Common Terminology Criteria for Adverse Events ( CTCAE )
The NCI Common Terminology Criteria for Adverse Events v3.0 is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.
Common Terminology Criteria for A...
Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS March 31, 2003 ( http://ctep.cancer.gov ), Publish Date: August 9, 2006 Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Publish Date: August 9, 2006 Quick Reference The NCI Common Terminology Criteria for Adverse Events v3.0 is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Components and Organization CATEGORY A CATEGORY is a broad classification of AEs based on anatomy and/or pathophysiology. Within each CATEGORY, AEs are listed accompanied by t heir descriptions of severity (Grade). Adverse Event Terms An 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 AE term is mapped to a MedDRA term and code. AEs are listed alphabetically within CATEGORIES. Short AE Name The ���SHORT NAME���column is new and it is used to simplify documentation of AE names on Case Report Forms. Supra-ordinate Terms A supra-ordinate term is located within a CATEGORY and is a grouping term based on disease process, signs, symptoms, or diagnosis. A supra-ordinate term is followed by the word ���Select��� and is accompanied by specific AEs that are all related to the supra-ordinate term. Supra-ordinate terms provide clustering and consistent representation of Grade for related AEs. Supra-ordinate terms are not AEs, are not mapped to a MedDRA term and code, cannot be graded and cannot be used for reporting. REMARK A ���REMARK��� is a clarification of an AE. ALSO CONSIDER An ���ALSO CONSIDER��� indicates additional AEs that are to be graded if they are clinically significant. NAVIGATION NOTE A ���NAVIGATION NOTE��� indicates the location of an AE term within the CTCAE document. It lists signs/symptoms alphabetically and the CTCAE term will appear in the same CATEGORY unless the ���NAVIGATION NOTE��� states differently. Grades Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE A Semi-colon indicates ���or��� within the description of the grade. An ���Em dash��� (���) indicates a grade not available. Not all Grades are appropriate for all AEs. Therefore, some AEs are listed with fewer than five options for Grade selection. Grade 5 Grade 5 (Death) is not appropriate for some AEs and therefore is not an option. The DEATH CATEGORY is new. Only one Supra-ordinate term is listed in this CATEGORY: ���Death not associated with CTCAE term ��� Select ��� with 4 AE options: Death NOS Disease progression NOS Multi-organ failure Sudden death. Important: ��� Grade 5 is the only appropriate Grade ��� This AE is to be used in the situation where a death 1. cannot be reported using a CTCAE v3.0 term associated with Grade 5, or 2. cannot be reported within a CTCAE CATEGORY as ���Other (Specify)��� Contents ALLERGY/IMMUNOLOGY ............................................1 AUDITORY/EAR............................................................2 BLOOD/BONE MARROW .............................................4 CARDIAC ARRHYTHMIA..............................................5 CARDIAC GENERAL....................................................7 COAGULATION ..........................................................10 CONSTITUTIONAL SYMPTOMS................................11 DEATH........................................................................13 DERMATOLOGY/SKIN ...............................................14 ENDOCRINE...............................................................17 GASTROINTESTINAL.................................................19 GROWTH AND DEVELOPMENT................................29 HEMORRHAGE/BLEEDING....................................... 30 HEPATOBILIARY/PANCREAS ................................... 34 INFECTION................................................................. 35 LYMPHATICS .............................................................38 METABOLIC/LABORATORY ......................................40 MUSCULOSKELETAL/SOFT TISSUE........................ 