Fasting cholesterol =< 300 mg/dL and triglycerides =< 2.5 x IULN obtained within 28 days prior to registration; patients may be on lipid lowering agents to reach these values
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
=< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting total cholesterol ?300 mg/dL (or ?7.75 millimoles [mmol]/L) and/or fasting triglycerides level ?2.5 × the ULN. Note: these participants can be included after initiation or adjustment of lipid-lowering medication.
Fasting serum cholesterol =< 300 mg/dl or 7.75 mmol/L and fasting triglycerides =< 2.5 × ULN; in case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved
Patients must have cholesterol level < 350 mg/dL and triglycerides < 400 mg/dL before starting therapy; in case one or both of these are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication and documentation of cholesterol < 350 mg/dL and triglycerides < 400 mg/dl before start of therapy
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L, AND fasting triglycerides =< 2.5 x\r\nULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR >= 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; note: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication with confirmed reduction of lab values to within eligibility parameters
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND\r\n* NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting triglycerides =< 2.5 x ULN\r\n* NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol < 300 mg/dL and triglycerides < 2.5 x ULN; Note: in case one or both of these thresholds are exceeded, the patient can be included after initiation of appropriate lipid lowering medication if on repeat analysis, both levels fall within parameters
TREATMENT: For patients on everolimus, fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x upper limit of normal (ULN); NOTE: in case one or both of these thresholds are exceeded, the patient can receive everolimus on study only after initiation of appropriate lipid lowering medication with follow up documentation of values below the above cut-off
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Adequate cardiac function (left ventricular ejection fraction >= 50% as measured by echocardiogram or multigated acquisition [MUGA] scan)\r\n* Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient may be included after initiation of appropriate lipid lowering medication with approval from the principal investigator
Fasting serum cholesterol ? 300 mg/dl or 7.75 mmol/L and fasting triglycerides ? 2.5 × ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 240 mg/dL or =< 7.75 mmol/L and fasting triglycerides =< 2.5 x ULN. \r\n* NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
Fasting cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x IULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL or =< 7.75 mmol/L and fasting triglycerides =< 2.5 x ULN; in case of any of these thresholds be exceeded, the patient can only be included after initiation of appropriate lipid lowering medications
Patients must have a fasting cholesterol =< 300 mg/dl OR =< 7.75 mmol/L and triglycerides =< 2.5 x IULN obtained within 28 days prior to registration; patients may be on lipid lowering agents to reach these values
Fasting serum cholesterol =< 240 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Patients with fasting serum cholesterol > 300 mg/dL OR > 7.75 mmol/L AND fasting triglycerides > 2.5 x upper limit of normal (ULN) should initiate lipid lowering medications
Patients with fasting serum cholesterol > 300 mg/dL OR > 7.75 mmol/L AND fasting triglycerides > 2.5 x ULN who would need to initiate lipid lowering medications
Fasting serum cholesterol =< 300 mg/dL OR ? 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL or =< 7.75 mmol/L AND fasting triglycerides =< 300 mg/dL or 3.42 mmol/L\r\n* NOTE: non-fasting cholesterol/triglyceride levels that meet these criteria are acceptable; if these thresholds are exceeded in non-fasting samples, then fasting samples should be obtained\r\n* NOTE: if one or both of these thresholds are exceeded in fasting samples, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN\r\n* NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x upper limit of normal (ULN); NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Total cholesterol =< 300 mg/dL AND fasting triglycerides =< 2.5 x institutional ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
EXPANSION COHORT ONLY: Total cholesterol =< 300 mg/dL AND fasting triglycerides =< 2.5 x institutional ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting total cholesterol >300 milligram per deciliter (mg/dL) (or ?7.75 millimole per liter (mmol/L)) and/or fasting triglycerides level ?2.5 x upper limit of normal (ULN). Note: these subjects can be included after initiation or adjustment of lipid-lowering medication
NOTE: In case one or both of these thresholds (for fasting serum cholesterol or triglyceride) are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol > 300 mg/dL OR > 7.75 mmol/L or fasting triglycerides > 2.5 x ULN; NOTE: in case of one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN obtained =< 90 days prior to registration; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x upper limit of normal (ULN); NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x upper limit of normal (ULN); NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Fasting total cholesterol ?300 milligrams (mg)/dL (or ?7.75 millimoles [mmol]/L) or fasting triglycerides level ?2.5 × ULN. Note: these participants can be included after initiation or adjustment of lipid-lowering medication.
