[c09aa8]: / clusters / 9knumclustersv2 / clust_2815.txt

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PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin: =<. institutional upper limit of normal (ULN), or =< x ULN for participants with Gilberts disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without AST or ALT elevation, and must have a total bilirubin less than . mg/dL), within weeks prior to enrollment
Total bilirubin =< . x institutional upper limit of normal (ULN) within days of day of study; NOTE: patients with elevated bilirubin secondary to Gilberts disease are eligible to participate in the study
Total bilirubin =< . x upper limit of normal (ULN) (except in patients with Gilberts syndrome who must have total bilirubin =< . x ULN)
Bilirubin =< . x institutional upper limits of normal (ULN); if patient has documented Gilberts syndrome bilirubin must be < x institutional ULN
Within 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 . x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin
Bilirubin =< . x ULN upper limit of normal (except in patients with documented Gilberts disease, who must have a total bilirubin =< . mg/dL), must be obtained within weeks prior to screening for protocol therapy
Total bilirubin < . x institutional upper limit of normal (=< mg/dL in case of Gilberts syndrome)
Total bilirubin =< ULN (institutional upper limit of normal) except elevated total bilirubin < . x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin, measured within days prior to randomization
Obtained within days prior randomization: total bilirubin must be =< . x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > . x ULN to x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin; and
Total bilirubin =< . x upper limit of normal (ULN), except for patients with known Gilberts syndrome
Total bilirubin =< . x upper limit of normal (ULN) except subjects with documented Gilberts syndrome (> x ULN) or liver metastasis, who must have a baseline total bilirubin =< . mg/dL
Total bilirubin =< . x upper limit of normal (ULN); patients with Gilberts Syndrome must have bilirubin =< x ULN (for treatment phase)
Measured within days prior to registration: total bilirubin =< . x institutional upper limit of normal (ULN). In the case of known Gilberts syndrome, a higher serum total bilirubin (< ULN) is allowed.
Serum total bilirubin =< . x upper limit of normal (ULN) or =< x ULN for patients with Gilberts disease
Bilirubin =< . x the upper limit of normal (ULN); for subjects with known Gilberts disease, bilirubin =< . mg/dL
Total Bilirubin ? . x upper limit of normal (ULN), or patients diagnosed with Gilberts syndrome, that have been reviewed and approved by the medical monitor.
Total bilirubin =< . x upper limit of normal (ULN) except patients with documented Gilberts syndrome (=< x ULN)
Total bilirubin within normal institutional limits (or < X the upper limit of normal in those with Gilberts disease)
Total bilirubin =< . x institutional upper limit of normal (ULN), with the exception of < . mg/dL for patients with Gilberts disease
Total bilirubin =< . x upper limit of normal (ULN) (or =< . x ULN for subjects with asymptomatic Gilberts syndrome)
Bilirubin =< . x the upper limit of normal (ULN) within days before the first dose of cabozantinib. For subjects with known Gilberts disease, bilirubin =< . mg/dL
Serum bilirubin ? . upper limit of normal (ULN) or ? x ULN if patient is known to have Gilberts disease as the only underlying hepatic disorder
Serum total bilirubin =< . x upper limit of normal (ULN). In the case of known Gilberts syndrome, a higher serum total bilirubin (< x ULN) is allowed.
Total bilirubin =< . x institutional upper limit of normal (ULN) (or . x ULN in patients with documented Gilberts syndrome)
Total bilirubin=< . x upper limit of normal (ULN) (if, however, the participant has Gilberts disease or unconjugated hyperbilirubinemia that is considered to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< x ULN)
Total bilirubin (except for Gilberts syndrome) =< . x upper limit of normal (ULN)
Total bilirubin ? . x institutional upper limit of normal (ULN) (or ? . x ULN with Gilberts disease) within days prior to registration
Serum bilirubin < . x upper limit of normal (ULN) (except for patients with documented Gilberts disease)
Total bilirubin =< x upper limit of normal (ULN) (except in the case of subjects with documented Gilberts disease >= x ULN)
Total bilirubin level =< . x upper limit of normal (ULN) or in patients with Gilberts syndrome, a total bilirubin of =< .
