[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-501884-105":3,"detail-sidebar-cat-0-en-105":81,"doc-detail-501884-en":131},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","ctcae-403-quick-reference","CTCAE 4.03 - Quick Reference","","Quick Reference for the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, published May 28, 2009 (v4.03: June 14, 2010). Provides a descriptive terminology for Adverse Event (AE) reporting, including severity grading for each AE term. Explains how CTCAE terms are organized by MedDRA System Organ Classes, defines AEs and CTCAE term purpose for documentation and analyses, and outlines Grade 1–5 with clinical severity descriptions and selection rules.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/ctcae-403-quick-reference/501884/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/ctcae-403-quick-reference/501884.png","ImageObject",300,407,{"name":42,"@type":43},"Finn","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-11-10","2026-10-03",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",11,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What is CTCAE v4.0 used for in adverse event reporting?","Question",{"text":63,"@type":64},"CTCAE is a descriptive terminology used for Adverse Event (AE) reporting. It provides grading (severity) criteria for each AE term.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"How are CTCAE terms organized and categorized?",{"text":68,"@type":64},"CTCAE terms are grouped by MedDRA Primary System Organ Classes (SOC). Within each SOC, AEs are listed with severity (Grade) descriptions.",{"name":70,"@type":61,"acceptedAnswer":71},"How does the CTCAE Grade 1–5 severity scale work?",{"text":72,"@type":64},"Grades 1 through 5 describe severity using general clinical guidelines: Grade 1 is mild; Grade 2 moderate; Grade 3 severe but not immediately life-threatening; Grade 4 life-threatening consequences; and Grade 5 death related to the AE. Some AEs do not include all grades.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},501884,1791361954,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,110,115,120,123,127],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":97,"doc_module":4,"doc_module_name":25,"category_name":98,"show_sort_weight":99,"slug":100},5,"Comic",60,"comic",{"id":102,"doc_module":4,"doc_module_name":25,"category_name":103,"show_sort_weight":104,"slug":105},6,"Technology",50,"technology",{"id":107,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":108,"slug":109},7,40,"healthcare",{"id":111,"doc_module":4,"doc_module_name":25,"category_name":112,"show_sort_weight":113,"slug":114},8,"Research & Report",30,"research-report",{"id":116,"doc_module":4,"doc_module_name":25,"category_name":117,"show_sort_weight":118,"slug":119},9,"Religion & Spirituality",20,"religion-spirituality",{"id":118,"doc_module":4,"doc_module_name":25,"category_name":121,"show_sort_weight":118,"slug":122},"World Cup","world-cup",{"id":124,"doc_module":4,"doc_module_name":25,"category_name":125,"show_sort_weight":124,"slug":126},10,"Lifestyle","lifestyle",{"id":128,"doc_module":4,"doc_module_name":25,"category_name":129,"show_sort_weight":97,"slug":130},19,"General","general",{"code":4,"msg":82,"data":132},{"doc_id":79,"user_id":133,"nickname":42,"user_avatar":134,"doc_module":4,"category_id":107,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":90,"language":140,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":12,"update_tm":144,"read_time":145,"preview_page_count":4},34359740700684,"https://ap-avatar.wpscdn.com/avatar/1f400023980c374ae676?_k=1777273430885731487","1. CTCAE 4.03  \nCommon Terminology Criteria for Adverse Events (CTCAE)  \nVersion 4.0  \nPublished: May 28, 2009 (v4.03: June 14, 2010)  \nU. S.DEPARTMENT OF HEALTH AND HUMAN SERVICES  \nNational Institutes of Health  \nNational Cancer Institute  \nCommon Terminology Criteria for Adverse Events v4.0 (CTCAE)  \nPublish Date: May 28, 2009  \nQuick Reference  \nThe NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.  \nComponents and Organization  \nSOC  \nSystem Organ Class, the highest level of the MedDRA hierarchy, is identified by anatomical or physiological system, etiology, or purpose (e.g., SOC Investigations for laboratory test results) . CTCAE terms are grouped by MedDRA Primary SOCs. Within each SOC, AEs are listed and accompanied by descriptions of severity (Grade) .  \nCTCAE Terms  \nAn Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. An AE is a term that is a unique representation of a specific event used for medical documentation and scientific analyses. Each CTCAE v4 .0 term is a MedDRA LLT (Lowest Level Term) .  \nDefinitions  \nA brief definition is provided to clarify the meaning of each AE term.  \nGrades  \nGrade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:  \nGrade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.  \nGrade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate  \ninstrumental ADL* .  \nGrade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL** .  \nGrade 4 Life-threatening consequences;  \nurgent intervention indicated.  \nGrade 5 Death related to AE.  \nA Semi-colon indicates ‘or’ within the description of the grade.  \nA single dash (-) indicates a grade is not available.  \nNot all Grades are appropriate for all AEs. Therefore, some AEs are listed with fewer than five options for Grade selection.  \nGrade 5  \nGrade 5 (Death) is not appropriate for some AEs and therefore is not an option.  \nActivities of Daily Living (ADL)  \n*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.  \n**Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.  \n__________  \n† CTCAE v4 .0 incorporates certain elements of the MedDRA terminology. For further details on MedDRA refer to the MedDRA MSSO Web site ([http://www.meddramsso.com](http://www.meddramsso.com)) .  \nCONTENTS  \n\n| SOC | Page |\n| --- | --- |\n| Blood and lymphatic system disorders | 3 |\n| Cardiac disorders | 4 |\n| Congenital, familial and genetic disorders | 7 |\n| Ear and labyrinth disorders | 8 |\n| Endocrine disorders | 9 |\n| Eye disorders | 10 |\n| Gastrointestinal disorders | 12 |\n| General disorders and administration site conditions | 22 |\n| Hepatobiliary disorders | 24 |\n| Immune system disorders | 26 |\n| Infections and infestations | 27 |\n| Injury, poisoning and procedural complications | 34 |\n| Investigations | 41 |\n| Metabolism and nutrition disorders | 44 |\n| Musculoskeletal and connective tissue disorders | 46 |\n| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 50 |\n| Nervous system disorders | 51 |\n| Pregnancy, puerperium and perinatal conditions | 56 |\n| Psychiatric disorders | 57 |\n| Renal and urinary disorders | 59 |\n| Reproductive system and breast disorders | 61 |\n| Respiratory, thoracic and mediastinal disorders | 65 |\n|","cbCaicMIzyGGBpfi","https://ap.wps.com/l/cbCaicMIzyGGBpfi","pdf",524757,"English","# Components and Organization\n## SOC (System Organ Class)\n# CTCAE Terms\n## Definition of Adverse Event (AE)\n## Definitions and Grades\n## Grade 1 to 5 Guidelines\n## Activities of Daily Living (ADL)","[{\"question\":\"What is CTCAE v4.0 used for in adverse event reporting?\",\"answer\":\"CTCAE is a descriptive terminology used for Adverse Event (AE) reporting. It provides grading (severity) criteria for each AE term.\"},{\"question\":\"How are CTCAE terms organized and categorized?\",\"answer\":\"CTCAE terms are grouped by MedDRA Primary System Organ Classes (SOC). Within each SOC, AEs are listed with severity (Grade) descriptions.\"},{\"question\":\"How does the CTCAE Grade 1–5 severity scale work?\",\"answer\":\"Grades 1 through 5 describe severity using general clinical guidelines: Grade 1 is mild; Grade 2 moderate; Grade 3 severe but not immediately life-threatening; Grade 4 life-threatening consequences; and Grade 5 death related to the AE. Some AEs do not include all grades.\"}]","CTCAE 4.03 - Quick Reference | PDF",1791026317,202]