubin is > 1.5 x ULN, a direct bilirubin should be performed and must be =< upper limit of normal (obtained =< 14 days prior to registration)
Total bilirubin =< 2 x upper limit of normal (ULN) (except in the case of subjects with documented Gilbert’s disease >= 3 x ULN)
Total bilirubin < 1.5 times upper limit of normal except for known conjugation diseases such as Gilbert’s; direct bilirubin is not an inclusion criteria
Total bilirubin level =< 1.5 x upper limit of normal (ULN) or in patients with Gilbert’s syndrome, a total bilirubin of =< 3.0
Total bilirubin =< upper limit of normal (ULN) (except in Gilbert’s syndrome)
TREATMENT WITH SJCAR19: Total bilirubin =< 3 times the upper limit of normal for age, except in subjects with Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s disease), =< 5 days prior to C1D1
Serum bilirubin >= 1.5 x upper limit of normal (ULN), patients with Gilbert’s syndrome and a total bilirubin of < 3 times ULN are permitted)
Total bilirubin ? 2 X upper limits of normal (ULN) (except in the case of subjects with documented Gilbert’s disease > 3 x ULN)
Total bilirubin ? 1.5 x upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin ? 3 x ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert’s syndrome in whom total bilirubin must be < 3.0 mg/dL, within 2 weeks of registration
Total bilirubin =< institutional upper limit of normal (except for patients with Gilberts' syndrome who must have normal direct bilirubin)
Serum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with Gilbert’s disease)
Obtained within 28 days prior to the first dose of cabozantinib: bilirubin =< 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL.
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s disease obtained =< 14 days prior to registration
Total bilirubin > 3 x institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.0 x ULN in patients with documented Gilbert’s syndrome)
Total bilirubin below the upper limit of normal (ULN), excluding patients with Gilbert’s syndrome
Total bilirubin =< 2 X upper limit laboratory normal (ULN); subjects with non-clinically significant elevations of bilirubin due to Gilbert’s disease are not required to meet these criteria
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert’s syndrome, who can have total bilirubin < 3 mg/DL)
Total bilirubin < 1.5 x upper limit of normal (ULN) \r\n* For patients with Gilbert’s syndrome total bilirubin < 3.0 x ULN
Total serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome.
Total bilirubin =< upper limit of normal (ULN) unless elevation is thought to be due to Gilbert’s syndrome
Total bilirubin within normal institutional limits (patients with confirmed Gilbert’s syndrome with a total bilirubin =< 2.0 x upper limit of normal [ULN], may be included in this study)
Within 7 days before the first dose of study treatment: Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Serum bilirubin > 1.5 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome: total bilirubin of > 3 x ULN) at the time of screening
Total serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome.
Total bilirubin (except for Gilbert’s syndrome) =< 2.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation due to Gilbert’s syndrome obtained =< 7 days prior to registration
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless related to Gilbert’s or Meulengracht’s syndrome)
Total bilirubin =< 1.5 X upper limit of normal (ULN) (patients with diagnosed Gilbert’s syndrome will not be excluded if their direct bilirubin is within normal institutional limits)
Serum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with Gilbert’s disease)
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s disease obtained =< 14 days prior to registration
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert’s syndrome.
