Direct bilirubin ? 1.5 × ULN (may be assumed if total bilirubin is below ULN)
Within 14 days of treatment initiation: Serum total bilirubin =< upper limit of normal (ULN) OR direct bilirubin =< ULN for patients with total bilirubin levels > ULN; (except 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 normal direct bilirubin or those with known Gilbert’s syndrome, obtained within 4 weeks prior to randomization
If total bilirubin is > upper limit of normal (ULN) (NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is \r\n> ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registration
Obtained within 14 days prior to treatment start: Total serum bilirubin =< 1.5 x ULN; or total bilirubin (TBILI) =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome
Total bilirubin =< 3.0 x ULN; if patient has known Gilbert’s syndrome direct bilirubin =< 1.5 x ULN
Total bilirubin < 1.5 x upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin and direct bilirubin =< ULN
Total bilirubin =< 2.0 x upper limit of normal (ULN) or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal obtained =< 14 days prior to registration
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)\r\n* Note: Patients with Gilbert’s syndrome with a total bilirubin =< 2.0 times ULN and direct bilirubin within normal limits are permitted
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin =< upper limit of normal performed within 30 days prior to the date of registration (ULN, Note: In subjects with Gilbert’s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is =< ULN, subject may be eligible)
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin within normal institutional limits (WLN) or =< 1.5 x upper limit of normal (ULN) in patients with liver metastases; or total bilirubin =< 3 x ULN with direct bilirubin WLN in patients with well documented Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome, who may only be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN, at the screening visit
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) (< 3 x ULN in patients with documented/suspected Gilbert’s disease with concomitant direct bilirubin =< 1.5 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be =< ULN =< 28 days prior to registration
Hepatic: Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dL
Total bilirubin =< 1.5 x ULN (unless Gilbert’s syndrome or disease infiltration of the liver is present, who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome, in which case the direct bilirubin must be =< 1.5 X ULN, obtained =< 14 days prior to registration
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN
Within 28 days prior to treatment start: Total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Serum total bilirubin =< 1.5 x institutional ULN (except subjects with Gilbert’s syndrome, who must have normal direct bilirubin)
Serum bilirubin < 1.5 x upper limit of normal (ULN); Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible
Serum total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 x ULN
Total bilirubin > ULN (NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
Serum bilirubin ? 1.5 x institutional ULN (in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and patient is eligible if direct bilirubin ? 1.5 x ULN)
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) (in patients with well-documented Gilbert’s syndrome and the total bilirubin is grade 1, then direct bilirubin value must be =< 1.0 mg/dL)
Direct (conjugated) bilirubin ?2 x ULN
Total serum bilirubin =< 1.5 x ULN (=< 3 x ULN or direct bilirubin =< 1.5 x ULN if known Gilbert’s syndrome)
Total bilirubin < 1.5 X institutional upper limit of normal OR direct bilirubin =< ULN for patients with total bilirubin > 1.5 ULN
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be =< 2.0 mg/dL
Total bilirubin: =< 3 x upper limit of normal (ULN) for age OR direct bilirubin =< 2 mg/dl
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) OR direct bilirubin =< ULN with total bilirubin > 1.5 x ULN
Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (for patients with a diagnosis of Gilbert’s syndrome, direct bilirubin =< 1.5 x ULN)
Determined within 3 weeks of treatment initiation: Serum bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for a subject with total bilirubin level > 1.5 x ULN
Total bilirubin: =< 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Total bilirubin =< 1.5 X upper limit of normal (ULN); if total bilirubin > 1.5 X ULN then direct bilirubin =< ULN (obtained =< 14 days prior to registration)
Total serum bilirubin =< upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with documented Gilbert’s syndrome
Direct bilirubin ? 2.0 × the upper limit of laboratory normal (ULN). (NOTE: direct bilirubin will only be determined if total bilirubin is ? 2.0 × ULN)
Total bilirubin =< 1.5 x ULN; (in patients with well documented Gilbert’s syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range)
Total bilirubin < institutional upper limit of normal (ULN), except for subjects with documented Gilbert’s syndrome, for which =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 X upper limit of normal (ULN) (or total bilirubin =< 3.0 X ULN with direct bilirubin =< 1.5 X ULN in patients with well-documented Gilbert’s syndrome) obtained =< 14 days prior to registration
Total bilirubin =< 1.5 x ULN; subjects with Gilbert’s syndrome should have direct bilirubin within normal institutional limits
Total serum bilirubin =< 1.5 x ULN; for patients with well documented Gilbert’s syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range
Serum total bilirubin =< 1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 × ULN, subject may be eligible)
Total serum bilirubin =< 1.5 x ULN; or total bilirubin =< 3 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome
