_id

683a165bc782e11e38d1b387

id

10547

title

Common Terminology Criteria for Adverse Events (CTCAE)

full_title

Common Terminology Criteria for Adverse Events (CTCAE)

short_title

CTCAE

med_description

Describes the severity of adverse hematologic and lymphatic events from cancer treatment.

short_description

Cancer treatment adverse events.

slug

common-terminology-criteria-adverse-events-ctcae

description

The Common Terminology Criteria for Adverse Events (CTCAE) describes the severity of adverse hematologic and lymphatic events from cancer treatment.

keywords

Common Terminology Criteria for Adverse Events (CTCAE), CTCAE, cancer, chemotherapy, adverse events, chemotherapy adverse events, chemo, chemotherapy complication, organ toxicity, immunotherapy, molecularly targeted agents, radiation therapy, AE, chemotherapy grade, neutropenia, thrombocytopenia, anemia, hematologic toxicity, infusion reaction, lymphopenia, bleeding

complaint

[ "Bleeding", "Cancer", "Dyspnea", "Fatigue", "Fever", "Hematemesis", "Loss of Appetite", "Melena", "Shortness of Breath", "Weakness", "Weight Loss/Gain", "Hematochezia" ]

formula

evidence

measurements

[]

information

Interpretation:

refrences

{ "Clinical Practice Guidelines": [], "Manufacturer Website": [], "Original/Primary Reference": [ { "href": "https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf", "text": "Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. National Institutes of Health" } ], "Other References": [], "Outcomes": [], "Validation": [], "Validations": [] }

pearls

• Developed by the National Cancer Institute (NCI) and National Institutes of Health (NIH).
• Describes any abnormal clinical finding associated with cancer therapy; causality is not required.
• Some adverse events are more subjective, and their misclassification can lead to inconsistent data.
• Staying current with the latest version (currently v5.0) is crucial as criteria and classifications are periodically updated.

Specific considerations:

• An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure, regardless of its considered relation to the treatment or procedure.
• Not all grades are appropriate for all AEs; hence, some AEs are listed with fewer than five grading options.
• Instrumental activities of daily living (ADLs) include tasks like preparing meals, shopping, using the telephone, and managing money.
• Self care ADLs include bathing, dressing, feeding oneself, using the toilet, and taking medications.

usecase

• Primarily employed in clinical trials to standardize the reporting of adverse events associated with cancer therapies.
• Helpful for meeting regulatory requirements when reporting trial results.
• May be useful in routine clinical practice to assess and document the severity of side effects in patients undergoing cancer treatment, ensuring consistent communication among healthcare providers.

reasons

Provides a standardized language for reporting adverse events, facilitating clear communication and comparison across different studies and treatments. Helps quantify the severity of adverse events, which can range from mild to life-threatening. Has been used by clinicians to guide treatment decisions.

next_advice

No specific treatment recommendations are provided by CTCAE itself; it is intended to document and grade the severity of adverse events.

next_actions

next_management

diseases

[ "Breast Cancer", "Cancer", "Colorectal Cancer", "Endometrial Cancer", "Gastric Cancer", "Hepatocellular Carcinoma", "Lung Cancer", "Ovarian Cancer", "Pancreatic Cancer", "Prostate Cancer", "Renal Cell Carcinoma", "Salivary Gland Cancer", "Skin Cancer", "Spinal Cancer", "Cervical Cancer" ]