Total bilirubin =< upper limit of normal (ULN) (except in Gilberts syndrome)
Total bilirubin ? X upper limits of normal (ULN) (except in the case of subjects with documented Gilberts disease > x ULN)
Total bilirubin ? . x upper limit of normal (ULN) (patients with Gilberts syndrome may have serum bilirubin ? x ULN)
Total bilirubin =< . x institutional upper limit of normal (ULN), except patients with Gilberts syndrome in whom total bilirubin must be < . mg/dL, within weeks of registration
Total bilirubin =< institutional upper limit of normal (except for patients with Gilberts' syndrome who must have normal direct bilirubin)
Serum bilirubin =< x the upper limit of normal (ULN) (except for patients with Gilberts disease)
Obtained within days prior to the first dose of cabozantinib: bilirubin =< . x the upper limit of normal (ULN). For subjects with known Gilberts disease, bilirubin =< . mg/dL.
Total bilirubin =< . x institutional upper limit of normal (ULN) (or =< . x ULN in patients with documented Gilberts syndrome)
Total bilirubin below the upper limit of normal (ULN), excluding patients with Gilberts syndrome
Total bilirubin =< X upper limit laboratory normal (ULN); subjects with non-clinically significant elevations of bilirubin due to Gilberts disease are not required to meet these criteria
Serum bilirubin =< . x institutional upper limit of normal (ULN) (except patients with Gilberts syndrome, who can have total bilirubin < mg/DL)
Total bilirubin < . x upper limit of normal (ULN) \r\n* For patients with Gilberts syndrome total bilirubin < . x ULN
Within days prior to administration of study treatment: Total bilirubin =<. x institutional upper limit of normal (ULN) (except for patients with known Gilberts disease).
Total bilirubin within normal institutional limits (patients with confirmed Gilberts syndrome with a total bilirubin =< . x upper limit of normal [ULN], may be included in this study)
Within days before the first dose of study treatment: Bilirubin =< . x the upper limit of normal (ULN); for subjects with known Gilberts disease, bilirubin =< . mg/dL
Total bilirubin (except for Gilberts syndrome) =< . x upper limit of normal (ULN)
Within days prior to cycle day of treatment: Bilirubin =< . x upper limit of normal (ULN) (subjects with known Gilberts disease who have serum bilirubin =< . x ULN may be enrolled)
Serum bilirubin =< . x upper limit of normal (ULN) or =< x ULN for patients with Gilberts disease
Total bilirubin =< . X upper limit of normal (ULN) (patients with diagnosed Gilberts syndrome will not be excluded if their direct bilirubin is within normal institutional limits)
Serum bilirubin =< x the upper limit of normal (ULN) (except for patients with Gilberts disease)
Total bilirubin =< . x institutional upper limit of normal ([ULN]; unless attributable to Gilberts disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< . x ULN)
Bilirubin =< . x upper limit of normal (ULN) (obtained within days prior to first study treatment)\r\n* Subjects with known Gilberts disease should have a serum bilirubin =< x ULN
Within days of registration: Bilirubin within normal institutional limits (or < X the upper limit of normal (ULN) in those with Gilberts disease)
Total bilirubin < . x upper limit of normal (ULN) (except in patients diagnosed with Gilberts disease)
Total bilirubin =< . x upper limit of normal (ULN) or =< ULN in the case of suspected/documented Gilberts syndrome
Total bilirubin < . x the upper limit of normal (ULN) for age (patients who have been diagnosed with Gilberts disease are allowed to exceed this limit)
Total bilirubin =< . x upper limit of normal (ULN) except subjects with documented Gilberts syndrome (> x ULN), who must have a baseline total bilirubin =< . mg/dL
Total bilirubin =< . x upper limit of normal (< x ULN if Gilberts disease)
Total serum bilirubin =< . x upper limit of normal (ULN), OR in patients with Gilberts syndrome, a total bilirubin =< .