Fasting cholesterol > 300 mg/dl or triglycerides > 300 while on lipid lowering agents
Fasting serum cholesterol =< 300 mg/dL or =< 7.75 mmol/L and fasting triglycerides =< 2.5 x ULN; Note: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Serum potassium > 3.5 mmol/L Parts C2 and D2
Serum potassium >= 3.5 mmol/L performed within 30 days prior to the date of registration (if < 3.5, can be repleted and reassess for eligibility as long as stable off potassium supplementation for > 48 hours [hrs])
Obtained within 14 days prior to registration: Potassium > 3.5 mmol/L (within institutional normal range)
Serum potassium ? 3.5 mmol/L. Supplementation and re-screening is allowed.
Documented within 14 days of registration: Sodium: >= 130 and =< 145 mmol/L
Documented within 14 days of registration: Potassium: 3.4- 4.8 mmol/L
The following metabolic values will exclude patients from study enrollment: \r\n* 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\r\n* Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels; 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 (eg, magnesium oxide) at the investigator’s discretion\r\n* Potassium < 3.5 mmol/L or > 6 mmol/L despite intervention to normalize levels\r\n* Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels
Serum potassium >= 3.5 mmol/L
Serum potassium >= 3.5 mmol/L
Serum potassium ? 3.5 mmol/L
Serum potassium >= 3.5 mmol/L.
Potassium > 3 and < 5.5 mmol/L.
Potassium >= 3.5 mmol/L (within institutional normal range) within 14 days of cycle 1 day 1
Within 14 days of registration: Potassium >= 3.5 mmol/L (within institutional normal range)
Serum potassium >= 3.5 mmol/L
Serum potassium < 3.5 mmol/L
Serum potassium >= 3.5 mmol/L
Serum potassium >= 3.5 mmol/L
Within 3 months of registration: Serum potassium >= 3.5 mmol/L
Potassium < 3.5 mmol/L or > 6 mmol/L despite intervention to normalize levels
Chloride 98-107 mmol/L
Within 28 days of study registration: Potassium >= 3.5 mmol/L
Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels
Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels
Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels
Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels
Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v]. 4):\r\n* Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl\r\n(> 3.1 mmol/L) despite intervention to normalize levels\r\n* Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels\r\n* Potassium < 3.5 mmol/L or > 6 mmol/L despite intervention to normalize levels\r\n* Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels
Serum potassium < 4.0 mmol/L or above 5.0 mmol/L
Patients with hyponatremia (sodium < 130 mmol/L)
Performed within 14 days of patient registration: Serum potassium > 3.8 mmol/L (can be achieved with replacement)
Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration\r\n* Transmural myocardial infarction within 6 months prior to registration\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients\r\n* Grade 3-4 electrolyte abnormalities (CTCAE, v. 4):\r\n** 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\r\n** Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L)\r\n** Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels\r\n** Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels\r\n** Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels
Potassium 3.4 – 5.0 mmol/L
Serum potassium >= 3.5 mmol/L
Have a baseline serum potassium >= 3.5 mmol/L
Serum potassium >= 3.5 mmol/L
Potassium levels < 3.5 mmol/L or > 5.1 mmol/L
Obtained within 14 days prior to registration: Potassium >= 3.5 mmol/L
Serum potassium (K)+ < 3.5 mmoL/L; patients with a K+ < 3.5 mmoL/L are required to have a documented subsequent K+ > 3.5 prior to enrollment to be eligible
Serum sodium level is ? 130 mmol/L
Serum sodium level ? 130 mmol/L
Serum sodium greater than 120 mmol/L
13.9 mmol/L]).
Potassium <3.5 mmol/L.
