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1 Quick Reference v3.0 JCOG/JSCO Common Terminology Criteria for Adverse Events v3.0 (CTCAE) - December 12, 2003 NCI v3.0, AE. AE. Components and Organization CATEGORY, AE. AE. AE Adverse Event Terms AE,,,,,.,. AE,. AE MedDRA. AE. AE Short AE Name v3.0 Short Name, Case Report Forms AE. Supra-ordinate Terms,,,, AE, / ALLERGY/IMMUNOLOGY... 3 / AUDITORY/EAR... 4 / BLOOD/BONE MARROW... 5 CARDIAC ARRHYTHMIA... 6 CARDIAC GENERAL... 8 COAGULATION CONSTITUTIONAL SYMPTOMS...11 DEATH / DERMATOLOGY/SKIN ENDOCRINE... 16, AE., AE,. AE, MedDRA, grading,. Remark AE. AE Also Consider AE, AE,, grading AE. Navigation Note, AE CTCAE. /., CTCAE. s AE. CTCAE v3.0 15, AE 1 AE 2 AE 3 AE 4 AE 5 AE GASTROINTESTINAL GROWTH AND DEVELOPMENT HEMORRHAGE/BLEEDING HEPATOBILIARY/PANCREAS INFECTION LYMPHATICS / METABOLIC/LABORATORY / MUSCULOSKELETAL/SOFT TISSUE NEUROLOGY / OCULAR/VISUAL ;,.. AE, AE 5. 5 AE 5.. CTCAE -, 4 -Death NOS; - Disease progression NOS; Multi-organ failure; Sudden death. 5. AE. 1.CTCAE v3.0 5, 2.CTCAE PAIN...47 / PULMONARY/UPPER RESPIRATORY...48 / RENAL/GENITOURINARY...52 SECONDARY MALIGNANCY...55 / SEXUAL/REPRODUCTIVE FUNCTION...56 / SURGERY/INTRA-OPERATIVE INJURY...58 SYNDROMES...60 VASCULAR...62 CTCAE v3.0 JCOG/JSCO

2 v3.0 JCOG/JSCO v3.0 JCOG/JSCO, CTCAE v3.0, National Cancer InstituteNCIhttp://ctep.cancer.gov/reporting/ctc.html,, 12 Common Terminology Criteria for Adverse Events v3.0 (CTCAE), CTCAE v3.0 JCOG/JSCO., 14-4, JCOGJapan Clinical Oncology Group/ JCOG, -., pdf JCOG International Journal of Clinical Oncology. JCOG. Microsoft-Word. JCOG. CTCAE v3.0 - CTCAE v3.0, CTCAE v3.0 JCOG/JSCO,., JCOG. CTCAE v3.0,. JCOG. MedDRA/J CTCAE v3.0 Medical Dictionary for Regulatory ActivitiesMedDRA, MedDRA ICH MedDRA/J,, CTCAE v3.0 MedDRA/J. MedDRA NCI ( Grading nearest match NCI-CTC JCOG 2, CTC NCI Common Toxicity Criteria Manualnearest match., NCI-CTC JCOG , 3, 3. NCI-CTC JCOG 2 CTCAE v3.0,,,. nearest match CTCAE v3.0 Online Instructions and Guidelines, indicated vs. required. indicated CTCAE v3.0 JCOG/JSCO , what was acturally done, what should be donemedical opinion grading. CTCAE v3.0 grading. or or, CTCAE v3.0, 1 or,, or,, /,. or. / 4/, disabling. CTCAE v3.0 disabling,,,, /.,,,,,. major major surgical intervention major, major. - -NOS-. CTCAE v3.0. LLN, ULN, ANC, AGC, prbc, TPN, IVR, CNS AE,, AE, AE, AE AE. (Angina), / CARDIAC-Cardiac grading., AE /. CTCAE AE, CARDIAC GENERAL, AE /(Cardiac ischemia/infarction).,, CTCAE v3.0,, (Angina) AE (Cardiac).,.

3 / ALLERGY/IMMUNOLOGY Page 1 of 1 Short Name / Allergic reaction/ hypersensitivity (including drug fever) Allergic reaction : /() grading. AE: / SYNDROMES-Cytokine,, Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) Rhinitis : /- PULMONARY- Airway grading. Autoimmune reaction Autoimmune reaction AE: GASTROINTESTINAL-Colitis; BLOOD-Hemoglobin; BLOOD-Hemolysis; ENDOCRINE-Thyroid Serum sickness Serum sickness : (Splenic function) BLOOD-Splenic grading. : (Urticaria) DERMATOLOGY-Urticaria grading. Vasculitis /- Allergy/Immunology- Other (Specify, ) Vasculitis - Allergy-Other CTCAE v3.0 JCOG/JSCO

4 / AUDITORY/EAR Page 1 of 1 Short Name : (Earache)- PAIN-Pain grading. : 1 Hearing: patients with/without baseline audiogram and enrolled in a monitoring program Hearing (monitoring program) 1,., 2. (1) /2.5, (2) / 2.5, (Morrel 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: , 1996; Shotland, et al. Recommendations for cancer prevention trials using potentially ototoxic test agents. Journal of Clinical Oncology 19: , 2001.,. ANSI. (1996) ANSI S (Standard S 3.44). New York: ANSI S3.44 Annex. :,. 18, /5dB. : 1 Hearing: patients without baseline audiogram and not enrolled in a monitoring program Hearing (without monitoring program) :,. 18, /5dB. Otitis, external ear (non-infectious) Otitis, external AE: Otitis, middle ear (non-infectious) Tinnitus Otitis, middle Tinnitus / AE: /- Auditory/Ear-Other (Specify, ) /- Auditory/Ear-Other / CTCAE v3.0 JCOG/JSCO

5 / BLOOD/BONE MARROW Page 1 of 1 Short Name Bone marrow cellularity CD4 CD4 count Haptoglobin Hemoglobin :, Hemolysis (e.g. immune hemolytic anemia, drug-related hemolysis) Bone marrow cellularity CD4 CD4 count Haptoglobin Hemoglobin Hemolysis AE: BLOOD-Haptoglobin; BLOOD- Hemoglobin Iron overload Leukocytes (total WBC) Lymphopenia Myelodysplasia /ANC/AGC Neutrophils/granulocytes ANC/AGC Platelets Splenic function /- Blood/Bone Marrow-Other (Specify, ) Iron overload Leukocytes Lymphopenia Myelodysplasia Neutrophils Platelets Splenic function - Blood -Other /ANC/AGC,,. CTCAE v3.0 JCOG/JSCO

6 CARDIAC ARRHYTHMIA Page 1 of 2 Short Name /-: Conduction abnormality/ atrioventricular heart block -Select: - Conduction abnormality -Select Asystole I AV Block-First degree II Mobitz I WenckebachAV Block-Second degree Mobitz type I(Wenckebach) II MobitzII AV Block-Second degree Mobitz type II III AV Block-Third degree (Complete AV block) Conduction abnormality NOS Sick Sinus Syndrome Stokes-Adams Syndrome Wolff-Parkinson-WhiteWPW Wolff-Parkinson-White Syndrome Palpitations Palpitations grading QTc Prolonged QTc interval - Supraventricular and nodal arrhythmia-select: QTc Prolonged QTc - Supraventricular arrhythmia -Select 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 : (Syncope) NEUROLOGY-Syncope grading. Vasovagal episode Vasovagal episode CTCAE v3.0 JCOG/JSCO