43 NEUROLOGY ............................................................. 47 OCULAR/VISUAL........................................................ 52 PAIN............................................................................ 55 PULMONARY/UPPER RESPIRATORY...................... 56 RENAL/GENITOURINARY.......................................... 60 SECONDARY MALIGNANCY.....................................63 SEXUAL/REPRODUCTIVE FUNCTION..................... 64 SURGERY/INTRA-OPERATIVE INJURY................... 66 SYNDROMES............................................................. 68 VASCULAR................................................................. 70
ALLERGY/IMMUNOLOGY Page 1 of 1 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 1 - March 31, 2003, Publish Date: August 9, 2006 Allergic reaction/ hypersensitivity (including drug fever) Allergic reaction Transient flushing or rash drug fever 38��C (100.4��F) Rash flushing urticaria dyspnea drug fever ���38��C (100.4��F) ��� Symptomatic bronchospasm, with or without urticaria parenteral medication(s) indicated allergy-related edema/angioedema hypotension Anaphylaxis Death REMARK: Urticaria with manifestations of allergic or hypersensitivity reaction is graded as Allergic reaction/hypersensitivity (including drug fever). ALSO CONSIDER:Cytokine release syndrome/acute infusion reaction. Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) Rhinitis Mild, intervention not indicated Moderate, intervention indicated ��� ��� ��� REMARK: Rhinitis associated with obstruction or stenosis is graded as Obstruction/stenosis of airway ��� Select in the PULMONARY/UPPER RESPIRATORY CATEGORY. Autoimmune reaction Autoimmune reaction Asymptomatic and serologic or other evidence of autoimmune reaction, with normal organ function and intervention not indicated Evidence of autoimmune reaction involving a non- essential organ or function (e.g., hypothyroidism) Reversible autoimmune reaction involving function of a major organ or other adverse event (e.g., transient colitis or anemia) Autoimmune reaction with life-threatening consequences Death ALSO CONSIDER: Colitis Hemoglobin Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) Thyroid function, low (hypothyroidism). Serum sickness Serum sickness ��� ��� Present ��� Death NAVIGATION NOTE: Splenic function is graded in the BLOOD/BONE MARROW CATEGORY. NAVIGATION NOTE: Urticaria as an isolated symptom is graded as Urticaria (hives, welts, wheals) in t he DERMATOLOGY/SKIN CATEGORY. Vasculitis Vasculitis Mild, intervention not indicated Symptomatic, non- steroidal medical intervention indicated Steroids indicated Ischemic changes amputation indicated Death Allergy/Immunology ��� Other (Specify, __) Allergy ��� Other (Specify) Mild Moderate Severe Life-threatening disabling Death
AUDITORY/EAR Page 1 of 2 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 2 - March 31, 2003, Publish Date: August 9, 2006 NAVIGATION NOTE: Earache (otalgia) is graded as Pain ��� Select in the PAIN CATEGORY. Hearing: patients with/without baseline audiogram and enrolled in a monitoring program1 Hearing (monitoring program) Threshold shift or loss of 15 ��� 25 dB relative to baseline, averaged at 2 or more contiguous test frequencies in at least one ear or subjective change in the absence of a Grade 1 threshold shift Threshold shift or loss of 25 ��� 90 dB, averaged at 2 contiguous test frequencies in at least one ear Adult only: Threshold shift of 25 ��� 90 dB, averaged at 3 contiguous test frequencies in at least one ear Pediatric: Hearing loss sufficient to indicate therapeutic intervention, including hearing aids (e.g., ���20 dB bilateral HL in the speech frequencies ���30 dB unilateral HL and requiring additional speech-language related services) Adult only: Profound bilateral hearing loss (90 dB) Pediatric: Audiologic indication for cochlear implant and requiring additional speech-language related services ��� REMARK: Pediatric recommendations are