Obtained within 14 days prior to treatment start: Potassium (K) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Obtained within 14 days prior to treatment start: Total calcium (CA) (corrected for serum albumin) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Obtained within 14 days prior to treatment start: Magnesium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Obtained within 14 days prior to treatment start: Sodium (NA) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Obtained within 14 days prior to treatment start: Phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Potassium, total calcium (corrected for serum albumin), magnesium, and phosphorus within normal limits for the institution or corrected to within normal limits with supplements
Potassium, total calcium (corrected for serum albumin), magnesium, and sodium within normal limits for the institution or corrected to within normal limits before first dose of study medication
Potassium, sodium, calcium (corrected for serum albumin), magnesium, and phosphorus within normal limits for the institution;
Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Patients must have the following laboratory values within the laboratory normal limits or corrected to within normal limits with supplements during screening:\r\n* Potassium\r\n* Magnesium\r\n* Phosphorus\r\n* Total calcium (corrected for serum albumin)
Total Ca (corrected for serum albumin) w/in normal limits
Serum sodium within normal limits or corrected to within normal limits with supplements before starting treatment
Potassium within normal limits or corrected to within normal limits with supplements before starting treatment
Magnesium within normal limits or corrected to within normal limits with supplements before starting treatment
Phosphorus within normal limits or corrected to within normal limits with supplements before starting treatment
Clotting parameters within normal limits or maximum 25% outside of the the normal ranges
serum troponin T levels within normal limits;
Patient must have the following laboratory values or have the following laboratory values corrected with supplements to be within normal limits before the first dose of ceritinib + trametinib:\r\n* Potassium\r\n* Magnesium\r\n* Phosphorus\r\n* Total calcium (corrected for serum albumin)
Potassium, total calcium (corrected for serum albumin), magnesium, and sodium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Potassium, sodium, and total calcium (corrected only in the case of hypoalbuminemia) within normal limits of the local laboratory (screening values can be rechecked after electrolyte repletion and before the first dose of study medication, if necessary)
Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Total calcium (corrected for serum albumin) within normal limits prior to the first dose of study medication
Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication
Potassium, sodium, magnesium, and calcium (corrected for serum albumin) =< grade 1 or within the institutional ranges of normal; if clinically appropriate, electrolytes may be corrected and values reassessed prior to enrollment (within 14 days prior to registration)
Patients must have the following laboratory values or have the following laboratory values corrected to be within normal limits before the first dose of ceritinib:\r\n* Potassium\r\n* Magnesium\r\n* Phosphorus\r\n* Total calcium (corrected for serum albumin)
Serum sodium, potassium, magnesium and calcium within normal limits for the institution (supplements may be given to correct values)
Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
CAPMATINIB INCLUSION CRITERIA: Serum potassium, calcium (corrected for serum albumin), magnesium, phosphorus within normal limits with or without supplementation
CERITINIB INCLUSION CRITERIA: Serum potassium, calcium (corrected for serum albumin), magnesium, phosphorus within normal limits with or without supplementation
REGORAFENIB INCLUSION CRITERIA: Serum potassium, calcium (corrected for serum albumin), magnesium, phosphorus within normal limits with or without supplementation
Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed)
Newly diagnosed MCL: Uric acid within normal limits (allopurinol is allowed to bring abnormal level to within normal limits)
Prothrombin time (PT) within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasty
Partial thromboplastin time (PTT) within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasty
Potassium, Magnesium, Phosphorus, total Calcium (corrected for serum albumin) outside of normal limits (patients may be enrolled if corrected to within normal limits with supplements during screening)
Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed)
9. Adequate organ function as defined by the following: \r\na. Serum creatinine =< 2 x the upper limit of normal (ULN), or glomerular filtration rate > 20 ml/hour (h) as calculated by Cockcroft-Gault formula.\r\nb. Serum potassium, magnesium, and calcium (corrected for albumin) within institutional normal limits or can be corrected with supplementation.\r\nc. Total serum bilirubin =< 2.5 x ULN.\r\nd. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =< 2.5 x ULN.
Albumin within normal limits
Potassium within normal limits for the institution, or corrected with supplements
Calcium (corrected for albumin) within normal limits (oral supplementation is allowed)
Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Serum sodium within normal limits
Serum potassium, magnesium, and calcium (serum calcium corrected for hypoalbuminemia) within institutional normal limits. Subjects with electrolytes outside the normal range will be eligible if these values are corrected upon retesting following any necessary supplementation.
