Microsoft Word - ctc-v2.0_r2.9_5-21-99

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 1 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

COMMON TOXICITY CRITERIA (CTC)

Grade

Adverse Event 0 1 2 3 4

ALLERGY/IMMUNOLOGY

Allergic reaction/

hypersensitivity

(including drug fever)

none

transient rash, drug

fever <38°C (<100.4°F)

urticaria, drug fever

≥38°C (≥100.4°F),

and/or asymptomatic

bronchospasm

symptomatic

bronchospasm,

requiring parenteral

medication(s), with or

without urticaria;

allergy-related

edema/angioedema

anaphylaxis

Note: Isolated urticaria, in the absence of other manifestations of an allergic or hypersensitivity 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 serologic 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

involving a non-

essential organ or

function (e.g.,

hypothyroidism),

requiring treatment

other than

immunosuppressive

drugs

reversible autoimmune

reaction involving

function of a major

organ or other adverse

event (e.g., transient

colitis or anemia),

requiring short-term

immunosuppressive

treatment

autoimmune reaction

causing major grade 4

organ dysfunction;

progressive and

irreversible reaction;

long-term

administration of high-

dose immuno-

suppressive therapy

required

Also consider Hypothyroidism, Colitis, Hemoglobin, Hemolysis.

Serum sickness none - - present -

Urticaria is graded in the DERMATOLOGY/SKIN category if it occurs as an isolated symptom. If it occurs with other manifestations of allergic or

hypersensitivity reaction, grade as Allergic reaction/hypersensitivity above.

Vasculitis none mild, not requiring

treatment

symptomatic, requiring

medication

requiring steroids ischemic changes or

requiring amputation

Allergy/Immunology - Other

(Specify, __________)

none mild moderate severe

life-threatening or

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.

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 2 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

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

severe unilateral or

bilateral hearing loss

(deafness), not

correctable

Middle ear/hearing normal serous otitis without

subjective decrease in

hearing

serous otitis or infection

requiring medical

intervention; subjective

decrease 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 severe

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

severely hypocellular or

>50 - ≤75% reduction

in 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

average

Note: Grade Bone marrow cellularity only for changes related to treatment not disease.

CD4 count WNL <LLN - 500/mm

200 - <500/mm

50 - <200/mm

<50/mm

Haptoglobin normal decreased - absent -

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 processes, if

specified in the protocol.

WNL 10 - <25% decrease

from pretreatment

25 - <50% decrease

from pretreatment

50 - <75% decrease

from pretreatment

≥75% decrease 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

decrease in hemoglobin,

no transfusion

requiring transfusion

and/or medical

intervention (e.g.,

steroids)

catastrophic

consequences of

hemolysis (e.g., renal

failure, hypotension,

bronchospasm,

emergency

splenectomy)

Also consider Haptoglobin, Hemoglobin.

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 3 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Leukocytes (total WBC) WNL <LLN - 3.0 x 10

<LLN - 3000/mm

≥2.0 - <3.0 x 10

≥2000 - <3000/mm

≥1.0 - <2.0 x 10

≥1000 - <2000/mm

<1.0 x 10

<1000/mm

For BMT studies, if

specified in the protocol.

WNL

≥2.0 - <3.0 X 10

≥2000 - <3000/mm

≥1.0 - <2.0 x 10

≥1000 - <2000/mm

≥0.5 - <1.0 x 10

≥500 - <1000/mm

<0.5 x 10

<500/mm

For pediatric BMT studies

(using age, race and sex

normal values), if specified

in the protocol.

≥

75 - <100% LLN

≥

50 - <75% LLN

≥

25 - 50% LLN

<25% LLN

Lymphopenia WNL

<LLN - 1.0 x 10

<LLN - 1000/mm

≥0.5 - <1.0 x 10

≥500 - <1000/mm

<0.5 x 10

<500/mm

For pediatric BMT studies

(using age, race and sex

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 10

≥1500 - <2000/mm

≥1.0 - <1.5 x 10

≥1000 - <1500/mm

≥0.5 - <1.0 x 10

≥500 - <1000/mm

<0.5 x 10

<500/mm

For BMT studies, if

specified in the protocol.

WNL

≥1.0 - <1.5 x 10

≥1000 - <1500/mm

≥0.5 - <1.0 x 10

≥500 - <1000/mm

≥0.1 - <0.5 x 10

≥100 - <500/mm

<0.1 x 10

<100/mm

For leukemia studies or bone

marrow infiltrative/

myelophthisic process, if

specified in the protocol.

WNL 10 - <25% decrease

from baseline

25 - <50% decrease

from baseline

50 - <75% decrease

from baseline

≥75% decrease from

baseline

Platelets WNL

<LLN - 75.0 x 10

<LLN - 75,000/mm

≥50.0 - <75.0 x 10

≥50,000 - <75,000/mm

≥10.0 - <50.0 x 10

≥10,000 - <50,000/mm

<10.0 x 10

<10,000/mm

For BMT studies, if

specified in the protocol.

WNL

≥50.0 - <75.0 x 10

≥50,000 - <75,000/mm

≥20.0 - <50.0 x 10

≥20,000 - <50,000/mm

≥10.0 - <20.0 x 10

≥10,000 - <20,000/mm

<10.0 x 10

<10,000/mm

For leukemia studies or bone

marrow infiltrative/

myelophthisic process, if

specified in the protocol.

WNL 10 - <25% decrease

from baseline

25 - <50% decrease

from baseline

50 - <75% decrease

from baseline

≥75% decrease from

baseline

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 the protocol.

none

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.

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 4 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Transfusion: pRBCs none - - yes -

For BMT studies, if

specified in the protocol.

none

≤2 u pRBC in 24 hours

elective or planned

3 u pRBC in 24 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 the protocol.

none

≤

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

improve hemoglobin

Also consider Hemoglobin.

Blood/Bone Marrow - Other

(Specify, __________)

none mild moderate severe

life-threatening or

disabling

CARDIOVASCULAR (ARRHYTHMIA)

Conduction abnormality/

Atrioventricular heart block

none

asymptomatic, not

requiring treatment

(e.g., Mobitz type I

second-degree AV

block, Wenckebach)

symptomatic, but not

requiring treatment

symptomatic and

requiring treatment

(e.g., Mobitz type II

second-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 present - - -

Note: Grade palpitations only in the absence of a documented arrhythmia.