identical to those for adults, unless specified. Fo r children and adolescents (18 ��� years of age) without a baseline test, pre-exposure/pre- treatment hearing should be considered to be 5 dB loss. Hearing: patients without baseline audiogram and not enrolled in a monitoring program1 Hearing (without monitoring program) ��� Hearing loss not requiring hearing aid or intervention (i.e., not interfering with ADL) Hearing loss requiring hearing aid or intervention (i.e., interfering with ADL) Profound bilateral hearing loss (90 dB) ��� REMARK: Pediatric recommendations are identical to those for adults, unless specified. Fo r children and adolescents (18 ��� years of age) without a baseline test, pre-exposure/pre- treatment hearing should be considered to be 5 dB loss. Otitis, external ear (non-infectious) Otitis, external External otitis with erythema or dry desquamation External otitis with moist desquamation, edema, enhanced cerumen or discharge tympanic membrane perforation tympanostomy External otitis with mastoiditis stenosis or osteomyelitis Necrosis of soft tissue or bone Death ALSO CONSIDER: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program1 Hearing: patients without baseline audiogram and not enrolled in a monitoring program 1 . Otitis, middle ear (non-infectious) Otitis, middle Serous otitis Serous otitis, medical intervention indicated Otitis with discharge mastoiditis Necrosis of the canal soft tissue or bone Death
AUDITORY/EAR Page 2 of 2 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 3 - March 31, 2003, Publish Date: August 9, 2006 Tinnitus Tinnitus ��� Tinnitus not interfering with ADL Tinnitus interfering with ADL Disabling ��� ALSO CONSIDER: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program1 Hearing: patients without baseline audiogram and not enrolled in a monitoring program 1 . Auditory/Ear ��� Other (Specify, __) Auditory/Ear ��� Other (Specify) Mild Moderate Severe Life-threatening disabling Death 1 Drug-induced ototoxicity should be distinguished from age-related threshold decrements or unrelated cochlear insult. When considering whether an adverse event has occurred, it is first necessary to classify the patient into one of two groups(1) . The patient is under standar d treatment/enrolled in a clinical trial 2.5 years, and has a 15 dB or greater threshold shift averaged across two contiguous frequencies or (2) The patient is under standard treatment/enrolled in a clinical trial 2.5 years, and the difference between the expected age- related and the observed threshold shifts is 15 dB or greater averaged across two contiguous frequencies. Consult standard references for appropriate age- and gender-specific hearing norms, e.g., Morrell, et al. Age- and gender-specific reference ranges for hearing level and longitudinal changes in hearing level. Journal of the Acoustical Society of America 100:1949-1967, 1996 or Shotland, et al. Recommendations for cancer prevention trials using potentially ototoxic test agents. J ournal of Clinical Oncology 19:1658-1663, 2001. In the absence of a baseline prior to initial treatment, subsequent audiograms should be referenced to an appropriate database of normals. ANSI. (1996) American National Standard: Determination of occupational noise exposure and estimation of noise-induced hearing impairment, ANSI S 3.44-1996. (Standard S 3.44). New York: American National Standards Institute. The recommended ANSI S3.44 database is Annex B.
