Cooperative Group Common Toxicity Criteria Toxicity Links Blood/Bone Marrow Hemorrhage Infection Gastrointestinal Liver Kidney/Bladder Alopecia Pulmonary Heart Blood Pressure Neurological Skin Allergy Fever w/o Infection Local Weight Gain/Loss Metabolic Coagulation Instructions 1. Toxicity grade should reflect the most severe degree occurring during the evaluated period, not an average. 2. When two criteria are available for similar toxicities, the one resulting in the more severe grade should be used. 3. Toxicity grade = 5 if that toxicity caused the death of the patient. 4. Refer to detailed toxicity guidelines in the protocol, or to RTOG Headquarters for toxicity not covered on this table. 5. The evaluator must attempt to discriminate between disease/treatment and related signs/symptoms. 6. An accurate baseline prior to start of therapy is necessary.   TOXICITY - 0 - - 1 - - 2 - - 3 - - 4 - Blood/Bone Marrow WBC >=4.0 3.0-3.9 2.0-2.9 1.0-1.9 <1.0 Platelets WNL 75.0 - normal 50.0 - 74.9 25.0 - 49.9 <25.0 Hemoglobin WNL 10.0 - normal 8.0 - 10.0 6.5 - 7.9 <6.5 Granulocytes/Bands >=2.0 1.5 - 1.9 1.0 - 1.2 0.5 - 0.9 <0.5 Lymphocytes >=2.0 1.5 - 1.9 1.0 - 1.2 0.5 - 0.9 <0.5   Hemorrhage (Clinical) None Mild, no transfusion Gross, 1-2 units transfusion per episode Gross, 3-4 units transfusion per episode Massive, 3-4 units transfusion per episode   Infection None Mild Moderate Severe Life-threatening Gastro- intestinal Nausea None Able to eat/ reasonable intake Intake significantly decreased but can eat No significant intake ------- Vomiting None 1 episode in 24 hours 2-5 episodes in 24 hours 6-10 episodes in 24 hours >10 episodes in 24 hours or requiring parenteral support Diarrhea None Increase of 2-3 stools per day over pre-Rx Increase of 4-6 stools/day, or nocturnal stools, or moderate cramping Increase of 7-9 stools/day or incontinence or severe cramping Increase of >=10 stools/day or grossly bloody diarrhea, or need for parenteral support Stomatitis None Painless ulcers, erythema or mild soreness Painful erythema, edema or ulcers but can eat Painful erythema, edema or ulcers and cannot eat Requires parenteral or enteral support Liver Bilirubin WNL ------- <1.5 X N 1.5 - 3.0 X N >3.0 X N Transaminase (SGOT, SGPT) WNL <=2.5 X N 2.6 - 5.0 X N 5.1 - 20.0 X N >20.0 X N Alkaline Phosphatase or S'nucleotidase WNL <=2.5 X N 2.6 - 5.0 X N 5.1 - 20.0 X N >20.0 X N Liver/clinical No change from baseline ------- ------- Precoma Hepatic coma Kidney/ bladder Creatinine WNL <1.5 X N 1.5 - 3.0 X N 3.1 - 6.0 X N >6.0 X N Proteinuria No change 1 + or < 0.3 g% or <3 g/1 2 - 3+ or 0.3 - 1.0 g% or 3 - 10 g/1 4+ or >1.0 g% or >10 g/1 Nephrotic syndrome Hematuria Negative Micro only Gross/no clots Gross + clots Requires transfusion   Alopecia No loss Mild hair loss Pronounced or total hair loss ------- -------   Pulmonary None or no change Asymptomatic with abnormality in PFTUs Dyspnea on significant exertion Dyspnea at normal level of activity Dyspnea at rest Heart Cardiac dysrhythmias None Asymptomatic/ transient/ requiring no therapy Recurrent or persistent/ no therapy required Requires treatment Requires monitoring or hypotension or ventricular tachycardia or fibrillation Cardiac function None Asymptomatic/ decline of resting ejection fraction by <20% of baseline value Asymptomatic/ decline of resting ejection friction by >20% of baseline value Mild CHF, responsive to therapy Severe or refractory CHF Cardiac/ ischemia None Non-specific T-wave flattening Asymptomatic/ST and T wave changes suggesting ischemia Angina without evidence for infarction