7 CARDIAC ARRHYTHMIA Page 2 of 2 Short Name Ventricular arrhythmia -Select: - Ventricular arrhythmia -Select Bigeminy Idioventricular rhythm PVCs Torsade de pointes Trigeminy - Ventricular arrhythmia NOS Ventricular fibrillation Ventricular flutter Ventricular tachycardia - Cardiac Arrhythmia-Other (Specify, ) - Cardiac Arrhythmia-Other CTCAE v3.0 JCOG/JSCO

8 CARDIAC GENERAL Page 1 of 2 Short Name : (Angina)/ CARDIAC-Cardiac grading. / Cardiac ischemia/infarction I (ctni) Cardiac troponin I (ctni) T (ctnt) Cardiac troponin T (ctnt) Cardiopulmonary arrest, cause unknown (non-fatal) / Cardiac ischemia/infarction I T Cardiopulmonary arrest : 4 non-fatal. CTCAE CTCAE 2. CTCAE 3. DEATH CTCAE - Death not associated with CTCAE term-select : (Chest pain (non-cardiac and non-pleuritic))- PAIN-Pain grading. : (CNS ischemia) NEUROLOGY-CNS grading. Hypertension Hypertension : ULN 95 Hypotension Hypotension AE: NEUROLOGY-Syncope Left ventricular diastolic dysfunction Left ventricular diastolic dysfunction CTCAE v3.0 JCOG/JSCO

9 CARDIAC GENERAL Page 2 of 2 Short Name 1 2 Left ventricular systolic dysfunction Left ventricular systolic dysfunction : (Myocardial infarction)/ CARDIAC-Cardiac grading. Myocarditis / Pericardial effusion (non-malignant) Myocarditis Pericardial effusion Pericarditis Pericarditis : (Pleuritic pain)- PAIN-Pain grading. Pulmonary hypertension Restrictive cardiomyopathy Pulmonary hypertension Restrictive cardiomyopathy Right ventricular dysfunction (cor pulmonale) Right ventricular dysfunction Valvular heart disease Valvular heart disease - Cardiac General-Other (Specify, ) - Cardiac General-Other CTCAE v3.0 JCOG/JSCO

10 Page 1 of 1 DIC DIC (disseminated intravascular coagulation) DIC : DIC grading D-dimer. AE: BLOOD-Platelets Fibrinogen Fibrinogen : LLN. INR( ) INR (International Normalized Ratio of prothrombin time) INR AE: HEMORRHAGE- CNS; - HEMORRHAGE-Hemorrhage, GI; - HEMORRHAGE-Hemorrhage, GU; /- HEMORRHAGE-Hemorrhage, pulmonary/upper PTT () PTT (Partial Thromboplastin time) PTT AE: HEMORRHAGE- CNS; - HEMORRHAGE-Hemorrhage, GI; - HEMORRHAGE-Hemorrhage, GU; /- HEMORRHAGE-Hemorrhage, pulmonary/upper : [TTP] [HUS] Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS] Thrombotic microangiopathy : grading. (:,, ) AE: METABOLIC-Creatinine; BLOOD-Hemoglobin; BLOOD-Platelets - Coagulation-Other (Specify, ) - Coagulation-Other CTCAE v3.0 JCOG/JSCO

11 CONSTITUTIONAL SYMPTOMS Page 1 of 1 Short Name (,, ) Fatigue (asthenia, lethargy, malaise) (ANC /L ) Fever (in the absence of neutropenia, where neutropenia is defined as ANC /L) Fatigue G3 Fever : AE: /()ALLERGY- Allergic : (Hot flashes/flushes) ENDOCRINE- Hot grading. Hypothermia Hypothermia Insomnia Insomnia : grading. grading. 2 Obesity Obesity : BMI [kg] / ( [m] ) 2 Odor (patient odor) Rigors/chills Patient odor Rigors/chills Sweating (diaphoresis) Sweating AE: ENDOCRINE- Hot Weight gain Weight gain : CARDIAC GENERAL LYMPHATICS Edema grading. AE: () GASTROINTESTINAL-Ascites; () PULMONARY-Pleural Weight loss Weight loss - Constitutional Symptoms-Other(Specify, ) - Constitutional Symptoms-Other 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.,.,. CTCAE v3.0 JCOG/JSCO

12 DEATH Page 1 of 1 Short Name CTCAE -: Death not associated with CTCAE term-select: CTCAE - Death not associated with CTCAE term-select - Death NOS - Disease progression NOS Multi-organ failure Sudden death : : 5 CTCAE 2: CTCAE ( ) CTCAE v3.0 JCOG/JSCO

13 / DERMATOLOGY/SKIN Page 1 of 3 Short Name Atrophy, skin Atrophy, subcutaneous fat Atrophy, skin Atrophy, subcutaneous fat AE: / DERMATOLOGY-Induration 34 Bruising (in absence of 3 or 4 thrombocytopenia) Burn G3-4 Bruising Burn Cheilitis Dry skin Flushing Hair loss/alopecia (scalp or body) Hyperpigmentation Hypopigmentation / Induration/fibrosis (skin and subcutaneous tissue) Cheilitis Dry skin Flushing Alopecia Hyperpigmentation Hypopigmentation Induration AE: - MUSCULOSKELETAL- Fibrosis-cosmesis; - MUSCULOSKELETAL -Fibrosis-deep / Injection site reaction/ extravasation changes Injection site reaction AE: /()ALLERGY- Allergic; DERMATOLOGY-Ulceration Nail changes Nail changes : (Petechiae)/ HEMORRHAGE-Petechiae grading Photosensitivity Photosensitivity CTCAE v3.0 JCOG/JSCO

14 / DERMATOLOGY/SKIN Page 2 of 3 Short Name / Pruritus/itching Pruritus AE: / DERMATOLOGY-Rash / Rash/desquamation Rash : GVHD. : / Rash: acne/acneiform : - Rash: dermatitis associated with radiationselect: Chemoradiation Radiation : : Stevens-Johnson, Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis : Rash: hand-foot skin reaction / Skin breakdown/decubitus ulcer Acne - DermatitisSelect Erythema multiforme Hand-foot Decubitus Striae Telangiectasia Ulceration Striae Telangiectasia Ulceration CTCAE v3.0 JCOG/JSCO

15 / DERMATOLOGY/SKIN Page 3 of 3 Short Name ,, Urticaria (hives, welts, wheals) Urticaria AE: /ALLERGY- Allergic - Wound complication, non-infectious - Wound complication, non-infectious /- Dermatology/Skin-Other (Specify, ) - Dermatology -Other CTCAE v3.0 JCOG/JSCO

16 ENDOCRINE Page 1 of 2 Short Name Adrenal insufficiency Adrenal insufficiency :, :,,,,,,, salt craving,,,,,.,,. AE: METABORIC- Hyperkalemia; ENDOCRINE- Thyroid Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae) Cushingoid AE: METABORIC- Hyperglycemia; METABORIC- Hypokalemia Feminization of male Feminization of male : (Gynecomastia) SEXUAL- Gynecomastia grading 3 Hot flashes/flushes Masculinization of female : ACTH Neuroendocrine: ACTH deficiency : ADH : SIADH ADH Neuroendocrine: ADH secretion abnormality (e.g., SIADH or low ADH) : Neuroendocrine: gonadotropin secretion abnormality : Neuroendocrine: growth hormone secretion abnormality Hot flashes Masculinization of female ACTH ADH Gonadotropin Growth hormone 3 Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl HJ, Methodologic Lessons Learned from Hot Flash Studies, J Clin Oncol 2001 Dec 1; 19 (23): CTCAE v3.0 JCOG/JSCO

