Serum creatinine =< 2 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 2 x ULN
Serum creatinine =< 2.5 times ULN
Serum creatinine =< 1.5 x ULN (for treatment phase)
Serum creatinine ? 2.0 × ULN
Serum creatinine =< 1.5 ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine < 1.5 x ULN
Serum creatinine =< 1.5 x institutional ULN
Have a serum creatinine ?1.5 × ULN.
Serum creatinine =< 1.5 x institutional ULN
Serum creatinine =< 2.0 x ULN
Serum creatinine =< 1.5 x institutional ULN
Serum creatinine =< 1.5 x institutional ULN OR
Serum creatinine < 2.5 times ULN
Serum creatinine =< 1.5 x ULN, OR
Serum creatinine =< 1.5 x institutional ULN
Serum creatinine =< 1.5 x institutional ULN within 14 days prior to start of protocol therapy.
Serum creatinine =< 1.5 x institutional ULN
Serum creatinine < 2 x ULN
Serum creatinine < 2.5 times ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine =< 2 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine < 2 x ULN
Serum creatinine =< 2 x the ULN
Renal: Serum creatinine < 2.0 x ULN or creatinine clearance ? 50 mL/min/1.73m^2 for patients with serum creatinine levels above 2 x ULN.
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 2.5 X ULN
Serum creatinine ? 1.5 x ULN
Serum creatinine =< 2.5
Serum creatinine ? 2.5
Subjects above specific amount of serum creatinine.
Within 7 days (+ 3 day window) of enrollment: Serum creatinine of =< 1.5 x institutional ULN
Serum creatinine =< 1.5 times ULN
(For both cohorts A and B): Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN OR
Serum creatinine =< 1.5 ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine > 1.5 ULN
Serum creatinine < 1.5 x ULN
Serum creatinine < 1.5 x ULN
Serum creatinine ?1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 X ULN
Serum creatinine =< 1.5 x ULN
Within 14 days prior to registration: Serum creatinine < 1.5 x ULN
Serum creatinine =< 3 x ULN for age
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum Creatinine < 2.5 X ULN
Creatinine serum levels ? 1.5 x ULN
Serum creatinine > 1.5 x ULN
Serum creatinine =<1.5 times the ULN or
Serum creatinine ?1.5 x ULN
Within 14 days prior to study entry: Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Has serum creatinine < 1.5 × ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine < or = to 2.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine < 2.5 times ULN, OR
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 3 x ULN for age
Serum creatinine < 1.5 times the institutional ULN
Serum creatinine =< 2.0 x local institutional ULN
Serum creatinine < 1.5 x institutional ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 2.0
Serum creatinine < 2.0
Renal: Serum creatinine < 1.5 x ULN or creatinine clearance ?60 mL/min/1.73m2 for patients with serum creatinine levels above 1.5 x ULN.
Serum creatinine concentration < 1.5 x ULN
Serum creatinine < 1.5 times ULN
Total serum creatinine ? 1.5 × ULN
Serum creatinine < 1.5 x ULN
Serum creatinine ?2.0 x ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine =< 1.5 times the ULN
Serum creatinine =< grade 1
Serum creatinine =< 1.5 x ULN
Serum creatinine > 2 x ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine < 2 x the institutional ULN
Serum creatinine =< 2
Serum creatinine < 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine > 2.5 × ULN. MDS Cohort:
Serum creatinine at least 1.5 × ULN
Renal: Serum creatinine ? 1.5 x ULN, or for patients with serum creatinine > 1.5 ULN, creatinine clearance ? 50 mL/min.
Serum creatinine =< 2 x ULN
Serum creatinine =< 2 x ULN
Serum creatinine > 1.5 x ULN
Serum creatinine ? 1.5 x ULN
Serum creatinine equal to or less than 1.5 x ULN
Serum creatinine < 1.5 times ULN
Serum Creatinine ? 1.5X ULN
Serum creatinine < 3 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine < 2.0 x ULN
Serum creatinine < 1.5 x ULN
Serum creatinine ? 1.5 x ULN
Serum creatinine < 1.5 x ULN (within 7 days prior to registration)
Within 4 weeks of administration of study therapy: Serum creatinine =< 1.5 x ULN
Serum creatinine 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine ? 1.5 × ULN
Serum creatinine =< ULN
Serum creatinine < 1.5 x ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine > 1.5 x ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine ?1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine ? 2.0 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 X institutional ULN
Serum creatinine >= 2.0
Serum creatinine =< 1.5 x ULN
Serum creatinine < 1.5 x ULN
Serum creatinine =< 2.0 x ULN
Serum creatinine < 1.5 time the institutional ULN
Serum creatinine less than or equal to 2 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine < 2 x ULN
Serum creatinine < 1.5 x ULN OR
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 X ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine concentration =< 2 x ULN
Serum creatinine concentration <2x ULN
Serum creatinine ? 1.5 x ULN
Within 8 weeks of randomization: Serum creatinine =< 1.5 x ULN
Serum creatinine < 1.5 x of ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine >1.5x ULN at screening
Serum Creatinine < 2.0 times the institutional ULN
Serum creatinine < 1.5 x ULN
Serum creatinine =< 2 x ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine ? 1.5 x ULN
Serum creatinine ? 1.5 x ULN
Serum creatinine =< 1.5 x the ULN
Serum creatinine =< 2.0 X ULN
Serum creatinine</=1.5 times the ULN
Serum creatinine ? 1.5 x ULN
Serum creatinine < 1.5 x ULN or creatinine (Cr) > 1.5 x ULN, but calculated clearances of > 60
Serum creatinine =< 1.5 x ULN or creatinine (Cr) > 1.5 x ULN, but calculated clearances of > 60
Serum creatinine < 2.0 x ULN
Serum creatinine =< 2 times ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine > 1.5 x ULN.