Total bilirubin =< 2.0 x institutional upper limit of normal ([ULN]; unless attributable to Gilbert’s disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 4.0 x ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless due to Gilbert’s disease or disease-related hemolysis, then =< 3.0 x ULN)
Total bilirubin =< 1.5 ULN (upper limit of normal), unless due to Gilbert’s syndrome
Bilirubin =< 1.5 x upper limit of normal (ULN) (obtained within 28 days prior to first study treatment)\r\n* Subjects with known Gilbert’s disease should have a serum bilirubin =< 3 x ULN
Within 14 days of registration: Bilirubin within normal institutional limits (or < 2 X the upper limit of normal (ULN) in those with Gilbert’s disease)
Total bilirubin < 1.5 x upper limit of normal (ULN) (except in patients diagnosed with Gilbert’s disease)
LYMPHODEPLETION: Bilirubin =< 1.5 x upper limit of normal (ULN) unless attributed to Gilbert’s syndrome, obtained within 72 hrs prior to procurement
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome
Bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome
Total bilirubin =< 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (e.g., Gilbert’s disease)
Total bilirubin =< 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert’s disease)
Total bilirubin =< 1.5 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 × ULN in the case of suspected/documented Gilbert’s syndrome
Total bilirubin =< 2 times the upper limit of normal (ULN) (or =< 3.0 x ULN if deemed to be elevated due to Gilbert’s disease or leukemia)
Total bilirubin =< 1.5 x upper normal limit if documented hepatic involvement with lymphoma, or =< 5 x upper normal limit if history of Gilbert’s disease
Bilirubin =< 2 x the upper limit of normal (except Gilbert’s syndrome)
Total bilirubin < 3.0 x the upper limit of normal (ULN) for age (patients who have been diagnosed with Gilbert’s disease are allowed to exceed this limit)
Total bilirubin =< 1.5 x upper limit of normal (ULN) except subjects with documented Gilbert’s syndrome (> 3 x ULN), who must have a baseline total bilirubin =< 3.0 mg/dL
PHASE I: Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s disease)
Total bilirubin =< 1.5 x upper limit of normal (< 3 x ULN if Gilbert’s disease)
Total bilirubin > 1.5 x upper limit of normal (ULN) (unless evidence of Gilbert’s disease)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) unless attributable to Gilbert’s syndrome
Total bilirubin =< 3 x institutional upper limit of normal, unless there is a known history of Gilbert’s disease
Total serum bilirubin =< 1.5 x upper limit of normal (ULN), OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Serum bilirubin < 1.5 x upper limit of normal (ULN) except in patients with Gilbert’s syndrome as defined by > 80% unconjugated bilirubin
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) unless related to disease or patient known to have underlying Gilbert’s disease
Total bilirubin =< 2 x institutional upper limit of normal (ULN) (except for known Gilbert’s syndrome/familial non-hemolytic jaundice)
Bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with Gilbert’s disease =< 3.0 mg/dL
Total bilirubin =< 2 x upper limit of normal (ULN) (unless related to lymphoma or Gilbert’s disease) OR =< 5 x ULN for subjects with documented or suspected Gilbert’s disease, or related to involvement of the liver by the lymphoma, obtained =< 7 days prior to registration
Total bilirubin =< 2 times upper limit of normal (x ULN) (3 x ULN if considered to be due to leukemia involvement or Gilbert’s syndrome)
Total bilirubin =< 2 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Total bilirubin =< 1.5 x the upper limit of normal (ULN) unless considered due to Gilbert’s syndrome
Total bilirubin =< 1.5 X upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Total bilirubin (Tbili) < 1.6 x upper limit of normal (ULN)\r\n* Except subjects with known Gilbert’s syndrome
Within 4 days prior to the first dose of cabozantinib: Bilirubin =< 1.5 x the upper limit of normal (ULN) (for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL)
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome (< 5 if liver involvement with primary tumor)
Total bilirubin < 2 times upper limit of normal (unless due to Gilbert’s syndrome), performed within 28 days prior to registration
Total bilirubin =< 1.5 x upper limit of normal (ULN) OR 3 x ULN for Gilbert’s disease
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 × ULN)
Total bilirubin =< 1.5 X institutional upper limit of normal (except for patients with documented Gilbert’s disease)
Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which Bilirubin =< 3 x upper limit of normal [ULN] is permitted); obtained within 2 weeks prior to registration
Total bilirubin =< 1.5 x upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Total bilirubin =< 2 x upper limit laboratory normal (ULN); subjects with non-clinically significant elevations of bilirubin due to Gilbert’s disease are not required to meet these criteria
Total bilirubin =< 1.5 x local institutional upper limit of normal (ULN)\r\n* If elevated total bilirubin is due Gilbert’s disease or disease-related hemolysis then total bilirubin =< 3.0 x local institutional ULN
Within 4 weeks of preregistration: Total bilirubin =< upper normal institutional limits (except for patients with Gilbert’s disease who are eligible despite elevated serum bilirubin level)
Bilirubin =< upper limit of normal (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL)
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 (repeat if more than 3 days before the first dose)
Bilirubin =< 1.5 times (x) upper limit of normal (ULN) (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin < 1.5 X upper limit of normal (ULN) (in women with prior documented bilirubin elevations consistent with Gilbert’s syndrome, total bilirubin up to 3 X ULN will be allowed)
Adequate hepatic function (>= 1.5 x upper limit of normal [ULN]; patient’s with Gilbert’s disease are not excluded)
Within 14 days prior to first dose of study drug treatment: Serum bilirubin =< 1.5 x the upper limit of normal (ULN); patients with known Gilbert’s disease may have a bilirubin =< 3.0 x ULN
RENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: bilirubin ? 1.5 x upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin ? 3.0 mg/dL
Within 7 days before the first dose of cabozantinib: Bilirubin =< 1.5 x the upper limit of nomal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Total bilirubin =< 1.5 X upper limit of normal (ULN) OR if Gilbert’s syndrome =< 3.0 X ULN
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert’s syndrome.