17 ENDOCRINE Page 2 of 2 Short Name : Neuroendocrine: prolactin hormone secretion abnormality Prolactin : Pancreatic endocrine: glucose intolerance Parathyroid function, low (hypoparathyroidism) Thyroid function, high (hyperthyroidism, thyrotoxicosis) Thyroid function, low (hypothyroidism) - Endocrine-Other(Specify, ) Diabetes Hypoparathyroidism Hyperthyroidism Hypothyroidism - Endocrine-Other CTCAE v3.0 JCOG/JSCO

18 GASTROINTESTINAL Page 1 of 8 Short Name : (Abdominal pain)cramp- PAIN-Pain grading. Anorexia Anorexia AE: CONSTITUTIONAL- Weight Ascites (non-malignant) Ascites Colitis Colitis AE: - HEMORRHAGE-Hemorrhage, GI Constipation Constipation AE: GASTROINTESTINAL- Ileus; - GASTROINTESTINAL- Obstruction Dehydration Dehydration AE: GASTROINTESTINAL- Diarrhea; CARDIAC-Hypotension; GASTROINTESTINAL- Vomiting : Dental: dentures or prosthesis : Dental: periodontal disease Dentures Periodontal : () MUSCULOSKELETAL- Osteonecrosis grading. : Dental: teeth : Dental: teeth development Diarrhea Teeth Teeth development Diarrhea :,. AE: GASTROINTESTINAL- Dehydration; CARDIAC-Hypotension CTCAE v3.0 JCOG/JSCO

19 GASTROINTESTINAL Page 2 of 8 Short Name / Distension/bloating, abdominal Distension AE: () GASTROINTESTINAL-Ascites; GASTROINTESTINAL- Ileus; - GASTROINTESTINAL- Obstruction / Dry mouth/ salivary gland (xerostomia) Dry mouth : /, grading..,. AE: / GASTROINTESTINAL- Salivary Dysphagia (difficulty swallowing) Dysphagia :,,,., - GASTROINTESTINAL- Stricture grading. AE: GASTROINTESTINAL- Dehydration; GASTROINTESTINAL- Esophagitis () Enteritis (inflammation of the small bowel) Enteritis AE: - HEMORRHAGE-Hemorrhage, GI; GASTROINTESTINAL- Typhlitis Esophagitis Esophagitis AE: GASTROINTESTINAL- Dysphagia CTCAE v3.0 JCOG/JSCO

20 GASTROINTESTINAL Page 3 of 8 Short Name Fistula, GI-Select: Fistula, GI-Select - Abdomen NOS Anus Biliary tree // Colon/cecum/appendix Duodenum Esophagus Gallbladder Ileum Jejunum Oral cavity Pancreas Pharynx Rectum Salivary gland - Small bowel NOS Stomach :, 2.,., --(Fistula, GI-Esophagus) grading. Flatulence ( ) Gastritis (including bile reflux gastritis) Flatulence Gastritis AE: - HEMORRHAGE-Hemorrhage, GI; - GASTROINTESTINAL- Ulcer, GI : (Head and neck soft tissue necrosis)- MUSCULOSKELETAL-Soft grading. / Heartburn/dyspepsia Hemorrhoids ( /) Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) Heartburn Hemorrhoids Ileus :,.(: ) AE: GASTROINTESTINAL- Constipation; GASTROINTESTINAL- Nausea; - GASTROINTESTINAL- Obstruction; GASTROINTESTINAL- Vomiting CTCAE v3.0 JCOG/JSCO

21 GASTROINTESTINAL Page 4 of 8 Short Name Incontinence, anal Incontinence, anal : () - Leak (including anastomotic), GI-Select: Leak, GI-Select Biliary tree Esophagus Large bowel - Leak NOS Pancreas Pharynx Rectum Small bowel Stoma Stomach :, /,.(:,,,,, ) Malabsorption / () - Mucositis/stomatitis (clinical exam) -Select: Anus Esophagus Large bowel Larynx Oral cavity Pharynx Rectum Small bowel Stomach Trachea Malabsorption Mucositis (clinical exam) -Select CTCAE v3.0 JCOG/JSCO

22 GASTROINTESTINAL Page 5 of 8 Short Name / (/)- Mucositis/stomatitis (functional/symptomatic) -Select: Anus Esophagus Large bowel Larynx Oral cavity Pharynx Rectum Small bowel Stomach Trachea (/)- Mucositis (functional/symptomatic) -Select :,,, GVHD /. Nausea Nausea AE: GASTROINTESTINAL-Anorexia; GASTROINTESTINAL- Vomiting - Necrosis, GI -Select: - Necrosis, GI-Select Anus // Colon/cecum/appendix Duodenum Esophagus Gallbladder Hepatic Ileum Jejunum Oral Pancreas Peritoneal cavity Pharynx Rectum - Small bowel NOS Stoma Stomach AE: () VASCULAR- Visceral CTCAE v3.0 JCOG/JSCO

23 - Obstruction, GI -Select: GASTROINTESTINAL Page 6 of 8 Short Name Cecum Colon Duodenum Esophagus Gallbladder Ileum Jejunum Rectum - Small bowel NOS Stoma Stomach - Obstruction, GI-Select : (Operative injury)-/- SURGERY-Intra-operative grading. : (Pelvic pain)- PAIN-Pain grading. - Perforation, GI Select: Appendix Biliary tree Cecum Colon Duodenum Esophagus Gallbladder Ileum Jejunum Rectum - Small bowel NOS Stomach Proctitis Prolapse of stoma, GI - Perforation, GISelect Proctitis Prolapse of stoma, GI : (Other stoma complications)- GASTROINTESTINAL-Fistula, GI; ()- GASTROINTESTINAL- Leak, GI; - GASTROINTESTINAL- Obstruction; - GASTROINTESTINAL-Perforation GI; ()- GASTROINTESTINAL- Stricture grading. : (Rectal)() (perirectal pain (proctalgia))- PAIN-Pain grading. CTCAE v3.0 JCOG/JSCO

24 GASTROINTESTINAL Page 7 of 8 Short Name / Salivary gland changes/ saliva Salivary gland changes AE: / GASTROINTESTINAL-Dry; /()- GASTROINTESTINAL- Mucositis; /(/)- GASTROINTESTINAL- Mucositis; () GASTROINTESTINAL- Taste : (Splenic function) BLOOD-Splenic grading. - Stricture/stenosis (including anastomotic),gi -Select: Anus Biliary tree Cecum Colon Duodenum Esophagus Ileum Jejunum / Pancreas/pancreatic duct Pharynx Rectum - Small bowel NOS Stoma Stomach () Taste alteration (dysgeusia) Typhlitis (cecal inflammation) - Stricture, GI-Select Taste alteration Typhlitis AE: GASTROINTESTINAL- Colitis; - HEMORRHAGE-Hemorrhage, GI; GASTROINTESTINAL- Ileus CTCAE v3.0 JCOG/JSCO

25 GASTROINTESTINAL Page 8 of 8 Short Name Ulcer, GI-Select: Ulcer, GI-Select Anus Cecum Colon Duodenum Esophagus Ileum Jejunum Rectum - Small bowel NOS Stoma Stomach AE: - HEMORRHAGE-Hemorrhage, GI Vomiting Vomiting AE: GASTROINTESTINAL- Dehydration - Gastrointestinal-Other (Specify, ) - GI-Other CTCAE v3.0 JCOG/JSCO