Serum creatinine =< 1.5 x ULN
Serum creatinine ? 1.5 x ULN
Serum creatinine < 1.5 x ULN
Serum creatinine < 2 x ULN
Serum creatinine < 1.5 × ULN
serum creatinine ?1.5 X ULN
Serum creatinine ?1.5 ULN.
Serum creatinine =< 1.5 x the ULN
Serum creatinine < 2 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 2 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 times the ULN
Serum creatinine < 2 x ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 X ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine < 2.0 x ULN
Serum creatinine >= 2.5 x ULN 14 days prior to study enrollment
Serum creatinine =< 1.5 x the ULN
Serum creatinine > 2.0
Serum creatinine greater than 3.0
Serum creatinine =< 2
Serum creatinine =< 1.5 times institutional ULN
Serum creatinine < 2 x ULN
Serum creatinine < 1.5 x ULN
Serum creatinine =< 1.5 times ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine =< 1.5 x institutional ULN
Serum creatinine =< institutional ULN
Serum creatinine =< 1.5 x ULN
Serum creatinine ? 1.5 x ULN
Serum creatinine < 2.0
Serum creatinine (serum or plasma) ? 1.5 x ULN or GFR>50 mL/min
Elevated serum creatinine of > 2
Serum creatinine =< 1.5 x ULN
Serum creatinine =< within 1.5 x ULN
Serum creatinine < 1.5 x ULN
Serum creatinine < 1.5 x ULN
Creatinine level greater than 1.5 times the upper limit of normal
Creatinine =< 1.5 x institutional upper limit of normal within 4 weeks before randomization
Creatinine < 1.5 times institutional upper limit of normal, within 21 days prior to study entry
Serum creatinine < 1.5 times upper limit of normal OR
Creatinine within less than the institutional upper limit of normal
Serum creatinine less than 3 times upper limit of normal
Creatinine =< 1.5 times the normal upper institutional limit OR creatinine clearance >= 60 mL/min/1.73 m^2 in participants with creatinine levels > 1.5 times the normal upper institutional limit
Serum creatinine =< 1.5 times upper limit of institutional normal for age, or and documented within 14 days prior to registration and within 14 days prior to the start of treatment
Serum creatinine value of < 1.5 times the upper limit of normal (ULN)
Creatinine < 2.0 times upper limit of normal
Serum creatinine < 1.5 times upper limit of normal; OR
Serum creatinine =< 2 x the institutional upper limit of normal.
Serum creatinine < 1.5 times institutional upper limit of normal
Creatinine =< 1.5 x institutional upper limit of normal
Serum creatinine =< upper limit of institutional normal
Creatinine =< 1.5 x institutional upper limit of normal
Serum creatinine > 2 times the upper limit of normal
Creatinine =< 1.5 X institutional upper limit of normal
Creatinine < 1.5 X institutional upper limit of normal
Creatinine =< 1.5 x institutional upper limit of normal
Serum creatinine =< 1.5 x institutional upper limit of normal
Creatinine =< 1.5 x institutional upper limit of normal
Creatinine ? 2 times upper limit of normal
Serum creatinine of =< 1.5 times upper limit of normal
Serum creatinine value of =< 1.5 times the upper limit of normal (ULN)
Creatinine =< 1.5 x institutional upper limit of normal
Serum creatinine less than or equal to 1.5 x institutional upper limit of normal for age
Creatinine =< 1.5 x institutional upper limit of normal
EXCLUSION CRITERIA FOR ENROLLMENT: Creatinine >= 2.5 times the upper limit of normal (ULN)
Serum creatinine < 1.5 times the upper limit of normal
Serum creatinine > 1.5 times the upper limit of normal
Serum creatinine =< 1.5 x the institutional upper limit of normal
Serum creatinine =< 1.5 times the upper limit of normal (ULN) (normal: =< 1.17 mL/min/1.73 m^2)
Serum creatinine =< 1.2 times the upper limit of normal
Serum creatinine less than 3 times the upper limit of normal
Creatinine =< 2 times upper limit of normal
Serum creatinine < 1.5 times upper limit of normal
Serum creatinine < 1.5 times upper limit of normal
Creatinine =< institutional upper limit of normal
Creatinine =< institutional upper limit of normal OR
Serum creatinine =< 1.5 times upper limit of institutional for age or
Serum creatinine 1.5 times or less than upper limit of normal
Creatinine: < 1.5 x institutional upper limit of normal
Creatinine =< 1.5 X institutional upper limit of normal
Creatinine =< 4 X institutional upper limit of normal
Creatinine =< 1.5 x institutional upper limit of normal
Serum creatinine =< 1.5 x upper limit of institutional normal
Creatinine =< institutional upper limit of normal OR
Serum creatinine =< 1.5 x institutional upper limit of normal
Creatinine =< 1.5 mg/dL x the institutional upper limit of normal
Renal disease: serum creatinine > 2 times upper limit of normal
Secondary Registration: serum creatinine =< 1.5 x institutional upper limit of normal
Serum creatinine =< 1.5 x institutional upper limit of normal
Serum creatinine < 1.5 times the upper limit of normal
Serum creatinine < 1.5 x the institutional upper limit of normal
Creatinine =< 2 X institutional upper limit of normal
Creatinine =< 2.5 x institutional upper limit of normal
Creatinine =< 1.5 X institutional upper limit of normal OR
Serum creatinine =< the institutional upper limit of normal
Creatinine < 1.5 x institutional upper limit of normal OR
Serum creatinine =< 1.5 times the institutional upper limit of normal
Serum creatinine less than 3 times upper limit of normal
Creatinine =< 2 times upper limit of normal
Serum creatinine less than 3 times upper limit of normal
