CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Metabolism and nutrition disorders

The 26 CTCAE v6.0 adverse events in Metabolism and nutrition disorders, with grades 1 to 5.

Acidosis

Metabolism and nutrition disorders
  1. G1pH <normal, but >=7.3
  2. G2Not applicable
  3. G3pH <7.3
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues.

MedDRA code (LLT): 10000486 · CTCAE v6.0 (NCI), original English text.

Alcohol intolerance

Metabolism and nutrition disorders
  1. G1Not applicable
  2. G2Present
  3. G3Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an increase in sensitivity to the adverse effects of alcohol, which can include nasal congestion, skin flushes, heart dysrhythmias, nausea, vomiting, indigestion and headaches.

MedDRA code (LLT): 10001598 · CTCAE v6.0 (NCI), original English text.

Alkalosis

Metabolism and nutrition disorders
  1. G1pH >normal, but <=7.5
  2. G2Not applicable
  3. G3pH >7.5
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by abnormally high alkalinity (low hydrogen-ion concentration) of the blood and other body tissues.

MedDRA code (LLT): 10001680 · CTCAE v6.0 (NCI), original English text.

Anorexia

Metabolism and nutrition disorders
  1. G1Loss of appetite without alteration in eating habits
  2. G2Oral intake altered without significant weight loss or malnutrition; oral nutritional supplements indicated
  3. G3Associated with significant weight loss or malnutrition (e.g., inadequate oral caloric and/or fluid intake); tube feeding or TPN indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a loss of appetite.

MedDRA code (LLT): 10002646 · CTCAE v6.0 (NCI), original English text.

Dehydration

Metabolism and nutrition disorders
  1. G1Increased oral fluids indicated; dry mucous membranes; diminished skin turgor
  2. G2IV fluids indicated
  3. G3Hospitalization indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis.

MedDRA code (LLT): 10012174 · CTCAE v6.0 (NCI), original English text.

Diabetes mellitus

Metabolism and nutrition disordersNew in v6.0
  1. G1Abnormal glucose above baseline; diet changes only; no change in baseline diabetic management
  2. G2Oral antiglycemic agent initiated; insulin sliding scale initiated
  3. G3Insulin therapy initiated or increased; hospitalization indicated
  4. G4Life-threatening consequences; urgent intervention indicated; diabetic ketoacidosis
  5. G5Death
Definition and note

DefinitionA disorder characterized by increased Hgb A1C that may result in organ damage.

Navigational noteConsider Metabolism and nutrition disorders: Hyperglycemia.

MedDRA code (LLT): 10012601 · CTCAE v6.0 (NCI), original English text.

Failure to thrive

Metabolism and nutrition disordersNew in v6.0
  1. G1Not applicable
  2. G2Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA condition characterized by global decline with weight loss, decreased appetite, poor intake, and/or inactivity.

MedDRA code (LLT): 10016165 · CTCAE v6.0 (NCI), original English text.

Hypercalcemia

Metabolism and nutrition disorders
  1. G1Corrected serum calcium of >ULN - 11.5 mg/dL; >ULN - 2.9 mmol/L; Ionized calcium >ULN - 1.5 mmol/L
  2. G2Corrected serum calcium of >11.5 - 12.5 mg/dL; >2.9 - 3.1 mmol/L; Ionized calcium >1.5 - 1.6 mmol/L; symptomatic
  3. G3Corrected serum calcium of >12.5 - 13.5 mg/dL; >3.1 - 3.4 mmol/L; Ionized calcium >1.6 - 1.8 mmol/L; hospitalization indicated
  4. G4Corrected serum calcium of >13.5 mg/dL; >3.4 mmol/L; Ionized calcium >1.8 mmol/L; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate an elevation in the concentration of calcium (corrected for albumin) in blood.

MedDRA code (LLT): 10020587 · CTCAE v6.0 (NCI), original English text.

Hyperglycemia

Metabolism and nutrition disorders
  1. G1Fasting glucose value >ULN - 160 mg/dL; Fasting glucose value >ULN - 8.9 mmol/L
  2. G2Fasting glucose value >160 - 250 mg/dL; Fasting glucose value >8.9 - 13.9 mmol/L
  3. G3>250 - 500 mg/dL; >13.9 - 27.8 mmol/L; hospitalization indicated
  4. G4>500 mg/dL; >27.8 mmol/L; life-threatening consequences
  5. G5Not applicable
Definition and note

DefinitionA condition characterized by laboratory test results that indicate a confirmed, short lasting and unexpected elevation in the concentration of blood sugar (glycemia).

Navigational noteConsider Metabolism and nutrition disorders: Diabetes mellitus.