BLOOD/BONE MARROW Page 1 of 1 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 4 - March 31, 2003, Publish Date: August 9, 2006 Bone marrow cellularity Bone marrow cellularity Mildly hypocellular or ���25% reduction from normal cellularity for age Moderately hypocellular or 25 ��� ���50% reduction from normal cellularity for age Severely hypocellular or 50 ��� ���75% reduction cellularity from normal for age ��� Death CD4 count CD4 count LLN ��� 500/mm3 LLN ��� 0.5 x 109/L 500 ��� 200/mm3 0.5 ��� 0.2 x 109/L 200 ��� 50/mm3 0.2 x 0.05 ��� 109/L 50/mm3 0.05 x 109/L Death Haptoglobin Haptoglobin LLN ��� Absent ��� Death Hemoglobin Hemoglobin LLN ��� 10.0 g/dL LLN ��� 6.2 mmol/L LLN ��� 100 g/L 10.0 ��� 8.0 g/dL 6.2 ��� 4.9 mmol/L 100 ��� 80g/L 8.0 ��� 6.5 g/dL 4.9 ��� 4.0 mmol/L 80 ��� 65 g/L 6.5 g/dL 4.0 mmol/L 65 g/L Death Hemolysis (e.g., immune hemolytic anemia, drug- related hemolysis) Hemolysis Laboratory evidence of hemolysis only (e.g., direct antiglobulin test [DAT, Coombs���] schistocytes) Evidence of red cell destruction and ���2 gm decrease in hemoglobin, no transfusion Transfusion or medical intervention (e.g., steroids) indicated Catastrophic consequences of hemolysis (e.g., renal failure, hypotension, bronchospasm, emergency splenectomy) Death ALSO CONSIDER: Haptoglobin Hemoglobin. Iron overload Iron overload ��� Asymptomatic iron overload, intervention not indicated Iron overload, intervention indicated Organ impairment (e.g., endocrinopathy, cardiopathy) Death Leukocytes (total WBC) Leukocytes LLN ��� 3000/mm3 LLN ��� 3.0 x 109/L 3000 ��� 2000/mm3 3.0 ��� 2.0 x 109/L 2000 ��� 1000/mm3 2.0 ��� 1.0 x 109/L 1000/mm3 1.0 x 109/L Death Lymphopenia Lymphopenia LLN ��� 800/mm3 LLN x 0.8 ��� 109/L 800 ��� 500/mm3 0.8 ��� 0.5 x 109/L 500 ��� 200 mm3 0.5 ��� 0.2 x 109/L 200/mm3 0.2 x 109/L Death Myelodysplasia Myelodysplasia ��� ��� Abnormal marrow cytogenetics (marrow blasts ���5%) RAEB or RAEB-T (marrow blasts 5%) Death Neutrophils/granulocytes (ANC/AGC) Neutrophils LLN ��� 1500/mm3 LLN ��� 1.5 x 109/L 1500 ��� 1000/mm3 1.5 ��� 1.0 x 109/L 1000 ��� 500/mm3 1.0 ��� 0.5 x 109/L 500/mm3 0.5 x 109/L Death Platelets Platelets LLN ��� 75,000/mm3 LLN ��� 75.0 x 109/L 75,000 ��� 50,000/mm3 75.0 ��� 50.0 x 109/L 50,000 ��� 25,000/mm3 50.0 ��� 25.0 x 109/L 25,000/mm3 25.0 x 109/L Death Splenic function Splenic function Incidental findings (e.g., Howell-Jolly bodies) Prophylactic antibiotics indicated ��� Life-threatening consequences Death Blood/Bone Marrow ��� Other (Specify, __) Blood ��� Other (Specify) Mild Moderate Severe Life-threatening disabling Death
CARDIAC ARRHYTHMIA Page 1 of 2 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 5 - March 31, 2003, Publish Date: August 9, 2006 Conduction abnormality/ atrioventricular heart block ��� Select : Conduction abnormality ��� Select Asymptomatic, intervention not indicated ��� Asystole ��� AV Block-First degree ��� AV Block-Second degree Mobitz Type I (Wenckebach) ��� AV Block-Second degree Mobitz Type II ��� AV Block-Third degree (Complete AV block) ��� Conduction abnormality NOS ��� Sick Sinus Syndrome ��� Stokes-Adams Syndrome ��� Wolff-Parkinson-White Syndrome Non-urgent medical intervention indicated Incompletely controlled medically or controlled with device (e.g., pacemaker) Life-threatening (e.g., arrhythmia associated with CHF, hypotension, syncope, shock) Death Palpitations Palpitations Present Present with associated symptoms (e.g., lightheadedness, shortness of breath) ��� ��� ��� REMARK: Grade palpitations only in the absence of a documented arrhythmia. Prolonged QTc interval Prolonged QTc QTc 0.45 ��� 0.47 second QTc 0.47 ��� 0.50 second ���0.06 second above baseline QTc 0.50 second QTc 0.50 second life- threatening signs or symptoms (e.g., arrhythmia, CHF, hypotension, shock syncope) Torsade de pointes Death Supraventricular and nodal arrhythmia ��� Select : Supraventricular arrhythmia ��� Select Asymptomatic, intervention not indicated Non-urgent medical intervention indicated ��� Atrial fibrillation ��� Atrial flutter ��� Atrial tachycardia/Paroxysmal Atrial Tachycardia ��� Nodal/Junctional ��� Sinus arrhythmia ��� Sinus bradycardia ��� Sinus tachycardia ��� Supraventricular arrhythmia NOS ��� Supraventricular extrasystoles (Premature Atrial Contractions Premature Nodal/Junctional Contractions) ��� Supraventricular tachycardia Symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker) Life-threatening (e.g., arrhythmia associated with CHF, hypotension, syncope, shock) Death NAVIGATION NOTE: Syncope is graded as Syncope (fainting) in the NEUROLOGY CATEGORY.