Creatinine =< 1.5 times the upper limit of normal (ULN)
Within 56 days prior to randomization: Serum creatinine =< 1.5 times upper limit of normal (ULN)
Serum creatinine should be within normal limits as specified by institutional guidelines; for patients with serum creatinine > upper limit of normal, a 24-hour creatinine clearance will be performed and should be equal to or more than the lower limit of normal
Serum creatinine =< 1.5 times the upper limit of normal
Creatinine =< 1.5 x the institutional normal upper limit
Creatinine =< 2.0 x institutional upper limit of normal
Serum creatinine < 1.5 X institutional upper limit of normal
Creatinine =< 2 x institutional upper limit of normal if patient has chronic renal insufficiency and creatinine has been stable x > 4 months
Serum creatinine 1.5 times or less than upper limit of normal
Creatinine within 1.5 times of the institution's upper limit of normal (ULN)
Serum creatinine < 1.5 times upper limit of normal; OR
Serum creatinine > 3 times the upper limit of normal
Creatinine =< 2 x institutional upper limit of normal
Creatinine < 2.0 times upper normal limit
Creatinine =< 1.5 times the upper limit of normal
Serum creatinine =< 1.5 times the upper limit of normal (ULN)
Serum creatinine =< 1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy
Serum creatinine =< 1.5 X institutional upper limit of normal
Creatinine =< 2.0 times the institutional upper limit of normal
Creatinine =< 1.5 x institutional upper limit of normal OR
Creatinine > 2.0 times upper normal limit
Creatinine > 1.5 times the institutional upper limit of normal
Creatinine =< 2 X institutional upper limit of normal
Serum creatinine =< 2 times upper limit of normal
Creatinine =< 2 X institutional upper limit of normal
Creatinine =< 1.5 times upper limit of normal (ULN)
Creatinine < 1.5 times upper limit of normal (ULN)
Creatinine =< 1.5 times upper limit of normal (ULN)
Patients must have normal organ and marrow function as defined below: leukocytes >3,000/mcL; absolute neutrophil count >1,500/mcL; platelets >100,000/mcL; total bilirubin <1.5 X institutional upper limits of normal; AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal; Alkaline phosphatase (AP) <2.5 X institutional upper limit of normal; creatinine <1.5X institutional upper limit of normal OR creatinine clearance >50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Creatinine < 1.5 institutional upper limit of normal OR
Serum creatinine < 1.5 times upper limit of laboratory normal
Creatinine < 2 times upper limit of normal
Serum creatinine of at least 1.5 times the upper limit of normal
Serum creatinine =< 2 times the upper limit of normal
Creatinine < 2.5 times the upper limit of normal
Serum creatinine =< 1.5 times the institutional upper limit of normal (ULN)
Creatinine =< 1.5 x institutional upper limit of normal
Serum creatinine =< 1.5 the institutional upper limit of normal
Creatinine =< 1.5 X institutional upper limit of normal
Creatinine =< 2.0 x upper limit of institutional normal for age
Serum creatinine =< 1.5 X institutional upper limit of normal
Creatinine =< 3 x institutional upper limit of normal
Creatinine =< 1.5 x institutional upper limit
Serum creatinine < 2 x institutional upper limit of normal OR
Creatinine ? 3 times the upper limit of normal (ULN)
Grade 2 renal dysfunction: creatinine > 2-3 times the upper limit of normal
Creatinine < 1.5 times the upper limit of normal, or:
Baseline creatinine (Cr) no greater than 1.5 times the upper limit of normal
Serum creatinine =< 2 times the upper limit of normal
Serum creatinine must be < 1.5 times the upper limit of the institutional normal range; test results must be no more than 3 months old
Serum creatinine < 1.5 times the upper limit of normal
Serum creatinine within 1.5 x upper limit of institutional normal
Creatinine =< 1.5 x institutional upper limit of normal
Creatinine =< institutional upper limit of normal OR
Creatinine =< twice upper limit institutional normal
Creatinine =< 2.0 times the upper limit of normal
SUB-STUDY III: Serum creatinine > 3 times the upper limit of normal
Serum creatinine > 2 times the upper limit of normal
Serum creatinine > 2 times the upper limit of normal
Creatinine =< 1.5 x the institutional upper limit of normal
Serum creatinine > 1.5 times upper limit of normal
Serum creatinine > 3 times the upper limit of normal
Serum ferritin < 2.0 X institutional upper limit of normal
Serum ferritin < 2.0 X institutional upper limit of normal
Creatinine >= 1.5 times upper limit of normal
Creatinine >= 1.5 times upper limit of normal
Serum creatinine > 2 times the upper limit of normal
Significant history or current renal insufficiency (serum creatinine > 1.5 institutional upper limit of normal)
Creatinine =< 1.5 times the institution upper limit of normal (ULN)
Creatinine > 1.5 times the institution upper limit of normal (ULN)
PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum lipase and amylase < 1.5 x ULN, within 2 weeks prior to enrollment
PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum lipase and amylase < 1.5 x ULN, within 2 weeks prior to enrollment
Serum lipase and amylase =< 1.5 x ULN
Amylase and lipase =< 2 x ULN
Amylase and lipase < 1.5 x ULN obtained ? 14 days prior to randomization
Amylase and lipase =< 1.5 ULN; subjects with amylase or lipase > 1.5 ULN may enroll if there are neither clinical nor radiographic signs of pancreatitis
Serum lipase and amylase =< 1.5 x ULN.
