Toxicity Criteria

Preferred toxicity scale is National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3

Link to NCI CTCAE version 3

NCI (National Cancer Institute)
Common Toxicity Criteria--Version 2 (for reference to older studies)

all Abdominal pain or cramping Acidosis (metabolic or respiratory) Acute vascular leak syndrome Adult Respiratory Distress Syndrome (ARDS) Alkaline phosphatase Alkalosis (metabolic or respiratory) Allergic reaction/ hypersensitivity Allergic rhinitis Alopecia Amylase Anorexia Apnea Arachnoiditis/meningismus/radiculitis Arthralgia (joint pain) Arthritis Ascites (non-malignant) Ataxia (incoordination) Autoimmune reaction Bicarbonate Bilirubin Bilirubin- graft versus host disease (GVHD) Bladder spasms Blood/Bone Marrow-Other (Specify, __________) Bone marrow cellularity Bone pain Bruising or (in absence of grade 3 or 4 thrombocytopenia) Carbon monoxide diffusion capacity (DLCO) Cardiac- ischemia/infarction Cardiac left ventricular function Cardiac troponin I (cTnI) Cardiac troponin T (cTnT) Cardiovascular/ Arrhythmia-Other (Specify, ___________) Cardiovascular/ General-Other (Specify, ______________) Cataract Catheter-related infection CD4 count Chest pain (non-cardiac and non-pleuritic) CNS cerebrovascular ischemia Coagulation-Other(Specify, __________) Cognitive disturbance/ learning problems Colitis Conduction abnormality/ Atrioventricular heart block Confusion Conjunctivitis Constipation Constitutional Symptoms-Other (Specify, __________) Cough CPK (creatine phosphokinase) Creatinine Cushingoid appearance Dehydration Delusions Depressed level of consciousness Dermatitis, focal (with high-dose chemotherapy and bone marrow transplant) Dermatology/Skin-Other (Specify, ________) Diarrhea for BMT Diarrhea for Pediatric BMT: Diarrhea-Patients with a colostomy: Diarrhea-Patients without colostomy: DIC (disseminated intravascular coagulation) Dizziness/lightheadedness Dry eye Dry skin Duodenal ulcer (requires radiographic or endoscopic documentation) Dysmenorrhea Dyspareunia Dyspepsia/heartburn Dysphagia - pharyngeal related to radiation Dysphagia- esophageal related to radiation Dysphagia, esophagitis, odynophagia (painful swallowing) Dyspnea (shortness of breath) Dysuria (painful urination) Earache (otalgia) Edema Endocrine-Other or (Specify, __________) Epistaxis Erectile impotence Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) External auditory canal Extrapyramidal/ or involuntary movement/ restlessness Fatigue (lethargy, malaise, asthenia) Febrile neutropenia with no documented infection Female sterility Feminization of male FEV1 Fever without neutropenia Fibrinogen Fibrinogen for leukemia studies: Fistula- esophageal Fistula- intestinal Fistula or GU fistula (e.g., vaginal, vesicovaginal) Fistula- pharyngeal Fistula- rectal/anal Flatulence Flushing Gastric ulcer (requires radiographic or endoscopic documentation) Gastritis Gastrointestinal-Other(Specify, __________) GGT (* - Glutamyl transpeptidase) Glaucoma Gynecomastia Hallucinations Hand-foot skin reaction Haptoglobin Headache Hematemesis Hematuria (in the absence of vaginal bleeding) Hemoglobin (Hgb) Hemoglobin for leukemia or bone marrow infiltrative/ myelophthisic processes Hemoglobinuria Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis, other) Hemoptysis Hemorrhage/bleeding associated with surgery Hemorrhage/bleeding in Central Nervous System Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia Hemorrhage-Other (Specify site, ___________) Hepatic enlargement Hepatic pain Hepatic-Other (Specify, __________) Hiccoughs (hiccups, singultus) Hot flashes/flushes Hypercalcemia Hypercholesterolemia Hyperglycemia Hyperkalemia Hypermagnesemia Hypernatremia Hypertension Hypertriglyceridemia Hyperuricemia Hypoalbuminemia Hypocalcemia Hypoglycemia Hypokalemia Hypomagnesemia Hyponatremia Hypophosphatemia Hypotension Hypothyroidism Hypoxia Ileus (or neuroconstipation) Incontinence Infection (documented ) with grade 3 or 4 neutropenia Infection with unknown ANC Infection without neutropenia Infection/Febrile