Sodium, potassium, phosphorus, magnesium and total calcium laboratory values within normal limits
Patients have the following laboratory values outside of the laboratory normal limits or cannot be corrected to within normal limits with supplements during screening: Potassium, Magnesium, Phosphorus, Total calcium (corrected for serum albumin)
Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within institutional upper limit of normal (IULN) or corrected to within normal limits with supplements before first dose of study medication; (supplements used for this purpose to be approved by primary investigator [PI])
Potassium and calcium (corrected for albumin), within normal limits for the institution, or =< grade 1 if judged not clinically significant by the investigator
Serum potassium (corrected for serum albumin) must be within clinically relevant limits (e.g., a patient can be enrolled if a lab value may be outside the normal laboratory range but the abnormality is not clinically relevant or can be repleted)
Sodium (corrected for serum albumin) must be within clinically relevant limits (e.g., a patient can be enrolled if a lab value may be outside the normal laboratory range but the abnormality is not clinically relevant or can be repleted)
Magnesium (corrected for serum albumin) must be within clinically relevant limits (e.g., a patient can be enrolled if a lab value may be outside the normal laboratory range but the abnormality is not clinically relevant or can be repleted)
Phosphorus (corrected for serum albumin) must be within clinically relevant limits (e.g., a patient can be enrolled if a lab value may be outside the normal laboratory range but the abnormality is not clinically relevant or can be repleted)
Total calcium (corrected for serum albumin) must be within clinically relevant limits (e.g., a patient can be enrolled if a lab value may be outside the normal laboratory range but the abnormality is not clinically relevant or can be repleted)
Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed)
Serum sodium within normal limits
Total calcium (corrected for serum albumin) within normal limits
Total calcium (corrected for serum albumin) within normal limits or corrected with supplements
Patients must have the following electrolyte values ? LLN (lower limit of normal) limits or corrected to within normal limits with supplements prior to the first dose of study medication:
Patients must have the following laboratory values (WNL = within normal limits at the local institution lab) or corrected to within normal limits with supplements prior to the first dose of study medication:\r\n* Potassium (WNL)\r\n* Phosphorus (WNL)\r\n* Calcium (WNL)
Serum calcium, magnesium, potassium within normal limits, or if outside of normal limits, must be deemed clinically insignificant by the investigator
Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed; the use of denosumab [Xgeva] is permitted)
Total calcium (corrected for serum albumin) within normal limits (biphosphonate use for malignant hypercalcemia control is not allowed)
Uric acid within normal limits
Potassium, magnesium, and calcium (corrected for albumin) > normal limits for the institution
Potassium and calcium (corrected for albumin), sodium and magnesium within institutional normal limits
Magnesium within 0.85 to 1.25 * institutional normal limits, Sodium greater than or equal to 130 milli equivalent per liter, Potassium within institutional normal limits (within 14 days prior to Day 1 of Cycle 1 up until pre-dose of Cycle 1)
Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed)
Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed)
Sodium, potassium, phosphorus, magnesium and total calcium laboratory values within normal limits
The following laboratory values must be within normal limits prior to starting study drug (supplementation allowed): potassium, magnesium, total calcium (corrected for serum albumin), phosphorous
Serum electrolytes within normal limits: potassium, calcium (total, or corrected for serum albumin in case of hypoalbuminemia) and magnesium. If outside of normal limits, subject will be eligible when electrolytes are corrected;
Corrected calcium within normal limits, previous hypercalcemia allowed
Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
Patients must have the following electrolyte values within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication:
No more than grade 1 abnormalities of potassium, calcium (confirmed by ionized calcium), magnesium, and phosphorus (supplementation allowed)
Uncontrolled hypercalcemia (ionized calcium >1.5 millimoles per liter [mmol/L], calcium >12 milligrams per deciliter [mg/dL], or corrected calcium greater than the upper limit of normal [ULN]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
Total serum calcium (corrected for serum albumin) or ionized calcium >= lower limit of normal (LLN)
Total and ionized serum calcium outside of normal limits
Normal ionized calcium (can be on oral supplementation)
Within 14 days prior to registration: Total serum calcium (corrected for serum albumin as needed) or ionized calcium within institution’s normal range
Uncontrolled symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dl or corrected serum calcium > ULN)
Normal ionized calcium, magnesium and phosphorus (can be on oral supplementation)
Current treatment with intravenous bisphosphonate or denosumab with elevated serum calcium corrected for albumin or ionized calcium levels outside institutional normal limits at screening
Adjusted (or ionized) calcium >= the institutional lower limit of normal (supplementation of electrolytes prior to screening is allowed)
Currently on bisphosphonate or denosumab with elevated serum calcium levels corrected for albumin/ionized calcium levels outside of institutional normal limits
Patient has serum potassium and magnesium levels WNL for the institution and total serum calcium or ionized calcium levels ? the lower limit of normal (LLN). Patients with low potassium, calcium, and/or magnesium levels may receive supplementation to meet the protocol entry criteria. (Calcium supplementation is prohibited after starting PBI-05204; see Appendix 2.)