Serum lipase and amylase =< 1.5 x ULN.
Serum amylase/lipase =< 1.5 x ULN
FULL STUDY INCLUSION CRITERIA: Amylase and lipase =< 1.5 x ULN
Serum amylase and lipase =< 2 x ULN
Serum amylase and lipase =< 1.5 x ULN
Serum amylase and lipase =< 1.5 x institutional ULN
Normal serum lipase and amylase (per institutional normal values)
Have normal pancreatic status as defined by the following criterion: a. Serum lipase and amylase ? 1.5 × ULN
Serum lipase and amylase =< 1.5 x ULN
Serum lipase and amylase =< 1.5 x ULN
Within 14 days prior to first dose of study drug treatment: Amylase and lipase =< 1.5 x ULN
Serum amylase and lipase within normal limits
Amylase and/or lipase =< 1.5 x ULN, obtained =< 7 days prior to registration
Patients must have a lipase and amylase performed within 7 days prior to sub-study registration
Serum amylase and lipase =< 1.5 x the ULN
Within 14 days of subject registration: Serum amylase =< 2 x ULN and serum lipase within normal limits
Amylase or lipase within normal limit (per institutional standards)
Amylase (0-160 U/L) and lipase (0-130 U/L) levels within 1.5 times the range of normal
Amylase and lipase =< 1.5 x the upper limit of normal
Patients must have a lipase, amylase, TSH with reflex free T3/T4 performed within 7 days prior to sub-study registration; (Note: For the Canadian sites, testing for lipase only is acceptable)
Amylase and lipase <=ULN [Applies to Phase 2].
Amylase and lipase ? 2X upper limit of normal
Asymptomatic serum amylase or lipase > Grade 2
Adequate pancreatic function, defined as amylase and lipase less than or equal to 1.5 X ULN
Amylase and lipase =< 2 times institutional ULN for age
Obtained =< 7 days prior to registration:\r\nSerum amylase and lipase =< 1.5 x upper limit of normal (ULN)
Serum lipase and amylase =< 2.5 x ULN; NOTE: if subject has tumor involvement in the liver =< 3 x ULN
Serum lipase/amylase ?1.5 x ULN
Serum amylase > 1.5 x ULN or serum lipase > 1.5 x ULN.
Amylase and lipase equal to, or less than, the institutional ULN
Amylase and lipase levels =< ULN
Amylase and lipase =< 1.5 x ULN
Amylase and lipase < 1.5 x of ULN
Serum amylase or lipase <1.5 x ULN;
Amylase and lipase =< 2 x ULN
Amylase and lipase ? 2.5 x ULN (? 5 x ULN for subjects with pancreas involvement with tumor)
Serum lipase ? 3 x ULN and serum amylase within the normal range
Serum lipase ? 3 x ULN and serum amylase within the normal range
Lipase and amylase =< 1.5 x ULN
Serum amylase and lipase within normal limits
Amylase and lipase ? 1.5 x ULN
Amylase and Lipase < 1.5 x normal for age.
Sodium or potassium outside normal reference range for site
Serum potassium within normal range.
Serum potassium within normal range.
Potassium (K) should be within the range of >= 3.6 mEq/L
Potassium within normal range (supplementation is allowed)
Within 28 days prior to treatment start: Potassium within institutional normal range
Patients with uncorrectable electrolyte abnormalities with potassium (K) > ULN (upper limit of normal)
Serum sodium and potassium within the institutional limits of normal, within 14 days of registration and within 7 days of the start of treatment
Potassium within normal limits (WNL)
Potassium within institutional normal limits
Potassium within institutional normal limit (WNL)
Potassium within normal limits prior to the first dose of study medication
Potassium within normal limits for the institution
Potassium > 3 and < 5.5 mEq/L
Potassium between range of 3.0 to 5.5
Potassium in normal range\r\n* Patients with hypokalemia at screening must be corrected prior to initiating treatment
Serum potassium >= 3.5 mEq/L
Patients with sodium, potassium, or creatinine serum electrolytes > grade 2.
