Category:CTCAE4 Investigations
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| Adverse Event | Grade1 | Grade2 | Grade3 | Grade4 | Grade5 |
|---|---|---|---|---|---|
| Activated partial thromboplastin time prolonged | >1 - 1.5 x ULN | >1.5 - 2.5 X ULN | > 2.5 x ULN; hemorrhage | - | - |
| Alanine aminotransferase increased | >ULN - 3.0 x ULN | Asymptomatic with ALT >3.0 - 5.0 x ULN; >3 x ULN with the appearance of worsening of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia | >5.0 - 20.0 x ULN; >5 x ULN for >2 weeks | >20.0 x ULN | - |
| Alkaline phosphatase increased | >ULN - 2.5 x ULN | >2.5 - 5.0 x ULN | >5.0 - 20.0 x ULN | >20.0 x ULN | - |
| Aspartate aminotransferase increased | >ULN - 3.0 x ULN | Asymptomatic with AST >3.0 - 5.0 x ULN; >3 x ULN with the appearance of worsening of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia | >5.0 - 20.0 x ULN; >5 x ULN for >2 weeks | >20.0 x ULN | - |
| Blood antidiuretic hormone abnormal | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; medical intervention indicated | Hospitalization indicated | - | - |
| Blood bilirubin increased | >ULN - 1.5 x ULN | >1.5 - 3.0 x ULN | >3.0 - 10.0 x ULN | >10.0 x ULN | - |
| Blood corticotrophin decreased | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; medical intervention indicated | Hospitalization indicated | - | - |
| Blood gonadotrophin abnormal | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; medical intervention indicated; limiting instrumental ADL | Severe symptoms; limiting self care ADL | - | - |
| Blood prolactin abnormal | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Moderate symptoms; limiting instrumental ADL | - | - | - |
| CD4 lymphocytes decreased | <LLN - 500/mm3; <LLN - 0.5 x 10e9 /L | <500 - 200/mm3; <0.5 - 0.2 x 10e9 /L | <200 - 50/mm3; <0.2 x 0.05 - 10e9 /L | <50/mm3; <0.05 x 10e9 /L | - |
| CPK increased | >ULN - 2.5 x ULN | >2.5 x ULN - 5 x ULN | >5 x ULN - 10 x ULN | >10 x ULN | - |
| Carbon monoxide diffusing capacity decreased | 3 - 5 units below LLN; for follow-up, a decrease of 3 - 5 units (ml/sec/mm Hg) below the baseline value | 6 - 8 units below LLN; for follow-up, an asymptomatic decrease of >5 - 8 units (ml/sec/mm Hg) below the baseline value | Asymptomatic decrease of >8 units drop; >5 units drop along with the presence of pulmonary symptoms (e.g. , >Grade 2 hypoxia or >Grade 2 or higher dyspnea) | - | - |
| Cardiac troponin I increased | Levels above the upper limit of normal and below the level of myocardial infarction as defined by the manufacturer | - | Levels consistent with myocardial infarction as defined by the manufacturer | - | - |
| Cardiac troponin T increased | Levels above the upper limit of normal and below the level of myocardial infarction as defined by the manufacturer | - | Levels consistent with myocardial infarction as defined by the manufacturer | - | - |
| Cholesterol high | >ULN - 300 mg/dL; >ULN - 7.75 mmol/L | >300 - 400 mg/dL; >7.75 - 10.34 mmol/L | >400 - 500 mg/dL; >10.34 - 12.92 mmol/L | >500 mg/dL; >12.92 mmol/L | - |
| Creatinine increased | >1 - 1.5 x baseline; >ULN - 1.5 x ULN | >1.5 - 3.0 x baseline; >1.5 - 3.0 x ULN | >3.0 baseline; > 3.0 - 6.0 x ULN | >6.0 x ULN | - |
| Ejection fraction decreased | - | Resting ejection fraction (EF) 50 - 40%; 10 - 19% drop from baseline | Resting ejection fraction (EF) 39 - 20%; > 20% drop from baseline | Resting ejection fraction (EF) <20% | - |
