[c09aa8]: / clusters / clustall9k / 292.txt

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Corrected serum calcium < 11 mg/dL, and no evidence of symptomatic hypercalcemia; (corrected serum calcium is calculated by adding 0.8 mg/dL to the measured serum calcium for every 1 g/dL that the serum albumin falls below 4.0 g/dL)
Serum calcium >11 mg/dL
Subjects with serum calcium (corrected for albumin) ? 12 mg/dL
Serum calcium > 8.5 and < 10.5 mg/dL
Primary hyperparathyroidism (serum calcium [Ca] > 10.5 mg/dL and parathyroid hormone (PTH) > 72 pg/ml)
Calcium (Ca) < 10.5 mg/dl
Corrected serum calcium >= 14 mg/dl within 2 weeks of enrollment (despite appropriate measure such a short course of steroids, bisphosphonates, hydration, and calcitonin)
Serum calcium =< 12.0 mg/dL
Total serum calcium (corrected for serum albumin) >= 8.5 mg/dL or ionized calcium >= 3.8 mg/dL
Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)
Patients must have a serum calcium of >= 2.0 mmol/L (8.0 mg/dL) or albumin-adjusted serum calcium =< 2.9 mmol/L (11.5 mg/dL) within 30 days of registration; (Note: if patients are undergoing treatment for hypocalcemia and the serum calcium value at screening is > 8.0 mg/dl, then the patient will be eligible for this study)
Corrected calcium >= 11.5 mg/dL within 2 weeks of randomization
Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)
Serum calcium =< 12.0 mg/dL
Corrected serum calcium > 11.5 mg/dl within 2 weeks of enrollment
Subjects with serum calcium (corrected for albumin) >= 12 mg/dL
Serum calcium =< 12 mg/dl within 14 days of study entry
Serum calcium (ionized or adjusted for albumin) < 8 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
Serum calcium < 11.6mg/dL
Total serum calcium (corrected for serum albumin) >= 8.5 mg/dL or ionized calcium >= 3.8 mg/dL
Corrected serum calcium level of > 10.5 mg/dL (serum corrected calcium = serum calcium + 0.8[4-serum albumin])
Uncontrolled hypercalcemia (defined as serum calcium > 14 mg/dL)
Hypercalcemia: serum calcium > 11.5 mg/100 ml or
Serum calcium or albumin-adjusted serum calcium >= 2.1 mmol/L (8.4 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL) (reference range 8.5-10.8 mg/dL)
Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
Patient has symptomatic MM, as defined by any of the following:\r\n* Lytic lesions or pathologic fractures\r\n* Anemia (hemoglobin < 10 g/dL)\r\n* Hypercalcemia (corrected serum calcium > 11.5 mg/dL)\r\n* Renal insufficiency (creatinine > 1.5 mg/dL)\r\n* Other: symptomatic hyperviscosity, amyloidosis
Calcium < 10.1 mg/dL (corrected to serum albumin)
Baseline serum calcium < 8.4 mg/dL (calcium supplementation may be given to restore the serum calcium above this level prior to study entry)
Screening serum calcium levels < 2.20 mmol/L [8.8 mg/dL] (after correction for serum\n albumin
Hypercalcemia, defined as a calcium of > 11 mg/dL
(C) Calcium elevation (serum calcium >11.5 mg/dl )(> 2.65 mmol/L)
Corrected serum calcium >13.5 mg/dL (> 3.4 mmol/L)
CTCAE version (v)4.0 grade 3-4 electrolyte abnormalities:\r\n* Calcium < 7 mg/dl or > 12.5 mg/dl;\r\n* Glucose < 40 mg/dl or > 250 mg/dl;\r\n* Magnesium < 0.9 mg/dl or > 3 mg/dl;\r\n* Potassium < 3 mmol/L or > 6 mmol/L;\r\n* Sodium < 130 mmol/L or > 155 mmol/L
Corrected serum calcium superior to 14 mg per dL (superior to 3.5 mmol per L).