CARDIAC ARRHYTHMIA Page 2 of 2 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 6 - March 31, 2003, Publish Date: August 9, 2006 Vasovagal episode Vasovagal episode ��� Present without loss of consciousness Present with loss of consciousness Life-threatening consequences Death Ventricular arrhythmia ��� Select: Ventricular arrhythmia ��� Select ��� Bigeminy ��� Idioventricular rhythm ��� PVCs ��� Torsade de pointes ��� Trigeminy ��� Ventricular arrhythmia NOS ��� Ventricular fibrillation ��� Ventricular flutter ��� Ventricular tachycardia Asymptomatic, no intervention indicated Non-urgent medical intervention indicated Symptomatic and incompletely controlled medically or controlled with device (e.g., defibrillator) Life-threatening (e.g., arrhythmia associated with CHF, hypotension, syncope, shock) Death Cardiac Arrhythmia ��� Other (Specify, __) Cardiac Arrhythmia ��� Other (Specify) Mild Moderate Severe Life-threatening disabling Death
CARDIAC GENERAL Page 1 of 3 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 7 - March 31, 2003, Publish Date: August 9, 2006 NAVIGATION NOTE: Angina is graded as Cardiac ischemia/infarction in the CARDIAC GENERAL CATEGORY. Cardiac ischemia/infarction Cardiac ischemia/infarction Asymptomatic arterial narrowing without ischemia Asymptomatic and testing suggesting ischemia stable angina Symptomatic and testing consistent with ischemia unstable angina intervention indicated Acute myocardial infarction Death Cardiac troponin I (cTnI) cTnI ��� ��� Levels consistent with unstable angina as defined by the manufacturer Levels consistent with myocardial infarction as defined by the manufacturer Death Cardiac troponin T (cTnT) cTnT 0.03 ��� 0.05 ng/mL 0.05 ��� 0.1 ng/mL 0.1 ��� 0.2 ng/mL 0.2 ng/mL Death Cardiopulmonary arrest, cause unknown (non-fatal) Cardiopulmonary arrest ��� ��� ��� Life-threatening ��� REMARK:Grade 4 (non-fatal) is the only appropriate grade. CTCAE provides three alternatives for reporting Death: 1. A CTCAE term associated with Grade 5. 2. A CTCAE 'Other (Specify, __)��� within any CATEGORY. 3. Death not associated with CTCAE term ��� Select in the DEATH CATEGORY. NAVIGATION NOTE: Chest pain (non-cardiac and non-pleuritic) is graded as Pain ��� Select in the PAIN CATEGORY. NAVIGATION NOTE: CNS ischemia is graded as CNS cerebrovascular ischemia in the NEUROLOGY CATEGORY. Hypertension Hypertension Asymptomatic, transient (24 hrs) increase by 20 mmHg (diastolic) or to 150/100 if previously WNL intervention not indicated Pediatric: Asymptomatic, transient (24 hrs) BP increase ULN intervention not indicated Recurrent or persistent (24 ��� hrs) or symptomatic increase by 20 mmHg (diastolic) or to 150/100 if previously WNL monotherapy may be indicated Pediatric: Recurrent or persistent (24 ��� hrs) BP ULN monotherapy may be indicated Requiring more than one drug or more intensive therapy than previously Pediatric: Same as adult Life-threatening consequences (e.g., hypertensive crisis) Pediatric: Same as adult Death REMARK: Use age and gender-appropriate normal values 95thpercentile ULN for pediatric patients.