26 GROWTH AND DEVELOPMENT Page 1 of 1 Short Name () Bone age (alteration in bone age) : ; Bone growth: femoral head; slipped capital femoral epiphysis : Bone growth: limb length discrepancy : / Bone growth: spine kyphosis/lordosis () Growth velocity (reduction in growth velocity) () Puberty (delayed) Bone age Femoral head growth Limb length / Kyphosis/lordosis Reduction in growth velocity Delayed puberty () Puberty (precocious) Short stature Precocious puberty Short stature AE: : ENDOCRINE- Growth - Growth and Development -Other (Specify, ) - Growth and Development-Other CTCAE v3.0 JCOG/JSCO

27 Hematoma HEMORRHAGE/BLEEDING Page 1 of 3 Short Name Hematoma :,, extravasation. prbc AE: COAGULATION- Fibrinogen; INR () COAGULATION-INR; BLOOD- Platelets; PTT() COAGULATION-PTT Hemorrhage/bleeding associated with surgery, intra-operative or postoperative Hemorrhage with surgery 72 prbc AE: COAGULATION- Fibrinogen; INR () COAGULATION-INR; BLOOD- Platelets; PTT() COAGULATION-PTT Hemorrhage, CNS CNS hemorrhage AE: COAGULATION- Fibrinogen; INR () COAGULATION-INR; BLOOD- Platelets; PTT() COAGULATION-PTT -: -: Hemorrhage, GI-Select: Hemorrhage, GI-Select - Abdomen NOS Anus Biliary tree / Cecum/appendix Colon Duodenum Esophagus Ileum Jejunum Liver - Lower GI NOS Oral cavity Pancreas Peritoneal cavity Rectum Stoma Stomach - Upper GI NOS () Varices (esophageal) () Varices (rectal) prbc AE: COAGULATION- Fibrinogen; INR () COAGULATION-INR; BLOOD- Platelets; PTT() COAGULATION-PTT 450mL 200mL CTCAE v3.0 JCOG/JSCO

28 HEMORRHAGE/BLEEDING Page 2 of 3 Short Name : Hemorrhage, GU-Select: Hemorrhage, GU-Select Bladder Fallopian tube Kidney Ovary Prostate Retroperitoneum Spermatic cord Stoma Testes Ureter Urethra - Urinary NOS Uterus Vagina Vas deferens prbc AE: COAGULATION- Fibrinogen; INR () COAGULATION-INR; BLOOD- Platelets; PTT() COAGULATION-PTT /- Hemorrhage, pulmonary/upper respiratory -Select: -: Hemorrhage, pulmonary -Select /- Bronchopulmonary NOS Bronchus Larynx Lung Mediastinum Nose Pharynx Pleura - Respiratory tract NOS Stoma Trachea : prbc AE: COAGULATION- Fibrinogen; INR () COAGULATION-INR; BLOOD- Platelets; PTT() COAGULATION-PTT CTCAE v3.0 JCOG/JSCO

29 HEMORRHAGE/BLEEDING Page 3 of 3 Short Name / () Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) Petechiae AE: COAGULATION- Fibrinogen; INR () COAGULATION-INR; BLOOD- Platelets; PTT() COAGULATION-PTT : (Vitreous hemorrhage) OCULAR- Vitreous grading. - Hemorrhage/Bleeding-Other (Specify, ) - Hemorrhage-Other CTCAE v3.0 JCOG/JSCO

30 HEPATOBILIARY/PANCREAS Page 1 of 1 Short Name : (Biliary tree damage), - GASTROINTESTINAL- Fistula, GI; ()- GASTROINTESTINAL- Leak, GI; - GASTROINTESTINAL- Necrosis, GI; - GASTROINTESTINAL- Obstruction; - GASTROINTESTINAL-Perforation, GI; - GASTROINTESTINAL- Stricture grading. Cholecystitis Cholecystitis AE: 34 - INFECTION- Infection; 12 INFECTION- Infection; - INFECTION- Infection / Liver dysfunction/failure (clinical) Liver dysfunction :, AE,,. / grading. AE: METABOLIC- Bilirubin Pancreas, exocrine enzyme deficiency Pancreas, exocrine enzyme deficiency AE: GASTROINTESTINAL- Diarrhea Pancreatitis Pancreatitis, /, IVR / :,, AE: METABOLIC- Amylase :,, (Stricture(biliary tree, hepatic or pancreatic))- GASTROINTESTINAL- Stricture grading. - Hepatobiliary/Pancreas -Other (Specify, ) - Hepatobiliary-Other CTCAE v3.0 JCOG/JSCO

31 INFECTION Page 1 of 3 Short Name : Clostridium difficile Colitis, infectious (e.g., Clostridium difficile) Colitis, infectious AE: - HEMORRHAGE-Hemorrhage, GI; GASTROINTESTINAL- Typhlitis Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection ANC fever 38.5 G3-4 Febrile neutropenia AE: /ANC/AGC BLOOD- Neutrophils 34 ANC - Infection (documented clinically or microbiologically) with 3 or 4 neutrophils (ANC /L) Select: G3-4 - Infection (documented clinically) -Select : 34, INFECTION-Febrile grading. AE: /ANC/AGC BLOOD- Neutrophils 12 - Infection with normal ANC or 1 or 2 neutrophils -Select: G0-2 - Infection with normal ANC-Select CTCAE v3.0 JCOG/JSCO

32 INFECTION Page 2 of 3 Short Name Infection with unknown ANC -Select: - Infection with unknown ANC -Select ANC 2 Opportunistic infection associated with 2 Lymphopenia G2 Opportunistic infection AE: BLOOD- Lymphopenia Viral hepatitis Viral hepatitis - grading AE: METABOLIC- hypoalbuminemia; ALT METABOLIC-ALT; AST METABOLIC-AST; METABOLIC-Bilirubin; NEUROLOGY- Encephalopathy - Infection-Other (Specify, ) - Infection-Other CTCAE v3.0 JCOG/JSCO

33 / AUDITORY/EAR External ear (otitis externa) Middle ear (otitis media) CARDIOVASCULAR Artery Heart (endocarditis) Spleen Vein / DERMATOLOGY/SKIN / Lip/perioral Peristomal Skin (cellulitis) Ungual (nails) - INFECTION - SELECT Page 3 of 3 GENERAL Blood Catheter-related :,,, Foreign body (e.g., graft, implant, prosthesis, stent) Wound HEPATOBILIARY/PANCREAS Biliary tree Gallbladder (cholecystitis) Liver Pancreas LYMPHATIC Lymphatic / PULMONARY/UPPER RESPIRATORY Bronchus Larynx Lung (pneumonia) - Mediastinum NOS Mucosa - Neck NOS Nose Paranasal Pharynx Pleura (empyema) Sinus Trachea /- Upper aerodigestive NOS - Upper airway NOS GASTROINTESTINAL - Abdomen NOS / Anal/perianal Appendix Cecum Colon Dental-tooth Duodenum Esophagus Ileum Jejunum Oral cavity-gums (gingivitis) Peritoneal cavity Rectum Salivary gland - Small bowel NOS Stomach MUSCULOSKELETAL Bone (osteomyelitis) Joint Muscle (infection myositis) - Soft tissue NOS NEUROLOGY Brain (encephalitis, infectious) + Brain + Spinal cord (encephalomyelitis) Meninges (meningitis) Nerve-cranial Nerve-peripheral Spinal cord (myelitis) OCULAR Conjunctiva Cornea - Eye NOS Lens / RENAL/GENITOURINARY Bladder (urinary) Kidney Prostate Ureter Urethra - Urinary tract NOS / SEXUAL/PEPRODUCTIVE FUNCTION Cervix Fallopian tube - Pelvis NOS Penis Scrotum Uterus Vagina Vulva CTCAE v3.0 JCOG/JSCO