Serum bilirubin < . x upper limit of normal (ULN) except in patients with Gilberts syndrome as defined by > % unconjugated bilirubin
Serum total bilirubin =< . x upper limit of normal (ULN) or =< x ULN for patients with Gilberts disease
Total bilirubin =< x institutional upper limit of normal (ULN) (except for known Gilberts syndrome/familial non-hemolytic jaundice)
Bilirubin =< . x upper limit of normal (ULN); for subjects with Gilberts disease =< . mg/dL
Total bilirubin =< . X upper limit of normal OR in patients with Gilberts syndrome, a total bilirubin =< .
Total bilirubin (Tbili) < . x upper limit of normal (ULN)\r\n* Except subjects with known Gilberts syndrome
Within days prior to the first dose of cabozantinib: Bilirubin =< . x the upper limit of normal (ULN) (for subjects with known Gilberts disease, bilirubin =< . mg/dL)
Total bilirubin =< . x upper limit of normal (ULN) OR x ULN for Gilberts disease
Total bilirubin =< . x institutional upper limit of normal (ULN) (patients with Gilberts syndrome may have serum bilirubin > . ULN)
Total bilirubin =< . X institutional upper limit of normal (except for patients with documented Gilberts disease)
Bilirubin =< . x the upper limit of normal (ULN); for subjects with known Gilberts disease, bilirubin =< . mg/dL
Total bilirubin =< . x upper limit of normal OR in patients with Gilberts syndrome, a total bilirubin =< .
Total bilirubin =< x upper limit laboratory normal (ULN); subjects with non-clinically significant elevations of bilirubin due to Gilberts disease are not required to meet these criteria
Total bilirubin =< . x local institutional upper limit of normal (ULN)\r\n* If elevated total bilirubin is due Gilberts disease or disease-related hemolysis then total bilirubin =< . x local institutional ULN
Within weeks of preregistration: Total bilirubin =< upper normal institutional limits (except for patients with Gilberts disease who are eligible despite elevated serum bilirubin level)
Bilirubin =< upper limit of normal (except in patients with documented Gilberts disease, who must have a total bilirubin =< . mg/dL)
Total bilirubin =< upper limit of normal (ULN) except in patients with Gilberts syndrome; patients with Gilberts syndrome may enroll if direct bilirubin =< . x ULN (repeat if more than days before the first dose)
Total bilirubin ? . institutional upper limit of normal (ULN) (however, patients with known Gilberts disease who have serum bilirubin level ? ULN may be enrolled)
Total bilirubin < . X upper limit of normal (ULN) (in women with prior documented bilirubin elevations consistent with Gilberts syndrome, total bilirubin up to X ULN will be allowed)
Within days prior to first dose of study drug treatment: Serum bilirubin =< . x the upper limit of normal (ULN); patients with known Gilberts disease may have a bilirubin =< . x ULN
RENAL COHORT: Laboratory values as follows within days before the first dose of daratumumab: bilirubin ? . x upper limit of normal (ULN); for subjects with known Gilberts disease, bilirubin ? . mg/dL
Within days before the first dose of cabozantinib: Bilirubin =< . x the upper limit of nomal (ULN); for subjects with known Gilberts disease, bilirubin =< . mg/dL
Total bilirubin =< . X institutional upper limit of normal or =< in subjects with Gilberts syndrome
Total bilirubin =< . x institutional upper limit of normal (ULN; unless attributable to Gilberts disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< . x ULN)
Total bilirubin =< . x upper limit of normal (ULN); except in case of Gilberts disease
Total bilirubin < . x institutional upper limit of normal (ULN) (< . x ULN for subjects with documented Gilberts syndrome or < . 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 . x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin within days before randomization
Total bilirubin =< . x institutional upper limit of normal (ULN), (except for patients with known Gilberts syndrome who must have normal direct bilirubin)
Serum bilirubin =< . x institutional upper limit of normal (ULN) except subjects with known Gilberts syndrome
Total bilirubin =< . x the upper limit of normal (ULN); for subjects with known Gilberts disease, =< mg/dl
Total bilirubin =< . x upper limit of normal (ULN) (except for patients with well-documented Gilberts syndrome) (obtained =< days prior to registration)
