COMMON TOXICITY CRITERIA (CTC)
Grade
Adver Event01234
ALLERGY/IMMUNOLOGY
Allergic reaction/ hypernsitivity (including drug fever)none transient rash, drug
fever <38°C (<100.4°F)
urticaria, drug fever
≥38°C (≥100.4°F),
考研心得
and/or asymptomatic
bronchospasm
symptomatic
bronchospasm,
requiring parenteral
medication(s), with or
without urticaria;
allergy-related
edema/angioedema
anaphylaxis
Note: Isolated urticaria, in the abnce of other manifestations of an allergic or hypernsitivity reaction, is graded in the DERMATOLOGY/SKIN category.
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)none mild, not requiring
treatment
moderate, requiring
treatment
--
Autoimmune reaction none rologic or other
evidence of
autoimmune reaction
but patient is
asymptomatic (e.g.,
vitiligo), all organ
function is normal and
no treatment is required evidence of
autoimmune reaction
pond
involving a non-
esntial organ or
function (e.g.,
hypothyroidism),
requiring treatmenttesol
other than
immunosuppressive
drugs
reversible autoimmune
reaction involving
function of a major
organ or other adver
event (e.g., transient
colitis or anemia),
requiring short-term
immunosuppressive
treatment
autoimmune reaction
causing major grade 4
organ dysfunction;
progressive and
irreversible reaction;
uj
long-term
administration of high-
do immuno-
suppressive therapy
required
Also consider Hypothyroidism, Colitis, Hemoglobin, Hemolysis.
Serum sickness none--prent-Urticaria is graded in the DERMATOLOGY/SKIN category if it occurs as an isolated symptom. If it occurs with other manifestations of allergic or hypernsitivity reaction, grade as Allergic reaction/hypernsitivity above.
Vasculitis none mild, not requiring
treatment symptomatic, requiring
medication
requiring steroids ischemic changes or
requiring amputation
Allergy/Immunology - Other (Specify, __________)none mild moderate vere life-threatening or
元旦的由来简写disabling
AUDITORY/HEARING
Conductive hearing loss is graded as Middle ear/hearing in the AUDITORY/HEARING category. Earache is graded in the PAIN category.
External auditory canal normal external otitis with
erythema or dry
desquamation external otitis with
moist desquamation
external otitis with
discharge, mastoiditis
necrosis of the canal
soft tissue or bone
Note: Changes associated with radiation to external ear (pinnae) are graded under Radiation dermatitis in the DERMATOLOGY/SKIN category.
Adver Event01234
Inner ear/hearing normal hearing loss on
audiometry only tinnitus or hearing loss,
not requiring hearing
aid or treatment
tinnitus or hearing loss,
correctable with hearing
aid or treatment
vere unilateral or
bilateral hearing loss
(deafness), not
correctable
Middle ear/hearing normal rous otitis without
subjective decrea in
hearing rous otitis or infection
requiring medical
intervention; subjective
decrea in hearing;
rupture of tympanic
membrane with
discharge
otitis with discharge,
mastoiditis or
conductive hearing loss
necrosis of the canal
soft tissue or bone
Auditory/Hearing - Other (Specify, __________)normal mild moderate vere life-threatening or
disabling
BLOOD/BONE MARROW
Bone marrow cellularity normal for age mildly hypocellular or
≤25% reduction from
normal cellularity for
age moderately hypocellular
or >25 - ≤50%
reduction from normal
cellularity for age or >2
but <4 weeks to
recovery of normal
bone marrow cellularity
verely hypocellular or
>50 - ≤75% reduction
carterin cellularity for age or
4 - 6 weeks to recovery
of normal bone marrow
cellularity
aplasia or >6 weeks to
recovery of normal
bone marrow cellularity
Normal ranges:
children (≤18 years)90% cellularity
average
younger adults (19-59)60 - 70%
cellularity average
older adults (≥60 years)50% cellularity
hkg是哪个地区的缩写average
Note: Grade Bone marrow cellularity only for changes related to treatment not dia.
CD4 count WNL<LLN - 500/mm3200 - <500/mm350 - <200/mm3<50/mm3 Haptoglobin normal decread-abnt-
Hemoglobin (Hgb)WNL<LLN - 10.0 g/dL
<LLN - 100 g/L
<LLN - 6.2 mmol/L 8.0 - <10.0 g/dL
80 - <100 g/L
4.9 - <6.2 mmol/L
6.5 - <8.0 g/dL
65 - <80 g/L
4.0 - <4.9 mmol/L
<6.5 g/dL
<65 g/L
<4.0 mmol/L
For leukemia studies or bone marrow infiltrative/ myelophthisic process, if specified in the protocol.WNL10 - <25% decrea
from pretreatment
25 - <50% decrea
from pretreatment
50 - <75% decrea
from pretreatment
≥75% decrea from
pretreatment
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis, other)none only laboratory
evidence of hemolysis
[e.g., direct antiglobulin
test (DAT, Coombs’)
schistocytes]
evidence of red cell
destruction and ≥2gm
decrea in hemoglobin,
no transfusion
requiring transfusion
and/or medical
intervention (e.g.,
steroids)
catastrophic
conquences of
hemolysis (e.g., renal
failure, hypotension,
bronchospasm,
emergency
splenectomy)
Also consider Haptoglobin, Hemoglobin.