34 LYMPHATICS Page 1 of 1 Short Name Chyle or lymph leakage Chyle or lymph leakage AE: PULMONARY- Chylothorax, Dermal change lymphedema, phlebolymphedema Dermal change AE: DERMATOLOGY-Ulceration : Edema: head and neck : Edema: limb : Edema: head and neck : Edema: limb : / Edema: trunk/genital : / Edema: trunk/genital : Edema: viscera Lymphedema-related fibrosis Lymphocele Phlebolymphatic cording - Lymphatics-Other (Specify, ) : Edema: viscera Lymphedema-related fibrosis Lymphocele Phlebolymphatic cording - Lymphatics -Other CTCAE v3.0 JCOG/JSCO

35 / METABOLIC/LABORATORY Page 1 of 3 Short Name Acidosis (metaboic or respiratory) Albumin, serum-low (hypoalbuminemia) Alkaline phosphatase Alkalosis (metabolic or respiratory) ALT, SGPT ALT, SGPT (serum glutamic pyruvic transaminase) Amylase AST, SGOT AST, SGOT (serum glutamic oxaloacetic transaminase) HCO 3- Bicarbonate, serum-low Bilirubin (hyperbilirubinemia) Acidosis Hypoalbuminemia Alkaline phosphatase Alkalosis ALT Amylase AST Bicarbonate, serum-low Bilirubin AE Bilirubin grading Calcium, serum-low (hypocalcemia) Hypocalcemia :,. 4.0 g/dl, hypocalcemia) grading : (mg/dl)=(mg/dl)0.8[(g/dl)4] 4.,. 4 Crit Rev Clin Lab Sci 1984; 21(1): CTCAE v3.0 JCOG/JSCO

36 / METABOLIC/LABORATORY Page 2 of 3 Short Name Calcium, serum-high (hypercalcemia) () Cholesterol, serum-high (hypercholesteremia) CPK CPK (creatine phosphokinase) Creatinine Hypercalcemia Cholesterol Creatinine AE: METABOLIC- GFR CPK GGT GGT ) GGT (-Glutamyl transpeptidase) Glomerular filtration rate GFR AE: METABOLIC-Creatinine () Glucose, serum-high (hyperglycemia) Hyperglycemia () Glucose, serum-low (hypoglycemia) Hemoglobinuria Lipase () Magnesium, serum-high (hypermagnesemia) () Magnesium, serum-low (hypomagnesemia) Hypoglycemia Hemoglobinuria Lipase Hypermagnesemia Hypomagnesemia CTCAE v3.0 JCOG/JSCO

37 / METABOLIC/LABORATORY Page 3 of 3 Short Name () Phosphate, serum-low (hypophosphatemia) () Potassium, serum-high (hyperkalemia) () Potassium, serum-low (hypokalemia) Proteinuria () Sodium, serum-high (hypernatremia) () Sodium, serum-low (hyponatremia) () Triglyceride, serum-high (hypertriglyceridemia) () Uric acid, serum-high (hyperuricemia) Hypophosphatemia Hyperkalemia Hypokalemia Proteinuria Hypernatremia Hyponatremia Hypertriglyceridemia Hyperuricemia AE: METABOLIC-Creatinine; METABORIC- Hyperkalemia; RENAL- Renal; SYNDROMES-Tumor /- Metabolic/Laboratory -Other (Specify, ) /- Metabolic/Lab -Other CTCAE v3.0 JCOG/JSCO

38 / MUSCULOSKELETAL/SOFT TISSUE Page 1 of 3 Short Name () Arthritis (non-septic) Arthritis : Bone: spine-scoliosis Cervical spine-range of motion Scoliosis Cervical spine ROM Exostosis () Extremity-lower (gait/walking) Exostosis Gait/walking AE: NEUROLOGY-Ataxia; ()- MUSCULOSKELETAL- Muscle () Extremity-upper function - Fibrosis-cosmesis - Fibrosis-deep connective tissue () Extremity-upper (function) - Fibrosis-cosmesis - Fibrosis-deep connective tissue AE: / DERMATOLOGY-Induration; ()- MUSCULOSKELETAL- Muscle; - NEUROLOGY-Neuropathy-motor; - NEUROLOGY-Neuropathy- sensory Fracture Joint-effusion Fracture Joint-effusion AE: () MUSCULOSKELETAL-Arthritis CTCAE v3.0 JCOG/JSCO

39 5 Joint-function / MUSCULOSKELETAL/SOFT TISSUE Page 2 of 3 Short Name Joint-function AE: () MUSCULOSKELETAL-Arthritis / Local complicationdevice/prosthesis-related Lumbar spine-range of motion ()- Muscle weakness, generalized or specific area (not due to neuropathy) - Select: Extraocular Extremity-lower Extremity-upper Facial Left-sided Ocular Pelvic Right-sided Trunk / device/prosthesis Lumbar spine ROM - Muscle weakness - Select Whole body/generalized AE: (,, ) CONSTITUTIONAL-Fatigue / Muscular/skeletal hypoplasia (/) Myositis (inflammation/damage of muscle) / Muscular/skeletal hypoplasia Myositis CPK AE: CPK() METABOLIC-CPK; - PAIN-Pain 5 International SFTR Method of Measuring and Recording Joint Motion, International Standard Orthopedic Measurements (ISOM, Jon J. Gerhardt and Otto A. Russee, Bern, Switzerland, Han Huber 9 Publisher, 1975 CTCAE v3.0 JCOG/JSCO

40 / MUSCULOSKELETAL/SOFT TISSUE Page 3 of 3 Short Name () Osteonecrosis (avascular necrosis) 6 Osteoporosis Seroma - Soft tissue necrosis -Select: Abdomen Extremity-lower Extremity-upper Head Neck Pelvic Thorax, Trismus (difficulty, restriction or pain when opening mouth) Osteonecrosis Osteoporosis Seroma - Soft tissue necrosis -Select Trismus : -(Wound-infections)- INFECTION-Infection grading. : -(Wound non-infectious)- DERMATOLOGY- Wound grading. /- Musculoskeletal/Soft Tissue-Other (Specify, ) - Musculoskeletal-Other 6 Assessment of Fracture Risk and its Application to Screening for Postmenopausal Osteoporosis, Report of a WHO Study Group Technical Report Series, No. 843, 1994, v+129 pages [C*, E, F, R, S], ISBN , Sw.fr.22.-/US $19.80; : Sw.fr , Order no CTCAE v3.0 JCOG/JSCO

41 NEUROLOGY Page 1 of 4 Short Name : (Attention Deficit DisorderADD NEUROLOGY-Cognitive grading. : (Aphasia, receptive and/or expressive) NEUROLOGY-Speech grading. Apnea // Arachnoiditis/ meningismus/ radiculitis Apnea // Arachnoiditis AE: (ANC /L ) CONSTITUTIONAL-Fever; 34 - INFECTION- Infection; 12 - INFECTION- Infection; - INFECTION- Infection; - PAIN-Pain; GASTROINTESTINAL- Vomiting Ataxia (incoordination) Ataxia Brachial plexopathy CNS cerebrovascular ischemia Brachial plexopathy CNS ischemia : (CNS hemorrhage/bleeding) HEMORRHAGE-Hemorrhage, CNS grading. / CNS necrosis/cystic progression Cognitive disturbance CNS necrosis Cognitive disturbance ADD Confusion Confusion : Attention Deficit DisorderADD NEUROLOGY-Cognitive grading. : (Cranial neuropathy),: - NEUROLOGY-Neuropathy grading. Dizziness Dizziness :,, lightheadedness,. AE: : - NEUROLOGY-Neuropathy; NEUROLOGY-Syncope CTCAE v3.0 JCOG/JSCO