CARDIAC GENERAL Page 2 of 3 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 8 - March 31, 2003, Publish Date: August 9, 2006 Hypotension Hypotension Changes, intervention not indicated Brief (24 hrs) fluid replacement or other therapy no physiologic consequences Sustained (24 ��� hrs) therapy, resolves without persisting physiologic consequences Shock (e.g., acidemia impairment of vital organ function) Death ALSO CONSIDER: Syncope (fainting). Left ventricular diastolic dysfunction Left ventricular diastolic dysfunction Asymptomatic diagnostic finding intervention not indicated Asymptomatic, intervention indicated Symptomatic CHF responsive to intervention Refractory CHF, poorly controlled intervention such as ventricular assist device or heart transplant indicated Death Left ventricular systolic dysfunction Left ventricular systolic dysfunction Asymptomatic, resting ejection fraction (EF) 60 ��� 50% shortening fraction (SF) 30 ��� 24% Asymptomatic, resting EF 50 ��� 40% SF 24 ��� 15% Symptomatic CHF responsive to intervention EF 40 ��� 20% SF 15% Refractory CHF or poorly controlled EF 20% intervention such as ventricular assist device, ventricular reduction surgery, or heart transplant indicated Death NAVIGATION NOTE: Myocardial infarction is graded as Cardiac ischemia/infarction in the CARDIAC GENERAL CATEGORY. Myocarditis Myocarditis ��� ��� CHF responsive to intervention Severe or refractory CHF Death Pericardial effusion (non-malignant) Pericardial effusion Asymptomatic effusion ��� Effusion with physiologic consequences Life-threatening consequences (e.g., tamponade) emergency intervention indicated Death Pericarditis Pericarditis Asymptomatic, ECG or physical exam (rub) changes consistent with pericarditis Symptomatic pericarditis (e.g., chest pain) Pericarditis with physiologic consequences (e.g., pericardial constriction) Life-threatening consequences emergency intervention indicated Death NAVIGATION NOTE: Pleuritic pain is graded as Pain ��� Select in the PAIN CATEGORY. Pulmonary hypertension Pulmonary hypertension Asymptomatic without therapy Asymptomatic, therapy indicated Symptomatic hypertension, responsive to therapy Symptomatic hypertension, poorly controlled Death Restrictive cardiomyopathy Restrictive cardiomyopathy Asymptomatic, therapy not indicated Asymptomatic, therapy indicated Symptomatic CHF responsive to intervention Refractory CHF, poorly controlled intervention such as ventricular assist device, or heart transplant indicated Death
CARDIAC GENERAL Page 3 of 3 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 9 - March 31, 2003, Publish Date: August 9, 2006 Right ventricular dysfunction (cor pulmonale) Right ventricular dysfunction Asymptomatic without therapy Asymptomatic, therapy indicated Symptomatic cor pulmonale, responsive to intervention Symptomatic cor pulmonale poorly controlled intervention such as ventricular assist device, or heart transplant indicated Death Valvular heart disease Valvular heart disease Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis treatment other than endocarditis prophylaxis not indicated Asymptomatic moderate regurgitation or stenosis by imaging Symptomatic severe regurgitation or stenosis symptoms controlled with medical therapy Life-threatening disabling intervention (e.g., valve replacement, valvuloplasty) indicated Death Cardiac General ��� Other (Specify, __) Cardiac General ��� Other (Specify) Mild Moderate Severe Life-threatening disabling Death