Uncontrolled hypercalcemia (greater than [>] 1.5 millimoles per liter [mmol/L] ionized calcium or Ca > 12 milligrams per deciliter [mg/dL] or corrected serum calcium > upper limits of normal [ULN]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
Electrolytes (including potassium, sodium, and serum calcium corrected for albumin or ionized calcium) must be within normal limits
Electrolytes (including potassium, sodium, and serum calcium corrected for albumin or ionized calcium) must be within normal limits
Participants with a serum potassium less than 3.5 mmol/L or a serum ionized calcium or magnesium below the lower limits of normal (or above CTCAE grade 1 upper limit); correction of these electrolyte abnormalities with supplements is allowed (serum calcium above the CTCAE grade 1 upper limit; in cases where the serum calcium is below the normal range, the calcium adjusted for albumin is to be obtained and substituted for the measured serum value; exclusion is to then be based on the calcium adjusted for albumin values falling below the normal limit)
Total serum calcium [corrected for serum albumin] or ionized calcium >= LLN
Patients with normal level of serum ionized calcium and phosphate.
Total serum calcium (corrected for serum albumin) or ionized calcium >= LLN
Total serum calcium (corrected for serum albumin) or ionized calcium >= LLN
Total serum calcium (corrected for serum albumin) or ionized calcium below ULN
Total serum calcium or ionized calcium level >= institutional lower limit of normal
Current treatment with intravenous bisphosphonate or denosumab with elevated serum calcium corrected for albumin or ionized calcium levels outside institutional normal limits at screening
Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal.
Serum calcium (ionized or corrected for albumin) ? 2.0 mmol/L (8.0 mg/dL or 1.0 mmol/L ionized calcium) to ? 1.2 x ULN.
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Serum total calcium (correct for serum albumin) or ionized calcium >= LLN
NON-PROGRESSED DIPG (STRATUM 2): Serum total calcium (correct for serum albumin) or ionized calcium >= LLN
Total serum calcium (corrected for serum albumin) or ionized calcium >= LLN
Total and ionized serum calcium outside of normal limits
Total serum calcium [corrected for serum albumin] or ionized calcium >= LLN
Serum calcium >=Grade 1 (per CTCAE v4.0) at time of enrolment, unless ionized calcium is within normal range
Serum total calcium (corrected for serum albumin) or serum ionized calcium >= LLN
Serum calcium (corrected for serum albumin) or ionized calcium >= lower limit of normal (LLN) (treatment of hypercalcemia is allowed and subject may enroll if hypercalcemia returns to normal with standard treatment)
Ionized calcium =< ULN
Serum calcium above the CTCAE grade 1 upper limit; in cases where the serum calcium is below the normal range, 2 options would be available: 1) the calcium adjusted for albumin is to be obtained and substituted for the measured serum value; exclusion is to then be based on the adjusted for albumin values falling below the normal limit; 2) determine the ionized calcium levels; if these ionized calcium levels are out of normal range despite supplementation, then the patient must be excluded
Participants must have an ionized serum calcium within normal limits
Patients with hypercalcemia (using ionized calcium)
Potassium >= 3.5 mmol/L (within institutional normal range, or correctable with supplements), within 14 days of registration
Potassium within normal range, or correctable with supplements; within 14 days start of study start
Potassium > lower limit of normal (LLN) or correctable with supplements prior to first dose of study medication
Magnesium > LLN or correctable with supplements prior to first dose of study medication
Total calcium (corrected for serum albumin) >= LLN or correctable with supplements prior to first dose of study medication
Potassium within normal institutional range, or correctable with supplements
Potassium within normal range or correctable with supplements
Magnesium within normal range or correctable with supplements
Corrected serum calcium within normal range, or correctable with supplements
Potassium within normal range, or correctable with supplements,
Potassium within normal limits or correctable with supplements.
Within 14 days of study start: Potassium within normal range, or correctable with supplements
Potassium within normal range, or correctable with supplements
Potassium within normal range, or correctable with supplements
Potassium within normal limits or correctable with supplements
Magnesium > lower limit of normal (LLN) or correctable with supplements
Calcium (after correction for albumin level) > LLN or correctable with supplements
Potassium within normal range or corrected with supplements
Potassium within normal range, or correctable with supplements;
Selected electrolytes within normal limits or correctable with supplements.
