CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Blood and lymphatic system disorders

The 18 CTCAE v6.0 adverse events in Blood and lymphatic system disorders, with grades 1 to 5.

Anemia

Blood and lymphatic system disorders
  1. G1Hemoglobin (Hgb) <LLN - 10.0 g/dL; <LLN - 6.2 mmol/L; <LLN - 100 g/L
  2. G2Hgb <10.0 - 8.0 g/dL; <6.2 - 4.9 mmol/L; <100 - 80 g/L
  3. G3Hgb <8.0 g/dL; <4.9 mmol/L; <80 g/L; transfusion indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a reduction in the amount of hemoglobin in 100 ml of blood. Signs and symptoms of anemia may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.

MedDRA code (LLT): 10002272 · CTCAE v6.0 (NCI), original English text.

Aplastic anemia

Blood and lymphatic system disordersNew in v6.0
  1. G1Not applicable
  2. G2Use of growth factor indicated; transfusion 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
  5. G5Death
Definition and note

DefinitionA disorder characterized by the inability of the bone marrow to make enough new blood cells.

Navigational noteDo not report individual cell count decreases in addition to this term.

MedDRA code (LLT): 10002969 · CTCAE v6.0 (NCI), original English text.

Blood and lymphatic system disorders - Other, specify

Blood and lymphatic system 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): 10005329 · CTCAE v6.0 (NCI), original English text.

Bone marrow hypocellular

Blood and lymphatic system disorders
  1. G1Mildly hypocellular or <=25% reduction from normal cellularity for age
  2. G2Moderately hypocellular or >25 - <50% reduction from normal cellularity for age
  3. G3Severely hypocellular or >50 - <=75% reduction cellularity from normal for age
  4. G4Aplastic persistent for longer than 2 weeks
  5. G5Death
Definition and note

DefinitionA disorder characterized by the inability of the bone marrow to produce hematopoietic elements.

Navigational noteConsider Blood and lymphatic system disorders: Anemia, Thrombocytopenia, and/or Investigations: Neutrophil count decreased if bone marrow hypocellularity is not seen.

MedDRA code (LLT): 10048580 · CTCAE v6.0 (NCI), original English text.

Disseminated intravascular coagulation

Blood and lymphatic system disorders
  1. G1Not applicable
  2. G2Laboratory findings with no bleeding
  3. G3Laboratory findings and bleeding
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by systemic pathological activation of blood clotting mechanisms which results in clot formation throughout the body. There is an increase in the risk of hemorrhage as the body is depleted of platelets and coagulation factors.

MedDRA code (LLT): 10013442 · CTCAE v6.0 (NCI), original English text.

Eosinophilia

Blood and lymphatic system disorders
  1. G1>ULN and >Baseline
  2. G2Not applicable
  3. G3Steroids initiated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate an increased number of eosinophils in the blood.

MedDRA code (LLT): 10014950 · CTCAE v6.0 (NCI), original English text.

Febrile neutropenia

Blood and lymphatic system disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3ANC <1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an ANC <1000/mm3 and a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour.

MedDRA code (LLT): 10016288 · CTCAE v6.0 (NCI), original English text.

Hemolysis

Blood and lymphatic system disorders
  1. G1Laboratory evidence of hemolysis only (e.g., direct antiglobulin test; DAT; Coombs'; schistocytes; decreased haptoglobin)
  2. G2Evidence of hemolysis and >=2 g decrease in hemoglobin
  3. G3Transfusion or medical intervention indicated (e.g., steroids)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate widespread erythrocyte cell membrane destruction.

MedDRA code (LLT): 10019491 · CTCAE v6.0 (NCI), original English text.

Hemolytic anemia

Blood and lymphatic system disordersNew in v6.0
  1. G1<10% drop in Hgb from last assessment; intervention not indicated
  2. G2<=2 units of PRBCs transfused per day
  3. G3>2 units of PRBCs per day indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionAnemia resulting from hemolysis.

MedDRA code (LLT): 10019493 · CTCAE v6.0 (NCI), original English text.

Hemolytic uremic syndrome

Blood and lymphatic system disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Laboratory findings with clinical consequences (e.g., renal insufficiency, petechiae)
  4. G4Life-threatening consequences, (e.g., CNS hemorrhage or thrombosis/embolism or renal failure)
  5. G5Death
Definition and note

DefinitionA disorder characterized by a form of thrombotic microangiopathy with renal failure, hemolytic anemia, and severe thrombocytopenia when the etiology is due to infections with shiga-toxin producing bacteria, such as E coli O157:H7.

MedDRA code (LLT): 10019515 · CTCAE v6.0 (NCI), original English text.

Leukocytosis

Blood and lymphatic system disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3>100,000/mm3
  4. G4Clinical manifestations of leucostasis; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate an increased number of white blood cells in the blood.

Navigational noteDo not use for increases due to growth factors, steroids, or leukemias.

MedDRA code (LLT): 10024378 · CTCAE v6.0 (NCI), original English text.

Lymph node pain

Blood and lymphatic system disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in a lymph node.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10025182 · CTCAE v6.0 (NCI), original English text.

Lymphopenia

Blood and lymphatic system disordersNew in v6.0
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate a decrease in number of lymphocytes in a blood specimen.

MedDRA code (LLT): 10025327 · CTCAE v6.0 (NCI), original English text.

Methemoglobinemia

Blood and lymphatic system disorders
  1. G1Not applicable
  2. G2>ULN
  3. G3Requiring urgent intervention
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate increased methemoglobin in the blood.

MedDRA code (LLT): 10027506 · CTCAE v6.0 (NCI), original English text.

Thrombocytopenia

Blood and lymphatic system disordersNew in v6.0
  1. G1<LLN - 75,000/mm3; <LLN - 75.0 x 10^9/L
  2. G2<75,000 - 50,000/mm3; <75.0 - 50.0 x 10^9/L
  3. G3<50,000 - 10,000/mm3; <50.0 - 10.0 x 10^9/L; transfusion indicated
  4. G4<10,000/mm3; <10.0 x 10^9/L; life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a decrease in number of platelets in a blood specimen.

MedDRA code (LLT): 10043554 · CTCAE v6.0 (NCI), original English text.

Thrombocytosis

Blood and lymphatic system disordersNew in v6.0
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an increase in number of platelets in a blood specimen.

MedDRA code (LLT): 10043563 · CTCAE v6.0 (NCI), original English text.

Thrombotic microangiopathy

Blood and lymphatic system disordersNew in v6.0
  1. G1Not applicable
  2. G2Outpatient intervention indicated (e.g., modification of immunosuppression)
  3. G3Transfusion or IV intervention indicated
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by a form of thrombotic microangiopathy with laboratory findings that indicate hemolytic anemia, severe thrombocytopenia, and renal insufficiency/failure.

MedDRA code (LLT): 10043645 · CTCAE v6.0 (NCI), original English text.

Thrombotic thrombocytopenic purpura

Blood and lymphatic system disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Laboratory findings with clinical consequences (e.g., renal insufficiency, petechiae)
  4. G4Life-threatening consequences, (e.g., CNS hemorrhage or thrombosis/embolism or renal failure)
  5. G5Death
Definition and note

DefinitionA disorder characterized by a deficiency of ADAMTS13 and the presence of microangiopathic hemolytic anemia, thrombocytopenic purpura, fever, renal abnormalities and neurological abnormalities such as seizures, hemiplegia, and visual disturbances. It is an acute or subacute condition.

MedDRA code (LLT): 10043648 · 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.