COAGULATION Page 1 of 1 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 10 - March 31, 2003, Publish Date: August 9, 2006 DIC (disseminated intravascular coagulation) DIC ��� Laboratory findings with no bleeding Laboratory findings and bleeding Laboratory findings, life- threatening or disabling consequences (e.g., CNS hemorrhage, organ damage, or hemodynamically significant blood loss) Death REMARK: DIC (disseminated intravascular coagulation) must have increased fibrin split products or D-dimer. ALSO CONSIDER: Platelets. Fibrinogen Fibrinogen 1.0 ��� 0.75 x LLN or 25% decrease from baseline 0.75 ��� 0.5 x LLN or 25 ��� 50% decrease from baseline 0.5 ��� 0.25 x LLN or 50 ��� 75% decrease from baseline 0.25 x LLN or 75% decrease from baseline or absolute value 50 mg/dL Death REMARK: Use % decrease only when baseline is LLN (local laboratory value). INR (International Normalized Ratio of prothrombin time) INR 1 ��� 1.5 x ULN 1.5 ��� 2 x ULN 2 x ULN ��� ��� ALSO CONSIDER: Hemorrhage, CNS Hemorrhage, GI ��� Select Hemorrhage, GU ��� Select Hemorrhage, pulmonary/upper respiratory ��� Select. PTT (Partial Thromboplastin Time) PTT 1 ��� 1.5 x ULN 1.5 ��� 2 x ULN 2 x ULN ��� ��� ALSO CONSIDER: Hemorrhage, CNS Hemorrhage, GI ��� Select Hemorrhage, GU ��� Select Hemorrhage, pulmonary/upper respiratory ��� Select. Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) Thrombotic microangiopathy Evidence of RBC destruction (schistocytosis) without clinical consequences ��� Laboratory findings present with clinical consequences (e.g., renal insufficiency, petechiae) Laboratory findings and life-threatening or disabling consequences, (e.g., CNS hemorrhage/ bleeding or thrombosis/ embolism or renal failure) Death REMARK: Must have microangiopathic changes on blood smear (e.g., schistocytes, helmet cells, red cell fragments). ALSO CONSIDER: Creatinine Hemoglobin Platelets. Coagulation ��� Other (Specify, __) Coagulation ��� Other (Specify) Mild Moderate Severe Life-threatening disabling Death
CONSTITUTIONAL SYMPTOMS Page 1 of 2 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 11 - March 31, 2003, Publish Date: August 9, 2006 Fatigue (asthenia, lethargy, malaise) Fatigue Mild fatigue over baseline Moderate or causing difficulty performing some ADL Severe fatigue interfering with ADL Disabling ��� Fever (in the absence of neutropenia, where neutropenia is defined as ANC 1.0 x 109/L) Fever 38.0 ��� 39.0��C (100.4 ��� 102.2��F) 39.0 ��� 40.0��C (102.3 ��� 104.0��F) 40.0��C (104.0��F) for ���24 hrs 40.0��C (104.0��F) for 24 hrs Death REMARK: The temperature measurements listed are oral or tympanic. ALSO CONSIDER: Allergic reaction/hypersensitivity (including drug fever). NAVIGATION NOTE: Hot flashes are graded as Hot flashes/flushes in the ENDOCRINE CATEGORY. Hypothermia Hypothermia ��� 35 ��� 32��C 95 ��� 89.6��F 32 ��� 28��C 89.6 ��� 82.4�� F ���28 ��C 82.4��F or life-threatening consequences (e.g., coma, hypotension, pulmonary edema, acidemia, ventricular fibrillation) Death Insomnia Insomnia Occasional difficulty sleeping, not interfering with function Difficulty sleeping, interfering with function but not interfering with ADL Frequent difficulty sleeping, interfering with ADL Disabling ��� REMARK: If pain or other symptoms interfere with sleep, do NOT grade as insomnia. Grade primary event(s) causing insomnia. Obesity2 Obesity ��� BMI 25 ��� 29.9 kg/m2 BMI 30 ��� 39.99 kg/m2 BMI ���40 kg/m2 ��� REMARK: BMI = (weight [kg]) / (height [m]) 2 Odor (patient odor) Patient odor Mild odor Pronounced odor ��� ��� ��� Rigors/chills Rigors/chills Mild Moderate, narcotics indicated Severe or prolonged, not responsive to narcotics ��� ��� 2 NHLBI Obesity Task Force. "Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults," The Evidence Report, Obes Res 6:51S- 209S, 1998.