Total bilirubin =< 2.5 X institutional upper limit of normal or =< 3 in subjects with Gilbert’s syndrome
Total bilirubin =< 1.5 × institutional upper limit of normal (ULN), unless known Gilbert’s syndrome has been diagnosed
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN; unless attributable to Gilbert’s disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 2.5 x ULN)
Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert’s disease
Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (< 2.0 x ULN for subjects with documented Gilbert’s syndrome or < 3.0 x ULN for subjects for whom the indirect bilirubin level suggests an extrahepatic source of elevation)
Total bilirubin must be =< ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin within 28 days before randomization
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), (except for patients with known Gilbert’s syndrome who must have normal direct bilirubin)
Serum bilirubin greater than 3 times the upper limit of normal, unless attributed to Gilbert’s syndrome
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome
Total bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, =< 3 mg/dl
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with well-documented Gilbert’s syndrome) (obtained =< 14 days prior to registration)
Total bilirubin < upper limit of normal (ULN) or up to 2 x ULN if patient has clinically documented Gilbert’s syndrome (elevated unconjugated bilirubin from decreased UDP glucuronosyltransferase 1 family, polypeptide A1 [UGT1A1] activity)
Total bilirubin < 1.5 x institutional upper limit of normal with direct bilirubin within normal limits except for participants with Gilbert’s disease
Total bilirubin must be =< upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin
Bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome, within 2 weeks of the first dose of study treatment
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome
Serum bilirubin =< 1.5 x upper limit of normal (ULN) (=< 3.0 if Gilbert’s syndrome)
Bilirubin (total) less than or equal to the upper limit of normal; an exception to this may be allowed for participants with Gilbert’s syndrome with prior approval by the protocol chair
Total bilirubin > 2 x upper limit of normal (ULN) (except in the case of subjects with documented Gilbert’s disease > 3 x ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN with Gilbert’s disease)
Total bilirubin < 1.5 times the upper limit of normal (ULN) unless due to Gilbert’s disease or hemolysis
Total bilirubin =< 1.5 x upper limit of normal (ULN) (or =< 3.0 mg/dL if known Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal; unless due to Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal in the absence of Gilbert’s disease; for patients with Gilbert’s syndrome: direct bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)
Total bilirubin =< 1.5X upper limit of normal (ULN) unless secondary to Gilbert’s disease
Total bilirubin within normal institutional limits or < 3 x the upper limit of normal in patients with Gilbert’s disease
Total bilirubin =< 2 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Serum bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (Participants with serum bilirubin abnormalities greater than this specified limit are eligible only if they have known Gilberts disease.)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s disease
Total bilirubin < upper limit of normal (ULN) (except for Gilbert’s disease)
Total bilirubin =< 1.5 X institutional upper limit of normal; =< 3.0 upper limit of normal (ULN) accepted in subjects with Gilbert’s syndrome
Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (< 2.0 x ULN for subjects with documented Gilbert’s syndrome or < 3.0 x ULN for subjects for whom the indirect bilirubin level suggests an extrahepatic source of elevation)
Total bilirubin =< 1.5 X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert’s, for whom the maximum will be 2.5 ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), except in cases of Gilbert’s disease
Total bilirubin =< 1.5 X upper limit of normal (ULN) obtained =< 7 days prior to randomization; patients with known Gilbert’s syndrome who have serum bilirubin =< 3 X ULN may enroll
Total bilirubin =< institutional upper limit of normal (ULN) (or =< 3 X ULN if Gilbert’s syndrome present or if bilirubin increase related to MF)
Total bilirubin =< 1.5 X upper limit of normal (ULN) unless history of Gilbert’s syndrome documented prior to first-line treatment of cancer and other liver function tests are within normal limits