Prolonged QTc interval

(QTc >0.48 seconds)

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 cause

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 -

present without loss of

consciousness

present with loss of

consciousness

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 5 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

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 cause

life-threatening (e.g.,

arrhythmia associated

with CHF, hypotension,

syncope, shock)

CARDIOVASCULAR (GENERAL)

Acute vascular leak

syndrome

absent -

symptomatic, but not

requiring fluid support

respiratory compromise

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

fraction of ≥10% but

<20% of baseline value;

shortening fraction

≥24% but <30%

asymptomatic but

resting ejection fraction

below LLN for

laboratory or decline of

resting ejection fraction

≥20% of baseline value;

<24% shortening

fraction

CHF responsive to

treatment

severe 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 (severe

generalized edema)

Hypertension none asymptomatic, transient

increase by >20 mmHg

(diastolic) or to

>150/100* if previously

WNL; not requiring

treatment

recurrent or persistent

or symptomatic increase

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, use age and sex appropriate normal values >95th percentile ULN.

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 6 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Hypotension none changes, but not

requiring therapy

(including transient

orthostatic hypotension)

requiring brief fluid

replacement or other

therapy but not

hospitalization; no

physiologic

consequences

requiring therapy and

sustained medical

attention, but resolves

without persisting

physiologic

consequences

shock (associated with

acidemia and impairing

vital organ function due

to tissue hypoperfusion)

Also consider Syncope (fainting).

Notes: Angina or MI is graded as Cardiac-ischemia/infarction in the CARDIOVASCULAR (GENERAL) category.

For pediatric patients, systolic BP 65 mmHg or less in infants up to 1 year old and 70 mmHg or less in children older than 1 year of age, use two successive

or three measurements in 24 hours.

Myocarditis none - - CHF responsive to

treatment

severe or refractory

CHF

Operative injury of

vein/artery

none primary suture repair

for injury, but not

requiring transfusion

primary suture repair

for injury, requiring

transfusion

vascular occlusion

requiring surgery or

bypass for injury

myocardial infarction;

resection of organ (e.g.,

bowel, limb)

Pericardial effusion/

pericarditis

none asymptomatic effusion,

not requiring treatment

pericarditis (rub, ECG

changes, and/or chest

pain)

with physiologic

consequences

tamponade (drainage or

pericardial window

required)

Peripheral arterial ischemia none - brief episode of

ischemia managed non-

surgically and without

permanent deficit

requiring surgical

intervention

life-threatening or with

permanent functional

deficit (e.g.,

amputation)

Phlebitis (superficial) none - present - -

Notes: Injection site reaction is graded in the DERMATOLOGY/SKIN category.

Thrombosis/embolism is graded in the CARDIOVASCULAR (GENERAL) category.

Syncope (fainting) is graded in the NEUROLOGY category.

Thrombosis/embolism none - deep vein thrombosis,

not requiring

anticoagulant

deep vein thrombosis,

requiring anticoagulant

therapy

embolic event including

pulmonary embolism

Vein/artery operative injury is graded as Operative injury of vein/artery in the CARDIOVASCULAR (GENERAL) category.

Visceral arterial ischemia

(non-myocardial)

none -

brief episode of

ischemia managed non-

surgically and without

permanent deficit

requiring surgical

intervention

life-threatening or with

permanent functional

deficit (e.g., resection of

ileum)

Cardiovascular/

General - Other

(Specify, ______________)

none mild moderate severe life-threatening or

disabling

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 7 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

COAGULATION

Note: See the HEMORRHAGE category for grading the severity of bleeding events.

DIC

(disseminated intravascular

coagulation)

absent - -

laboratory findings

present with no

bleeding

laboratory findings and

bleeding

Also consider Platelets.

Note: Must have increased fibrin split products or D-dimer in order to grade as DIC.

Fibrinogen WNL

≥0.75 - <1.0 x LLN ≥0.5 - <0.75 x LLN ≥0.25 - <0.5 x LLN

<0.25 x LLN

For leukemia studies or bone

marrow infiltrative/

myelophthisic process, if

specified in the protocol.

WNL <20% decrease from

pretreatment value or

LLN

≥20 - <40% decrease

from pretreatment value

or LLN

≥40 - <70% decrease

from pretreatment value

or LLN

<50 mg

Partial thromboplastin time

(PTT)

WNL

>ULN - ≤1.5 x ULN >1.5 - ≤2 x ULN

>2 x ULN -

Phlebitis is graded in the CARDIOVASCULAR (GENERAL) category.

Prothrombin time (PT) WNL

>ULN - ≤1.5 x ULN >1.5 - ≤2 x ULN

>2 x ULN -

Thrombosis/embolism is graded in the CARDIOVASCULAR (GENERAL) category.

Thrombotic

microangiopathy (e.g.,

thrombotic

thrombocytopenic

purpura/TTP or hemolytic

uremic syndrome/HUS)

absent - - laboratory findings

present without clinical

consequences

laboratory findings and

clinical consequences,

(e.g., CNS hemorrhage/

bleeding or thrombosis/

embolism or renal

failure) requiring

therapeutic intervention

For BMT studies, if

specified in the protocol.

- evidence of RBC

destruction

(schistocytosis) without

clinical consequences

evidence of RBC

destruction with

elevated creatinine (≤3

x ULN)

evidence of RBC

destruction with

creatinine (>3 x ULN)

not requiring dialysis

evidence of RBC

destruction with renal

failure requiring

dialysis and/or

encephalopathy

Also consider Hemoglobin, Platelets, Creatinine.

Note: Must have microangiopathic changes on blood smear (e.g., schistocytes, helmet cells, red cell fragments).

Coagulation - Other

(Specify, __________)

none mild moderate severe

life-threatening or

disabling

CONSTITUTIONAL SYMPTOMS

Fatigue

(lethargy, malaise, asthenia)

none

increased fatigue over

baseline, but not

altering normal

activities

moderate (e.g., decrease

in performance status

by 1 ECOG level or

20% Karnofsky or

Lansky) or causing

difficulty performing

some activities

severe (e.g., decrease in

performance status by

≥2 ECOG levels or 40%

Karnofsky or Lansky) or

loss of ability to

perform some activities

bedridden or disabling

Note: See Appendix III for performance status scales.