Potassium within normal limits for the institution
Potassium 3.5-5.0 mEq/L
Potassium within normal limits (oral supplementation is allowed)
Baseline serum potassium < 3.5 mmol/L (potassium supplementation may be given to restore the serum potassium above this level prior to study entry)
Serum potassium within normal limits
Subjects must have potassium (K+) >3.5 mEq/l.
Serum potassium >= 3.5 mEq/L\r\n* Hypokalemia can be managed and corrected at the physician’s discretion; patients who have hypokalemia must have a repeat serum potassium level drawn within 7 days before starting study drug; patients with a supported potassium level at >= 3.5 can be considered eligible at the physician’s discretion
Serum potassium levels outside the laboratory’s reference range
Serum potassium within institutional limits of normal (may be corrected with potassium repletion)
Potassium within normal limits for the institution
Serum or plasma potassium >= 3.5 mmol/L or institutional lower limit of normal (LLN) (independent of potassium supplementation)
Serum potassium >= 3.5 mEq/L
Potassium within normal limits for the institution
Obtained =< 7 days prior to registration: Potassium WNL
Potassium within normal limits
Serum potassium >= 3.5 mEq/L
Potassium
Potassium =< 3.5 mEq/L
Potassium levels =< grade 1
Use of potassium wasting diuretics during study treatment
Serum potassium within normal limits (WNL)
Potassium (K) levels: preferred normal limits with no clinical abnormalities
Potassium levels within normal limits
Potassium within normal limits for the institution
Potassium >= 3.0 mg/dl and =< upper limit of normal
Serum potassium > 3.3; electrolyte repletion is allowed to reach these values
Adequate potassium level > 3.5 mEq/dL
Because of the potential risk of corrected QT (QTc) changes, serum potassium levels must be within institutional normal limits
Potassium within normal limits for the institution
Serum potassium of >= 3.5 mEq/L
Serum potassium must be within institutional normal limits
Potassium within the normal range of 3.5-5.3 mEq/L
Potassium with institutional limits (supplementation allowed)
Potassium >= 3.5 mg/dL
Potassium within institutional range, obtained within 14 days prior to treatment start
Potassium within normal limits
Sodium, potassium, chloride, bicarbonate: all =< upper limit of institutional normal
Potassium (K) within 2 x ULN
Hypersensitivity to potassium iodide or Lugols products
Creatinine no greater than the institutional upper limits of normal
Creatinine within 1.5 x the ULN institutional limits
Creatinine within normal institutional limits
Creatinine ? 1.5 x upper limits of normal
Creatinine within normal laboratory limits
Creatinine =< upper normal institutional limits
PIK3CA WILD TYPE COHORT (closed 03/17/2016): Creatinine =< upper normal institutional limits
ENDOCRINE RESISTANT COHORT: Creatinine =< upper normal institutional limits
Free T4 within institutional normal limits.
Creatinine within normal institutional limits
Serum creatinine within normal institutional limits OR
Creatinine within normal institutional limits
Creatinine within institutional normal limits
Serum creatinine ? 1.5 X age-adjusted upper limits of normal (ULN)
Creatinine within normal institutional limits
Creatinine within normal institutional limits OR
Creatinine within 1.5 x normal institutional limits.
Creatinine within 1.5 x upper limit of normal institutional limits
Creatinine within 1.5 x normal institutional limits
Serum creatinine within the institutional normal limits, OR if the creatinine is elevated
Creatinine within normal institutional limits OR
Serum creatinine < 1.5 x upper limits of normal (ULN)
Serum creatinine =< 1.5 x normal institutional limits
Creatinine within normal institutional limits, assessed within 14 days prior to registration OR
PHASE II: Serum creatinine within normal institutional limits
Creatinine within normal institutional limits
Glucose within normal institutional limits
Creatinine < 1.5 x institutional upper limits of normal (ULN)
Creatinine within normal institutional limits OR according to Johns Hopkins MRI policy
Creatinine =< 1.5 X upper limits of normal
Creatinine within normal institutional limits OR
Creatinine within normal institutional limits OR
Creatinine within or below normal institutional limits
Creatinine =< 1.5 X upper limits of normal (ULN)
Creatinine < 2 times the upper limits of normal (ULN)
Creatinine within normal institutional limits OR
Serum creatinine < 2.0 x the upper limits of institutional normal (ULN)
Serum creatinine less than 1.5 times the upper limits of normal within 7 days prior to starting treatment
Creatinine within normal limits
Creatinine within normal institutional limits
Urinalysis within normal institutional limits
Serum creatinine < 2.0 x the upper limits of institutional normal (ULN)
Cardiac function within institutional normal limits on echocardiogram
Creatinine within normal institutional limits OR
Creatinine =< 1.5 x upper limits of normal
Creatinine within normal institutional limits OR
Creatinine within normal institutional limits OR
Creatinine =< 2 x institutional upper limits of normal
Regimens I and II: Creatinine =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1\r\n* Regimen III: Creatinine no greater than the institutional upper limits of normal
Creatinine =< 1.5 x upper limits of normal (ULN)