42 NEUROLOGY Page 2 of 4 Short Name : (Dysphasia, receptive and/or expressive): NEUROLOGY-Speech grading Encephalopathy Encephalopathy AE: NEUROLOGY-Cognitive; NEUROLOGY- Confusion; NEUROLOGY -Dizziness; NEUROLOGY- Memory; NEUROLOGY-Mental; - NEUROLOGY-Mood; / NEUROLOGY-Psychosis; / NEUROLOGY- Somnolence // Extrapyramidal/involuntary movement/restlessness involuntary movement : /(Headache/neuropathic pain):,,, - PAIN-Pain grading. Hydrocephalus 3 Irritability (children 3 years of age) Laryngeal nerve dysfunction Leak, cerebrospinal fluid (CSF) Hydrocephalus Irritability Laryngeal nerve CSF leak :, 72. Leukoencephalopathy (radiographic findings) Leukoencephalopathy lacuna Memory impairment 7 Mental status Memory impairment Mental status 7 Folstein MF, Folstein, SE and McHugh PF (1975) Mini-Mental State: A Practical Method for Grading the State of Patients for the Clinician, Journal of Psychiatric Research, 12: CTCAE v3.0 JCOG/JSCO

43 NEUROLOGY Page 3 of 4 Short Name Mood alteration-select: Agitation Anxiety Depression Euphoria Myelitis -: Mood alteration-select Myelitis : (Neurophathic pain)- PAIN-Pain grading. : - Neuropathy: cranial-select: I CNI II CNII III CNIII IV CNIV V CNV VI CNVI VII CNVII VIII CN VIII IX CNIX X CNX XI CN XI XII CN XII : Neuropathy: Motor : - Neuropathy: cranial-select Smell Vision,, Pupil, upper eyelid, extra ocular movements, Downward, inward movement of eye ; Motor-jaw muscles; Sensory-facial Lateral deviation of eye ; Motor-face; Sensory-taste Hearing and balance ;,, Motor-pharynx; Sensory-ear, pharynx, tongue,, Motor-palate; pharynx, larynx Motor-sternomastoid and trapezius Motor-tongue : Neuropathy-motor : (Cranial nerve motor neuropathy): - NEUROLOGY-Neuropathy: cranial grading. AE: NEUROLOGY-Laryngeal; NEUROLOGY- Phrenic : Neuropathy: sensory : Neuropathy-sensory : (Cranial nerve sensory neuropathy): - NEUROLOGY-Neuropathy: cranial grading. / Personality/behavioral Personality Phrenic nerve dysfunction Phrenic nerve CTCAE v3.0 JCOG/JSCO

44 NEUROLOGY Page 4 of 4 Short Name / Psychosis (hallucinations/ delusions) :,, Babinski, Pyramidal tract dysfunction (e.g., tone, hyperreflexia, positive Babinski, ine motor coordination) Seizure / Somnolence/depressed level of consciousness : / Speech impairment (e.g., dysphasia or aphasia) Psychosis Pyramidal tract dysfunction Seizure Somnolence Speech impairment AE: NEUROLOGY- Laryngeal; :,, PULMONARY-Voice Syncope (fainting) Syncope (fainting) AE: NEUROLOGY- CNS; /- CARDIAC- Conduction; NEUROLOGY-Dizziness; - CARDIAC- Supraventricular; CARDIAC-Vasovagal; - CARDIAC-Ventricular : CN VII, IX(Taste alteration (dysgeusia))gastrointestinal- Taste grading. Tremor - Neurology-Other (Specify, ) Tremor - Neurology-Other CTCAE v3.0 JCOG/JSCO

45 Cataract Dry eye syndrome Eyelid dysfunction / OCULAR/VISUAL Page 1 of 2 Short Name Cataract Dry eye Eyelid dysfunction AE: : - NEUROLOGY-Neuropathy: cranial Glaucoma / Keratitis (corneal inflammation/ corneal ulceration) Glaucoma Keratitis : (Ocular muscle weakness)()- MUSCULOSKELETAL- Muscle grading. Night blindness (nyctalopia) Nyctalopia Nystagmus Nystagmus AE: : - NEUROLOGY-Neuropathy; / OCULAR- diplopia Ocular surface disease Ocular surface disease :,,,,,. / Ophthalmoplegia/ diplopia (double vision) Diplopia AE: : - NEUROLOGY-Neuropathy Optic disc edema Optic disc edema AE: : - NEUROLOGY-Neuropathy CTCAE v3.0 CTCAE v3.0 JCOG/JSCO

46 / OCULAR/VISUAL Page 2 of 2 Short Name / Proptosis/enophthalmos / Proptosis/enophthalmos Retinal detachment Retinal detachment Retinopathy Retinopathy / Scleral necrosis/melt Scleral necrosis Uveitis Uveitis - Vision-blurred vision Blurred vision -/ Vision-flashing lights/floaters Flashing lights - Vision-photophobia Photophobia Vitreous hemorrhage Vitreous hemorrhage Watery eye (epiphora, tearing) /- Ocular/Visual-Other (Specify, ) Watery eye - Ocular-Other CTCAE v3.0 CTCAE v3.0 JCOG/JSCO

47 PAIN Page 1 of 1 Short Name Pain-Select: - Pain-Other (Specify, ) - Pain-Select - Pain-Other - PAIN - SELECT / AUDITORY/EAR External ear Middle ear CARDIOVASCULAR Cardiac/heart Pericardium / DERMATOLOGY/SKIN Face Lip - Oral-gums Scalp Skin GASTROINTESTINAL - Abdomen NOS Anus //Dental/teeth/periodontal Esophagus Oral cavity Peritoneum Rectum Stomach GENERAL - Pain NOS Tumor pain HEPATOBILIARY/PANCREAS Gallbladder Liver LYMPHATIC Lymph node MUSCULOSKELETAL Back Bone Buttock Extremity-limb Intestine Joint Muscle Neck Phantom (pain associated with missing limb) NEUROLOGY / Head/headache / Neuralgia/peripheral nerve OCULAR Eye / PULMONARY/UPPER RESPIRATORY Chest wall /- Chest/thorax NOS Larynx Pleura Sinus // Throat/pharynx/larynx / RENAL/GENITOURINARY Bladder Kidney / SEXUAL/REPRODUCTIVE FUNCTION Breast Ovulatory Pelvis Penis Perineum Prostate Scrotum Testicle Urethra Uterus Vagina CTCAE v3.0 JCOG/JSCO

48 / PULMONARY/UPPER RESPIRATORY Page 1 of 4 Short Name ARDS Adult Respiratory Distress Syndrome (ARDS) ARDS PULMONARY- Dyspnea; PULMONARY- Hypoxia; / PULMONARY-Pneumonitis Aspiration Aspiration AE: 34 - INFECTION- Infection; 12 - INFECTION- Infection; - INFECTION- Infection; NEUROLOGY-Laryngeal nerve; : - NEUROLOGY-Neuropathy: cranial; / PULMONARY-Pneumonitis Atelectasis Atelectasis AE: ARDS PULMONARY- ARDS; PULMONARY- Cough; PULMONARY- Dyspnea; PULMONARY- Hypoxia; 34 - INFECTION- Infection; 12 - INFECTION- Infection; - INFECTION- Infection; /- PULMONARY- Airway; / PULMONARY-Pneumonitis; PULMONARY-Pulmonary, Bronchospasm, wheezing Bronchospasm AE: /()ALLERGY- Allergic; PULMONARY- Dyspnea (DL CO ) Carbon monoxide diffusion capacity (DL CO ) DL CO AE: PULMONARY- Hypoxia; / PULMONARY-Pneumonitis; PULMONARY-Pulmonary Chylothorax Cough Dyspnea (shortness of breath) Chylothorax Cough Dyspnea AE: PULMONARY- Hypoxia; - NEUROLOGY-Neuropathy-motor; / PULMONARY-Pneumonitis; PULMONARY-Pulmonary Edema, larynx Edema, larynx AE: /ALLERGY- Allergic 1 FEV 1 1 FEV 1 CTCAE v3.0 JCOG/JSCO