Total bilirubin < upper limit of normal (ULN) or up to x ULN if patient has clinically documented Gilberts syndrome (elevated unconjugated bilirubin from decreased UDP glucuronosyltransferase family, polypeptide A [UGTA] activity)
Total bilirubin < . x institutional upper limit of normal with direct bilirubin within normal limits except for participants with Gilberts disease
Total bilirubin must be =< upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to . x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin
Bilirubin =< . x institutional upper limit of normal (ULN) except subjects with known Gilberts syndrome, within weeks of the first dose of study treatment
Serum bilirubin =< . x institutional upper limit of normal (ULN) except subjects with known Gilberts syndrome
Serum bilirubin =< . x upper limit of normal (ULN) (=< . if Gilberts syndrome)
Bilirubin (total) less than or equal to the upper limit of normal; an exception to this may be allowed for participants with Gilberts syndrome with prior approval by the protocol chair
Total bilirubin > x upper limit of normal (ULN) (except in the case of subjects with documented Gilberts disease > x ULN)
Total bilirubin =< . x institutional upper limit of normal (ULN) (or =< . x ULN with Gilberts disease)
Total bilirubin =< . x upper limit of normal (ULN) (or =< . mg/dL if known Gilberts syndrome)
Total bilirubin =< . x upper limit of normal (ULN) (patients with Gilberts syndrome may have serum bilirubin > . ULN)
Total bilirubin =< . x upper limit of normal in the absence of Gilberts disease; for patients with Gilberts syndrome: direct bilirubin =< . x upper limit of normal
Total bilirubin within normal institutional limits or < x the upper limit of normal in patients with Gilberts disease
Serum bilirubin less than or equal to . 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 bilirubin < upper limit of normal (ULN) (except for Gilberts disease)
Total bilirubin =< . X institutional upper limit of normal; =< . upper limit of normal (ULN) accepted in subjects with Gilberts syndrome
Total bilirubin < . x institutional upper limit of normal (ULN) (< . x ULN for subjects with documented Gilberts syndrome or < . x ULN for subjects for whom the indirect bilirubin level suggests an extrahepatic source of elevation)
Total bilirubin =< . X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilberts, for whom the maximum will be . ULN
Total bilirubin =< . x upper limit of normal (ULN), except in cases of Gilberts disease
Total bilirubin =< . X upper limit of normal (ULN) obtained =< days prior to randomization; patients with known Gilberts syndrome who have serum bilirubin =< X ULN may enroll
Total bilirubin =< institutional upper limit of normal (ULN) (or =< X ULN if Gilberts syndrome present or if bilirubin increase related to MF)
Total bilirubin =< . x upper limit of normal (ULN) except subject with documented Gilberts syndrome (=< x ULN) or liver metastasis, who must have a baseline total bilirubin =< . mg/dL
Total bilirubin =< . x upper limit of normal (ULN) (except in patients diagnosed with Gilberts disease) (within days prior to registration)
Total bilirubin =< . x institutional upper limit of normal (patients with documented Gilberts disease are allowed total bilirubin up to x upper limit of normal [ULN])
Total bilirubin =< x upper limit of normal (ULN), unless patient has a documented history of Gilberts disease, then direct bilirubin =< . mg/dL
Total bilirubin < institutional upper limit of normal (patients with documented Gilberts disease are allowed total bilirubin up to . x upper limit of normal [ULN])
Serum bilirubin =< x the upper limit of normal (ULN) (except for patients with a confirmed diagnosis of Gilberts disease)
Total bilirubin =< . x upper limit of normal (ULN) (patients with diagnosed Gilberts syndrome will not be excluded if their direct bilirubin is within normal institutional limits)
Total bilirubin =< . X institutional upper limit of normal (ULN); in case of known Gilberts syndrome, < x ULN is allowed
Total bilirubin =< . upper limit of normal (ULN) (or =< . x ULN for subjects with asymptomatic Gilberts syndrome)
Total bilirubin =< . x upper limit of normal (ULN); if patient has Gilberts disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin =< X institutional ULN
Bilirubin =< . X the upper limit of normal (ULN); for participants with known Gilberts disease, bilirubin =< . mg/dL
