CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

General disorders and administration site conditions

The 24 CTCAE v6.0 adverse events in General disorders and administration site conditions, with grades 1 to 5.

Chills

General disorders and administration site conditions
  1. G1Mild sensation of cold; shivering; chattering of teeth
  2. G2Moderate tremor of the entire body; narcotics indicated
  3. G3Severe or prolonged, not responsive to narcotics
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of cold that often marks a physiologic response to sweating after a fever.

Navigational noteConsider Injury, poisoning and procedural complications: Infusion related reaction.

MedDRA code (LLT): 10008531 · CTCAE v6.0 (NCI), original English text.

Death NOS

General disorders and administration site conditions
  1. G1Not applicable
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Death
Definition and note

DefinitionDeath that cannot be attributed to a CTCAE term associated with Grade 5.

Navigational noteIf death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.

MedDRA code (LLT): 10011914 · CTCAE v6.0 (NCI), original English text.

Disease progression

General disorders and administration site conditions
  1. G1Not applicable
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Death
Definition and note

DefinitionDeath due to disease progression that cannot be attributed to a CTCAE term associated with Grade 5.

Navigational noteIf death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.

MedDRA code (LLT): 10061818 · CTCAE v6.0 (NCI), original English text.

Edema face

General disorders and administration site conditions
  1. G1Localized edema
  2. G2Moderate localized edema; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe swelling; 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 swelling due to excessive fluid accumulation in facial area tissues.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10014222 · CTCAE v6.0 (NCI), original English text.

Facial pain

General disorders and administration site conditions
  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 the face.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10016059 · CTCAE v6.0 (NCI), original English text.

Fatigue

General disorders and administration site conditions
  1. G1Fatigue relieved by rest
  2. G2Fatigue not relieved by rest; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Fatigue not relieved by rest, 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 state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10016256 · CTCAE v6.0 (NCI), original English text.

Fever

General disorders and administration site conditions
  1. G138.0 - 39.0 degrees C (100.4 - 102.2 degrees F)
  2. G2>39.0 - 40.0 degrees C (102.3 - 104.0 degrees F)
  3. G3>40.0 degrees C (>104.0 degrees F) for <=24 hrs
  4. G4>40.0 degrees C (>104.0 degrees F) for >24 hrs
  5. G5Death
Definition and note

DefinitionA disorder characterized by elevation of the body's temperature above the upper limit of normal.

Navigational noteConsider Injury, poisoning and procedural complications: Infusion related reaction.

MedDRA code (LLT): 10016558 · CTCAE v6.0 (NCI), original English text.

Flu like symptoms

General disorders and administration site conditions
  1. G1Mild flu-like symptoms present
  2. G2Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; 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 group of symptoms similar to those observed in patients with the flu. It includes fever, chills, body aches, malaise, loss of appetite and dry cough.

Navigational noteSynonym: Flu, Influenza; Consider Injury, poisoning and procedural complications: Infusion related reaction.

MedDRA code (LLT): 10016791 · CTCAE v6.0 (NCI), original English text.

Gait disturbance

General disorders and administration site conditions
  1. G1Mild change in gait (e.g., wide-based, limping or hobbling)
  2. G2Moderate change in gait (e.g., wide-based, limping or hobbling); assistive device indicated; limiting 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 disorder characterized by walking difficulties.

MedDRA code (LLT): 10017577 · CTCAE v6.0 (NCI), original English text.

General disorders and administration site conditions - Other, specify

General disorders and administration site conditions
  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): 10018065 · CTCAE v6.0 (NCI), original English text.

Generalized edema

General disorders and administration site conditions
  1. G1Noted on exam; 1+ pitting edema
  2. G2Oral therapy initiated; interfering with instrumental ADLs or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Interferes with self-care ADL or severe impact on age-appropriate normal daily activity (pediatric); intravenous IV therapy indicated; skin breakdown
  4. G4Life-threatening consequences
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by fluid accumulation in the tissues of the body including the skin.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10018112 · CTCAE v6.0 (NCI), original English text.

Hypothermia

General disorders and administration site conditions
  1. G1Not applicable
  2. G235 - >32 degrees C; 95 - >89.6 degrees F
  3. G332 - >28 degrees C; 89.6 - >82.4 degrees F
  4. G4<=28 degrees C; 82.4 degrees F; life-threatening consequences (e.g., coma, hypotension, pulmonary edema, acidemia, ventricular fibrillation)
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormally low body temperature. Treatment is required when the body temperature is 35C (95F) or below.