Serum potassium >= 3.8 mmol/L
Serum potassium greater than 3.5 mmol/L without oral supplementation
Serum sodium level is ? 130 mmol/L
Serum potassium >= 3.5 mmol/L
Serum potassium >= 3.8 mmol/L
Potassium 3.2-4.8 mmol/L (inclusive)
Serum potassium >= 3.5 mmol/L
Hyponatremia (sodium < 135 mmol/L)
Serum triglyceride level =< 300 mg/dL
Serum total cholesterol level =< 300 mg/dL
Patients must have a serum triglyceride level =< 300 mg/dL and serum cholesterol level =< 300 mg/dL; if an initial random draw (i.e. non-fasting) is out of range, it is acceptable to repeat this test as a fasting draw
Serum triglyceride level =< 300 mg/dL and serum cholesterol =< 300 mg/dL; if these labs were drawn non-fasting and do not meet the eligibility criteria then it is suggested that they are repeated fasting, i.e. no food or drink other than water for 8 hours; the use of medication to achieve these parameters is not allowed
Total cholesterol < 300 mg/dL
Patients must have a fasting LDL cholesterol within the normal range per institutional guidelines
Fasting serum cholesterol =< 300 mg/dL
Fasting triglyceride =< 2.5 x ULN
Fasting cholesterol =< 1.5 x ULN
Fasting serum triglyceride level =< 500 mg/dL
Serum cholesterol levels must be less than grade 2 (< 300 mg/dL), and serum triglyceride levels must be less than grade 2 (< 2.5 x ULN)
Fasting or non-fasting serum triglyceride level =< 300 mg/dL and serum cholesterol level =< 300 mg/dL
Cholesterol =< 300 mg/dL
Serum triglyceride level =< 300 mg/dL within 7 days prior to enrollment
Serum total cholesterol level =< 300 mg/dL within 7 days prior to enrollment
Serum cholesterol and serum triglyceride levels must be less than 300 mg/dl
Serum cholesterol and serum triglyceride levels must be < grade 2
Fasting level of total cholesterol of no more than 350 mg/dL
Triglyceride level of no more than 400 mg/dL
Fasting triglyceride =< 200 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)
Fasting cholesterol =< 240 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)
Serum triglyceride =< 300 mg/dL (applicable only for dose levels that include isotretinoin) (note that a non-fasting triglyceride value could be obtained, if this is > 300 mg/dL then a fasting triglyceride should be obtained and patient will be eligible if the fasting level is =< 300 mg/dL)
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L
History of hypertriglyceridemia with triglyceride levels > 200 mg/dl; patients with triglyceride levels < 200 receiving treatment for hypertriglyceridemia or hyperlipidemia are considered eligible
Fasting serum triglyceride level =< 500 mg/dL
Fasting serum cholesterol less than or equal to 300 mg/dL
Have plasma total cholesterol < 300 mg/dL
Have plasma total cholesterol > 300 mg/dL
Serum triglyceride level =< 300 mg/dL (=< 3.42 mmol/L)
Serum cholesterol level =< 300 mg/dL (7.75 mmol/L)
Subject has cholesterol panel and triglyceride done before first treatment
Cholesterol level =< 350 mg/dl; fasting is not required before testing, but if elevated without fasting, repetition with fasting can be performed to determine eligibility
May be on cholesterol medications
Cholesterol =< 350 mg/dL
Fasting level of total cholesterol of no more than 350 mg/dL
Triglyceride level of no more than 400 mg/dL
Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND
Serum cholesterol >= Grade 2
Serum fasting triglyceride level =< 300 mg/dL (=< 3.42 mmol/L) and serum cholesterol level =< 300 mg/dL (=< 7.75 mmol/L)
Low-density lipoprotein (LDL) -cholesterol ?130 mg/dL (individuals with elevated LDL-cholesterol will be referred for clinical management of dyslipidemia)
Fasting cholesterol level < 350 mg/dl
Fibrinogen level < 150 mg/dl
Cholesterol =< 300 mg/dL (7.75 mmol/L)
Total cholesterol =< 200 mg/dl
Patients with hypertriglyceridemia with serum triglyceride level >= 500 mg/d (lipid lowering drugs may be used to control level)
Fasting cholesterol =< 1.5 x ULN
Have plasma total cholesterol < 200 mg/dL
Fasting triglycerides =< 300 mg/dL
Within less than or equal to 14 days prior to registration: Fasting triglycerides =< 300 mg/dL
Fasting triglycerides =< 300 mg/dL
Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)
Triglycerides < 250 mg/dL
Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL); if a patient is excluded solely based upon a non-fasting triglyceride level, a fasting test should be performed to determine eligibility
Metabolic status: HbA1c < 7.0%, fasting serum glucose ? 130 mg/dL, and fasting triglycerides ? 300 mg/dL.