Total bilirubin < . X institutional upper limit of normal (patients with documented Gilberts disease are allowed total bilirubin up to X upper limit of normal [ULN])
Total bilirubin =< upper limit of normal (ULN) (except for Gilberts disease)
Bilirubin =< . X upper limit of normal (ULN) or =< X ULN for patients with Gilberts disease
Total bilirubin less than institutional upper limit of normal; NOTE: patients with a diagnosis or history of Gilberts will be eligible
Bilirubin* =< x upper limit of normal\r\n* In the absence of Gilberts disease
Total bilirubin =< . x upper limit of normal (ULN) appropriate for age (except for patients with Gilberts syndrome, who must have a total bilirubin < mg/dL) within days prior to registration
Total serum bilirubin =< . X upper limit of normal (ULN) except for subjects with known Gilberts disease, who may enroll if the conjugated bilirubin is =< . ULN
Total bilirubin =< upper limit of normal (ULN) (excluding Gilberts disease)
Bilirubin =< upper limit of normal (ULN); for patients with Gilberts disease, =< . x ULN is allowed
Total bilirubin =< . x upper limit of normal (ULN) except in patients with Gilberts disease
Total bilirubin < . x upper limits of normal (ULN) except Gilberts syndrome where < x ULN is allowed
Total bilirubin: within normal institutional limits; if, however, the participant has Gilberts disease or unconjugated hyperbilirubinemia which is felt to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< x upper limit of normal [ULN])
Total bilirubin =< . x institutional upper limit of normal (ULN)\r\n* Patients with Gilberts disease: =< x ULN
Total bilirubin =< . x upper limit of normal (ULN); for subjects with known Gilberts disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< . mg/dL
Total bilirubin must be =< the upper limit of normal (ULN) for the lab unless the patient has a grade bilirubin elevation (> ULN to . x ULN) resulting from Gilberts disease or similar syndrome due to slow conjugation of bilirubin; and
Total bilirubin =< . x upper limit of normal (ULN) unless due to Gilberts disease; if total bilirubin is > . x ULN, a direct bilirubin should be performed and must be < . mg/dL for Gilberts to be diagnosed
Serum total bilirubin =< . x upper limit of normal (ULN) (except for patients with documented Gilberts syndrome)
Serum bilirubin =< upper limit of normal (ULN) (except for subjects with Gilberts disease who are eligible despite elevated serum bilirubin level)
Total bilirubin =< . x upper limit of normal OR in patients with Gilberts syndrome, a total bilirubin =< .
Serum bilirubin =< . x upper limit of normal (ULN) or =< x ULN for patients with Gilberts disease
Total/direct bilirubin < . X institutional upper limit of normal; patients with elevation of indirect (unconjugated) bilirubin alone, as in Gilberts syndrome, are eligible
Serum total bilirubin < . x upper limit normal (ULN) (or < . x ULN if deemed to be elevated due to leukemia or Gilberts syndrome)
Total bilirubin =< . x upper limit of normal (ULN) except if the elevation is due to Gilberts syndrome (allowable at =< x ULN) or myelofibrosis (per principle investigator [PI] discretion)
Unless felt due to underlying disease and approved by the overall PI: Total bilirubin =< . x institutional upper limit of normal (ULN); patients with Gilberts disease may have total bilirubin up to =< x institutional ULN
Total bilirubin =< . x institutional upper limit of normal (ULN); an exception to this may be allowed for participants with Gilberts syndrome with documented approval by the protocol chair
Total bilirubin =< . x institutional upper limit of normal (ULN) Note: Higher total bilirubin levels (=< mg/dL) can be allowed if due to known benign liver condition, i.e. Gilberts
Total bilirubin =< institutional upper limit of normal (ULN) and/or history of Gilberts syndrome
Obtained within days prior to registration: Bilirubin =< . x upper limit of normal (ULN) (subjects with known Gilberts disease should have a serum bilirubin =< x ULN)
Bilirubin = < . X upper limit of normal (ULN) except for patients (pts) with (w/) documented history of Gilberts disease, obtained within days prior to PET scan
Bilirubin > x institutional upper limits of normal (ULN), with exception of patients with Gilberts disease
Total bilirubin =< . x upper limit of normal (ULN); patients with Gilberts syndrome are excluded from this requirement