MedDRA code (LLT): 10021113 · CTCAE v6.0 (NCI), original English text.

Infusion site extravasation

General disorders and administration site conditions
  1. G1Painless edema
  2. G2Erythema with associated symptoms (e.g., edema, pain, induration, phlebitis)
  3. G3Ulceration or necrosis; severe tissue damage; operative intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by leakage of the infusion into the surrounding tissue. Signs and symptoms may include induration, erythema, swelling, burning sensation and marked discomfort at the infusion site.

MedDRA code (LLT): 10064774 · CTCAE v6.0 (NCI), original English text.

Injection site reaction

General disorders and administration site conditions
  1. G1Tenderness with or without associated symptoms (e.g., warmth, erythema, itching)
  2. G2Pain; lipodystrophy; edema; phlebitis
  3. G3Ulceration or necrosis; severe tissue damage; operative intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an intense adverse reaction (usually immunologic) developing at the site of an injection.

MedDRA code (LLT): 10022095 · CTCAE v6.0 (NCI), original English text.

Localized edema

General disorders and administration site conditions
  1. G1Localized to dependent areas, no disability or functional impairment
  2. G2Moderate localized edema and intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe localized edema and intervention indicated; 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 swelling due to excessive fluid accumulation at a specific anatomic site.

Navigational notePrior to using this term consider specific edema areas and/or causes: Cardiac disorders: Heart failure; General disorders and administration site conditions: Edema face, Peripheral edema; Nervous system disorders: Edema cerebral; Respiratory, thoracic and mediastinal disorders: Laryngeal edema, Pulmonary edema; Eye disorders: Periorbital edema; Vascular disorders: Lymphedema. Record final diagnosis/cause once determined.

MedDRA code (LLT): 10062466 · CTCAE v6.0 (NCI), original English text.

Malaise

General disorders and administration site conditions
  1. G1Uneasiness or lack of well being
  2. G2Uneasiness or lack of well being limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Uneasiness or lack of well being 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 feeling of general discomfort or uneasiness, an out-of-sorts feeling.

MedDRA code (LLT): 10025482 · CTCAE v6.0 (NCI), original English text.

Multi-organ failure

General disorders and administration site conditions
  1. G1Not applicable
  2. G2Not applicable
  3. G3Shock with azotemia and acid-base disturbances; significant coagulation abnormalities
  4. G4Life-threatening consequences (e.g., vasopressor dependent and oliguric or anuric or ischemic colitis or lactic acidosis)
  5. G5Death
Definition and note

DefinitionA disorder characterized by progressive deterioration of the lungs, liver, kidney and clotting mechanisms.

MedDRA code (LLT): 10028154 · CTCAE v6.0 (NCI), original English text.

Non-cardiac chest pain

General disorders and administration site conditions
  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 the chest unrelated to a heart disorder.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10062501 · CTCAE v6.0 (NCI), original English text.

Pain

General disorders and administration site conditions
  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 the sensation of marked discomfort, distress or agony.

Navigational notePrior to using this term consider using a specific body part pain term found throughout the CTCAE (over 40 different pain terms). Record final diagnosis/cause once determined.

MedDRA code (LLT): 10033371 · CTCAE v6.0 (NCI), original English text.

Peripheral edema

General disorders and administration site conditionsNew in v6.0
  1. G1Swelling or obscuration of anatomic architecture on close inspection
  2. G2Readily apparent obscuration of anatomic architecture; obliteration of skin folds; readily apparent deviation from normal anatomic contour; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Gross deviation from normal anatomic contour; 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 swelling due to excessive fluid accumulation in the body periphery.

Navigational noteConsider Cardiac disorders: Heart failure; Record final diagnosis/cause once determined.

MedDRA code (LLT): 10034570 · CTCAE v6.0 (NCI), original English text.

Pneumatosis

General disorders and administration site conditionsNew in v6.0
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate symptoms; medical intervention indicated
  3. G3Severe symptoms; operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of gas in the bowel wall.

MedDRA code (LLT): 10051986 · CTCAE v6.0 (NCI), original English text.

Sudden death NOS

General disorders and administration site conditions
  1. G1Not applicable
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Death
Definition and note

DefinitionAn unexpected death that cannot be attributed to a CTCAE term associated with Grade 5.

Navigational noteIf death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.

MedDRA code (LLT): 10042435 · CTCAE v6.0 (NCI), original English text.

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