CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Immune system disorders

The 8 CTCAE v6.0 adverse events in Immune system disorders, with grades 1 to 5.

Allergic reaction

Immune system disorders
  1. G1Systemic intervention not indicated
  2. G2Oral intervention indicated
  3. G3Bronchospasm; hospitalization indicated for clinical sequelae; IV intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an adverse general response from exposure to an allergen.

Navigational noteIf related to infusion, consider Injury, poisoning and procedural complications: Infusion related reaction. If related to immunization, consider Injury, poisoning and procedural complications: Systemic post-immunization reaction. Do not report both.

MedDRA code (LLT): 10001718 · CTCAE v6.0 (NCI), original English text.

Anaphylaxis

Immune system disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Symptomatic bronchospasm, with or without urticaria; parenteral intervention indicated; allergy-related edema/angioedema; hypotension
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an acute inflammatory reaction resulting from the release of histamine and histamine-like substances from mast cells, causing a hypersensitivity immune response. Clinically, it presents with breathing difficulty, dizziness, hypotension, cyanosis and loss of consciousness and may lead to death.

Navigational noteIf related to infusion, consider Injury, poisoning and procedural complications: Infusion related reaction. Do not report both.

MedDRA code (LLT): 10002218 · CTCAE v6.0 (NCI), original English text.

Autoimmune disorder

Immune system disorders
  1. G1Asymptomatic; serologic or other evidence of autoimmune reaction, with normal organ function; intervention not indicated
  2. G2Evidence of autoimmune reaction involving a non-essential organ or function (e.g., hypothyroidism)
  3. G3Autoimmune reactions involving major organ (e.g., colitis, anemia, myocarditis, kidney)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by loss of function or tissue destruction of an organ or multiple organs, arising from humoral or cellular immune responses of the individual to his own tissue constituents.

Navigational notePrior to using this term consider specific autoimmune AEs.

MedDRA code (LLT): 10061664 · CTCAE v6.0 (NCI), original English text.

Cytokine release syndrome

Immune system disorders
  1. G1Fever with or without constitutional symptoms
  2. G2Hypotension responding to fluids; hypoxia requiring low-flow nasal cannula or blow-by
  3. G3Hypotension managed with one pressor; hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by fever, tachypnea, headache, tachycardia, hypotension, rash, and/or hypoxia caused by the release of cytokines.

Navigational noteConsider reporting other organ dysfunctions including neurological toxicities such as: Psychiatric disorders: Confusion, Hallucinations; Nervous system disorders: Dysphasia, Headache, Seizure, Tremor.

MedDRA code (LLT): 10052015 · CTCAE v6.0 (NCI), original English text.

Graft versus host disease

Immune system disordersNew in v6.0
  1. G1Not applicable
  2. G2Oral intervention indicated
  3. G3IV intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by donor cells attacking the recipient's organs.

MedDRA code (LLT): 10018651 · CTCAE v6.0 (NCI), original English text.

Immune system disorders - Other, specify

Immune 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

Navigational noteUse for diagnoses not present in CTCAE (ex. Sjogren's syndrome, etc.).

MedDRA code (LLT): 10021428 · CTCAE v6.0 (NCI), original English text.

Secondary hemophagocytic lymphohistiocytosis

Immune system disordersNew in v6.0
  1. G1Asymptomatic or mild symptoms; requiring clinical and/or diagnostic evaluation; intervention not indicated
  2. G2Moderate symptoms; intervention indicated (e.g., immunosuppressive agents)
  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 development of a pathological and biochemical hyperinflammatory syndrome characterized by fever, cytopenias, hyperferritinemia, coagulopathy, hypofibrinogenemia and/or transaminitis and is attributable to therapy.

MedDRA code (LLT): 10081409 · CTCAE v6.0 (NCI), original English text.

Serum sickness

Immune system disorders
  1. G1Clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate arthralgia; fever, rash, urticaria, antihistamines indicated
  3. G3Severe arthralgia or arthritis; extensive rash; steroids or IV fluids indicated
  4. G4Life-threatening consequences; pressor or ventilatory support indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a delayed-type hypersensitivity reaction to foreign proteins derived from an animal serum. It occurs approximately six to twenty-one days following the administration of the foreign antigen. Symptoms include fever, arthralgias, myalgias, skin eruptions, lymphadenopathy, chest marked discomfort and dyspnea.

MedDRA code (LLT): 10040400 · 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.