CONSTITUTIONAL SYMPTOMS Page 2 of 2 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 12 - March 31, 2003, Publish Date: August 9, 2006 Sweating (diaphoresis) Sweating Mild and occasional Frequent or drenching ��� ��� ��� ALSO CONSIDER: Hot flashes/flushes. Weight gain Weight gain 5 ��� 10% of baseline 10 ��� 20% of baseline ���20% of baseline ��� ��� REMARK:Edema, depending on etiology, is graded in t he CARDIAC GENERAL or LYMPHATICS CATEGORIES. ALSO CONSIDER: Ascites (non-malignant) Pleural effusion (non-malignant). Weight loss Weight loss 5 to 10% from baseline intervention not indicated 10 ��� 20% from baseline nutritional support indicated ���20% from baseline tube feeding or TPN indicated ��� ��� Constitutional Symptoms ��� Other (Specify, __) Constitutional Symptoms ��� Other (Specify) Mild Moderate Severe Life-threatening disabling Death
DEATH Page 1 of 1 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 13 - March 31, 2003, Publish Date: August 9, 2006 Death not associated with CTCAE term ��� Select: Death not associated with CTCAE term ��� Select ��� Death NOS ��� Disease progression NOS ��� Multi-organ failure ��� Sudden death ��� ��� ��� ��� Death REMARK: Grade 5 is the only appropriate grade. 'Death not associated with CTCAE term ��� Select' is to be used where a death: 1. Cannot be attributed to a CTCAE term associated with Grade 5. 2. Cannot be reported within any CATEGORY using a CTCAE 'Other (Specify, __)���.
DERMATOLOGY/SKIN Page 1 of 3 Grade Adverse Event Short Name 1 2 3 4 5 CTCAE v3.0 - 14 - March 31, 2003, Publish Date: August 9, 2006 Atrophy, skin Atrophy, ski n Detectable Marked ��� ��� ��� Atrophy, subcutaneous fat Atrophy, subcutaneous fat Detectable Marked ��� ��� ��� ALSO CONSIDER: Induration/fibrosis (skin and subcutaneous tissue). Bruising (in absence of Grade 3 or 4 thrombocytopenia) Bruising Localized or in a dependent area Generalized ��� ��� ��� Burn Burn Minimal symptoms intervention not indicated Medical intervention minimal debridement indicated Moderate to major debridement or reconstruction indicated Life-threatening consequences Death REMARK: Burn refers to all burns including radiation, chemical, etc. Cheilitis Cheilitis Asymptomatic Symptomatic, not interfering with ADL Symptomatic, interfering with ADL ��� ��� Dry skin Dry skin Asymptomatic Symptomatic, not interfering with ADL Interfering with ADL ��� ��� Flushing Flushing Asymptomatic Symptomatic ��� ��� ��� Hair loss/alopecia (scalp or body) Alopecia Thinning or patchy Complete ��� ��� ��� Hyperpigmentation Hyperpigmentation Slight or localized Marked or generalized ��� ��� ��� Hypopigmentation Hypopigmentation Slight or localized Marked or generalized ��� ��� ��� Induration/fibrosis (skin and subcutaneous tissue) Induration Increased density on palpation Moderate impairment of function not interfering with ADL marked increase in density and firmness on palpation with or without minimal retraction Dysfunction interfering with ADL very marked density, retraction or fixation ��� ��� ALSO CONSIDER: Fibrosis-cosmesis Fibrosis-deep connective tissue. Injection site reaction/ extravasation changes Injection site reaction Pain itching erythema Pain or swelling, with inflammation or phlebitis Ulceration or necrosis that is severe operative intervention indicated ��� ��� ALSO CONSIDER: Allergic reaction/hypersensitivity (including drug fever) Ulceration.
222 Readers on Mendeley
by Academic Status
16% Other Professional
16% Ph.D. Student
10% Student (Postgraduate)
22% United States
6% United Kingdom