Creatinine =< normal institutional limits OR
Creatinine =< 2 times the upper limits of normal (ULN)
Serum creatinine within 3 times the upper limits of normal
Renal insufficiency: anything over institutional normal limits for creatinine that is also clinically documented
Within 14 days of registration: Creatinine within normal institutional limits OR
Creatinine < 2 x institutional limits
Creatinine within 1.5 x the upper limit of normal (ULN) institutional limits
Creatinine =< 2 x upper limits of normal (ULN)
Creatinine =< 2 times the upper limits of normal (ULN)
Obtained within 2 weeks from study entry: Creatinine =< 1.5 X upper limits of normal
Free thyroxine (T4) within normal limits
Creatinine within normal institutional limits OR
creatinine within normal institutional limits OR
Creatinine < 1.5 x institutional upper limits of normal
Creatinine =< 2 x normal institutional limits
Troponin T or I within normal institutional limits
Serum creatinine within normal limits within 90 days prior to registration
creatinine within normal institutional limits OR
Serum creatinine =< 1.5 X upper limits of normal or creatinine clearance > 60 mg/min for subjects with creatinine levels >= 1.5 X upper limits of normal
Cardiac function within institutional normal limits on echocardiogram
Serum creatinine within normal institutional limits
Troponin I or T within normal limits
Serum creatinine less than 1.5 times the upper limits of normal
Serum creatinine (Cr) within normal limits (WNL) or
Electrolytes within normal limits
Coagulation: INR within normal limits, PTT within normal limits
Serum creatinine within normal limits
Creatinine up to 1.5 X normal institutional limits
Creatinine within normal institutional limits OR
Hemoglobin within institutional normal limits
Platelet count within institutional normal limits
Creatinine within normal institutional limits for age
Creatinine =< 1.5 x upper limits of normal
Creatinine within normal limits
Creatinine =< institutional upper limits of normal (ULN)
Creatinine =< the upper institutional limits
Creatinine within normal institutional limits
Serum creatinine < 1.5 x upper limits of normal, or
Serum creatinine =< 2.0 x upper limits of normal, or
Creatinine within normal institutional limits
Normal renal function (defined as creatinine within normal institutional limits)
Known chronic kidney disease with creatinine greater than normal institutional limits
Within 30 days of eligibility confirmation: Creatinine not above the upper limit of normal institutional limits
Renal insufficiency (i.e., serum creatinine outside of normal limits)
Platelets within normal institutional limits
Creatinine =< the upper institutional limits
Creatinine within institutional normal limits
Creatinine clearance within normal limits
Creatinine within normal institutional limits
Creatinine within normal institutional limits
serum creatinine w/in normal limits or
Total bilirubin within normal limits (must be obtained =< 2 weeks prior to randomization)
Total bilirubin < 1.5 x upper limits of normal (ULN)
Within 14 days of registration: Bilirubin =< 1.5 x upper limits of normal (ULN)
Total bilirubin < 1.5 x upper limits of normal (ULN)
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin < 1.5 x upper limits of normal (ULN)
Bilirubin =< 2.0 x upper limits of normal (ULN)
Total bilirubin =< 1.5 x upper limits of normal (ULN) (=< 28 days prior to registration)
Bilirubin ? 1.5 x upper limits of normal
PIK3CA WILD TYPE COHORT (closed 03/17/2016): Total bilirubin =< upper normal institutional limits
ENDOCRINE RESISTANT AND ADJUVANT COHORT: Total bilirubin =< upper normal institutional limits
Bilirubin should be within normal limits (CTCAE v4.0, grade 1)
Total bilirubin =< 1.5 x upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Bilirubin < 1.5 x upper limits of normal (ULN)
Total bilirubin =< 1.5 mg/dL X institutional upper limits of normal (ULN)
Total bilirubin < 2.5 times the upper limits of normal (ULN)
Hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits, LDH, SGOT and SGPT>2 times upper limits of normal or albumin <3.5 g/dL.
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN) except for patients with Gilbert’s disease
Bilirubin =< 1.5 times upper limits of normal (ULN)
For pts with liver metastasis: total bilirubin outside of normal limits
Total bilirubin outside of normal limits
Total bilirubin =< 1.5 X upper limits of normal
Total bilirubin with normal institutional limits; NOTE: for this study, subjects with bilirubin levels > 1.5 upper limit of normal (ULN) are excluded from this enrollment in this study
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Normal serum total bilirubin (lower and upper limits of local Laboratory)
Bilirubin within normal limits unless patients has Gilbert’s disease and then bilirubin =< 3 x upper limits of normal (ULN)
Serum total bilirubin > 2.0 and/or serum transaminases > 3 X the upper limits of normal
Total bilirubin < 2.0 x the upper limit of normal and direct bilirubin within normal limits
Serum SGOT/AST <3.0 x upper limits of normal (ULN)
Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
Serum total bilirubin =< 2X the upper limits of normal (ULN).
TSH within normal limits at baseline, (if not WLN, then total T3 or free T3 and free T4 should be within normal limits) or stable with treatment.