Obtained =< 14 days prior to randomization: Total bilirubin =< upper limit of normal (ULN)\r\n* NOTE: If total bilirubin is out of range then direct bilirubin must be =< ULN
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2.5 x ULN; Note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible
Serum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
PART 2 GROUP 1 INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x upper limit of normal (ULN), except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULN
PART 2 GROUP 2A INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x ULN, except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULN
PART 2 GROUP 3 INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x ULN, except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULN
Total serum bilirubin levels < 1.5 x ULN (note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Total bilirubin =< 1.5 x ULN, except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN and direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease (in patients [pts] with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin =< 1.5 x ULN are eligible)
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome or documented hepatic involvement with lymphoma who may be included if bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Total bilirubin > 2 X upper limit of normal (ULN) , or direct bilirubin > 2.0 mg/dL (except patients with Gilbert’s syndrome, then total bilirubin greater than 2 X ULN allowed in the absence of other hepatic signs or symptoms)
Total bilirubin =< 1.5 x ULN; subjects with Gilbert’s syndrome should have direct bilirubin within normal institutional limits
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well documented Gilbert’s syndrome
Total bilirubin within 1.5 x institutional level of normal or direct bilirubin =< upper limit of normal (ULN) for patient with total bilirubin levels > 1.5 ULN
CAPMATINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN
CERITINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN and direct bilirubin =< 1.5 x ULN
REGORAFENIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN
ENTRECTINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 x ULN for age, direct bilirubin ? ULN for age
Within 3 months of registration: Bilirubin =< 1.5 x upper limit of normal (ULN); in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin; if direct bilirubin is =< 1.5 x ULN, subject may be eligible
Direct bilirubin > 2 x ULN
Total bilirubin =< 1.5 x ULN for the laboratory\r\n* Exception: if a patient has documented Gilbert’s syndrome and a total bilirubin is > 1.5 x ULN, the total bilirubin requirement may be waived provided the direct bilirubin is within normal limits (WNL) for the laboratory
Total bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, total bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
Must be met within 28 days of C1D1: Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless evidence of Gilbert’s syndrome, in which case, direct bilirubin must be =< 1.0 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Total bilirubin =< 1.5 x ULN (patient with diagnosed Gilbert’s syndrome and normal direct bilirubin will be allowed)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN
Serum total bilirubin =< 1.5 x institutional ULN (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Total bilirubin =< 2 x upper limit of normal (ULN) (if > 2 x ULN direct bilirubin is required and should be =< 1.5 x ULN), obtained =< 14 days prior to registration
Total bilirubin (<=) 2* ULN or direct bilirubin level (<=) 2.0* ULN
Alanine transaminase ALT >3x upper limit of normal (ULN) AND bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Within 14 days prior to registration: Total serum bilirubin level =< 1.5 x ULN; direct bilirubin =< ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert’s syndrome are eligible)
Serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert’s syndrome
Within 14 days prior to randomization: Total bilirubin must be =< 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin =< ULN for patients with bilirubin levels > 1.5 x ULN
Within 14 days of study drug(s) initiation: Serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert’s syndrome.
For high risk and very high risk CLL-IPI (Arms A and B) only; obtained ? 30 days prior to randomization: Total bilirubin ? 1.5 x upper limit of normal (ULN) (or total bilirubin ? 3.0 x ULN with direct bilirubin ? 1.5 x ULN in patients with well-documented Gilbert’s syndrome)
Obtained ? 14 days prior to registration: total bilirubin ? 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome, in which case the direct bilirubin must be ? 1.5 x ULN
Total serum bilirubin ? 1.5 x ULN; in subjects with known or suspected Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, direct bilirubin is ? 1.5 x ULN
Bilirubin =< ULN, if total bilirubin is > ULN, measure direct/indirect bilirubin to evaluate for Gilbert’s Syndrome (if direct bilirubin is within normal range, subject may be eligible)
Total bilirubin < institutional upper limit of normal (ULN), except for subjects with documented Gilbert’s syndrome, for which =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 X upper limit of normal (ULN) or if total bilirubin is > 1.5 X ULN, the direct bilirubin =< ULN
Total bilirubin =< 1.5 x ULN (institutional upper limit of normal) (patients with Gilbert’s syndrome may have direct bilirubin > 2.5 x ULN)
Within 28 days of study registration: 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; if the total bilirubin is > 1.5 x the institutional ULN, direct and indirect bilirubin will be measured and if direct bilirubin is =< 1.5 x the institutional ULN, the patient will be eligible to participate
Total serum bilirubin =< 1.5 times upper limit of normal (ULN) (=< grade 1); if total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert’s syndrome