Patients must have serum chemistries (including potassium and magnesium) within 21 days prior to registration to obtain baseline values
Abnormal serum calcium, magnesium, or potassium levels
Documented within 14 days of registration: Magnesium: >= 0.7 mmol/L
The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed).
The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin
Magnesium within normal range (supplementation is allowed)
Potassium and magnesium within normal range, patients may receive supplements to meet this requirement
Potassium and magnesium within normal range
Magnesium WNL
Magnesium within 0.85 to 1.25 x institutional normal limits
Patients whose electrolytes (sodium, potassium, calcium, magnesium) are abnormal or cannot be normalized with standard intervention on the day of treatment with study drug
Serum calcium, magnesium, and phosphorous with institutional normal limits (supplementation is permissible)
Magnesium WNL
Magnesium within normal limits prior to the first dose of study medication
Serum magnesium >= ILLN
Clinically significant abnormal serum potassium (regardless of potassium agent supplementation); serum calcium (ionic or binding to albumin post-adjusted) or serum magnesium (regardless of magnesium agent supplementation);
Magnesium > 1.2 and < 2.5 mEq
For Phase I and II: Serum potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limits.
Patients with electrolyte abnormalities at study entry defined as follows: Serum potassium < 3.5 mEq/L despite supplementation, or > 5.5 mEq/L; Serum magnesium above or below the institutional normal limit despite adequate management; Serum calcium (corrected for albumin levels) above or below institutional normal limit despite adequate management.
Clinically significant electrolyte disorders including sodium < 130 or > 145 and/or potassium < 3.0 or > 5.5 and/or magnesium < 1.8 or > 2.9
Normal magnesium (can be on oral supplementation)
Serum potassium, magnesium, and calcium levels normal per current Yale-New Haven Hospital (YNHH) lab medicine standards (may be corrected to those levels by supplementation during screening period) within 2 weeks prior to start of any therapy
Potassium, magnesium and phosphorus within the normal range for the institution (supplementation is permissible)
Serum potassium, magnesium and calcium levels which fall within normal limits or levels outside the normal range determined not to be clinically significant by the principal investigator (PI)
Within 14 days prior to registration: Magnesium within institution’s normal range
Serum potassium, magnesium, and calcium levels within 28 days before randomization must be within normal limits (WNL) for the lab within 28 days before randomization
The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chlorine (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator’s discretion
The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; Note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator’s discretion
Serum calcium or magnesium outside the institutional range of normal
Within 14 days of subject registration: Potassium, calcium (corrected for serum albumin) and magnesium within IULN
Uncorrected severe electrolyte disorder, including severe potassium (< 3.0 mEq/L) or magnesium (< 1.0 mEq/L) deficiency
Serum magnesium within normal limits
Potassium (K) and magnesium (Mg) >= grade 2 toxicity
Serum magnesium within normal range (patients may receive magnesium supplementation to achieve normal levels)
Performed within 14 days of patient registration: Serum magnesium > 1.8 mg/dL(can be achieved with replacement)\r\n* NOTE: The package insert for the study drug, romidepsin, does not require subject blood levels of potassium (K) and magnesium (Mg) to be at a certain level; therefore in this study, we will require K > 3.8 and Mg > 1.8 for eligibility, but for the rest of the treatment parameters during the course of the study we will require these electrolytes to be within normal range (WNL)
The following assessments are required within 2 weeks prior to the start of registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator’s discretion
Serum magnesium levels outside the laboratory’s reference range
Patient must have magnesium, calcium, glucose, potassium and sodium levels within normal limits
Serum potassium and magnesium-within normal limits (WNL)
Serum potassium, magnesium and calcium within normal limits (supplementation to maintain normal electrolyte levels is acceptable)
Obtained =< 7 days prior to registration: Magnesium within normal limits (WNL)
Patients with abnormal calcium, potassium, or magnesium levels that is or cannot be adequately corrected to =< grade 1 prior to initiation of study drugs
Calcium (Ca), magnesium (Mg), potassium (K) within normal
Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
Serum magnesium greater than or equal to 1.8 mg/dL
Magnesium (Mg) levels: preferred normal limits with no clinical abnormalities
Magnesium levels within normal limits
Serum potassium and magnesium levels within institutional normal limits; patients with low potassium and magnesium levels may be repleted to allow for protocol entry
Serum electrolyte values (sodium, potassium, magnesium, calcium) must be checked prior to enrollment and clinically significant abnormalities corrected prior to surgery/AdV-tk injection
Serum electrolyte values < Grade 2 (sodium, potassium, calcium, phosphorous and magnesium), per CTCAE v.4.03.
