National Cancer Institute (NCI) Common Toxicity Criteria Version 1 Page 1 of 4 NCI (National Cancer Institute) Common Toxicity Criteria Version 1 Category Toxicity Grade0 Grade1 Slight None incoordination, dysdiadokinesis No Mild anxiety, change depression NEUROLOGICAL Cerebellar NEUROLOGICAL Mood NEUROLOGICAL Headache None NEUROLOGICAL Constipation None or no Mild change NEUROLOGICAL Hearing None or Asymptomatic no hearing loss on change audiometry only NEUROLOGICAL Vision Mild None or no -change Scattered macular None or or papular rash or no erythema that is change asymptomatic SKIN SKIN ALLERGY ALLERGY None Transient rash, drug fever<38° FEVER/NO INFECTION FEVER/NO INFECTION None 37.1 - 38.0° http://www.accessdata.fda.gov/scripts/cder/onctools/toxcrit1.cfm Grade2 Intention tremor, dysmetria, slurred speech, nystagmus Moderate anxiety, depression Moderate or severe, transient Grade3 Grade4 Locomotor ataxia cerebellar necrosis Severe anxiety, depression Severe, unrelenting Suicidal ideation -- Moderate Severe Ileus > 96 hrs Tinnitus Hearing loss interfering with function, Deafness not correctable correctable with aid -- Symptomatic subtotal loss Blindness Scattered macular or papular rash or erythema with pruritis or other symptoms Generalized symptomatic Exfoliative or ulcerating macular, papular, dermatitis or vesicular rash Serum sickness, Urticaria, drug fever = bronchospasm 38° mild Anaphylaxis requiring bronchospasm parenteral meds >40° for > 24 hrs or 38.1 - 40.0° >40° for < 24 hrs fever accompanied by hypotension 7/9/2007 National Cancer Institute (NCI) Common Toxicity Criteria Version 1 TISSUE LOCAL Pain & swelling with inflammation or Ulceration phlebitis Plastic surgery indicated < 5.0% 5.0 - 9.9% 10.0 - 19.9% >20% -- < 116 >64 WNL < 10.6 >8.4 >1.4 None or no change 116 - 160 55 - 64 < 1.5 x N 10.6 - 11.5 8.4 - 7.8 1.4 - 1.2 161 - 250 40 - 54 1.5 - 2.0 x N 11.6 - 12.5 7.7 - 7.0 1.1 - 0.9 251 - 500 30 - 39 2.1 - 5.0 x N 12.6 - 13.5 6.9 - 6.1 0.8 - 0.6 >500 or ketoacidosis < 30 >5.1 x N >13.5 < 6.0 < 0.5 Asymptomatic with abnl PFT's Dyspnea on significant exertion Dyspnea with normal activity Dyspnea at rest Asymptomatic, transient requires no Rx. Asymptomatic, resting ejection fraction Ø'd by <20% of baseline Recurrent or persistent Requires no Rx. Asymptomatic, resting ejection fraction Ø'd by >20% of baseline Asymptomatic, ST/T wave changes suggesting ischemia Pericarditis - rub, chest pain, ECG changes Requires Rx. Requires monitoring; or hypotension; or vent. tachycardia/fibrillation Mild CHF, responds to Rx. Severe, refractory CHF None METABOLIC METABOLIC METABOLIC METABOLIC METABOLIC METABOLIC WEIGHT GAIN/LOSS Hyperglycemia Hypoglycemia Amylase Hypercalcemia Hypocalcemia Hypomagnesemia PULMONARY Pulmonary CARDIAC Dysrhythmias None CARDIAC Function WNL WEIGHT GAIN/LOSS CARDIAC Ischemia None CARDIAC Pericardial None BLOOD PRESSURE Hypertension Page 2 of 4 Pain Nonspecific Twave flattening Asymptomatic effusion, no Rx. required Asymptomatic, transient _ by >20 None or mm (D) or to no >150/100 if change previously WNL. No Rx. Angina without evidence for infarction Symptomatic effusion, drainage required Recurrent/persistent _ by >20 mm (D) or to Requires Rx. >150/100 if previously WNL. No Rx. Acute myocardial infarction Tamponade; drainage urgently required Hypertensive