49 / PULMONARY/UPPER RESPIRATORY Page 2 of 4 Short Name /- Fistula, pulmonary/upper respiratory - Select: Bronchus Larynx Lung Oral cavity Pharynx Pleura Trachea - Fistula, pulmonary- Select :, 2.,., -- (Fistula, GI-esophagus) grading. : (Hemoptysis)/- HEMORRHAGE- Hemorrhage grading Hiccoughs (hiccups, singultus) Hypoxia / Nasal cavity/ paranasal sinus reactions Hiccoughs Hypoxia / Nasal/ paranasal reactions AE: 34 - INFECTION- Infection; 12 - INFECTION- Infection; - INFECTION- Infection /- Obstruction/stenosis of airway -Select: Bronchus Larynx Pharynx Trachea Pleural effusion (non-malignant) - Airway obstruction-select Pleural effusion AE: PULMONARY-Atelectasis; PULMONARY- Cough; PULMONARY- Dyspnea; PULMONARY- Hypoxia; / PULMONARY-Pneumonitis; PULMONARY-Pulmonary : (Pleuritic pain)- PAIN-Pain grading CTCAE v3.0 JCOG/JSCO

50 / PULMONARY/UPPER RESPIRATORY Page 3 of 4 Short Name / Pneumonitis/ pulmonary infiltrates Pneumonitis AE: ARDS PULMONARY- ARDS; PULMONARY- Cough; PULMONARY- Dyspnea; PULMONARY- Hypoxia; 34 - INFECTION- Infection; 12 - INFECTION- Infection; - INFECTION- Infection; PULMONARY-Pulmonary Pneumothorax Prolonged chest tube drainage or air leak after pulmonary resection 24 Prolonged intubation after pulmonary resection (24 hrs after surgery) Pneumothorax Chest tube drainage or leak Prolonged intubation : (Pulmonary embolism), / VASCULAR-Thrombosis/embolism // VASCULAR-Thrombosis/thrombus 4 grading. Pulmonary fibrosis (radiographic changes) Pulmonary fibrosis 3 3 AE: ARDS PULMONARY- ARDS; PULMONARY- Cough; PULMONARY- Dyspnea; PULMONARY- Hypoxia; 34 - INFECTION- Infection; 12 - INFECTION- Infection; - INFECTION- Infection : (Recurrent laryngeal nerve dysfunction) NEUROLOGY-Laryngeal grading. Vital capacity / :,, Voice changes/ dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) Vital capacity Voice changes AE: NEUROLOGY-Laryngeal; : / NEUROLOGY-Speech CTCAE v3.0 JCOG/JSCO

51 / PULMONARY/UPPER RESPIRATORY Page 4 of 4 Short Name /- Pulmonary/ Upper Respiratory-Other(Specify, ) - Pulmonary -Other CTCAE v3.0 JCOG/JSCO

52 Bladder spasms / RENAL/GENITOURINARY Page 1 of 3 Short Name Bladder spasms Cystitis Cystitis AE: 34 - INFECTION- Infection; 12 - INFECTION- Infection; - INFECTION- Infection; - PAIN-Pain - - Fistula, GU-Select: Fistula, GU-Select Bladder Genital tract-female Kidney Ureter Urethra Uterus Vagina Incontinence, urinary - Leak (including anastomotic), GU-Select: Bladder Fallopian tube Kidney Spermatic cord Stoma Ureter Urethra Uterus Vagina Vas deferens Incontinence, urinary - Leak GU-Select CTCAE v3.0 JCOG/JSCO

53 / RENAL/GENITOURINARY Page 2 of 3 Short Name Obstruction, GU-Select: Bladder Fallopian tube Prostate Spermatic cord Stoma Testes Ureter Urethra Uterus Vagina Vas deferens - Obstruction, GU-Select : (Operative injury)-/- SURGERY- Intra-operative grading. - Perforation, GU-Select: Bladder Fallopian tube Kidney Ovary Prostate Spermatic cord Stoma Testes Ureter Urethra Uterus Vagina Vas deferens Prolapse of stoma, GU - Perforation, GU-Select Prolapse stoma, GU : - RENAL-Fistula; - RENAL-Leak; - RENAL-Obstruction; - RENAL-Perforation, GU; - RENAL-Stricture grading. Renal failure Renal failure AE: MEATABOLIC- GFR CTCAE v3.0 JCOG/JSCO

54 / RENAL/GENITOURINARY Page 3 of 3 Short Name Stricture/stenosis (including anastomotic), GU -Select: - Stricture, anastomotic, GU-Select Bladder Fallopian tube Prostate Spermatic cord Stoma Testes Ureter Urethra Uterus Vagina Vas deferens AE: - RENAL-Obstruction : Fanconi, Urinary electrolyte wasting (e.g., Fanconi s syndrome, renal tubular acidosis) Urinary electrolyte wasting AE: METABOLIC-Acidosis; HCO 3- METABOLIC-Bicarbonate; METABOLIC-Hypocalcemia; METABOLIC- Hypophosphatemia / Urinary frequency/ urgency Urinary retention (including neurogenic bladder) Urinary frequency Urinary retention :, - RENAL-Obstruction; - RENAL-Stricture grading. AE: - RENAL-Obstruction; - RENAL-Stricture Urine color change Urine color change :, :,,. /- Renal/Genitourinary-Other (Specify, ) - Renal-Other CTCAE v3.0 JCOG/JSCO

55 SECONDARY MALIGNANCY Page 1 of 1 Short Name Secondary Malignancy - possibly related to cancer treatment (Specify, ) Secondary Malignancy (possibly related to cancer treatment) :,. AML/MDS,. : NCI. 4,, NCI NCI. NCI AML/MDS, CTEP http: //ctep.cancer.gov... CTCAE v3.0 JCOG/JSCO

56 / SEXUAL/REPRODUCTIVE FUNCTION Page 1 of 2 Short Name / Breast function/ lactation / Breast nipple/ areolar deformity Breast function / Nipple/ areolar / Breast volume/ hypoplasia Breast :. : (Dysmenorrhea)- PAIN-Pain grading : (Dyspareunia)- PAIN-Pain grading : (Dysuria (painful urination))- PAIN-Pain grading Erectile dysfunction Ejaculatory dysfunction Erectile dysfunction Ejaculatory dysfunction : (Feminization of male) ENDOCRINE-Feminization grading Gynecomastia Gynecomastia AE: - PAIN-Pain Infertility/sterility Irregular menses (change from baseline) Libido Infertility/sterility Irregular menses Libido : (Masculinization of female) ENDOCRINE-Masculinization grading. Orgasmic dysfunction Orgasmic function : (Pelvic pain)- PAIN-Pain grading : (Ulcers of the labia or perineum) DERMATOLOGY-Ulceration grading CTCAE v3.0 JCOG/JSCO