MedDRA code (LLT): 10020639 · CTCAE v6.0 (NCI), original English text.

Hyperkalemia

Metabolism and nutrition disorders
  1. G1>ULN - 5.5 mmol/L
  2. G2>5.5 - 6.0 mmol/L; intervention initiated
  3. G3>6.0 - 7.0 mmol/L; hospitalization indicated
  4. G4>7.0 mmol/L; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate an elevation in the concentration of potassium in the blood; associated with kidney failure or sometimes with the use of diuretic drugs.

MedDRA code (LLT): 10020647 · CTCAE v6.0 (NCI), original English text.

Hyperlipidemia

Metabolism and nutrition disorders
  1. G1Requiring diet changes
  2. G2Requiring pharmaceutical intervention
  3. G3Hospitalization
  4. G4Life-threatening consequences
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate an elevation in the concentration of lipids in blood.

Navigational noteConsider Gastrointestinal disorders: Pancreatitis.

MedDRA code (LLT): 10020667 · CTCAE v6.0 (NCI), original English text.

Hypermagnesemia

Metabolism and nutrition disorders
  1. G1>ULN - 3.0 mg/dL; >ULN - 1.23 mmol/L
  2. G2Not applicable
  3. G3>3.0 - 8.0 mg/dL; >1.23 - 3.30 mmol/L
  4. G4>8.0 mg/dL; >3.30 mmol/L; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate an elevation in the concentration of magnesium in the blood.

MedDRA code (LLT): 10020670 · CTCAE v6.0 (NCI), original English text.

Hypernatremia

Metabolism and nutrition disorders
  1. G1>ULN - 150 mmol/L
  2. G2>150 - 155 mmol/L; intervention initiated
  3. G3>155 - 160 mmol/L; hospitalization indicated
  4. G4>160 mmol/L; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate an elevation in the concentration of sodium in the blood.

MedDRA code (LLT): 10020680 · CTCAE v6.0 (NCI), original English text.

Hyperphosphatemia

Metabolism and nutrition disorders
  1. G1Laboratory finding only and intervention not indicated
  2. G2Noninvasive intervention indicated
  3. G3Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated
  4. G4Life-threatening consequences; urgent intervention indicated (e.g., dialysis)
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate an elevation in the concentration of phosphate in a blood.

MedDRA code (LLT): 10020712 · CTCAE v6.0 (NCI), original English text.

Hypertriglyceridemia

Metabolism and nutrition disorders
  1. G1150 mg/dL - 300 mg/dL; 1.71 mmol/L - 3.42 mmol/L
  2. G2>300 mg/dL - 500 mg/dL; >3.42 mmol/L - 5.7 mmol/L
  3. G3>500 mg/dL - 1000 mg/dL; >5.7 mmol/L - 11.4 mmol/L
  4. G4>1000 mg/dL; >11.4 mmol/L; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate an elevation in the concentration of triglyceride concentration in the blood.

MedDRA code (LLT): 10020870 · CTCAE v6.0 (NCI), original English text.

Hyperuricemia

Metabolism and nutrition disorders
  1. G1>ULN without physiologic consequences
  2. G2Not applicable
  3. G3>ULN with physiologic consequences
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate an elevation in the concentration of uric acid.

MedDRA code (LLT): 10020907 · CTCAE v6.0 (NCI), original English text.

Hypoalbuminemia

Metabolism and nutrition disorders
  1. G1<LLN - 3 g/dL; <LLN - 30 g/L
  2. G2<3 - 2 g/dL; <30 - 20 g/L
  3. G3<2 g/dL; <20 g/L
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate a low concentration of albumin in the blood.

MedDRA code (LLT): 10020943 · CTCAE v6.0 (NCI), original English text.

Hypocalcemia

Metabolism and nutrition disorders
  1. G1Corrected serum calcium of <LLN - 8.0 mg/dL; <LLN - 2.0 mmol/L; Ionized calcium <LLN - 1.0 mmol/L
  2. G2Corrected serum calcium of <8.0 - 7.0 mg/dL; <2.0 - 1.75 mmol/L; Ionized calcium <1.0 - 0.9 mmol/L; symptomatic
  3. G3Corrected serum calcium of <7.0 - 6.0 mg/dL; <1.75 - 1.5 mmol/L; Ionized calcium <0.9 - 0.8 mmol/L; hospitalization indicated
  4. G4Corrected serum calcium of <6.0 mg/dL; <1.5 mmol/L; Ionized calcium <0.8 mmol/L; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate a low concentration of calcium (corrected for albumin) in the blood.

MedDRA code (LLT): 10020949 · CTCAE v6.0 (NCI), original English text.