crisis Changes not http://www.accessdata.fda.gov/scripts/cder/onctools/toxcrit1.cfm 7/9/2007 National Cancer Institute (NCI) Common Toxicity Criteria Version 1 BLOOD PRESSURE Hypotension NEUROLOGICAL Sensory NEUROLOGICAL Motor BLOOD/BONE MARROW BLOOD/BONE MARROW BLOOD/BONE MARROW BLOOD/BONE MARROW BLOOD/BONE MARROW Page 3 of 4 requiring Rx. None or Requires fluids or (includes transient no other Rx. but not orthostatic change hospitalized hypotension) Requires Rx. and Requires therapy and hospitalization; hospitalization for >48 h resolves within after stopping agent Severe objective None or Mild paresthesias, Mild or moderate sensory loss or no loss of deep objective sensory loss; paresthesias that -change tendon reflexes moderate paresthesias interfere with function Mild objective None or Subjective Objective weakness, no no weakness, no weakness with Paralysis significant loss of change objective findings loss of function function WBC (x1000/mm3) >4.0 3.0-3.9 2.0-2.9 1.0-1.9 < 1.0 PLT (x1000/mm3) WNL 75.0-WNL 50.0-74.9 25.0-49.9 < 25.0 Hgb (gm/dl) 10.0-WNL 8.0-10.0 6.5-7.9 < 6.5 ANC (x1000/mm3) >2.0 1.5-1.9 1.0-1.4 0.5-0.9 < 0.5 Lymph (x1000/mm3) >2.0 1.5-1.9 1.0-1.4 0.5-0.9 < 0.5 HEMORRHAGE Hemorrhage None INFECTION Infection None Mild, no Tx.per episode Mild None Able to eat Gross, 3-4 units Tx. per episode Severe Unable to eat Ø intake Massive, >4 units Tx. per episode Life-threatening GASTROINTESTINAL Nausea Gross, 1-2 units Tx. per episode Moderate Able to eat reasonable intake GASTROINTESTINAL Vomiting None 1 emesis/24 h 2-5 emeses/24 h 6-10 emeses/24 h GASTROINTESTINAL Diarrhea None _ of 2-3 stools/d over pre-Rx _ of 4-6 stools/d moderate cramping nocturnal stools >10 emeses/24 h or parenteral support _ of 7-9 stools/d _ of >10 stools/d severe cramping parenteral support incontinence grossly bloody stools Erythema, Painful erythema, Painful WNL http://www.accessdata.fda.gov/scripts/cder/onctools/toxcrit1.cfm -- Parenteral or enteral 7/9/2007 National Cancer Institute (NCI) Common Toxicity Criteria Version 1 WNL WNL painless ulcers, mild soreness -< 2.5 x N edema, ulcers can eat erythema, edema, support ulcers cannot eat < 1.5 x N 1.5-3.0 x N >3.0 x N 2.6-5.0 x N 5.1-20.0 x N >20.0 x N WNL < 2.5 x N 2.6-5.0 x N -< 1.5 x N 1+ or <0.3 gm% (<3 gm/L) Microscopic Mild hair loss -1.5-3.0 x N 2-3+ or 0.3-1.0 gm% (3-10 gm/L) Gross, no clots Near or total hair loss GASTROINTESTINAL Stomatitis None HEPATIC HEPATIC HEPATIC RENAL/BLADDER Bilirubin SGOT/SGPT Alk Phos/5'Nucleotidase Clinical Creatinine RENAL/BLADDER Proteinuria RENAL/BLADDER ALOPECIA Hematuria Alopecia -WNL No change Neg. No loss NEUROLOGICAL Cortical None COAGULATION COAGULATION Fibrinogen WNL Protrombin time WNL Partial WNL thromboplastin time HEPATIC COAGULATION Page 4 of 4 5.1-20.0 x N >20.0 x N Precoma 3.1-6.0 x N 4+ or >1.0 gm% (>10 gm/L) Gross + clots -Severe somnolence, Mild somnolence, Moderate agitation, agitation somnolence, agitation confusion, disorientation, hallucinations 0.99 - 0.75 x N 0.74 - 0.5 x N 0.49 - 0.25 x N 1.01 - 1.25 x N 1.26 - 1.5 x N 1.51 - 2.0 x N Hepatic coma >6.0 x N 1.01 - 1.66 x N >3.0 x N http://www.accessdata.fda.gov/scripts/cder/onctools/toxcrit1.cfm 1.67 - 2.33 x N 2.34 - 3.0 x N Nephrotic syndrome Requires Tx. -- Coma, seizures, toxic psychosis < 0.24 x N >2.0 x N 7/9/2007