input_schema

[ { "inct": null, "option_fhir_rules": null, "subheading": "Blood and lymphatic system disorders", "subheading_instructions": null, "type": "subheading" }, { "conditionality": null, "default": null, "label_en": "<p>CTCAE term</p>", "mdcalc_info_concept": null, "name": "ae_blood", "option_fhir_rules": null, "optional": false, "options": [ { "label": "Anemia", "value": 1 }, { "label": "Bone marrow hypocellular", "value": 2 }, { "label": "Disseminated intravascular coagulation (DIC)", "value": 3 }, { "label": "Eosinophilia", "value": 4 }, { "label": "Febrile neutropenia", "value": 5 }, { "label": "Hemolysis", "value": 6 }, { "label": "Hemolytic uremic syndrome", "value": 7 }, { "label": "Leukocytosis", "value": 8 }, { "label": "Lymph node pain", "value": 9 }, { "label": "Methemoglobinemia", "value": 10 }, { "label": "Thrombotic thrombocytopenic purpura (TTP)", "value": 11 }, { "label": "Blood and lymphatic system disorders", "value": 12 } ], "show_points": false, "tips_en": "", "type": "dropdown" }, { "conditionality": "ae_blood == 1", "default": null, "label_en": "<p>Anemia</p>", "mdcalc_info_concept": null, "name": "b1", "option_fhir_rules": null, "optional": false, "options": [ { "label": "Hemoglobin (Hgb)<br/><<abbr title=\"Lower limit of normal\">LLN</abbr>-10.0 g/dL; &lt;LLN-6.2 mmol/L; &lt;LLN-100 g/L", "value": 0 }, { "label": "Hgb<br/> <10.0-8.0 g/dL; <6.2-4.9 mmol/L; <100-80g/L", "value": 1 }, { "label": "Hgb<br/> <8.0 g/dL; <4.9 mmol/L; <80 g/L<br/> Transfusion indicated.", "value": 2 }, { "label": "Life-threatening consequences.<br/> Urgent intervention indicated.", "value": 3 }, { "label": "Death", "value": 4 } ], "show_points": false, "tips_en": "<ul><li>A disorder characterized by a reduction in the amount of hemoglobin in 100 ml of blood.</li><li>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.</li></ul>", "type": "radio" }, { "conditionality": "ae_blood == 2", "default": null, "label_en": "<p>Bone marrow hypocellular</p>", "mdcalc_info_concept": null, "name": "b2", "option_fhir_rules": null, "optional": false, "options": [ { "label": "Mildly hypocellular or ≤25% reduction from normal cellularity for age", "value": 0 }, { "label": "Moderately hypocellular or >25-<50% reduction from normal cellularity for age", "value": 1 }, { "label": "Severely hypocellular or >50-≤75% reduction cellularity from normal for age", "value": 2 }, { "label": "Aplastic persistent for longer than 2 weeks", "value": 3 }, { "label": "Death", "value": 5 } ], "show_points": false, "tips_en": "<ul><li>A disorder characterized by systemic pathological activation of blood clotting mechanisms which results in clot formation throughout the body.</li><li>There is an increase in the risk of hemorrhage as the body is depleted of platelets and coagulation factors.</li></ul>", "type": "radio" }, { "conditionality": "ae_blood == 3", "default": null, "label_en": "<p>Disseminated intravascular coagulation (DIC)</p>", "mdcalc_info_concept": null, "name": "b3", "option_fhir_rules": null, "optional": false, "options": [ { "label": "Laboratory findings with no bleeding", "value": 1 }, { "label": "Laboratory findings and bleeding", "value": 2 }, { "label": "Life-threatening consequences.<br/>Urgent intervention indicated.", "value": 3 }, { "label": "Death", "value": 4 } ], "show_points": false, "tips_en": "<ul><li>A disorder characterized by systemic pathological activation of blood clotting mechanisms which results in clot formation throughout the body.</li><li>There is an increase in the risk of hemorrhage as the body is depleted of platelets and coagulation factors.</li></ul>", "type": "radio" }, { "conditionality": "ae_blood == 4", "default": null, "label_en": "<p>Eosinophilia</p>", "mdcalc_info_concept": null, "name": "b4", "option_fhir_rules": null, "optional": false, "options": [ { "label": "><abbr title=\"Upper limit of normal\">ULN</abbr> and >baseline", "value": 0 }, { "label": "Steroids initiated", "value": 2 } ], "show_points": false, "tips_en": "A disorder characterized by laboratory test results that indicate an increased number of eosinophils in the blood.", "type": "radio" }, { "conditionality": "ae_blood == 5", "default": null, "label_en": "<p>Febrile neutropenia</p>", "mdcalc_info_concept": null, "name": "b5", "option_fhir_rules": null, "optional": false, "options": [ { "label": "ANC <1000/mm³ with a single temperature of >38.3 °C (101 °F) or a sustained temperature of ≥38 °C (100.4 °F) for more than one hour", "value": 2 }, { "label": "Life-threatening consequences.