Adver Event01234
Leukocytes (total WBC)WNL<LLN - 3.0 x 109 /L
<LLN - 3000/mm3≥2.0 - <3.0 x 109 /L
≥2000 - <3000/mm3
≥1.0 - <2.0 x 109 /L
≥1000 - <2000/mm3
<1.0 x 109 /L
<1000/mm3
For BMT studies, if specified in the protocol.WNL≥2.0 - <3.0 X 109/L
≥2000 - <3000/mm3
≥1.0 - <2.0 x 109 /L
≥1000 - <2000/mm3
≥0.5 - <1.0 x 109 /L
≥500 - <1000/mm3
<0.5 x 109 /L
<500/mm3
For pediatric BMT studies
(using age, race and x
normal values), if specified
in the protocol.
≥75 - <100% LLN≥50 - <75% LLN≥25 - 50% LLN<25% LLN
Lymphopenia WNL<LLN - 1.0 x 109 /L
<LLN - 1000/mm3≥0.5 - <1.0 x 109 /L
≥500 - <1000/mm3
<0.5 x 109 /L
<500/mm3
-
For pediatric BMT studies
(using age, race and x
normal values), if specified
in the protocol.
≥75 - <100%LLN≥50 - <75%LLN≥25 - <50%LLN<25%LLN
Neutrophils/granulocytes (ANC/AGC)WNL≥1.5 - <2.0 x 109 /L
≥1500 - <2000/mm3
≥1.0 - <1.5 x 109 /L
≥1000 - <1500/mm3
≥0.5 - <1.0 x 109 /L
≥500 - <1000/mm3
<0.5 x 109 /L
<500/mm3
For BMT studies, if specified in the protocol.WNL≥1.0 - <1.5 x 109 /L
≥1000 - <1500/mm3
≥0.5 - <1.0 x 109 /L
≥500 - <1000/mm3
≥0.1 - <0.5 x 109 /L
≥100 - <500/mm3
<0.1 x 109 /L
<100/mm3
For leukemia studies or bone marrow infiltrative/ myelophthisic process, if specified in the protocol.WNL10 - <25% decrea
from baline
25 - <50% decrea
from baline
50 - <75% decrea
from baline
≥75% decrea from
baline
Platelets WNL<LLN - 75.0 x 109 /L
<LLN - 75,000/mm3≥50.0 - <75.0 x 109 /L
≥50,000 - <75,000/mm3
≥10.0 - <50.0 x 109 /L
≥10,000 - <50,000/mm3
<10.0 x 109 /L
<10,000/mm3
For BMT studies, if specified in the protocol.WNL≥50.0 - <75.0 x 109 /L
≥50,000 - <75,000/mm3
≥20.0 - <50.0 x 109 /L
≥20,000 - <50,000/mm3
≥10.0 - <20.0 x 109 /L
≥10,000 - <20,000/mm3
<10.0 x 109 /L
<10,000/mm3
For leukemia studies or bone marrow infiltrative/ myelophthisic process, if specified in the protocol.WNL10 - <25% decrea
from baline
25 - <50% decrea
from baline
50 - <75% decrea
from baline
≥75% decrea from
baline
Transfusion: Platelets none--yes platelet transfusions and
other measures required
to improve platelet
increment; platelet
transfusion
refractoriness associated
with life-threatening
bleeding. (e.g., HLA or
cross matched platelet
transfusions)
For BMT studies, if specified in 1 platelet transfusion in
24 hours
2 platelet transfusions in
24 hours
≥3 platelet transfusions
in 24 hours
platelet transfusions and
other measures required
to improve platelet
increment; platelet
transfusion
refractoriness associated
with life-threatening
bleeding. (e.g., HLA or
cross matched platelet
transfusions)
Also consider Platelets.
Adver Event01234 Transfusion: pRBCs none--yes-
For BMT studies, if specified in ≤2 u pRBC in 24 hours
elective or planned
3 u pRBC in 2
4 hours
elective or planned
≥4 u pRBC in 24 hours hemorrhage or
hemolysis associated
with life-threatening
anemia; medical
intervention required to
improve hemoglobin
For pediatric BMT studies, if specified in ≤15mL/kg in 24 hours
elective or planned
>15 - ≤30mL/kg in 24
hours elective or
planned
>30mL/kg in 24 hours hemorrhage or
hemolysis associated
with life-threatening
anemia; medical
intervention required to
正式英文improve hemoglobin
Also consider Hemoglobin.
