[c09aa8]: / clusters / 9knumclustersv2 / clust_769.txt

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