57 / SEXUAL/REPRODUCTIVE FUNCTION Page 2 of 2 Short Name Vaginal discharge (non-infectious) Vaginal dryness Vaginal discharge Vaginal dryness AE: - PAIN-Pain Vaginal mucositis / Vaginal stenosis/length Vaginitis (not due to infection) /- Sexual/ Reproductive Function-Other (Specify, ) Vaginal mucositis Vaginal stenosis Vaginitis (not due to infection) - Sexual-Other CTCAE v3.0 JCOG/JSCO

58 / SURGERY/INTRA-OPERATIVE INJURY Page 1 of 2 Short Name : (Intraoperative hemorrhage) HEMORRHAGE-Hemorrhage grading. -/- Intra-operative injury -Select Organ or Structure - Intraop injury-select : AE,,., AE., CTCAE grading. - Intra-operative Injury-Other (Specify, ) - Intraop injury-other : -, AE Select AE /., CTCAE grading. CTCAE v3.0 JCOG/JSCO

59 /- SURGERY/INTRA-OPERATIVE INJURY-SELECT Page 2 of 2 / AUDITORY/EAR Inner ear Middle ear - Outer ear NOS - Outer ear-pinna CARDIOVASCULAR Artery-aorta Artery-carotid Artery-cerebral Artery-extremity (lower) Artery-extremity (upper) Artery-hepatic Artery-major visceral artery Artery-pulmonary - Artery NOS Heart Spleen Vein-extremity (lower) Vein-extremity (upper) Vein-hepatic Vein-inferior vena cava Vein-jugular Vein-major visceral vein Vein-portal vein Vein-pulmonary Vein-superior vena cava - Vein NOS / DERMATOLOGY/SKIN Breast Nails Skin ENDOCRINE Adrenal gland Parathyroid Pituitary Thyroid HEAD AND NECK Gingiva Larynx / Lip/ perioral area - Face NOS Nasal cavity Nasopharynx - Neck NOS Nose - Oral cavity NOS Parotid gland Pharynx Salivary duct Salivary gland Sinus Teeth Tongue /- Upper aerodigestive NOS GASTROINTESTINAL - Abdomen NOS Anal sphincter Anus Appendix Cecum Colon Duodenum Esophagus Ileum Jejunum Oral Peritoneal cavity Rectum - Small bowel NOS Stoma (GI) Stomach HEPATOBILIARY/ PANCREAS - Biliary tree- common bile duct - Biliary tree- common hepatic duct - Biliary tree- left hepatic duct - Biliary tree- right hepatic duct - Biliary tree NOS Gallbladder Liver Pancreas Pancreatic duct MUSCULOSKELETAL Bone Cartilage Extremity-lower Extremity-upper Joint Ligament Muscle - Soft tissue NOS Tendon NEUROLOGY Brain Meninges Spinal cord NERVES: Brachial plexus I CN I olfactory II CN II optic III CN III oculomotor IV CN IV trochlear V CN V trigeminal motor V CN V trigeminal sensory VI CN VI abducens VII CN VII facial - motor-face VII CN VII facial - sensory-taste VIII CN VIII vestibulocochlear IX CN IX glossopharyngeal motor pharynx IX CN IX glossopharyngeal -- sensory ear-pharynx-tongue X CN X vagus XI CN XI spinal accessory XII CN XII hypoglossal - Cranial nerve or branch NOS Lingual Lung thoracic - Peripheral motor NOS - Peripheral sensory NOS Recurrent laryngeal Sacral plexus Sciatic Thoracodorsal OCULAR Conjunctiva Cornea - Eye NOS Lens Retina / PULMONARY/UPPER RESPIRATORY Bronchus Lung Mediastinum Pleura Thoracic duct Trachea - Upper airway NOS / RENAL/GENITOURINARY Bladder Cervix Fallopian tube Kidney Ovary - Pelvis NOS Penis Prostate Scrotum Testis Ureter Urethra Urinary conduit - Urinary tract NOS Uterus Vagina Vulva CTCAE v3.0 JCOG/JSCO

60 SYNDROMES Page 1 of 2 Short Name : (Acute vascular leak syndrome) VASCULAR-Acute grading : (Adrenal insufficiency) ENDOCRINE- Adrenal grading : (Adult Respiratory Distress Syndrome (ARDS)) PULMONARY- ARDS grading Alcohol intolerance syndrome (antabuse-like syndrome) Alcohol intolerance syndrome nilutamide : (Autoimmune reaction)/allergy-autoimmune grading / Cytokine release syndrome/ acute infusion reaction Cytokine release syndrome :, /(Allergic/ hypersensitive reaction), AE. :.,, 24. /: / ; ; ; ; ; ;,, ; ; ; ; ; ; ; /; ; ; ; ( ); (,, );. AE: /()ALLERGY- Allergic;, PULMONARY-Bronchospasm; PULMONARY- Dyspnea; CARDIAC-Hypertension; CARDIAC-Hypotension; PULMONARY- Hypoxia; QTc CARDIAC- Prolonged; - CARDIAC- Supraventricular; - CARDIAC-Ventricular : (DIC), COAGULATION-DIC grading : Fanconi (Fanconi s syndrome): Fanconi, RENAL- Urinary grading Flu-like syndrome Flu-like syndrome : (Renal tubular acidosis): Fanconi, RENAL- Urinary grading Retinoic acid syndrome Retinoic acid syndrome :,, ( Retinoic acid syndrome ).,,,, /.. AE: VASCULAR-Acute; PULMONARY-Pleural; / PULMONARY-Pneumonitis : SIADH ; ADH : SIADH ADH ENDOCRINE- ADH grading : Stevens-Johnson (Stevens-Johnson syndrome): (: Stevens-Johnson, ) DERMATOLOGY- Rash grading : (Thrombotic microangiopathy): [TTP][HUS] COAGULATION-Thrombotic grading CTCAE v3.0 JCOG/JSCO

61 Tumor flare SYNDROMES Page 2 of 2 Short Name Tumor flare AE: () MATABOLIC- Hypercalcemia Tumor lysis syndrome Tumor lysis syndrome AE: METABOLIC-Creatinine; METABORIC- Hyperkalemia - Syndromes-Other (Specify, ) - Syndromes-Other CTCAE v3.0 JCOG/JSCO

62 VASCULAR Page 1 of 2 Short Name Acute vascular leak syndrome Peripheral arterial ischemia () Phlebitis (including superficial thrombosis) Acute vascular leak syndrome Peripheral arterial ischemia Phlebitis AE: / DERMATOLOGY- Injection Portal vein flow / () Thrombosis/ embolism (vascular access-related) // Thrombosis/ thrombus/ embolism -- Vessel injury-artery-select: Aorta Carotid Extremity-lower Extremity-upper - Other NOS Visceral Portal flow / () Thrombosis/ embolism (vascular access) // Thrombosis/ thrombus/ embolism - Artery injury-select : (Vessel injury an artery intra-operatively), -/- SURGERY-Intra-operative grading -- Vessel injury- vein-select: Extremity-lower Extremity-upper IVC Jugular - Other NOS SVC Viscera - Vein injury-select : (Vessel injury to a vein intra-operatively), -/- SURGERY-Intra-operative grading CTCAE v3.0 JCOG/JSCO

63 VASCULAR Page 2 of 2 Short Name Visceral arterial ischemia (non-myocardial) Visceral arterial ischemia AE: NEUROLOGY-CNS - Vascular-Other (Specify, ) - Vascular-Other CTCAE v3.0 JCOG/JSCO

64 CTCAE v3.0 JCOG/JSCO