Hypoglycemia

Metabolism and nutrition disorders
  1. G1<LLN - 55 mg/dL; <LLN - 3.0 mmol/L
  2. G2<55 - 40 mg/dL; <3.0 - 2.2 mmol/L
  3. G3<40 - 30 mg/dL; <2.2 - 1.7 mmol/L
  4. G4<30 mg/dL; <1.7 mmol/L; life-threatening consequences; seizures
  5. G5Death
Definition and note

DefinitionA condition characterized by laboratory test results that indicate a low concentration of glucose in the blood.

MedDRA code (LLT): 10021005 · CTCAE v6.0 (NCI), original English text.

Hypokalemia

Metabolism and nutrition disorders
  1. G1<LLN - 3.0 mmol/L
  2. G2Symptomatic with <LLN - 3.0 mmol/L; intervention indicated
  3. G3<3.0 - 2.5 mmol/L; hospitalization indicated
  4. G4<2.5 mmol/L; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood.

MedDRA code (LLT): 10021018 · CTCAE v6.0 (NCI), original English text.

Hypomagnesemia

Metabolism and nutrition disorders
  1. G1<LLN - 1.2 mg/dL; <LLN - 0.5 mmol/L
  2. G2<1.2 - 0.9 mg/dL; <0.5 - 0.4 mmol/L
  3. G3<0.9 - 0.7 mg/dL; <0.4 - 0.3 mmol/L
  4. G4<0.7 mg/dL; <0.3 mmol/L; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate a low concentration of magnesium in the blood.

MedDRA code (LLT): 10021028 · CTCAE v6.0 (NCI), original English text.

Hyponatremia

Metabolism and nutrition disorders
  1. G1<LLN - 130 mmol/L
  2. G2125 - <130 mmol/L and asymptomatic
  3. G3125 - <130 mmol/L symptomatic; 120 - <125 mmol/L regardless of symptoms
  4. G4<120 mmol/L; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood.

MedDRA code (LLT): 10021038 · CTCAE v6.0 (NCI), original English text.

Hypophosphatemia

Metabolism and nutrition disorders
  1. G1Laboratory finding only and intervention not indicated
  2. G2Oral replacement therapy indicated
  3. G3Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood.

MedDRA code (LLT): 10021059 · CTCAE v6.0 (NCI), original English text.

Iron overload

Metabolism and nutrition disorders
  1. G1Not applicable
  2. G2Moderate symptoms; intervention not indicated
  3. G3Severe symptoms; intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by accumulation of iron in the tissues.

MedDRA code (LLT): 10065973 · CTCAE v6.0 (NCI), original English text.

Metabolism and nutrition disorders - Other, specify

Metabolism and nutrition disorders
  1. G1Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

MedDRA code (LLT): 10027433 · CTCAE v6.0 (NCI), original English text.

Tumor lysis syndrome

Metabolism and nutrition disorders
  1. G1Laboratory tumor lysis syndrome (LTLS) AND creatinine >ULN - 1.5 × ULN
  2. G2LTLS AND creatinine >1.5 – 3.0 × ULN; cardiac arrhythmia managed medically; one brief generalized seizure; seizure(s) well controlled by anticonvulsants; infrequent focal motor seizures not limiting age-appropriate instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3LTLS AND creatinine >3.0 – 6.0 × ULN; cardiac arrhythmia controlled with device (e.g. defibrillator); seizure in which consciousness is altered; poorly controlled seizure disorder; breakthrough generalized seizures despite medical intervention
  4. G4LTLS AND creatinine >6.0 x ULN; life-threatening cardiac arrhythmia or seizure
  5. G5Death
Definition and note

DefinitionA disorder characterized by metabolic abnormalities that result from a spontaneous or therapy-related cytolysis of tumor cells. Clinical tumor lysis syndrome (CTLS) requires one or more clinical manifestations along with criteria for laboratory tumor lysis syndrome (LTLS). LTLS is defined by two or more of the following laboratory abnormalities within 3 days before or 7 days after the initiation of chemotherapy: Uric acid ≥ 476 mcmol/L or 25% increase from baseline, Potassium ≥ 6.0 mmol/L or 25% increase from baseline, Phosphorous ≥ 2.1 mmol/L (children), ≥1.45 mmol/L (adults) or 25% increase from baseline, Calcium ≤ 1.75 mmol/L or 25% decrease from baseline.

MedDRA code (LLT): 10045152 · CTCAE v6.0 (NCI), original English text.

From the same authorCódigo OncoCódigo Onco (in Portuguese): Brazilian public health system (SUS) codes for systemic cancer treatment.