Blood/Bone Marrow - Other (Specify, __________)none mild moderate vere life-threatening or
disabling CARDIOVASCULAR (ARRHYTHMIA)
Conduction abnormality/ Atrioventricular heart block none asymptomatic, not
requiring treatment
(e.g., Mobitz type I
cond-degree AV
block, Wenckebach)
symptomatic, but not
requiring treatment
symptomatic and
requiring treatment
(e.g., Mobitz type II
cond-degree AV
block, third-degree AV
block)
life-threatening (e.g.,
arrhythmia associated
with CHF, hypotension,
syncope, shock)
Nodal/junctional arrhythmia/dysrhythmia none asymptomatic, not
requiring treatment
symptomatic, but not
requiring treatment
symptomatic and
requiring treatment
life-threatening (e.g.,
arrhythmia associated
with CHF, hypotension,
syncope, shock)
Palpitations none prent---Note: Grade palpitations only in the abnce of a documented arrhythmia.
Prolonged QTc interval (QTc >0.48 conds)none asymptomatic, not
requiring treatment
symptomatic, but not
requiring treatment
symptomatic and
requiring treatment
life-threatening (e.g.,
arrhythmia associated
with CHF, hypotension,
syncope, shock)
Sinus bradycardia none asymptomatic, not
requiring treatment symptomatic, but not
requiring treatment
symptomatic and
requiring treatment
life-threatening (e.g.,
arrhythmia associated
with CHF, hypotension,
syncope, shock)
Sinus tachycardia none asymptomatic, not
requiring treatment symptomatic, but not
requiring treatment
symptomatic and
requiring treatment of
underlying cau
-
Supraventricular arrhythmias (SVT/atrial fibrillation/ flutter)none asymptomatic, not
requiring treatment
symptomatic, but not
requiring treatment
symptomatic and
requiring treatment
life-threatening (e.g.,
arrhythmia associated
with CHF, hypotension,
syncope, shock)
Syncope (fainting) is graded in the NEUROLOGY category.
Vasovagal episode none-prent without loss of
consciousness prent with loss of consciousness
-
Adver Event01234
Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ ventricular tachycardia)none asymptomatic, not
requiring treatment
symptomatic, but not
requiring treatment
symptomatic and
requiring treatment
life-threatening (e.g.,
arrhythmia associated
with CHF, hypotension,
syncope, shock)
Cardiovascular/ Arrhythmia - Other (Specify, ___________)none asymptomatic, not
requiring treatment
symptomatic, but not
requiring treatment
symptomatic, and
requiring treatment of
underlying cau
life-threatening (e.g.,
arrhythmia associated
with CHF, hypotension,
syncope, shock) CARDIOVASCULAR (GENERAL)5360
Acute vascular leak syndrome abnt-symptomatic, but not
requiring fluid support
respiratory compromi
or requiring fluids
life-threatening;
requiring pressor
support and/or
ventilatory support
Cardiac-ischemia/infarction none non-specific T - wave
flattening or changes asymptomatic, ST - and
T - wave changes
suggesting ischemia
angina without evidence
of infarction
acute myocardial
infarction
Cardiac left ventricular function normal asymptomatic decline
of resting ejection
小区英文
fraction of ≥10% but
<20% of baline value;
shortening fraction
≥24% but <30%
asymptomatic but
resting ejection fraction
below LLN for
laboratory or decline of
resting ejection fraction
≥20% of baline value;
<24% shortening
fraction
CHF responsive to
treatment
vere or refractory
CHF or requiring
intubation
CNS cerebrovascular ischemia is graded in the NEUROLOGY category.
Cardiac troponin I (cTnI)normal--levels consistent with
unstable angina as
defined by the
manufacturer levels consistent with myocardial infarction as defined by the manufacturer
Cardiac troponin T (cTnT)normal≥0.03 - <0.05 ng/mL≥0.05 - <0.1 ng/mL≥0.1 - <0.2 ng/mL≥0.2 ng/mL
Edema none asymptomatic, not
requiring therapy symptomatic, requiring
therapy
symptomatic edema
limiting function and
unresponsive to therapy
or requiring drug
discontinuation
anasarca (vere
generalized edema)
Hypertension none asymptomatic, transient
increa by >20 mmHg
(diastolic) or to
>150/100* if previously
WNL; not requiring
treatment recurrent or persistent
or symptomatic increa
by >20 mmHg
(diastolic) or to
>150/100* if previously
WNL; not requiring
treatment
requiring therapy or
more intensive therapy
than previously
hypertensive crisis
*Note: For pediatric patients, u age and x appropriate normal values >95th percentile ULN.