Fasting triglycerides =< 1.5 x upper limit of normal (ULN)
Fasting triglycerides =< 300 mg/dL
Fasting triglycerides =< 300 mg/dL.
Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL).
Uncontrolled hypertriglyceridemia (triglycerides > 450mg/dL).
Only for subjects enrolled in Arm 1 - Neratinib and everolimus: fasting lipid profile: cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL.
Fasting serum glucose < 130 milligram per deciliter (mg/dL) and fasting triglycerides <= 300 mg/dL.
Fasting triglycerides =< 300 mg/dL
Fasting triglycerides =< 300 mg/dL
Fasting triglycerides =< 300 mg/dL
Metabolic: fasting triglycerides =< 300 mg/dL
Fasting triglycerides =< 300 mg/dL
Fasting triglycerides =< 300 mg/dL
Have uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)
Serum triglycerides < 300mg/dL fasting or on a random plasma test
Fasting triglycerides =< 300 mg/dL
Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)
Fasting cholesterol less than or equal to 300 mg/dl; fasting triglycerides less than or equal to 300 mg/dl
Metabolic: fasting serum glucose (=< 130 mg/dL) and fasting triglycerides =< 300 mg/dL
Baseline cholesterol must be < 350 mg/dL and triglycerides < 300 mg/dL (with or without the use of antihyperlipidemic medications)
Uncontrolled hyperlipidemia (total cholesterol > 350 or triglycerides > 300)
Fasting triglycerides =< 300 mg/dL or =< 1.71 mmol/L
Patients must not have uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 x ULN) obtained within 28 days prior to registration; optimal lipid control must be achieved before registration and monitored during protocol treatment
Fasting triglycerides =< 5 x time the upper limit of normal; patients above this level may be eligible with permission of the study chair; triglycerides may be \normalized\ prior to study entry with use of an antilipemic agent (atorvastatin, fenofibrate)
Screening fasting lipid panel: LDL cholesterol < 190 mg/dL, triglycerides < 300 mg/dL
Glycosylated hemoglobin (HbA1c) less than (<) 7.0%, fasting serum glucose <=130 milligram per deciliter (mg/dL), and fasting triglycerides <=300 mg/dL.
Fasting triglycerides less than or equal to 300 mg/
Fasting triglycerides =< 300 mg/dL
Triglycerides level =< 400 mg/dl; fasting is not required before testing, but if elevated without fasting, repetition with fasting can be performed to determine eligibility
Fasting serum cholesterol less than or equal to 300 mg/dL OR less than or equal to 7.75 mmol/L AND fasting triglycerides less than or equal to 2.5 x ULN
Normal fasting cholesterol and triglycerides
PART B: Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)
Fasting serum cholesterol =< 300 mg/dl OR =< 7.75 mmol/l AND fasting triglycerides =< 2.5 times ULN*
Cholesterol > 300 mg/dl or triglycerides > 400 mg/dl despite treatment
Known uncontrolled hyperlipidemia defined as LDL-C >= 190 mg/dL or triglycerides >= 500 mg/dL
Triglycerides =< 400 mg/dL (sirolimus and hydroxychloroquine only)
Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
Fasting triglycerides =< 2.5 x ULN
Uncontrolled (? Grade 2) hypertriglyceridemia (fasting triglycerides > 300 mg/dL (3.42 mmol/L))
fasting serum cholesterol ?300 mg/dL OR ?7.75 mmol/L AND fasting triglycerides ?2.5 x ULN.
Fasting triglycerides =< 300 mg/dl
Elevated triglycerides
Elevated triglycerides
Fasting triglycerides =< 300 mg/dL
Obtained =< 30 days prior to registration: Triglycerides < 500 mg/dL
Fasting triglycerides =< 300 mg/dL (3.42 mmol/L)
Triglycerides =< 150 mg/dl
Triglycerides (fasting) >= 400
Fasting triglycerides =< 1.5 x upper limit of normal (ULN)
Have plasma triglycerides < 200 mg/dL
Have plasma total cholesterol > 200 mg/dL or plasma triglycerides > 200 mg/dL
Fasting triglycerides > 300 mg/dL
Fasting serum glucose ?130 mg/dL and fasting triglycerides ?300 mg/dL.