Total bilirubin =< 1.5 x upper limit of normal (ULN) except subject with documented Gilbert’s syndrome (=< 5 x ULN) or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless bilirubin rise due to Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients diagnosed with Gilbert’s disease) (within 7 days prior to registration)
Total bilirubin =< 1.5 x institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 3 x upper limit of normal [ULN])
Total bilirubin =< 1.5 times the upper limit of normal (ULN) unless due to Gilbert’s disease or hemolysis
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome
Total bilirubin =< 1.5 times upper limit of normal unless due to Gilbert’s disease within 14 days before enrollment
Total bilirubin =< 2 x upper limit of normal (ULN), unless patient has a documented history of Gilbert’s disease, then direct bilirubin =< 1.0 mg/dL
Serum bilirubin =< 1.5 times the upper institutional limits of normal (ULN); patients with a history of Gilbert’s syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin
Total bilirubin < institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 1.5 x upper limit of normal [ULN])
Total bilirubin =< 4 X institutional upper limit of normal unless 2nd to Gilbert’s disease
Serum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with a confirmed diagnosis of Gilbert’s disease)
Total bilirubin =< 1.5 x ULN (upper limit of normal), unless the patient meets the criteria for Gilbert’s syndrome; the upper limit value for bilirubin for subjects with Gilbert’s syndrome is less than 3 mg/dl\r\n* Note: A diagnosis of Gilbert’s disease will be made in the presence of (1) unconjugated hyperbilirubinemia noted on several occasions; (2) normal results from complete blood cell (CBC) count, reticulocyte count, and blood smear; (3) normal liver function test results; and (4) an absence of other disease processes that can explain the unconjugated hyperbilirubinemia
Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with diagnosed Gilbert’s syndrome will not be excluded if their direct bilirubin is within normal institutional limits)
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN); in case of known Gilbert’s syndrome, < 2 x ULN is allowed
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilberts disease
PART B: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), unless due to Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless Gilbert’s syndrome or disease infiltration of the liver is present
Total bilirubin =< 1.5 × upper limit of normal (ULN) (or =< 2.5 x ULN for subjects with asymptomatic Gilbert’s syndrome)
Total bilirubin =< the institutional upper limit of normal (exception permitted in patients with Gilbert’s syndrome after discussion with study principal investigator [PI], on a case by case basis and if liver function tests are within normal limits)
Total bilirubin =< 1.5 x institutional upper limit of normal (unless elevated from documented Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN); if patient has Gilbert’s disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin =< 2 X institutional ULN
Total bilirubin =< 1.5 times the upper limit of normal (ULN); for patients with known Gilbert’s disease, total bilirubin should be =< 3 mg/dL
Bilirubin =< 1.5 X the upper limit of normal (ULN); for participants with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Bilirubin =< 2 x the upper limit of normal (except Gilbert’s syndrome)
Total bilirubin < 1.5 X institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 3 X upper limit of normal [ULN])
Bilirubin < to 2.0 x normal (except Gilbert’s Syndrome)
Total bilirubin =< upper limit of normal (ULN) (except for Gilbert’s disease)
Bilirubin =< 1.5 X upper limit of normal (ULN) or =< 3 X ULN for patients with Gilbert’s disease
Total bilirubin less than institutional upper limit of normal; NOTE: patients with a diagnosis or history of Gilberts will be eligible
Bilirubin* =< 2 x upper limit of normal\r\n* In the absence of Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) appropriate for age (except for patients with Gilbert’s syndrome, who must have a total bilirubin < 3 mg/dL) within 30 days prior to registration
Within 8 weeks of randomization: Serum bilirubin =< 1.5 times the upper institutional limits of normal (ULN); patients with a history of Gilbert’s syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin
Total serum bilirubin =< 1.5 X upper limit of normal (ULN) except for subjects with known Gilbert’s disease, who may enroll if the conjugated bilirubin is =< 1.5 ULN
Total bilirubin =< upper limit of normal (ULN) (excluding Gilbert’s disease)
Bilirubin =< upper limit of normal (ULN); for patients with Gilbert’s disease, =< 2.5 x ULN is allowed
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (unless known Gilbert’s disease)