<br/>Urgent intervention indicated.", "value": 3 }, { "label": "Death", "value": 4 } ], "show_points": false, "tips_en": "", "type": "radio" }, { "conditionality": "ae_blood == 6", "default": null, "label_en": "<p>Hemolysis</p>", "mdcalc_info_concept": null, "name": "b6", "option_fhir_rules": null, "optional": false, "options": [ { "label": "Laboratory evidence of hemolysis only<br/>(e.g., direct antiglobulin test; <abbr title=\"Direct antiglobulin test\">DAT</abbr>; Coombs'; schistocytes; decreased haptoglobin)", "value": 0 }, { "label": "Evidence of hemolysis and ≤2 g decrease in hemoglobin", "value": 1 }, { "label": "Transfusion or medical intervention indicated<br/>(e.g., steroids)", "value": 2 }, { "label": "Life-threatening consequences.<br/>Urgent intervention indicated.", "value": 3 }, { "label": "Death", "value": 4 } ], "show_points": false, "tips_en": "A disorder characterized by laboratory test results that indicate widespread erythrocyte cell membrane destruction.", "type": "radio" }, { "conditionality": "ae_blood == 7", "default": null, "label_en": "<p>Hemolytic uremic syndrome</p>", "mdcalc_info_concept": null, "name": "b7", "option_fhir_rules": null, "optional": false, "options": [ { "label": "Laboratory findings with clinical consequences<br/> (e.g., renal insufficiency, petechiae)", "value": 2 }, { "label": "Life-threatening consequences<br/> (e.g., CNS hemorrhage or thrombosis/embolism or renal failure)", "value": 3 }, { "label": "Death", "value": 4 } ], "show_points": false, "tips_en": "A disorder characterized by a form of thrombotic microangiopathy with renal failure, hemolytic anemia, and severe thrombocytopenia.", "type": "radio" }, { "conditionality": "ae_blood == 8", "default": null, "label_en": "<p>Leukocytosis</p>", "mdcalc_info_concept": null, "name": "b8", "option_fhir_rules": null, "optional": false, "options": [ { "label": ">100,000/mm³", "value": 2 }, { "label": "Clinical manifestations of leukostasis.<br/>Urgent intervention indicated.", "value": 3 }, { "label": "Death", "value": 4 } ], "show_points": false, "tips_en": "A disorder characterized by laboratory test results that indicate an increased number of white blood cells in the blood.", "type": "radio" }, { "conditionality": "ae_blood == 9", "default": null, "label_en": "<p>Lymph node pain</p>", "mdcalc_info_concept": null, "name": "b9", "option_fhir_rules": null, "optional": false, "options": [ { "label": "Mild pain", "value": 0 }, { "label": "Moderate pain.<br/> Limiting instrumental ADL.", "value": 1 }, { "label": "Severe pain.<br/> Limiting self care ADL.", "value": 2 } ], "show_points": false, "tips_en": "A disorder characterized by a sensation of marked discomfort in a lymph node.", "type": "radio" }, { "conditionality": "ae_blood == 10", "default": null, "label_en": "<p>Methemoglobinemia</p>", "mdcalc_info_concept": null, "name": "b10", "option_fhir_rules": null, "optional": false, "options": [ { "label": ">ULN", "value": 1 }, { "label": "Requiring urgent intervention", "value": 2 }, { "label": "Life-threatening consequences", "value": 3 }, { "label": "Death", "value": 4 } ], "show_points": false, "tips_en": "A disorder characterized by laboratory test results that indicate increased methemoglobin in the blood.", "type": "radio" }, { "conditionality": "ae_blood == 11", "default": null, "label_en": "<p>Thrombotic<br>thrombocytopenic purpura (TTP)</p>", "mdcalc_info_concept": null, "name": "b11", "option_fhir_rules": null, "optional": false, "options": [ { "label": "Laboratory findings with clinical consequences<br/> (e.g., renal insufficiency, petechiae)", "value": 2 }, { "label": "Life-threatening consequences<br/> (e.g., CNS hemorrhage or thrombosis/embolism or renal failure)", "value": 3 }, { "label": "Death", "value": 4 } ], "show_points": false, "tips_en": "A disorder characterized by 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.", "type": "radio" }, { "conditionality": "ae_blood == 12", "default": null, "label_en": "<p>Blood and lymphatic system disorders</p>", "mdcalc_info_concept": null, "name": "b12", "option_fhir_rules": null, "optional": false, "options": [ { "label": "Asymptomatic or mild symptoms.<br/> Clinical or diagnostic observations only.<br/> Intervention not indicated.", "value": 0 }, { "label": "Moderate.<br/> Minimal, local or noninvasive intervention indicated.<br/> Limiting age-appropriate instrumental ADL.", "value": 1 }, { "label": "Severe or medically significant but not immediately life-threatening.<br/> Hospitalization or prolongation of existing hospitalization indicated.<br/> Limiting self care ADL.", "value": 2 }, { "label": "Life-threatening consequences.<br/> Urgent intervention indicated.", "value": 3 }, { "label": "Death", "value": 4 } ], "show_points": false, "tips_en": "Other, specify", "type": "radio" } ]

