Appendix 5 NCIC Common Toxicity Criteria (CTC)

NCIC Common Toxicity Criteria (CTC) / Grading System (May 1991 revised)

no antacid req vigorous medical management or non–surgical trtuncontrolled by medical management ; req surgery for GI ulcerationperforation of bleeding
Grade 0 Grade 1 (mild) Grade 2 (moderate) Grade 3 (severe) Grade 4 (life–threatening)
Allergy none transient rash, fever < 38°C, 100.4°F urticaria, fever=38°C, 100.4°F, mild brochospasm serum sickness, bronchospasm, req parenteral meds anaphylaxis

BLOOD / BONE MARROW
White Blood Cells(109/l) ≥ 4.0 3.0 – 3.9 2.0 – 2.9 1.0 – 1.9 < 1.0
Platelets (109/l) WNL 75.0 - normal 50.0 – 74.9 25.0 – 49.9 < 25.0
Hemoglobin (g/dl) WNL 10.0 – normal 8.0 – 9.9 6.5 – 7.9 < 6.5
Granulocytes (109/l) (ie. neuts.+baso.+eosin.) ≥ 2.0 1.5 – 1.9 1.0 – 1.4 0.5 – 0.9 < 0.5
Lymphocytes (109/l) ≥ 2.0 1.5 – 1.9 1.0 – 1.4 0.5 – 0.9 <0.5
Hemorrhage (clinical) (includes nosebleeds, menorrhagia etc) none mild, no transfusion (includes bruise/hematoma, petachiae) gross, 1–2 units transfusion per episode gross, 3–4 units transfusion per episode massive, > 4 units transfusion per episode

CARDIOVASCULAR
Arterial none - - transient events permanent event
Venous none superficial (excludes IV site reaction – code under skin) deep vein thrombosis not requiring anticoagulant therapy deep vein thrombosis req anticoagulant therapy pulmonary embolism
Dysrhythmias none asymptomatic, transient, req no therapy recurrent or persistent, no therapy req req trt req monitoring, or hypotension, or ventricular tachycardia, or fibrillation
Edema none 1+ or dependent in evening only 2+ or dependent throughout day 3+ 4+, generalized anasarca
Function none asymptomatic, decline of resting ejection fraction of 10% or greater but less than 20% of baseline value asymptomatic, decline of resting ejection fraction by > 20% of baseline value mild CHF, responsive to therapy severe or refractory CHF
Hypertension none or no change asymptomatic, transient increase by > 20mm Hg or to > 150/100 if previously WNL. No trt req recurrent or persistent increase by > 20mm Hg or to > 150/100 if previously WNL. No trt req req therapy hypertensive crisis
Hypotension none or no change changes req no therapy (incl transient orthostatic hypotension) req fluid replacement or other therapy but not hospitalization req therapy & hospitalization; resolves within 48hrs of stopping agent req therapy & hospitalization for > 48hrs after stopping agent
Ischemia none or no change non–specific T wave flattening asymptomatic, ST & T wave changes suggesting ischemia angina without evidence for infarction acute myocardial infarction
Pain (chest) none mild moderate severe life–threatening
Pericardial none asymptomatic, effusion, no intervention req pericarditis (rub, chest pain, ECG changes) symptomatic effusion; drainage req tamponade, drainage urgently req; or constrictive pericarditis req surgery

COAGULATION
Fibrinogen WNL 0.99 – 0.75 x N 0.74 – 0.5 x N 0.49 – 0.25 x N < 0.24 x N
Prothrombin Time WNL 1.01 – 1.25 x N 1.26 – 1.5 x N 1.51 – 2.00 x N > 2.00 x N
Partial Thromboplastintime WNL 1.01 – 1.66 x N 1.67 – 2.33 x N 2.34 – 3.00 x N > 3.00 x N

ENDOCRINE
Amenorrhea no yes > 3 months - - -
Cushingoid normal mild pronounced - -
Hot Flashes none mild or < 1/day moderate & > 1/day frequent & interferes with normal function -
Gynecomastia normal mild pronounced or painful - -
Impotence / Libido normal decrease in normal function - absence of function -

FLU–LIKE SYMPTOMS
Arthralgia (joint pain) none mild moderate Severe -
Diaphoresis(sweating) none mild moderate Severe -
Fever in absence of infection none 37.1 – 38.0°C 98.7 – 100.4°F 38.1 – 40.0°C 100.5 – 104.5°F > 40.0°C > 104.0°F for < 24hrs > 40.0°C (104.0°F) for > 24hrs or fever accompanied by hypotension
(includes drug fever) Fever felt to be caused by drug allergy should be coded as ALLERGY. Non–allergic drug fever (e.g. as from biologics) should be coded under FLU–LIKE SYMPTOMS. If fever is due to infection, code INFECTION only.
Hayfever (includes sneezing, nasal stuffiness, post–nasal drip) none mild moderate Severe -
Lethargy (fatigue, malaise) none mild, fall of 1 level in performance status moderate, fall of 2 levels in perf. status severe, fall of 3 levels in perf. status -
Myalgia (muscle ache) none mild moderate Severe -
Rigors/Chills (Gr 3 incl cyanosis) none mild or brief pronounced and/or prolonged cyanosis -