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 8 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Fever (in the absence of

neutropenia, where

neutropenia is defined as

AGC <1.0 x 10

/L)

none 38.0 - 39.0°C (100.4 -

102.2°F)

39.1 - 40.0°C (102.3 -

104.0°F )

>40.0°C (>104.0°F ) for

<24hrs

>40.0°C (>104.0°F ) for

>24hrs

Also consider Allergic reaction/hypersensitivity.

Note: The temperature measurements listed above are oral or tympanic.

Hot flashes/flushes are graded in the ENDOCRINE category.

Rigors, chills none

mild, requiring

symptomatic treatment

(e.g., blanket) or non-

narcotic medication

severe and/or

prolonged, requiring

narcotic medication

not responsive to

narcotic medication

Sweating

(diaphoresis)

normal mild and occasional frequent or drenching - -

Weight gain <5% 5 - <10% 10 - <20%

≥20%

Also consider Ascites, Edema, Pleural effusion (non-malignant).

Weight gain associated with

Veno-Occlusive Disease

(VOD) for BMT studies, if

specified in the protocol.

<2%

≥2 - <5% ≥5 - <10% ≥10% or as ascites ≥10% or fluid retention

resulting in pulmonary

failure

Also consider Ascites, Edema, Pleural effusion (non-malignant).

Weight loss <5% 5 - <10% 10 - <20%

≥20%

Also consider Vomiting, Dehydration, Diarrhea.

Constitutional Symptoms -

Other

(Specify, __________)

none mild moderate severe

life-threatening or

disabling

DERMATOLOGY/SKIN

Alopecia normal mild hair loss pronounced hair loss - -

Bruising

(in absence of grade 3 or 4

thrombocytopenia)

none localized or in

dependent area

generalized - -

Note: Bruising resulting from grade 3 or 4 thrombocytopenia is graded as Petechiae/purpura and Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia in the

HEMORRHAGE category, not in the DERMATOLOGY/SKIN category.

Dry skin normal controlled with

emollients

not controlled with

emollients

Erythema multiforme (e.g.,

Stevens-Johnson syndrome,

toxic epidermal necrolysis)

absent -

scattered, but not

generalized eruption

severe or requiring IV

fluids (e.g., generalized

rash or painful

stomatitis)

life-threatening (e.g.,

exfoliative or ulcerating

dermatitis or requiring

enteral or parenteral

nutritional support)

Flushing absent present - - -

Hand-foot skin reaction none skin changes or

dermatitis without pain

(e.g., erythema, peeling)

skin changes with pain,

not interfering with

function

skin changes with pain,

interfering with

function

Injection site reaction none pain or itching or

erythema

pain or swelling, with

inflammation or

phlebitis

ulceration or necrosis

that is severe or

prolonged, or requiring

surgery

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 9 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Nail changes normal discoloration or ridging

(koilonychia) or pitting

partial or complete loss

of nail(s) or pain in

nailbeds

Petechiae is graded in the HEMORRHAGE category.

Photosensitivity none painless erythema painful erythema

erythema with

desquamation

Pigmentation changes (e.g.,

vitiligo)

none localized pigmentation

changes

generalized

pigmentation changes

Pruritus none mild or localized,

relieved spontaneously

or by local measures

intense or widespread,

relieved spontaneously

or by systemic measures

intense or widespread

and poorly controlled

despite treatment

Purpura is graded in the HEMORRHAGE category.

Radiation dermatitis none

faint erythema or dry

desquamation

moderate to brisk

erythema or a patchy

moist desquamation,

mostly confined to skin

folds and creases;

moderate edema

confluent moist

desquamation ≥1.5 cm

diameter and not

confined to skin folds;

pitting edema

skin necrosis or

ulceration of full

thickness dermis; may

include bleeding not

induced by minor

trauma or abrasion

Note: Pain associated with radiation dermatitis is graded separately in the PAIN category as Pain due to radiation.

Radiation recall reaction

(reaction following

chemotherapy in the absence

of additional radiation

therapy that occurs in a

previous radiation port)

none

faint erythema or dry

desquamation

moderate to brisk

erythema or a patchy

moist desquamation,

mostly confined to skin

folds and creases;

moderate edema

confluent moist

desquamation ≥1.5 cm

diameter and not

confined to skin folds;

pitting edema

skin necrosis or

ulceration of full

thickness dermis; may

include bleeding not

induced by minor

trauma or abrasion

Rash/desquamation none

macular or papular

eruption or erythema

without associated

symptoms

macular or papular

eruption or erythema

with pruritus or other

associated symptoms

covering <50% of body

surface or localized

desquamation or other

lesions covering <50%

of body surface area

symptomatic

generalized

erythroderma or

macular, papular or

vesicular eruption or

desquamation covering

≥50% of body surface

area

generalized exfoliative

dermatitis or ulcerative

dermatitis

Also consider Allergic reaction/hypersensitivity.

Note: Stevens-Johnson syndrome is graded separately as Erythema multiforme in the DERMATOLOGY/SKIN category.

Rash/dermatitis associated

with high-dose

chemotherapy or BMT

studies.

none

faint erythema or dry

desquamation

moderate to brisk

erythema or a patchy

moist desquamation,

mostly confined to skin

folds and creases;

moderate edema

confluent moist

desquamation ≥1.5 cm

diameter and not

confined to skin folds;

pitting edema

skin necrosis or ulcera-

tion of full thickness

dermis; may include

spontaneous bleeding

not induced by minor

trauma or abrasion

Rash/desquamation

associated with graft versus

host disease (GVHD) for

BMT studies, if specified in

the protocol.

None

macular or papular

eruption or erythema

covering <25% of body

surface area without

associated symptoms

macular or papular

eruption or erythema

with pruritus or other

associated symptoms

covering ≥25 - <50% of

body surface or

localized desquamation

or other lesions

covering ≥25 - <50% of

body surface area

symptomatic

generalized

erythroderma or

symptomatic macular,

papular or vesicular

eruption, with bullous

formation, or

desquamation covering

≥50% of body surface

area

generalized exfoliative

dermatitis or ulcerative

dermatitis or bullous

formation

Also consider Allergic reaction/hypersensitivity.