Total bilirubin =< 1.5 x upper limit of normal (ULN) except in patients with Gilbert’s disease
Total bilirubin =< 2 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Total bilirubin < 1.5 x upper limits of normal (ULN) except Gilbert’s syndrome where < 3 x ULN is allowed
Total serum bilirubin < 2 x upper limit of normal (unless due to hemolysis or Gilbert’s syndrome, then no upper limit)
Total bilirubin: within normal institutional limits; if, however, the participant has Gilbert’s disease or unconjugated hyperbilirubinemia which is felt to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x upper limit of normal [ULN])
Total bilirubin =< 1.5 × upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)
Total bilirubin =< 1.5 x upper normal limit, or =< 5 x upper normal limit if documented hepatic involvement with lymphoma or history of Gilbert’s syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)\r\n* Patients with Gilbert’s disease: =< 3 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with known Gilbert’s disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< 3.0 mg/dL
Total bilirubin must be =< the upper limit of normal (ULN) for the lab unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert’s disease or similar syndrome due to slow conjugation of bilirubin; and
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s disease; if total bilirubin is > 1.5 x ULN, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert’s to be diagnosed
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert’s syndrome)
Serum bilirubin =< upper limit of normal (ULN) (except for subjects with Gilbert’s disease who are eligible despite elevated serum bilirubin level)
Total bilirubin =< 1.5 x upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Serum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Total bilirubin =< 1.5 x the upper limit of normal (ULN), unless presence of Gilbert’s syndrome
Total bilirubin > institutional upper limit of normal (ULN), unless due to hemolysis or Gilbert’s disease
Total bilirubin > 2 x institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome)
Total bilirubin =< 1.5 X institutional upper limit of normal (unless associated with Gilbert’s syndrome)
Total/direct bilirubin < 1.5 X institutional upper limit of normal; patients with elevation of indirect (unconjugated) bilirubin alone, as in Gilbert’s syndrome, are eligible
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert’s syndrome
Serum total bilirubin < 2.0 x upper limit normal (ULN) (or < 3.0 x ULN if deemed to be elevated due to leukemia or Gilbert’s syndrome)
Total bilirubin =< 2.5 x upper limit of normal (ULN) except if the elevation is due to Gilbert’s syndrome (allowable at =< 5 x ULN) or myelofibrosis (per principle investigator [PI] discretion)
Total bilirubin < 1.5 X institutional upper limit of normal (unless associated with Gilbert’s syndrome)
Total bilirubin =< 1.2 x upper limit of normal (ULN) unless due to Gilbert’s disease
Total bilirubin >= 1.5 x upper limit of normal (ULN) (unless documented Gilbert’s)
Unless felt due to underlying disease and approved by the overall PI: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); patients with Gilbert’s disease may have total bilirubin up to =< 3 x institutional ULN
Total bilirubin =< 1.5 X institutional upper limit of normal, unless there is a known history of Gilbert’s disease
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); an exception to this may be allowed for participants with Gilbert’s syndrome with documented approval by the protocol chair
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Note: Higher total bilirubin levels (=< 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert’s
Within 28 days prior to signing consent: Total bilirubin > upper limit of normal (ULN) (unless the patient has documented Gilbert’s syndrome)
Total bilirubin =< 2 × institutional upper limit of normal (ULN) and/or history of Gilbert’s syndrome
Obtained within 28 days prior to registration: Bilirubin =< 1.5 x upper limit of normal (ULN) (subjects with known Gilbert’s disease should have a serum bilirubin =< 3 x ULN)
Bilirubin > 1.5 x upper limit of normal (ULN) unless with Gilberts syndrome or
Bilirubin = < 1.5 X upper limit of normal (ULN) except for patients (pts) with (w/) documented history of Gilbert’s disease, obtained within 14 days prior to PET scan
Bilirubin < 1.5 x upper limit of normal (ULN) (unless Gilbert’s is suspected)
Bilirubin > 2 x institutional upper limits of normal (ULN), with exception of patients with Gilberts disease
Bilirubin (total) =< 1.5 times upper limit normal (with exception of Gilberts syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome are excluded from this requirement