GASTROINTESTINAL
Anorexia (loss of appetite) none mild moderate Severe -
Appetite– increased none mild moderate – –
Diarrhea none increase of 2–3 stools/day over pre–trt increase of 4–6 stools/day, or nocturnal stools increase of 7–9 stools/day, or incontinence, malabsorption increase of >10 stools/day or grossly bloody diarrhea, or need for parenteral support
Esophagitis/dysphagia/odynophagia none dys. or odyn. not req trt, or painless ulcers on esophagoscopy dys. or odyn. req trt dys. or odyn. lasting > 14 days despite trt dys. or odyn. with 10% loss of body wt, dehydration, hosp.req
Mouth Dryness none mild moderate severe -
Intestinal Fistula no - - req intervention req operation
Heartburn (includes dyspepsia) none mild moderate severe -
Nausea none able to eat reasonable intake intake significantly decreased but can eat no significant intake -
Small bowel obstruction no - intermittent, no intervention req intervention req operation
Pain/Cramping (abdominal) (includes rectal pain) none mild moderate severe -
Proctitis (rectal) none - tenesmus or ulcerations relieved with therapy tenesmus or ulcerations or other symptoms not relieved mucosal necrosis with hemorrhage or other life threatening
Stomatitis/oral none painless ulcers, erythema, or mild soreness painful erythema, edema, or ulcers but can eat with therapy painful erythema, edema, or ulcers, and cannot eat Proctitis, mucosal necrosis and/or req parenteral or enteral support
Taste altered none mild moderate severe -
Gastritis/ulcer
Vomiting or req parenteral none 1 episode in 24hrs 2–5 episodes in 24hrs 6–10 episodes in 24hrs > 10 eposodes in 24hrs

GENITO URINARY
Bladder changes none light, epithelial atrophy, or minor telangiectasia generalized telangiectasia severe generalized telangiectasia (often with petechiae) or reduction in bladder capacity necrosis, or contracted bladder (capacity <100ml), or fibrosis/fistulae
Creatinine WNL <1.5 x N 1.5–3.0 x N 3.1–6.0 x N > 6.0 x N
Cystitis none mild symptoms req no intervention symptoms relieved completely with therapy symptoms not relieved despite therapy severe (life threatening) cystitis
(non–bacterial) Urinary tract infection should be coded under infection, not Genito Urinary.
Dysuria none dysuria not req trt dysuria req trt - -
Fistula none - - yes -
Frequency none freq of urination or nocturia twice pre–trt habit freq of urination or nocturia < hourly freq with urgency and nocturia w hourly -
Hematuria neg micro only gross, no clots gross + clots req transfusion
Hematuria resulting from thrombocytopenia should be coded under hemorrhage not Genito Urinary.
Ureteral obstruction none unilateral, no surgery req bilateral, no surgery req not complete bilateral, but stents, nephrostomy tubes or surgery req complete bilateral obstruction
Proteinuria no change 1 + or < 0.3g % or < 3g/L 2–3 + or 0.3–1.0g % or 3–10g/L 4 + or > 1.0g % or > 10g/L nephrotic syndrome

HEPATIC
Alk Phos or 5nucleotidase WNL <2.5 x N 2.6–5.0 x N 5.1–20.0 x N > 20.0 x N
Transaminase ALAT (SGPT) WNL <2.5 x N 2.6–5.0 x N 5.1–20.0 x N > 20.0 x N
Transaminase ASAT (SGOT) WNL ≤2.5 x N 2.6–5.0 x N 5.1–20.0 x N > 20.0 x N
Bilirubin WNL - < 1.5 x N 1.5–3.0 x N > 3.0 x N
Liver (clinical) no change from baseline - - precoma hepatic coma
LDH WNL <2.5 x N 2.6–5.0 x N 5.1–20.0 x N > 20.0 x N
Infections none mild, no active trt moderate, localized infect req active trt severe, systemic infect req parenteral trt, specify site life threatening sepsis, specify site
Febrile neutropenia none - - present -
Fever felt to be caused by drug allergy should be coded as ALLERGY. Non–allergic drug fever (eg. as from biologics) should be coded under FLU–LIKE SYMPTOMS. If fever is due to infection, code INFECTION only.