Note: Stevens-Johnson syndrome is graded separately as Erythema multiforme in the DERMATOLOGY/SKIN category.

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 10 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Urticaria

(hives, welts, wheals)

none requiring no medication requiring PO or topical

treatment or IV

medication or steroids

for <24 hours

requiring IV medication

or steroids for ≥24

hours

Wound-infectious none cellulitis superficial infection infection requiring IV

antibiotics

necrotizing fasciitis

Wound-non-infectious none incisional separation incisional hernia fascial disruption

without evisceration

fascial disruption with

evisceration

Dermatology/Skin - Other

(Specify, ________)

none mild moderate severe

life-threatening or

disabling

ENDOCRINE

Cushingoid appearance (e.g.,

moon face, buffalo hump,

centripetal obesity,

cutaneous striae)

absent - present - -

Also consider Hyperglycemia, Hypokalemia.

Feminization of male absent - - present -

Gynecomastia none mild pronounced or painful

pronounced or painful

and requiring surgery

Hot flashes/flushes none

mild or no more than 1

per day

moderate and greater

than 1 per day

Hypothyroidism absent asymptomatic,TSH

elevated, no therapy

given

symptomatic or thyroid

replacement treatment

given

patient hospitalized for

manifestations of

hypothyroidism

myxedema coma

Masculinization of female absent - - present -

SIADH (syndrome of

inappropriate antidiuretic

hormone)

absent - - present -

Endocrine - Other

(Specify, __________)

none mild moderate severe

life-threatening or

disabling

GASTROINTESTINAL

Amylase is graded in the METABOLIC/LABORATORY category.

Anorexia none loss of appetite oral intake significantly

decreased

requiring IV fluids requiring feeding tube

or parenteral nutrition

Ascites (non-malignant) none asymptomatic

symptomatic, requiring

diuretics

symptomatic, requiring

therapeutic paracentesis

life-threatening

physiologic

consequences

Colitis none - abdominal pain with

mucus and/or blood in

stool

abdominal pain, fever,

change in bowel habits

with ileus or peritoneal

signs, and radiographic

or biopsy

documentation

perforation or requiring

surgery or toxic

megacolon

Also consider Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia, Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia, Melena/GI bleeding,

Rectal bleeding/hematochezia, Hypotension.

Constipation none

requiring stool softener

or dietary modification

requiring laxatives

obstipation requiring

manual evacuation or

enema

obstruction or toxic

megacolon

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 11 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Dehydration none dry mucous membranes

and/or diminished skin

turgor

requiring IV fluid

replacement (brief)

requiring IV fluid

replacement (sustained)

physiologic

consequences requiring

intensive care;

hemodynamic collapse

Also consider Diarrhea, Vomiting, Stomatitis/pharyngitis (oral/pharyngeal mucositis), Hypotension.

Diarrhea

patients without colostomy:

none

increase of <4

stools/day over pre-

treatment

increase of 4-6

stools/day, or nocturnal

stools

increase of ≥7

stools/day or

incontinence; or need

for parenteral support

for dehydration

physiologic

consequences requiring

intensive care; or

hemodynamic collapse

patients with a colostomy: none mild increase in loose,

watery colostomy

output compared with

pretreatment

moderate increase in

loose, watery colostomy

output compared with

pretreatment, but not

interfering with normal

activity

severe increase in loose,

watery colostomy

output compared with

pretreatment, interfering

with normal activity

physiologic

consequences, requiring

intensive care; or

hemodynamic collapse

Diarrhea associated with

graft versus host disease

(GVHD) for BMT studies, if

specified in the protocol.

None

>500 - ≤1000mL of

diarrhea/day

>1000 - ≤1500mL of

diarrhea/day

>1500mL of

diarrhea/day

severe abdominal pain

with or without ileus

For pediatric BMT studies, if

specified in the protocol.

>5 -

≤

10 mL/kg of

diarrhea/day

>10 -

≤

15 mL/kg of

diarrhea/day

>15 mL/kg of

diarrhea/day

Also consider Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia, Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia, Pain, Dehydration,

Hypotension.

Duodenal ulcer (requires

radiographic or endoscopic

documentation)

none - requiring medical

management or non-

surgical treatment

uncontrolled by

outpatient medical

management; requiring

hospitalization

perforation or bleeding,

requiring emergency

surgery

Dyspepsia/heartburn none mild moderate severe -

Dysphagia, esophagitis,

odynophagia (painful

swallowing)

none

mild dysphagia, but can

eat regular diet

dysphagia, requiring

predominantly pureed,

soft, or liquid diet

dysphagia, requiring IV

hydration

complete obstruction

(cannot swallow saliva)

requiring enteral or

parenteral nutritional

support, or perforation

Note: If the adverse event is radiation-related, grade either under Dysphagia-esophageal related to radiation or Dysphagia-pharyngeal related to radiation.

Dysphagia-esophageal

related to radiation

none mild dysphagia, but can

eat regular diet

dysphagia, requiring

predominantly pureed,

soft, or liquid diet

Dysphagia, requiring

feeding tube, IV

hydration or

hyperalimentation

complete obstruction

(cannot swallow saliva);

ulceration with bleeding

not induced by minor

trauma or abrasion or

perforation

Also consider Pain due to radiation, Mucositis due to radiation.

Note: Fistula is graded separately as Fistula-esophageal.

Dysphagia-pharyngeal

related to radiation

none

mild dysphagia, but can

eat regular diet

dysphagia, requiring

predominantly pureed,

soft, or liquid diet

dysphagia, requiring

feeding tube, IV

hydration or

hyperalimentation

complete obstruction

(cannot swallow saliva);

ulceration with bleeding

not induced by minor

trauma or abrasion or

perforation

Also consider Pain due to radiation, Mucositis due to radiation.

Note: Fistula is graded separately as Fistula-pharyngeal.