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin: within normal limits at each study site local laboratory
Performed within 14 days prior to study: Bilirubin < 3 times the upper limits of the institutional normal
Bilirubin =< 1.5 x upper limits of normal
Total bilirubin < 1.5 x upper limits of normal
Total bilirubin =< 1.5 x upper limits of normal (ULN)
Aspartate aminotransferase (AST) =< 2.5 x upper limits of normal (ULN); for patients with liver metastasis: =< 5 x upper limits of normal (ULN)
Total bilirubin ? 1.5 x Upper Limits of Normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin ? 1.5 x the upper limits of normal (ULN)
Bilirubin, AST and ALT not more than 2 x Upper Limits of Normal
Total bilirubin within 3 times the upper limits of normal
Total serum bilirubin within normal limits regardless of liver metastases
Total bilirubin outside of normal limits; for pts with liver metastasis: total bilirubin outside of normal limits
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 2.0 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x upper limits of normal (ULN)
Patients must have the following laboratory values: ANC greater than 1500/mcL, platelet count greater than 100,000/mcL, hemoglobin greater than 10 g/dL, bilirubin less than 1.5 x upper limits of normal, AST less than 1.5 x upper limits of normal
REGISTRATION INCLUSION CRITERIA: Total bilirubin within institutional upper limits of normal unless related to primary disease
Serum bilirubin > 1.5 x upper limits of normal (ULN)
total bilirubin <1.5X upper limits of normal
Total bilirubin =< 2 X institutional upper limits of normal (ULN)
Part A: Serum alpha fetoprotein greater than or equal to 1.5 Upper Limits of Normal, Part B: Serum alpha fetoprotein less than 1.5 Upper Limits of Normal. Not applicable for Part C or D
Serum SGOT/AST <3.0 x upper limits of normal (ULN)
Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
Subject with liver failure as defined by a serum total bilirubin > 2.0 and/or serum transaminases > 3 x the upper limits of normal
Bilirubin =< 1.5 x normal limits
Bilirubin within normal limits within 90 days prior to registration
total bilirubin within normal institutional limits (or <2X the upper limit of normal in those with Gilbert's disease)
Total bilirubin outside of normal limits; for patients (pts) with liver metastasis: total bilirubin outside of normal limits
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
TREATMENT: Total bilirubin < 1.5 x upper limits of normal
Serum total bilirubin is less than or equal to the upper limits of normal
Total Bilirubin ? 1.5 x upper limits of normal
AST (SGOT) ? 2.5 x upper limits of normal
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin < 1.5 x upper limits of normal
Total bilirubin =< 1.5 x upper limits of normal (ULN)
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Bilirubin =< 1.5 x upper limits of normal
Total bilirubin =< 1.5 x the upper limits of normal (ULN)
Total bilirubin < 1.5 x upper limits of normal
Total bilirubin < 2.0 x upper limits of normal
Bilirubin > 2.0 x ULN (institutional upper limits of normal)
Bilirubin > 1.5 x ULN (institutional upper limits of normal)
Bilirubin =< 2.5 x upper limits of normal if no liver metastases present; serum total bilirubin must be =< 3 x upper limits of normal for patients with Gilbert disease; total bilirubin =< 5 x upper limits of normal if liver metastases present
Bilirubin > 1.5 x institutional upper limits of normal (ULN)
Total bilirubin =< 1.5x upper limit of normal (ULN) (or if =< 4 gm/dL and direct bilirubin is within normal limits [WNL])
Bilirubin within normal limits
Subjects must have adequate renal function defined as a serum creatinine based on age/gender
Renal insufficiency with serum creatinine > 1.6
Adequate renal function as evidenced by a serum creatinine =< 1.5 x upper limit of normal (ULN)
Adequate renal function as evidenced by a serum/plasma creatinine < 1.5 x ULN
Renal: Serum creatinine ? 1.5 times ULN.
Renal: creatinine ? 2x of ULN for age
Have adequate renal function (Serum creatinine <3 mg/dL).
Abnormal renal function (serum creatinine > 2 x ULN)
Acceptable renal function: *Serum creatinine ? 1.5 times the ULN.
Adequate renal function with serum creatinine ?2.5 mg/dL
Patients with impaired renal function as evidenced by creatinine-clearance < 50% for age, weight, height or serum creatinine > 2 x upper normal limit or dialysis-dependent
Renal function: serum creatinine ? 1.5 times the ULN range of each institution.
Adequate renal function including creatinine < 2 unless related to the disease
Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN)
Renal function: Creatinine ? 2.0 × ULN
Renal function (creatinine <1.5 × ULN)
Renal function (creatinine <1.5 × ULN)
Adequate renal function with creatinine (Cr) =< 2.5 mg/dL
Adequate renal function assessed by: serum creatinine ? 1.5 × ULN
Adequate renal function: creatinine ?1.5 x ULN
Preservation of renal function, serum creatinine did NOT increase by more than 2 fold above the normal range
Preservation of renal function, serum creatinine did NOT increase by more than 2 fold above the normal reference range
Renal function: preservation of renal function, serum creatinine did NOT increase by more than 2 fold above the normal reference range
Renal function criteria: preservation of renal function, serum creatinine did NOT increase by more than 2 fold above the normal reference range
Subjects must have adequate renal function defined as: Serum creatinine based on age/gender.
Patients must have adequate Hematologic function(ANC ? 1,500/mcl and platelets ? 100,000/mcl), Renal function(serum creatinine ? ULN or calculated creatinine clearance ? 60 mL/min), Hepatic function(serum bilirubin ? 1.5 x ULN and AST ? 2.5 x ULN and ALT? 2.5 x ULN)
Patient must have adequate renal function as defined by serum creatinine < -2.5 mg/dl obtained within 28 days prior to registration
Creatinine =< 1.2 mg/dl (urinary diversion is permitted to improve renal function)
Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (ULN)
Renal function: Serum creatinine >1.5x ULN
Renal insufficiency or serum creatinine >1.5 X ULN at screening.