Subjects with > Grade 1 (high or low) serum potassium, magnesium, or calcium levels.
Serum potassium and magnesium levels within normal limits
Serum magnesium =< 1.4 mEq/L
Serum potassium, and magnesium within normal limits
Subjects with initial magnesium < 0.5 mmol/liter (1.2 mg/deciliter) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation
Serum magnesium > 1.3; electrolyte repletion is allowed to reach these values
Serum magnesium, calcium, and phosphorus must be within normal reference ranges as per local tests. [If initial screening results are outside of normal reference range, the Investigator may initiate appropriate measures to correct. However administration of FS102 may not proceed until the specified electrolytes have normalized.]
Serum calcium and magnesium within the normal range (or corrected with supplements)
Subject has any abnormalities in serum sodium, potassium, chloride, calcium and magnesium levels ? Grade 2 at screening (CTCAE Version 4.03).
Normal serum potassium magnesium levels
Serum potassium, magnesium, and calcium levels (corrected for albumin) outside the laboratory’s reference range despite correction
Must have adequate bone marrow and renal/hepatic function at the screening visit (?7 days preceding the lab assessment): i. ANC ? 1,500/mm3, without G-CSF ii. Platelets ? 100,000/mm3, without transfusion iii. Hemoglobin ? 9 g/dL, without transfusion support iv. AST or ALT ? 3 × ULN v. Total serum bilirubin ? 1.5 times ULN vi. Serum creatinine ? ULN vii. Potassium and magnesium levels within normal limits. If below the lower limit of normal, must have levels corrected by supplementation prior to starting study drug. viii. albumin > 3.0 g/dL
Serum magnesium > 1.2mEq/L
Serum magnesium must be within institutional normal limits
Renal function: Serum creatinine ? 1.5 x ULN or 24-hour clearance ? 40 ml/min, Serum potassium, magnesium and calcium must be within normal limits
Serum calcium, magnesium and potassium must be within normal limits; supplementation to achieve normal values is permitted
Magnesium within normal limits (supplementation allowed)
Participants with a calcium/magnesium intake ratio > 2.6
Magnesium below the normal range despite supplementation, or above the CTCAE grade 1 upper limit
Serum potassium, calcium, magnesium, phosphorus within normal limits (may be supplemented)
Serum magnesium and corrected serum calcium within the institution’s normal reference range
The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed).
Patients with hypersensitivity to albumin are not eligible
Calcium >= LLN (corrected for serum albumin, if albumin abnormal)
Serum albumin >= 30 g/L
Serum albumin >= 2.5
Albumin > 25 g/L
Within 14 days of randomization: Albumin > 30 g/L
Albumin >= 3.0.
Serum albumin concentration ?30 g/L
Albumin > 25 g/L
Patients with albumin allergy
Serum albumin > 28 g/L
Albumin < 2.5
Albumin > 25 g/L
Albumin > 3.0
Baseline serum albumin > 30 g/L
Hypoalbuminaemia (serum albumin < 30 g/L)
Calcium >= LLN (corrected for serum albumin, if albumin abnormal) =< 14 days prior to registration\r\n* NOTE: Supplementation may be given before the first dose of study medication
Serum albumin >= 28 g/L
Total calcium (corrected for serum albumin if albumin abnormal) above lower limit normal range for the institution; supplementation may be given before the first dose of study medication
Albumin within institutional normal range
Albumin >= 2
Serum albumin > 30 g/L, or serum albumin = 30 g/L but normal prothrombin time
Albumin <2.8
Albumin > 25 g/L
Albumin >= 3.0
Serum albumin ? 30 g/L
Serum albumin ?3.2 g/dL in the absence of receipt of (IV) albumin within the previous 72 hours.
Albumin should be >= 3
Known hypersensitivity to human albumin
Albumin > 25 g/L
Serum albumin >= 3.0
Albumin < 3.5
Urinary albumin > 1 g/day
Serum albumin < 3.0
Albumin > 3.4
Albumin within 2 x ULN
Serum albumin >= 30 g/L
Albumin >= 3.2 g/dL (in the absence of receipt of intravenous albumin in the previous 72 hours)
Serum albumin must be planned to be collected after admission, but prior to treatment
Serum albumin <25 gram per liter (g/L)