Fistula-esophageal none - - present requiring surgery

Fistula-intestinal none - - present requiring surgery

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 12 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Fistula-pharyngeal none - - present requiring surgery

Fistula-rectal/anal none - - present requiring surgery

Flatulence none mild moderate - -

Gastric ulcer

(requires radiographic or

endoscopic documentation)

none - requiring medical

management or non-

surgical treatment

bleeding without

perforation, uncon-

trolled by outpatient

medical management;

requiring hospitalization

or surgery

perforation or bleeding,

requiring emergency

surgery

Also consider Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia, Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia.

Gastritis none -

requiring medical

management or non-

surgical treatment

uncontrolled by out-

patient medical

management; requiring

hospitalization or

surgery

life-threatening

bleeding, requiring

emergency surgery

Also consider Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia, Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia.

Hematemesis is graded in the HEMORRHAGE category.

Hematochezia is graded in the HEMORRHAGE category as Rectal bleeding/hematochezia.

Ileus (or neuroconstipation) none -

intermittent, not

requiring intervention

requiring non-surgical

intervention

requiring surgery

Mouth dryness normal mild moderate - -

Mucositis

Notes: Mucositis not due to radiation is graded in the GASTROINTESTINAL category for specific sites: Colitis, Esophagitis, Gastritis, Stomatitis/pharyngitis

(oral/pharyngeal mucositis), and Typhlitis; or the RENAL/GENITOURINARY category for Vaginitis.

Radiation-related mucositis is graded as Mucositis due to radiation.

Mucositis due to radiation none erythema of the mucosa patchy pseudomembra-

nous reaction (patches

generally ≤1.5 cm in

diameter and non-

contiguous)

confluent pseudomem-

branous reaction

(contiguous patches

generally >1.5 cm in

diameter)

necrosis or deep

ulceration; may include

bleeding not induced by

minor trauma or

abrasion

Also consider Pain due to radiation.

Notes: Grade radiation mucositis of the larynx here.

Dysphagia related to radiation is also graded as either Dysphagia-esophageal related to radiation or Dysphagia-pharyngeal related to radiation, depending on

the site of treatment.

Nausea none able to eat

oral intake significantly

decreased

no significant intake,

requiring IV fluids

Pancreatitis none - - abdominal pain with

pancreatic enzyme

elevation

complicated by shock

(acute circulatory

failure)

Also consider Hypotension.

Note: Amylase is graded in the METABOLIC/LABORATORY category.

Pharyngitis is graded in the GASTROINTESTINAL category as Stomatitis/pharyngitis (oral/pharyngeal mucositis).

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 13 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Proctitis none increased stool

frequency, occasional

blood-streaked stools or

rectal discomfort

(including hemorrhoids)

not requiring

medication

increased stool

frequency, bleeding,

mucus discharge, or

rectal discomfort

requiring medication;

anal fissure

increased stool fre-

quency/diarrhea requir-

ing parenteral support;

rectal bleeding requir-

ing transfusion; or per-

sistent mucus discharge,

necessitating pads

perforation, bleeding or

necrosis or other life-

threatening

complication requiring

surgical intervention

(e.g., colostomy)

Also consider Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia, Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia, Pain due to radiation.

Notes: Fistula is graded separately as Fistula-rectal/anal.

Proctitis occurring more than 90 days after the start of radiation therapy is graded in the RTOG/EORTC Late Radiation Morbidity Scoring Scheme. (See

Appendix IV)

Salivary gland changes none

slightly thickened

saliva; may have

slightly altered taste

(e.g., metallic);

additional fluids may be

required

thick, ropy, sticky

saliva; markedly altered

taste; alteration in diet

required

acute salivary gland

necrosis

Sense of smell normal slightly altered markedly altered - -

Stomatitis/pharyngitis

(oral/pharyngeal mucositis)

none painless ulcers,

erythema, or mild

soreness in the absence

of lesions

painful erythema,

edema, or ulcers, but

can eat or swallow

painful erythema,

edema, or ulcers

requiring IV hydration

severe ulceration or

requires parenteral or

enteral nutritional

support or prophylactic

intubation

For BMT studies, if

specified in the protocol.

none painless ulcers,

erythema, or mild

soreness in the absence

of lesions

painful erythema,

edema or ulcers but can

swallow

painful erythema,

edema, or ulcers

preventing swallowing

or requiring hydration

or parenteral (or enteral)

nutritional support

severe ulceration

requiring prophylactic

intubation or resulting

in documented

aspiration pneumonia

Note: Radiation-related mucositis is graded as Mucositis due to radiation.

Taste disturbance

(dysgeusia)

normal slightly altered markedly altered - -

Typhlitis

(inflammation of the cecum)

none - - abdominal pain,

diarrhea, fever, and

radiographic or biopsy

documentation

perforation, bleeding or

necrosis or other life-

threatening

complication requiring

surgical intervention

(e.g., colostomy)

Also consider Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia, Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia, Hypotension, Febrile

neutropenia.

Vomiting none

1 episode in 24 hours

over pretreatment

2-5 episodes in 24 hours

over pretreatment

≥6 episodes in 24 hours

over pretreatment; or

need for IV fluids

requiring parenteral

nutrition; or physiologic

consequences requiring

intensive care;

hemodynamic collapse

Also consider Dehydration.

Weight gain is graded in the CONSTITUTIONAL SYMPTOMS category.

Weight loss is graded in the CONSTITUTIONAL SYMPTOMS category.

Gastrointestinal - Other

(Specify, __________)

none mild moderate severe

life-threatening or

disabling

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 14 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

HEMORRHAGE

Notes: Transfusion in this section refers to pRBC infusion.

For any bleeding with grade 3 or 4 platelets (<50,000), always grade Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia. Also consider Platelets,

Transfusion: pRBCs, and Transfusion: platelets in addition to grading severity by grading the site or type of bleeding.

If the site or type of Hemorrhage/bleeding is listed, also use the grading that incorporates the site of bleeding: CNS Hemorrhage/bleeding, Hematuria,

Hematemesis, Hemoptysis, Hemorrhage/bleeding with surgery, Melena/lower GI bleeding, Petechiae/purpura (Hemorrhage/bleeding into skin), Rectal

bleeding/hematochezia, Vaginal bleeding.