| Electrocardiogram QT corrected interval prolonged | QTc 450 - 480 ms | QTc 481 - 500 ms | QTc >= 501 ms on at least two separate ECGs | QTc >= 501 or >60 ms change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia | - |
| Fibrinogen decreased | <1.0 - 0.75 x LLN or <25% decrease from baseline | <0.75 - 0.5 x LLN or 25 - <50% decrease from baseline | <0.5 - 0.25 x LLN or 50 - <75% decrease from baseline | <0.25 x LLN or 75% decrease from baseline or absolute value <50 mg/dL | - |
| Forced expiratory volume decreased | FEV1% (percentages of observed FEV1 and FVC related to their respective predicted values) 99 - 70% predicted | FEV1 60 - 69 % | 50 - 59% | <= 49% | - |
| GGT increased | >ULN - 2.5 x ULN | >2.5 - 5.0 x ULN | >5.0 - 20.0 x ULN | >20.0 x ULN | - |
| Growth hormone abnormal | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; medical intervention indicated; limiting instrumental ADL | - | - | - |
| Haptoglobin decreased | <LLN | - | - | - | - |
| Hemoglobin increased | Increase in >0 - 2 gm/dL above ULN or above baseline if baseline is above ULN | Increase in >2 - 4 gm/dL above ULN or above baseline if baseline is above ULN | Increase in >4 gm/dL above ULN or above baseline if baseline is above ULN | - | - |
| INR increased | >1 - 1.5 x ULN; >1 - 1.5 times above baseline if on anticoagulation | >1.5 - 2.5 x ULN; >1.5 - 2.5 times above baseline if on anticoagulation | >2.5 x ULN; >2.5 times above baseline if on anticoagulation | - | - |
| Investigations - Other, specify | Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated | Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL | Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self care ADL | Life-threatening consequences; urgent intervention indicated | Death |
| Lipase increased | >ULN - 1.5 x ULN | >1.5 - 2.0 x ULN | >2.0 - 5.0 x ULN | >5.0 x ULN | - |
| Lymphocyte count decreased | <LLN - 800/mm3; <LLN x 0.8 - 10e9 /L | <800 - 500/mm3; <0.8 - 0.5 x 10e9 /L | <500 - 200 mm3; <0.5 - 0.2 x 10e9 /L | <200/mm3; <0.2 x 10e9 /L | - |
| Lymphocyte count increased | - | >4000/mm3 - 20,000/mm3 | >20000/mm3 | - | - |
| Neutrophil count decreased | <LLN - 1500/mm3; <LLN - 1.5 x 10e9 /L | <1500 - 1000/mm3; <1.5 - 1.0 x 10e9 /L | <1000 - 500/mm3; <1.0 - 0.5 x 10e9 /L | <500/mm3; <0.5 x 10e9 /L | - |
| Pancreatic enzymes decreased | <LLN and asymptomatic | Increase in stool frequency, bulk, or odor; steatorrhea | Sequelae of absorption deficiency | - | - |
| Platelet count decreased | <LLN - 75,000/mm3; <LLN - 75.0 x 10e9 /L | <75,000 - 50,000/mm3; <75.0 - 50.0 x 10e9 /L | <50,000 - 25,000/mm3; <50.0 - 25.0 x 10e9 /L | <25,000/mm3; <25.0 x 10e9 /L | - |
| Serum amylase increased | >ULN - 1.5 x ULN | >1.5 - 2.0 x ULN | >2.0 - 5.0 x ULN | >5.0 x ULN | - |
| Urine output decreased | - | - | Oliguria (<80 ml in 8 hr) | Anuria (<240 ml in 24 hr) | - |
| Vital capacity abnormal | 90 - 75% of predicted value | <75 - 50% of predicted value; limiting instrumental ADL | <50% of predicted value; limiting self care ADL | - | - |
| Weight gain | 5 - <10% from baseline | 10 - <20% from baseline | >=20% from baseline | - | - |
| Weight loss | 5 to <10% from baseline; intervention not indicated | 10 - <20% from baseline; nutritional support indicated | >=20% from baseline; tube feeding or TPN indicated | - | - |
| White blood cell decreased | <LLN - 3000/mm3; <LLN - 3.0 x 10e9 /L | <3000 - 2000/mm3; <3.0 - 2.0 x 10e9 /L | <2000 - 1000/mm3; <2.0 - 1.0 x 10e9 /L | <1000/mm3; <1.0 x 10e9 /L | - |
Articles in category "CTCAE4 Investigations"
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