Acute myocardial infarction Cardiac/pericardial None Asymptomatic effusion/ no intervention required Pericarditis (rub, chest pain, ECG changes Symptomatic effusion: drainage required Tamponade/ drainage urgently required Blood Pressure Hypertension None or no change Asymptomatic/ transient increase by >20 mm Hg (d) or to >150/100 if previously WNL/ No treatment required Recurrent or persistent increase by >20 mm Hg (D) or to >150/100 if previously WNL/ No treatment required Requires therapy Hypertensive crisis Hypotension None or no change Changes requiring no therapy/ including transient orthostatic hypotension Requires fluid replacement or other therapy but not hospitalization Requires therapy and hospitalization/ resolves within 48 hours of stopping the agent Requires therapy and hospitalization for >48 hrs after stopping the agent Neurologic Neurological/ sensory None or no change Mild paresthesias/ loss of deep tendon reflexes Mild or moderate objective sensory loss/ moderate paresthesias Severe objective sensory loss or paresthesias that interfere with function ------- Neurological/ 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 Neurological/ cortical None Mild somnolence or agitation Moderate somnolence or agitation Severe somnolence, agitation, confusion, disorientation or hallucinations Coma, seizures, toxic paralysis Neurological/ cerebellar None Slight incoordination/ dysdiadokinesis Intention tremor, dysmetria, slurred speech, nystagmus Locomotor ataxia Cerebellar necrosis Neurological/ mood No change Mild anxiety or depression Moderate anxiety or depression Severe anxiety or depression Suicidal ideation Neurological/ headache None Mild Moderate or severe but transient Unrelenting and severe ------- Neurological/ constipation None or no change Mild Moderate Severe Ileus >96 hours Neurological/hearing None or no change Asymptomatic/ hearing loss on audiometry only Tinnitus Hearing loss interfering with function but correctable with hearing aid Deafness not correctable Neurological/vision None or no change ------- ------- Symptomatic subtotal loss of vision Blindness   Skin None or no change Scattered macular or papular eruption or erythema that is asymptomatic Scattered macular or papular eruption or erythema with pruritis or other associated symptoms Generalized symptomatic macular, papular, or vesicular eruption Exfoliative dermatitis or ulcerating dermatitis   Allergy None Transient rash/drug fever <38oC, 100.4oF Urticaria, drug fever = 38oC, 100.4oF/ mild bronchospasm Serum sickness, bronchospasm, requiring parenteral medicationg Anaphylaxis   Fever in absence of infection None 37.1 - 38.0oC, 98.7 - 100.4oF 38.1 - 40.0oC, 100.5 - 104.0oF >40.0oC/>104.0oF for less than 24 hours >40.0oC/104.0oF for more than 24 hrs or fever accompanied by hypertension   Local None Pain Pain and swelling with inflammation or phlebitis Ulceration Plastic surgery indicated   Weight gain/loss <5.0% 5.0 - 9.9% 10.0 - 19.9% >=20.0% ------- Meta- bolic Hyperglycemia <116 116-160 161-250 251 - 500 >500 or ketoacidosis Hypoglycemia >64 55-64 40-54 30-39 <30 Amylase WNL <1.5 X N 1.5 - 2.0 X N 2.1 - 5.0 X N >5.1 X N Hypercalcemia <10.6 10.6 - 11.5 11.6 - 12.5 12.6 - 13.5 >=13.5 Hypocalcemia >8.4 8.4 - 7.8 7.7 - 7.0 6.9 - 6.1 <=6.0 Hypomagnesemia >1.4 1.4 - 1.2 1.1 - 0.9 0.8 - 0.6 <=0.5 Coagulation Fibrinogen WNL 0.99 - 0.75 X N 0.74 - 0.50 X N 0.49 - 0.25 X N <=0.24 X N Prothrombin time WNL 1.01 - 1.25 X N 1.26 - 1.50 1.51 - 2.00 X N >=2.00 X N Partial thromboplastin time WNL 1.01 - 1.66 X N 1.67 - 2.33 X N 2.34 - 3.00 X N >3.00 X N