If the platelet count is ≥50,000 and the site or type of bleeding is listed, grade the specific site. If the site or type is not listed and the platelet count is

≥50,000, grade Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia and specify the site or type in the OTHER category.

Hemorrhage/bleeding with

grade 3 or 4

thrombocytopenia

none mild without

transfusion

requiring transfusion catastrophic bleeding,

requiring major non-

elective intervention

Also consider Platelets, Hemoglobin, Transfusion: platelets, Transfusion: pRBCs, site or type of bleeding. If the site is not listed, grade as Hemorrhage-Other

(Specify site, ___________).

Note: This adverse event must be graded for any bleeding with grade 3 or 4 thrombocytopenia.

Hemorrhage/bleeding

without grade 3 or 4

thrombocytopenia

none mild without

transfusion

requiring transfusion catastrophic bleeding

requiring major non-

elective intervention

Also consider Platelets, Hemoglobin, Transfusion: platelets, Transfusion: pRBCs, Hemorrhage - Other (Specify site, ___________).

Note: Bleeding in the absence of grade 3 or 4 thrombocytopenia is graded here only if the specific site or type of bleeding is not listed elsewhere in the

HEMORRHAGE category. Also grade as Other in the HEMORRHAGE category.

CNS hemorrhage/bleeding none - - bleeding noted on CT or

other scan with no

clinical consequences

hemorrhagic stroke or

hemorrhagic vascular

event (CVA) with

neurologic signs and

symptoms

Epistaxis none mild without

transfusion

- requiring transfusion catastrophic bleeding,

requiring major non-

elective intervention

Hematemesis none mild without

transfusion

- requiring transfusion catastrophic bleeding,

requiring major non-

elective intervention

Hematuria

(in the absence of vaginal

bleeding)

none microscopic only intermittent gross

bleeding, no clots

persistent gross

bleeding or clots; may

require catheterization

or instrumentation, or

transfusion

open surgery or necrosis

or deep bladder

ulceration

Hemoptysis none

mild without

transfusion

- requiring transfusion

catastrophic bleeding,

requiring major non-

elective intervention

Hemorrhage/bleeding

associated with surgery

none mild without

transfusion

- requiring transfusion catastrophic bleeding,

requiring major non-

elective intervention

Note: Expected blood loss at the time of surgery is not graded as an adverse event.

Melena/GI bleeding none mild without

transfusion

- requiring transfusion catastrophic bleeding,

requiring major non-

elective intervention

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 15 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Petechiae/purpura

(hemorrhage/bleeding into

skin or mucosa)

none rare petechiae of skin petechiae or purpura in

dependent areas of skin

generalized petechiae or

purpura of skin or

petechiae of any

mucosal site

Rectal bleeding/

hematochezia

none mild without

transfusion or

medication

persistent, requiring

medication (e.g., steroid

suppositories) and/or

break from radiation

treatment

requiring transfusion catastrophic bleeding,

requiring major non-

elective intervention

Vaginal bleeding none spotting, requiring <2

pads per day

requiring ≥2 pads per

day, but not requiring

transfusion

requiring transfusion catastrophic bleeding,

requiring major non-

elective intervention

Hemorrhage - Other

(Specify site, ___________)

none

mild without

transfusion

- requiring transfusion

catastrophic bleeding,

requiring major non-

elective intervention

HEPATIC

Alkaline phosphatase WNL >ULN - 2.5 x ULN >2.5 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN

Bilirubin WNL >ULN - 1.5 x ULN >1.5 - 3.0 x ULN >3.0 - 10.0 x ULN >10.0 x ULN

Bilirubin associated with

graft versus host disease

(GVHD) for BMT studies, if

specified in the protocol.

normal

≥2 - <3 mg/100 mL ≥3 - <6 mg/100 mL ≥6 - <15 mg/100 mL ≥15 mg/100 mL

GGT

(γ - Glutamyl transpeptidase)

WNL >ULN - 2.5 x ULN >2.5 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN

Hepatic enlargement absent - - present -

Note: Grade Hepatic enlargement only for treatment related adverse event including Veno-Occlusive Disease.

Hypoalbuminemia WNL <LLN - 3 g/dL

≥2 - <3 g/dL

<2 g/dL -

Liver dysfunction/ failure

(clinical)

normal - - asterixis encephalopathy or coma

Portal vein flow normal -

decreased portal vein

flow

reversal/retrograde

portal vein flow

SGOT (AST)

(serum glutamic oxaloacetic

transaminase)

WNL >ULN - 2.5 x ULN >2.5 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN

SGPT (ALT)

(serum glutamic pyruvic

transaminase)

WNL >ULN - 2.5 x ULN >2.5 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN

Hepatic - Other

(Specify, __________)

none mild moderate severe

life-threatening or

disabling

INFECTION/FEBRILE NEUTROPENIA

Catheter-related infection none mild, no active

treatment

moderate, localized

infection, requiring

local or oral treatment

severe, systemic

infection, requiring IV

antibiotic or antifungal

treatment or

hospitalization

life-threatening sepsis

(e.g., septic shock)

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 16 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Febrile neutropenia

(fever of unknown origin

without clinically or

microbiologically

documented infection)

none - - Present Life-threatening sepsis

(e.g., septic shock)

(ANC <1.0 x 10

/L, fever

≥38.5°C)

Also consider Neutrophils.

Note: Hypothermia instead of fever may be associated with neutropenia and is graded here.

Infection (documented

clinically or

microbiologically) with

grade 3 or 4 neutropenia

none - - present

life-threatening sepsis

(e.g., septic shock)

(ANC <1.0 x 10

/L)

Also consider Neutrophils.

Notes: Hypothermia instead of fever may be associated with neutropenia and is graded here.

In the absence of documented infection grade 3 or 4 neutropenia with fever is graded as Febrile neutropenia.

Infection with unknown

ANC

none - - present life-threatening sepsis

(e.g., septic shock)

Note: This adverse event criterion is used in the rare case when ANC is unknown.

Infection without

neutropenia

none mild, no active

treatment

moderate, localized

infection, requiring

local or oral treatment

severe, systemic

infection, requiring IV

antibiotic or antifungal

treatment, or

hospitalization

life-threatening sepsis

(e.g., septic shock)

Also consider Neutrophils.