Absence of hypercalcemia attributed to the plasma cell disorder*: calcium (Ca) < 10.5 mg/dl or =< 2.5 mmol/L\r\n* To be determined based on clinical and laboratory assessment by the primary oncologist
Serum calcium =< 12.0 mg/dL
Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)
Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)
Serum phosphate levels >= 2.5 mg/dL or >= 0.8 mmol/L
Serum calcium =< 12.0 mg/dL
Calcium < 10.1 mg/dL (corrected to serum albumin)
Serum calcium =< 12.0 mg/dL
Patients with hypercalcemia (blood levels greater than 11.5 mg/dL) and/or abnormally high vitamin D levels (in patients with kidney disease, blood calcium levels must be 9.5 mg/dL or lower before starting paricalcitol)
Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)
Patient must have a calcium phosphate product (CPP) =< 4.0 mmol^2/L^2 or 50 mg^2/dL^2
Serum calcium =< 12.0 mg/dL
Serum calcium =< 12.0 mg/dL
Serum calcium =< 12.0 mg/dL
For Cohort C only: Subjects must have a calcium phosphate product (CPP) of <4.4 mmol^2/L^2 (55 mg^2/dL^2) if they are to continue treatment with GSK1120212
Corrected calcium =< 10 mg/dL
Serum calcium or albumin-adjusted serum calcium ? 2.0 mmol/L (8.0 mg/dL) and ? 2.9 mmol/L (11.5 mg/dL)
Corrected calcium ? 11.5 mg/dL
Serum calcium =< 12.0 mg/dL
Corrected serum calcium > 14 mg/dL
Serum calcium below the CTCAE grade 1 upper limit (11.5 mg/dL or 2.9 mmol/L); in cases where the serum calcium is below the normal range, the calcium adjusted for albumin is calculated and substituted for the measured value
Subjects with serum calcium (corrected for albumin) ? 12 mg/dL.
Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis AND have measurable disease by protein electrophoresis analyses as defined by the following:
Be diagnosed with PHPT (inappropriate PTH level in the setting of a high or high-normal serum calcium level greater than or equal to 10.0 mg/dL).
Patients with a calcium level greater than 13mg/dL.
Corrected serum calcium less than or equal to 10.5 mg/dL
Corrected calcium > 10.6 mg/dL
Preoperative serum calcium levels >= 10.9 mg/dL
Corrected serum calcium level less than or equal to 10.5 mg/dL
Serum calcium <9.8 mg/dL
Serum calcium or albumin-adjusted serum calcium 2.0 mmol/L (8.0 mg/dL) and 2.9 mmol/L (11.5 mg/dL)
Serum calcium or albumin adjusted >= 8.0 mg/dL and =< 11.5 mg/dL
Hypocalcemia (serum calcium or albumin adjusted calcium < 8.0 mg/dL) or renal dysfunction (creatinine clearance < 30 mL/min)
Hypercalcemia (serum calcium greater than [>]0.25 millimoles per liter [mmol/L] [>1 milligram per deciliter {mg/d
Hypo- (calcium [Ca] < 8.5 mg/dL) or hyper-calcemia (Ca > 10.5 mg/dL)
Serum calcium > 11 mg/dL
Calcium > 11 mg/dL
History of calcium oxalate stones
Serum calcium within normal institutional limits
Calcium within normal range (supplementation is allowed)
Patients with contraindication to use leucovorin calcium (calcium folinate), 5-fluorouracil, and oxaliplatin (FOLFOX) chemotherapy and pelvic radiation.