Patients must have adequate renal function defined as age-adjusted serum creatinine =< 1.5 x normal for age
With impaired renal function as evidenced by creatinine-clearance < 50% for age, weight, height or serum creatinine > 2 x upper limit of normal or dialysis-dependent
Adequate renal function: serum creatinine =< 1.5 x ULN
Renal Function (creatinine clearance or serum creatinine):
Subjects must have adequate renal function as evidenced by a serum creatinine of <2.0 mg/dl.
Renal: Creatinine > 1.5x ULN
Renal: Creatinine > 1.5x ULN.
Renal: Creatinine > 1.5x ULN
Adequate renal function: serum creatinine <2.5mg/dL
Renal function: • Creatinine less than or equal to 1.5 x ULN
Renal: Serum creatinine 1.5 times ULN.
Adequate renal function defined as serum creatinine ?3 times the institutional upper limit of normal (ULN)
Adequate renal function (defined as serum creatinine =< 1.5 X ULN)
Has adequate renal function defined as serum creatinine or ? 1.5 × ULN and creatinine clearance or ? 40 ml/min.
Patient has adequate renal function defined as: Serum creatinine ?1.5 the institutional ULN
Adequate renal function, defined as serum creatinine ?1.5x ULN
Patients with normal renal function according to MD Anderson testing standards and no prior renal disease [screening cut off for serum creatinine < 1.5 times ULN]
Renal Status (within 30 days prior to randomization): a) Creatinine no greater than 1.5 times ULN
Patients must have adequate renal function (creatinine < 1.5 mg/dL) before starting therapy and the test must be performed within 14 days prior to registration
Adequate renal function, defined as serum creatinine ? 2.0 times ULN and creatinine clearance > 50 mL/min
Adequate renal function, defined by serum creatinine ? 1.5 x ULN.
Patients must have adequate renal function as defined by a serum creatinine =< 1.5 times ULN within one week prior to treatment
Has adequate renal function as evidenced by serum creatinine ?2.5 × the upper limit of normal (ULN) for the reference lab;
Patients must have an adequate renal function as documented by serum creatinine less than or equal to 2.0 mg/dL.
Patient must have adequate renal function documented by a serum creatinine of ? 1.5 times the ULN for the reference lab.
Renal function: creatinine ? 1.5 x ULN
Adequate renal function, defined as serum creatinine ? 1.5x ULN
Adequate renal function as demonstrated by serum creatinine ? 1.5 x ULN, or 24-hr urine creatinine clearance calculation >60 mL/min
Creatinine (renal function) =< 1.5 X ULN
Abnormal renal function tests (creatinine > 1.5)
Renal: Serum creatinine less than or equal to 1.5 times ULN.
Renal Function Creatinine >1.5 mg%
Hepatic and renal function meeting the strata as outlined below; nota bene (NB): patients must fulfill both total bilirubin and serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) criteria and creatinine function to be included in a group; however, if a patient’s total bilirubin and SGOT/AST and creatinine levels indicate different groups, the patient may be enrolled in the indicated group with the greatest degree of liver dysfunction; all liver and renal function tests must be completed within 24 hours prior to the start of treatment; Note: patients on dialysis will not be eligible\r\n* Group A: hepatic function: normal function (bilirubin =< upper limit of normal [ULN]; AST =< ULN); renal function: normal function (creatinine clearance [CrCl] >= 60 mL/min) \r\n* Group B: hepatic function: normal function (bilirubin =< ULN; AST =< ULN); renal function: moderate dysfunction (CrCl >= 30 and < 60 ml/min)\r\n* Group C: hepatic function: normal function (bilirubin =< ULN; AST =< ULN); renal function: severe dysfunction (CrCl >= 15 and < 30 ml/min)\r\n* Group D: hepatic function: mild dysfunction D1: bilirubin =< ULN; AST > ULN, D2: bilirubin > ULN and =< 1.5 x ULN; any AST; renal function: normal function (creatinine clearance [CrCl] >= 60 mL/min)\r\n* Group E: hepatic function: mooderate dysfunction (bilirubin 1.5 x > ULN and =< 3 x ULN; any AST); renal function: normal function (creatinine clearance [CrCl] >= 60 mL/min)\r\n* Group F: hepatic function: severe dysfunction (bilirubin > 3 x ULN and up to investigator’s discretion; any AST); renal function: normal function (creatinine clearance [CrCl] >= 60 mL/min)
Patients must have normal renal function test and no prior renal disease; the screening cut off for serum creatinine is < 1.5 mg/dL
Abnormal renal function (serum creatinine level > 2X upper limit of normal [ULN]) as assessed by the central laboratory during screening.
Adequate renal function: serum creatinine ? 1.5x ULN;
Renal function: serum creatinine ?1.5 times the ULN range of each institution.
Subjects must have adequate renal function as defined by serum creatinine < 1.5 x upper limit of normal
The participant has adequate renal function as defined by serum creatinine less than or equal to 1.5 x the institutional ULN or creatinine clearance greater than or equal to 60 mL/min for participants with creatinine levels above the ULN.
The participant has adequate renal function as defined by serum creatinine less than or equal to 1.5 x the institutional ULN or creatinine clearance greater than or equal to 60 mL/min for participants with creatinine levels above the ULN.