Wound-infectious is graded in the DERMATOLOGY/SKIN category.

Infection/Febrile

Neutropenia - Other

(Specify, __________)

none mild moderate severe

life-threatening or

disabling

LYMPHATICS

Lymphatics normal mild lymphedema moderate lymphedema

requiring compression;

lymphocyst

severe lymphedema

limiting function;

lymphocyst requiring

surgery

severe lymphedema

limiting function with

ulceration

Lymphatics - Other

(Specify, __________)

none mild moderate severe life-threatening or

disabling

METABOLIC/LABORATORY

Acidosis

(metabolic or respiratory)

normal

pH <normal, but ≥7.3

- pH <7.3 pH <7.3 with life-

threatening physiologic

consequences

Alkalosis

(metabolic or respiratory)

normal

pH >normal, but ≤7.5

- pH >7.5 pH >7.5 with life-

threatening physiologic

consequences

Amylase WNL >ULN - 1.5 x ULN >1.5 - 2.0 x ULN >2.0 - 5.0 x ULN >5.0 x ULN

Bicarbonate WNL <LLN - 16 mEq/dL 11 - 15 mEq/dL 8 - 10 mEq/dL <8 mEq/dL

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 17 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

CPK

(creatine phosphokinase)

WNL >ULN - 2.5 x ULN >2.5 - 5 x ULN >5 - 10 x ULN >10 x ULN

Hypercalcemia WNL

>ULN - 11.5 mg/dL

>ULN - 2.9 mmol/L

>11.5 - 12.5 mg/dL

>2.9 - 3.1 mmol/L

>12.5 - 13.5 mg/dL

>3.1 - 3.4 mmol/L

>13.5 mg/dL

>3.4 mmol/L

Hypercholesterolemia WNL

>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

Hyperglycemia WNL >ULN - 160 mg/dL

>ULN - 8.9 mmol/L

>160 - 250 mg/dL

>8.9 - 13.9 mmol/L

>250 - 500 mg/dL

>13.9 - 27.8 mmol/L

>500 mg/dL

>27.8 mmol/L or

acidosis

Hyperkalemia WNL >ULN - 5.5 mmol/L >5.5 - 6.0 mmol/L >6.0 - 7.0 mmol/L >7.0 mmol/L

Hypermagnesemia WNL

>ULN - 3.0 mg/dL

>ULN - 1.23 mmol/L

>3.0 - 8.0 mg/dL

>1.23 - 3.30 mmol/L

>8.0 mg/dL

>3.30 mmol/L

Hypernatremia WNL >ULN - 150 mmol/L >150 - 155 mmol/L >155 - 160 mmol/L >160 mmol/L

Hypertriglyceridemia WNL >ULN - 2.5 x ULN >2.5 - 5.0 x ULN >5.0 - 10 x ULN >10 x ULN

Hyperuricemia WNL

>ULN - ≤10 mg/dL

≤0.59 mmol/L without

physiologic

consequences

>ULN - ≤10 mg/dL

≤0.59 mmol/L with

physiologic

consequences

>10 mg/dL

>0.59 mmol/L

Also consider Tumor lysis syndrome, Renal failure, Creatinine, Hyperkalemia.

Hypocalcemia WNL <LLN - 8.0 mg/dL

<LLN - 2.0 mmol/L

7.0 - <8.0 mg/dL

1.75 - <2.0 mmol/L

6.0 - <7.0 mg/dL

1.5 - <1.75 mmol/L

<6.0 mg/dL

<1.5 mmol/L

Hypoglycemia WNL

<LLN - 55 mg/dL

<LLN - 3.0 mmol/L

40 - <55 mg/dL

2.2 - <3.0 mmol/L

30 - <40 mg/dL

1.7 - <2.2 mmol/L

<30 mg/dL

<1.7 mmol/L

Hypokalemia WNL <LLN - 3.0 mmol/L - 2.5 - <3.0 mmol/L <2.5 mmol/L

Hypomagnesemia WNL <LLN - 1.2 mg/dL

<LLN - 0.5 mmol/L

0.9 - <1.2 mg/dL

0.4 - <0.5 mmol/L

0.7 - <0.9 mg/dL

0.3 - <0.4 mmol/L

<0.7 mg/dL

<0.3 mmol/L

Hyponatremia WNL <LLN - 130 mmol/L - 120 - <130 mmol/L <120 mmol/L

Hypophosphatemia WNL <LLN -2.5 mg/dL

<LLN - 0.8 mmol/L

≥2.0 - <2.5 mg/dL

≥0.6 - <0.8 mmol/L

≥1.0 - <2.0 mg/dL

≥0.3 - <0.6 mmol/L

<1.0 mg/dL

<0.3 mmol/L

Hypothyroidism is graded in the ENDOCRINE category.

Lipase WNL >ULN - 1.5 x ULN >1.5 - 2.0 x ULN >2.0 - 5.0 x ULN >5.0 x ULN

Metabolic/Laboratory -

Other (Specify,

__________)

none mild moderate severe

life-threatening or

disabling

MUSCULOSKELETAL

Arthralgia is graded in the PAIN category.

Arthritis none mild pain with

inflammation, erythema

or joint swelling but not

interfering with

function

moderate pain with

inflammation,

erythema, or joint

swelling interfering

with function, but not

interfering with

activities of daily living

severe pain with

inflammation,

erythema, or joint

swelling and interfering

with activities of daily

living

disabling

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 18 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Muscle weakness

(not due to neuropathy)

normal asymptomatic with

weakness on physical

exam

symptomatic and

interfering with

function, but not

interfering with

activities of daily living

symptomatic and

interfering with

activities of daily living

bedridden or disabling

Myalgia [tenderness or pain in muscles] is graded in the PAIN category.

Myositis

(inflammation/damage of

muscle)

none mild pain, not

interfering with

function

pain interfering with

function, but not

interfering with

activities of daily living

pain interfering with

function and interfering

with activities of daily

living

bedridden or disabling

Also consider CPK.

Note: Myositis implies muscle damage (i.e., elevated CPK).