instructions

published

2024-07-09T18:22:35.250Z

purpose

[ "Prognosis" ]

search_terms

[ "Common Terminology Criteria for Adverse Events (CTCAE)", "CTCAE", "cancer", "chemotherapy", "adverse events", "chemotherapy adverse events", "chemo", "chemotherapy complication", "organ toxicity", "immunotherapy", "molecularly targeted agents", "radiation therapy", "AE", "chemotherapy grade", "neutropenia", "thrombocytopenia", "anemia", "hematologic toxicity", "infusion reaction", "lymphopenia", "bleeding" ]

seo

{ "keywords_en": "Common Terminology Criteria for Adverse Events (CTCAE), CTCAE, cancer, chemotherapy, adverse events, chemotherapy adverse events, chemo, chemotherapy complication, organ toxicity, immunotherapy, molecularly targeted agents, radiation therapy, AE, chemotherapy grade, neutropenia, thrombocytopenia, anemia, hematologic toxicity, infusion reaction, lymphopenia, bleeding", "meta_description_en": "The Common Terminology Criteria for Adverse Events (CTCAE) describes the severity of adverse hematologic and lymphatic events from cancer treatment." }

specialty

[ "Hematology and Oncology", "Hospitalist Medicine", "Infectious Disease", "Internal Medicine", "Palliative Care/Hospice", "Primary Care", "Pulmonology", "Radiation Oncology", "Radiology" ]

departments

[ "Hematologic", "Infectious", "Oncologic" ]

tags

[]

version_number

1

versions

[]

related

[ { "calcId": 10585, "short_title_en": "CP-AKI", "slug": "cisplatin-associated-acute-kidney-iInjury-cp-aki-risk-calculator" }, { "calcId": 10425, "short_title_en": "CRASH", "slug": "chemotherapy-risk-assessment-scale-high-age-patients-crash-score" }, { "calcId": 10424, "short_title_en": "CARG-TT", "slug": "cancer-aging-research-group-chemotherapy-toxicity-tool-carg-tt" } ]

ismed

false

section

[ "whenToUseViewed", "pearlsPitfallsViewed", "whyUseViewed", "nextStepsViewed", "evidenceViewed" ]

cleaned_departments

[ "hematology", "infectious", "oncology" ]

cleaned_use

[ "Primarily employed in clinical trials to standardize the reporting of adverse events associated with cancer therapies.", "Helpful for meeting regulatory requirements when reporting trial results.", "May be useful in routine clinical practice to assess and document the severity of side effects in patients undergoing cancer treatment, ensuring consistent communication among healthcare providers." ]

pub

false