Neutropenia-Other(Specify, __________) Injection site reaction Inner ear/hearing Insomnia Irregular menses (change from baseline) Irritability (children <3 years of age) Keratitis (corneal inflammation/ corneal ulceration) Leucocytes for BMT studies: Leucocytes for infants and young children Leukocytes (total WBC) Leukoencephalopathy associated radiological findings Libido Lipase Liver dysfunction/failure (clinical) Lymphatics Lymphatics-Other (Specify, __________) Lymphopenia Lymphopenias for infants and young children Male infertility Masculinization of female Melena/GI bleeding Memory loss Metabolic/Laboratory-Other (Specify, __________) Middle ear/hearing Mood alteration- anxiety agitation Mood alteration- depression Mood alteration- euphoria Mouth dryness Mucositis due to radiation Muscle weakness (not due to neuropathy) Musculoskeletal-Other (Specify, __________) Myalgia (muscle pain) Myocarditis Myositis (inflammation/damage of muscle) Nail changes Nausea Neurology-Other(Specify, __________) Neuropathic pain Neuropathy- cranial Neuropathy- motor Neuropathy-sensory Neutrophils For BMT: Neutrophils for leukemia or bone marrow infiltrative/ myelophthisic process Neutrophils/granulocytes (ANC/AGC) Nodal/junctional arrhythmia/dysrhythmia Nystagmus Ocular/Visual-Other (Specify, __________) Operative injury of vein/artery Operative injury to bladder and/or ureter Osteonecrosis (avascular necrosis) Pain due to radiation Pain-Other (Specify, __________) Palpitations Pancreatitis Partial thromboplastin time (PTT) Pelvic pain Pericardial effusion/ pericarditis Peripheral arterial ischemia Personality/behavioral Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) Phlebitis (superficial) Photosensitivity Pigmentation changes (e.g., vitiligo) Platelets Platelets For BMT: Platelets For BMT: Platelets for leukemia studies or bone marrow infiltrative/myelophthisic process Platelets Transfusion: Pleural effusion (non-malignant) Pleuritic pain Pneumonitis/pulmonary infiltrates Pneumothorax Portal vein flow Proctitis Prolonged QTc interval (QTc > 0.48 seconds) Proteinuria Prothrombin time (PT) Pruritus Pulmonary fibrosis Pulmonary-Other (Specify, __________) Pyramidal tract dysfunction Radiation dermatitis Radiation recall reaction Rash for BMT: Rash/desquamation Rectal bleeding/hematochezia Rectal or perirectal pain (proctalgia) Renal failure Renal/Genitourinary-Other (Specify, __________) Rigors, chills Salivary gland changes Secondary Malignancy-(Specify type, __________) excludes metastastic tumors Seizure(s) Sense of smell Serum sickness Sexual/Reproductive Function-Other (Specify, __________) SGOT (AST) (serum glutamic oxaloacetic transaminase) SGPT (ALT) (serum glutamic pyruvic transaminase) SIADH (syndrome of inappropriate antidiuretic hormone) Sinus bradycardia Sinus tachycardia Speech impairment or (e.g., dysphasia or aphasia) Stomatitis for BMT: Stomatitis/pharyngitis (oral/pharyngeal mucositis) Supraventricular arrhythmias (SVT/atrial fibrillation/ flutter) Sweating (diaphoresis) Syncope (fainting) Syndromes-Other (Specify, __________) Taste disturbance (dysgeusia) Tearing (watery eyes) Thrombosis/embolism Thrombotic microangiopathy Thrombotic phemomena for BMT: Transfusion packed red cells for BMT: Transfusion: packed red cellss Tremor Tumor flare Tumor lysis syndrome Tumor pain (onset or exacerbation of tumor pain due to treatment) Typhlitis or (inflammation of the cecum) Ureteral obstruction Urinary electrolyte wasting Urinary frequency/urgency Urinary retention Urine color change Urticaria (hives, welts, wheals) Vaginal bleeding Vaginal dryness Vaginitis (not due to infection) Vasculitis Vasovagal episode Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia) Vertigo Visceral arterial ischemia (non-myocardial) Vision- blurred vision Vision- double vision (diplopia) Vision- flashing lights/floaters Vision- night blindness (nyctalopia) Vision- photophobia Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) Vomiting Weight gain Weight gain - veno-occlusive disease (VOD) Weight loss Wound- infectious Wound- non-infectious

Link to National Cancer Institute (NCI) Web Page for Toxicity- Version 2 (for comparison to version 3)

NCI (National Cancer Institute)
Common Toxicity Criteria--Version 1 (for reference to older studies)

all Alk Phos/5'Nucleotidase ALLERGY Alopecia Amylase ANC (x1000/mm3) Bilirubin Cerebellar Clinical Constipation Cortical Creatinine Diarrhea Dysrhythmias FEVER/NO INFECTION Fibrinogen Function Headache Hearing Hematuria Hemorrhage Hgb (gm/dl) Hypercalcemia Hyperglycemia Hypertension Hypocalcemia Hypoglycemia Hypomagnesemia Hypotension Infection Ischemia LOCAL Lymph (x1000/mm3) Mood Motor Nausea Partial thromboplastin time Pericardial PLT (x1000/mm3) Proteinuria Protrombin time Pulmonary Sensory SGOT/SGPT SKIN Stomatitis Vision Vomiting WBC (x1000/mm3) WEIGHT GAIN/LOSS

SWOG (Southwestern Oncology Group)
Toxicity Criteria

all Abdominal Pain Abscess Acute GVHD Alk Phos or 5’ nucleotidase Allergy (also code rash if it applies) Alopecia Amylase Anorexia Anxiety/Depression Arachnoiditis Bilirubin Bladder – Other (specify) Bladder Cramps Blistering Bone Pain Cardiac- Other (specify) Cardiac-Dysrhythmia Cardiac-EF/CHF Cardiac-Ischemia Cardiac-Pericardial Cerebellar Necrosis Cerebral Necrosis Chills Chronic Skin Change Circulatory Other (specify) Clotting – Other (specify) CNS – Other (specify) CO Diffusion Capacity Conjunctivitis/Keratitis Constipation Convulsions Cough Creatinine Cushingoid Dehydration Dermatologic – Other (specify) Desquamation Desquamation in RT Field Diarrhea Disorientation Dizziness/Vertigo Dry eye Dry skin Dyspnea Dysuria Edema Endocrine – Other (specify) Epistaxis Erectile impotence Erythema Erythema in RT Field Eye – Other (specify) Facial flushing Fever in absence of infection Fibrinogen Gastritis/Ulcer GI – Other (specify) Glaucoma Granuloma GU – Other (specify) GU Fistula Gynecomastia Hand-foot Syndrome Headache Hearing Hematologic-Other Hematuria Hemorrhage (clinical) Hemorrhagic Cystitis Hgb Hot flashes Hypercalcemia Hyperglycemia Hypertension Hypocalcemia Hypoglycemia Hypokalemia Hypomagnesemia Hyponatremia Hypotension Hypothyroidism Ileus Immuno – Other (specify) Immunosensitivity reaction Impotence/Libido Incontinence Incoordination/Ataxia Increased frequency/Urgency Infection at catheter site Insomnia Intestinal Fistula Laryngitis Liver – Clinical Liver – Other (specify) Local Lung – Other (specify) Lymphocytes Malaise/Fatigue/:Lethargy Menses: returned post rx? Metabolic – Other (specify) Miscellaneous – Other (specify) Myalgia/Arthralgia Nausea Neuro – other (specify) Neurocerebellar – Other (specify) Neurocortical – Other (specify) Neuromotor – Other (specify) Neurosensory – Other (specify) Neutrophils/Bands Numbness/Other PNS Other flu-like symptoms (specify) Other infection (specify site) Other Mucositis (specify site) Other Pain (specify site) P02/pCO2 Pancreatitis Paresthesia Partial Thromboplastin Time Personality change Pharynx/Esophagitis Phlebitis/Thrombosis/Embolism Photosensitivity Pigmentation Changes PLT Pneumonitis (non-infectious) Proteinuria Prothrombin Time Pruritus Pseudo-membranes Pulmonary edema Pulmonary Effusions/Infiltrates Pulmonary fibrosis Rectal bleeding Rectal laceration Reflexes Renal – Other (specify) Renal failure Respiratory infection Restlessness Salivary Skin Necrosis (non-local) Skin Rash/Urticaria Skin Ulceration (non-local) Skin Yellowing Small Bowel Obstruction Somnolence/Agitation Speech impairment Sterility Stomatitis Sweats Taste Transaminase (SGOT,SGPT) Tumor Flare (add Hypercalcemia prn) Ureteral Obstruction Urinary Retention Urinary tract infection Vaginal bleeding Vaginitis Veno-Occlusive Disease Vision Vomiting WBC Weakness Weight gain Weight loss Wound Dehiscence Wound infection Wound necrosis

RTOG (Radiation Therapy Oncology Group)
Toxicity Criteria

all CNS LUNG SALIVARY GLAND EAR EYE GENIT0 URINARY HEART HEMATOCRIT (%) HEMATOLOGIC WBC (X 1000) HEMOGLOBIN (GM %) LARYNX LOWER GI INCLUDING PELVIS MUCOUS MEMBRANE NEUTROPHILS (X 1000) PHARYNX & ESOPHAGUS PLATELETS (X 10 3 /cu mm3 SKIN UPPER GI

WHO (World Health Organization)
Toxicity Criteria

all Alk Phos or 5 nucleotidase Allergy Alopecia Amylase Anorexia Asthenia Bilirubin (N = 17 µmol/L) Cardiac- pericardial Cardiac arrhythmias Cardiac function Cardiac ischaemia Chills Creatinine Diarrhoea Fever of unknown origin Fibrinogen Granulocytes/ Bands (x103/l) Haematuria Haemoglobin (g/dl) Haemorrhage Hypercalcaemia (mg/dl) Hyperglycaemia (mg/dl) Hypertension Hypocalcaemia (mg/dl) Hypoglycaemia (mg/dl) Hypomagnesaemia (mg/dl) Hypotension Infection Liver- clinical Local Lymphocytes (x103/l) Nausea Neuro: cerebellar Neuro: constipation Neuro: cortical Neuro: headache Neuro: hearing Neuro: mood Neuro: motor Neuro: sensory Neuro: vision Pain Partial thrombo- plastin time Peripheral oedema Platelets (x103/l) Proteinuria Prothrombin time(Quick) Pulmonary Skin Stomatitis Transaminase (SGOT, SGPT) Vomiting WBC (x103/l) Weight gain/ loss