Calcium WNL
Corrected calcium value =< 1.1 x upper limit of normal (ULN)
History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
Corrected calcium at or below ULN
Corrected calcium WNL
Use of medications that increase serum levels of phosphorus and/or calcium (e.g., calcium, phosphate, vitamin D, parathyroid hormone)
Total calcium (corrected for serum albumin) before the first dose of ceritinib
Hypercalcemia at baseline, defined as any corrected calcium greater than the laboratory’s normal parameters
Patients must have corrected calcium and phosphate < upper limit or normal (ULN) obtained within 7 days prior to sub-study registration
Patients must have corrected calcium and phosphate < ULN obtained within 7 days prior to sub-study registration
Serum calcium within normal limits
Total calcium (corrected for serum calcium) =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration
Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
Serum calcium levels outside the laboratory’s reference range
History of a calcium/phosphate homeostasis disorder
Subjects with a history of calcium oxalate nephrolithiasis are excluded
Plasma calcium > 8.5 and < 10.5
Total calcium (corrected for serum albumin)
Corrected serum calcium ? ULN
Serum calcium (corrected for albumin level) =< 1x institutional ULN
Pre-existing hypercalcemia (defined as baseline serum calcium above the institutional ULN, corrected for albumin level if albumin is not within institutional limits of normal); the use of supplemental calcium is prohibited while on study
Normal serum calcium (or normal corrected serum calcium)
Calcium levels must be normalized and maintained within normal limits for study entry and while on treatment
Normal corrected calcium levels
Corrected calcium =< institutional ULN (corrected calcium = (4- Albumin) x 0.8 + calcium)
Calcium: not above normal institutional limit
Serum calcium > 8.4; electrolyte repletion is allowed to reach these values
No dietary supplements allowed during the study period, except multivitamins, vitamin D and calcium.
Patient has a corrected serum calcium ?ULN.
Corrected serum calcium concentration within normal range per local clinical laboratory standard
Preoperative parathyroid hormone (PTH) elevated beyond normal range or inappropriately high for associated calcium level
Fatigue brought on by conditions other than cancer such as (the indicated tests are required only if that mechanism of fatigue is suspected):\r\n* Uncontrolled hypothyroidism (thyroid-stimulating hormone [TSH] > 10 IU)\r\n* Hypercalcemia (calcium > 11 mg/dL) calcium (Ca)=SerumCA + 0.8* (Normal/Albumin –PatientAlbumin)\r\n* Decompensated congestive heart failure\r\n* Chronic obstructive pulmonary disease requiring oxygen replacement
Subjects with any pathology associated with altered serum calcium levels
If taking more than 1000 mg/day of elemental calcium, must be willing and able to discontinue or reduce their calcium use and/or use non-calcium based therapies for the duration of the study
Has history of calcium oxalate stones
History of known abnormalities in calcium metabolism
Hypercalcemia (serum calcium in excess of laboratory upper limit of normal [ULN])
Participants with a calcium intake >= 700 mg/day measuring with 24 hour dietary recalls
Participants with a calcium intake < 2000 mg/day measuring with 24 hour dietary recalls
Serum calcium =< institutional ULN
Acute liver disease, unexplained transaminase elevations, or elevated serum calcium
History of known abnormalities in calcium metabolism
Hypercalcemia (serum calcium in excess of laboratory upper limit normal [ULN])
Has serum calcium less than or equal to ULN (for patients with an albumin lower than 3.0, a corrected calcium serum calcium = serum calcium +[0.8][3.5-serum albumin]) within 72 hours prior to registration
Patients receiving calcium-lowering therapy or drugs that may affect calcium levels (e.g., calcitonin, mithramycin, phosphate, denosumab) within 4 weeks of initiation of topical calcitriol. Patients who have been managed with bisphosphonates or calcium-lowering therapy for 3 months or greater prior to the start of the trial and have demonstrated evidence for stability of calcium metabolism would be considered eligible for participation in the trial.
Patients treated with medications that are known to affect calcium levels within 4 weeks of initiation of topical therapy (>500 IU vitamin A, calcium supplements, fluoride, antiepileptics).with the exception of subjects on stable therapy for more than six months
Calcium within 2 x ULN
Participants must have serum calcium (corrected for albumin level) =< 1 x institutional upper limit of normal (ULN)
Pre-existing hypercalcemia (defined as baseline serum calcium above the institutional ULN, corrected for albumin level if albumin is not within institutional limits of normal)\r\n* The use of supplemental calcium or supplements containing calcium is prohibited during the treatment period of this clinical trial
Total calcium (corrected for serum albumin)