METABOLIC (SI UNITS)
Amylase WNL < 1.5 x N 1.5 – 2.0 x N 2.1 – 5.0 x N > 5.1 x N
Hypercalcemia < 2.64mmol/L 2.64 – 2.88 2.89 – 3.12 3.13 – 3.37 > 3.37
Hypocalcemia > 2.10mmol/L 2.10 – 1.93 1.92 – 1.74 1.73 – 1.51 < 1.50
Hyperglycemia < 6.44mmol/L 6.44 – 8.90 8.91 – 13.8 13.9 – 27.8 > 27.8 or ketoacidosis
Hypoglycemia > 3.55mmol/L 3.03 – 3.55 2.19 – 3.02 1.66 – 2.18 < 1.66
Hypokalemia no change or > 3.5mmol/L 3.1 – 3.5 2.6 – 3.0 2.1 – 2.5 < 2.0
Hypomagnesemia > 0.70mmol/L 0.70 – 0.58 0.57 – 0.38 0.37 – 0.30 < 0.29
Hyponatremia no change or > 135mmol/L 131 – 135 126 – 130 121 – 125 < 120

NEUROLOGIC
Cerebellar none slight incoordination, dysdiadochokinesis intention tremor, dysmetria, slurred speech, nystagmus locomotor ataxia cerebellar necrosis
Constipation none or no change mild moderate severe ileus > 96hrs
Cortical (includes drowsiness) none mild somnolence moderate somnolence severe somnolence, confusion, disorientation, hallucinations coma, seizures, toxic psychosis
Dizziness (includes lightheadedness) none mild moderate severe (includes fainting) -
Extrapyramidal/Involuntary Movement agitation (includes restlessness) none mild moderate agitation torticollis, oculogyric crisis, severe agitation -
Headache none mild moderate or severe but transient unrelenting & sever -
Hearing none or no change asymptomatic, hearing loss on audiometry only tinnitus aid hearing loss interfering with function but correctable with hearing deafness not correctable
Insomnia none mild moderate severe -
Mood no change mild anxiety or depression moderate anxiety or depression severe anxiety or depression suicidal ideation
Motor none or no change subjective weakness ; no objective findings mild objective weakness without significant impairment of function objective weakness with impairment of function paralysis
Personality Change no change change, not disruptive to pt or family disruptive to pt or family harmful to others or self psychosis
Sensory none or no change mild paresthesias, loss of deep tendon reflexes (incl. tingling) mild or moderate objective sensory loss ; moderate paresthesias sensory loss or paresthesias that interfere with function -
Vision none or no change blurred vision - symptomatic subtotal loss of vision blindness

OCULAR
Conjunctivitis/keratitis none erythema or chemosis not req steroids or antibiotics req trt with steroids or antibiotics corneal ulceration or visible opacification -
Dry eye normal mild req artificial tears severe req enucleation
Glaucoma no change . - yes -

PULMONARY
Carbon Monoxide Diffusion Capacity (DLCO) %gt; 90 % of pretreatment value decrease to 76–90 % of pre–trt decrease to 51–75 % of pre–trt decrease to 26–50 % of pre–trt decrease to < 25 % of pre–trt
Cough none mild moderate severe -
Pulmonary Edema none - out–pt management in–pt management req intubation
Pulmonary Fibrosis normal radiographic changes, no symptoms - changes with symptoms -
Pneumonitis (non–infectious) normal radiographic changes, symptoms do not req steroids steroids req oxygen req req assisted ventilation
SOB (dyspnea) (includes wheezing) none or no change asymptomatic, with abnormality in PFT's dyspnea on significant exertion dyspnea at normal level of activity dyspnea at rest

SKIN
Alopecia no loss mild hair loss pronounced or total head hair loss total body hair loss -
Skin changes none hyperpigmentation atrophy subcut, fibrosis ulceration or necrosis
Desquamation none dry desquamation moist desquamation confluent moist desquamation -
Flushing–facial none mild moderate severe -
Local Toxicity (reaction at IV site) none pain pain & swelling, with inflammation or phlebitis ulceration plastic surgery indicated
Rash/Itch (not due to allergy) (includes recall reaction) none or no change scattered macular or papular eruption or erythema that is asymptomatic scattered macular or papular eruption or erythema with pruritus or other associated symptoms generalized symptomatic macular, papular, or vesicular eruption exfoliative dermatitis or ulceration dermatitis

WEIGHT
Weight Gain < 5.0 % 5.0 – 9.9 % 10.0 – 19.9 % > 20.0 % -
Weight Loss < 5.0 % 5.0 – 9.9 % 10.0 – 19.9 % > 20.0 % -

Last update: Tuesday, January 18, 2011
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