Serum total bilirubin =< 1.5 x institutional ULN (=< 3 x institutional ULN for Gilbert’s syndrome) OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be =< 1.5 x ULN (=< 0.45 mg/dL)
Total bilirubin =< upper limit of normal (ULN) (except for patients with Gilbert’s syndrome who may only be included if the total bilirubin is =< 3.0 x institutional ULN or direct bilirubin =< 1.5 x ULN)
Total bilirubin =< ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin in patients with well-documented Gilbert’s syndrome
Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dL, and
Total bilirubin =< ULN; or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 ULN n patients with well documented Gilbert’s syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Direct bilirubin =< 1.5 X upper limit of normal (ULN) (subjects with Gilbert’s syndrome and elevations of indirect bilirubin only are eligible)
Total bilirubin < 1.5 X upper limit of normal (ULN); or < 3 x institutional ULN for Gilbert’s syndrome or HIV protease inhibitors; or < 5 x ULN and direct bilirubin < 0.7 mg/dL for patients on atazanavir containing HIV regimen
Total bilirubin: serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with documented Gilbert’s syndrome
Total bilirubin =< 1 x upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome, obtained =< 21 days prior to registration
MF PATIENTS: Direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal
Total bilirubin < 1.5 x upper limit of normal (ULN) or normal direct bilirubin if the patient has Gilberts
Direct bilirubin (bili) < 3 x ULN
Direct bilirubin ? 2.0 x ULN
Serum direct bilirubin =< 1.5 x ULN; if considered related to ASM/MCL =< 3 x ULN
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), or direct bilirubin =< ULN in patients with Gilbert’s syndrome
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome.
Within 72 h of initiating study treatment: Bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN for subject with total bilirubin > 1.5 x ULN
Total serum bilirubin =< ULN (or =< 1.5 x ULN if documented hepatic involvement; or total bilirubin =< 3 x ULN with direct bilirubin =< 1.5 ULN in patients with documented Gilbert’s syndrome)
Total bilirubin =< 2 x upper limit of normal (ULN) or if total bilirubin is > 2 x ULN, the direct bilirubin must be normal
Hepatic total bilirubin =< 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Serum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
The direct bilirubin must be within normal parameters
Total bilirubin =< 1.5 x upper limit of normal (ULN); if patient has known Gilbert’s syndrome, direct bilirubin =< 2.0 x ULN obtained =< 14 days prior to registration
Total bilirubin =< 1.5mg/dL (in patients with known Gilbert’s syndrome direct bilirubin =< 1.5 x upper limit of normal [ULN] will be used as organ function criteria, instead of total bilirubin)
Direct bilirubin ? 2.0 x ULN
Total bilirubin within normal institutional limits (isolated bilirubin > 1.5 × institutional ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Serum total and direct bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be normal
Bilirubin =< 1.5 times ULN (if total bilirubin elevated, but direct is within normal limits [WNL], patient is eligible)
Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (isolated total bilirubin > 1.5 institutional ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%)
Total bilirubin ? 1.5x ULN for age. If the total bilirubin is elevated, patient will still be eligible if the conjugated (direct) serum bilirubin ? ULN for age.
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal
Direct bilirubin ? 2.0 x ULN
Direct bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, direct bilirubin =< 3.0 mg/dL
Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.5 mg/dL
Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dl and
Total bilirubin =< 1.5 × upper limit of normal (ULN), except in patients with previously documented Gilbert’s syndrome, in which case the direct bilirubin should be less than or equal to the ULN
Total bilirubin =< 1.5 mg/dL; in patients with known Gilbert’s syndrome, direct bilirubin =< 1.5 x upper limit of normal (ULN) will be used as organ function criteria, instead of total bilirubin
Total bilirubin =< 2 X ULN unless related to antiretroviral use (e.g., atazanavir and indinavir), then the direct bilirubin must be =< 2 X ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), or if total bilirubin is > 1.5 ULN, the direct bilirubin must be normal
Total bilirubin < 1.5 x upper limit of normal (ULN), If patient has known Gilbert’s syndrome, direct bilirubin < 2.0 x ULN
Serum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
Total bilirubin =< 1.5 x ULN, except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN OR direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin =< ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert’s syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Serum bilirubin < institutional ULN (in patients with Gilbert’s disease, direct bilirubin < institutional ULN)
Direct serum bilirubin ? 1.5 x ULN
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well- documented Gilbert’s syndrome
Total bilirubin within 1.5 x institutional level of normal or direct bilirubin =< upper limit of normal (ULN) for patient with total bilirubin levels > 1.5 ULN)
Total bilirubin =< 2 x institutional upper limit of normal (ULN); if total bilirubin is > 2 x ULN, the direct bilirubin must be normal
Total serum bilirubin < 1.5 x ULN or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome or hemolysis or who required regular blood transfusions
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) (=< 3 X ULN if Gilbert’s syndrome) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) (=< 3 X ULN if Gilbert’s syndrome) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN