The Common Toxicity Criteria (CTC) define adverse events following cancer therapy. It was designed for use in clinical trials of different therapeutic regimens.
Adverse events affecting the cardiovascular system:
(1) acute vascular leak syndrome (4)
(2) cardiac ischemia and/or infarction (includes angina) (5)
(3) left ventricular function (5)
(4) cardiac troponin I (3)
(5) cardiac troponin T (5)
(6) edema (5)
(7) hypertension (5)
(8) hypotension (5)
(9) myocarditis (3)
(10) operative injury of artery or vein (5)
(11) pericardial effusion or pericarditis (5)
(12) peripheral arterial ischemia (4)
(13) phlebitis, superficial (2)
(14) thrombosis and/or embolism (4)
(15) visceral (non-myocardial) arterial ischemia (4)
(16) other cardiovascular adverse event (5)
Adverse Event |
Finding |
Grade |
---|---|---|
acute vascular leak syndrome |
none |
0 |
|
symptomatic but not requiring fluid support |
2 |
|
respiratory compromise, or requires fluids |
3 |
|
life threatening, requires pressor support or ventilatory support |
4 |
cardiac ischemia and/or infarction |
none |
0 |
|
nonspecific T-wave flattening or changes |
1 |
|
asymptomatic ST and T wave changes suggesting ischemia |
2 |
|
angina without evidence of infarction |
3 |
|
acute myocardial infarction |
4 |
left ventricular function |
normal |
0 |
|
asymptomatic decline in resting ejection fraction >= 10% but < 20% of baseline value; shortening fraction >= 24% but < 30% |
1 |
|
asymptomatic but resting ejection fraction below the lower limit of normal for laboratory, or decline of resting ejection fraction >= 20% of baseline value, or < 24% shortening fraction |
2 |
|
CHF responsive to therapy |
3 |
|
severe or refractory CHF or requiring intubation |
4 |
cardiac troponin I |
normal |
0 |
|
level consistent with unstable angina |
3 |
|
levels consistent with myocardial infarction |
4 |
cardiac troponin T |
normal (< 0.03 ng/mL |
0 |
|
borderline (0.03 - 0.0499 ng/mL) |
1 |
|
level consistent with stable angina (0.05 - 0.099 ng/mL) |
2 |
|
level consistent with unstable angina (0.10 to 0.199 ng/mL) |
3 |
|
levels consistent with myocardial infarction (>= 0.2 ng/mL) |
4 |
edema |
none |
0 |
|
asymptomatic, not requiring therapy |
1 |
|
symptomatic, requiring therapy |
2 |
|
symptomatic edema that limits function, unresponsive to therapy or requiring drug discontinuation |
3 |
|
anasarca (severe, massive generalized edema) |
4 |
hypertension |
none |
0 |
|
asymptomatic, transient increase not requiring therapy (> 150/100 if previously normal, or increase by 20 mm Hg diastolic) |
1 |
|
recurrent or persistent or symptomatic increase by > 20 mm Hg (diastolic) or to > 150/100 if previously normal; does not require therapy |
2 |
|
requires therapy or more intensive therapy then previously |
3 |
|
hypertensive crisis |
4 |
hypotension |
none |
0 |
|
not requiring therapy, includes transient orthostatic hypotension |
1 |
|
requires brief fluid replacement or other therapy but not hospitalization; no permanent physiologic consequences |
2 |
|
requires therapy and sustained medical attention but resolves without persistent physiologic consequences |
3 |
|
shock with organ failure from tissue hypoperfusion |
4 |
myocarditis |
none |
0 |
|
CHF responsive to treatment |
3 |
|
severe or refractory CHF |
4 |
operative injury of artery or vein |
none |
0 |
|
primary suture repair for injury but not requiring transfusion |
1 |
|
primary suture repair for injury and requires transfusion |
2 |
|
vascular occlusion requiring surgery or bypass for injury |
3 |
|
myocardial infarction; resection of organ |
4 |
pericardial effusion or pericarditis |
none |
0 |
|
asymptomatic effusion not requiring treatment |
1 |
|
pericarditis (rub on auscultation, ECG changes, chest pain) |
2 |
|
with physiologic consequences |
3 |
|
tamponade; drainage or pericardial window required |
4 |
peripheral arterial ischemia |
none |
0 |
|
brief episode of ischemia managed nonsurgically and without permanent deficit |
2 |
|
requires surgical intervention |
3 |
|
life-threatening or with permanent functional deficit or amputation |
4 |
phlebitis, superficial |
none |
0 |
|
present |
2 |
thrombosis and/or embolism |
none |
0 |
|
deep vein thrombosis not requiring anticoagulation |
2 |
|
deep vein thromobosis requiring anticoagulation |
3 |
|
embolic event (including pulmonary embolism) |
4 |
visceral (non-myocardial) arterial ischemia |
none |
0 |
|
brief episode of ischemia managed nonsurgically and without permanent deficit |
2 |
|
requires surgical intervention |
3 |
|
life-threatening or with permanent functional deficit |
4 |
other cardiovascular adverse event |
none |
0 |
|
mild |
1 |
|
moderate |
2 |
|
severe |
3 |
|
life-threatening or disabling |
4 |
where:
• The criteria for an changes of cardiac troponin T (cTnT) involve specific serum levels. However, different methods from different manufacturers might give different values than those specified, so each cutoff needs to be locally determined.
• Superficial phlebitis could be in a single vein or extensive.
• Myocarditis might benefit from an asymptomatic, non-CHF category.
• Thrombosis and/or embolism could be shifted down 1 grade and add a Grade 4 for massive embolization (to distinguish it from a minor embolic event).
Specialty: Hematology Oncology, Cardiology