Osteonecrosis

(avascular necrosis)

none asymptomatic and

detected by imaging

only

symptomatic and

interfering with

function, but not

interfering with

activities of daily living

symptomatic and

interfering with

activities of daily living

symptomatic; or

disabling

Musculoskeletal - Other

(Specify, __________)

none mild moderate severe life-threatening or

disabling

NEUROLOGY

Aphasia, receptive and/or expressive, is graded under Speech impairment in the NEUROLOGY category.

Arachnoiditis/meningismus/

radiculitis

absent mild pain not interfering

with function

moderate pain

interfering with

function, but not

interfering with

activities of daily living

severe pain interfering

with activities of daily

living

unable to function or

perform activities of

daily living; bedridden;

paraplegia

Also consider Headache, Vomiting, Fever.

Ataxia (incoordination) normal asymptomatic but

abnormal on physical

exam, and not

interfering with

function

mild symptoms

interfering with

function, but not

interfering with

activities of daily living

moderate symptoms

interfering with

activities of daily living

bedridden or disabling

CNS cerebrovascular

ischemia

none - - transient ischemic event

or attack (TIA)

permanent event (e.g.,

cerebral vascular

accident)

CNS hemorrhage/bleeding is graded in the HEMORRHAGE category.

Cognitive disturbance/

learning problems

none

cognitive disability; not

interfering with

work/school

performance;

preservation of

intelligence

cognitive disability;

interfering with

work/school

performance; decline of

1 SD (Standard

Deviation) or loss of

developmental

milestones

cognitive disability;

resulting in significant

impairment of

work/school

performance; cognitive

decline >2 SD

inability to work/frank

mental retardation

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 19 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Confusion normal confusion or

disorientation or

attention deficit of brief

duration; resolves

spontaneously with no

sequelae

confusion or

disorientation or

attention deficit

interfering with

function, but not

interfering with

activities of daily living

confusion or delirium

interfering with

activities of daily living

harmful to others or

self; requiring

hospitalization

Cranial neuropathy is graded in the NEUROLOGY category as Neuropathy-cranial.

Delusions normal - - present toxic psychosis

Depressed level of

consciousness

normal somnolence or sedation

not interfering with

function

somnolence or sedation

interfering with

function, but not

interfering with

activities of daily living

obtundation or stupor;

difficult to arouse;

interfering with

activities of daily living

coma

Note: Syncope (fainting) is graded in the NEUROLOGY category.

Dizziness/lightheadedness none not interfering with

function

interfering with

function, but not

interfering with

activities of daily living

interfering with

activities of daily living

bedridden or disabling

Dysphasia, receptive and/or expressive, is graded under Speech impairment in the NEUROLOGY category.

Extrapyramidal/

involuntary movement/

restlessness

none mild involuntary

movements not

interfering with

function

moderate involuntary

movements interfering

with function, but not

interfering with

activities of daily living

severe involuntary

movements or torticollis

interfering with

activities of daily living

bedridden or disabling

Hallucinations normal - - present toxic psychosis

Headache is graded in the PAIN category.

Insomnia normal

occasional difficulty

sleeping not interfering

with function

difficulty sleeping

interfering with

function, but not

interfering with

activities of daily living

frequent difficulty

sleeping, interfering

with activities of daily

living

Note: This adverse event is graded when insomnia is related to treatment. If pain or other symptoms interfere with sleep do NOT grade as insomnia.

Irritability

(children <3 years of age)

normal mild; easily consolable

moderate; requiring

increased attention

severe; inconsolable -

Leukoencephalopathy

associated radiological

findings

none

mild increase in SAS

(subarachnoid space)

and/or mild

ventriculomegaly;

and/or small (+/-

multiple) focal T2

hyperintensities,

involving

periventricular white

matter or <1/3 of

susceptible areas of

cerebrum

moderate increase in

SAS; and/or moderate

ventriculomegaly;

and/or focal T2

hyperintensities

extending into centrum

ovale; or involving 1/3

to 2/3 of susceptible

areas of cerebrum

severe increase in SAS;

severe

ventriculomegaly; near

total white matter T2

hyperintensities or

diffuse low attenuation

(CT); focal white matter

necrosis (cystic)

severe increase in SAS;

severe

ventriculomegaly;

diffuse low attenuation

with calcification (CT);

diffuse white matter

necrosis (MRI)

Memory loss normal

memory loss not

interfering with

function

memory loss interfering

with function, but not

interfering with

activities of daily living

memory loss interfering

with activities of daily

living

amnesia

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 20 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Mood alteration-anxiety,

agitation

normal mild mood alteration

not interfering with

function

moderate mood

alteration interfering

with function, but not

interfering with

activities of daily living

severe mood alteration

interfering with

activities of daily living

suicidal ideation or

danger to self

Mood alteration-depression normal

mild mood alteration

not interfering with

function

moderate mood

alteration interfering

with function, but not

interfering with

activities of daily living

severe mood alteration

interfering with

activities of daily living

suicidal ideation or

danger to self

Mood alteration-euphoria normal

mild mood alteration

not interfering with

function

moderate mood

alteration interfering

with function, but not

interfering with

activities of daily living

severe mood alteration

interfering with

activities of daily living

danger to self

Neuropathic pain is graded in the PAIN category.

Neuropathy-cranial absent -

present, not interfering

with activities of daily

living

present, interfering with

activities of daily living

life-threatening,

disabling

Neuropathy-motor normal

subjective weakness but

no objective findings

mild objective

weakness interfering

with function, but not

interfering with

activities of daily living

objective weakness

interfering with

activities of daily living

paralysis

Neuropathy-sensory normal loss of deep tendon

reflexes or paresthesia

(including tingling) but

not interfering with

function

objective sensory loss

or paresthesia

(including tingling),

interfering with

function, but not

interfering with

activities of daily living

sensory loss or

paresthesia interfering

with activities of daily

living

permanent sensory loss

that interferes with

function

Nystagmus absent present - - -

Also consider Vision-double vision.

Personality/behavioral normal

change, but not

disruptive to patient or

family

disruptive to patient or

family

disruptive to patient and

family; requiring mental

health intervention

harmful to others or

self; requiring

hospitalization

Pyramidal tract dysfunction

(e.g., ↑ tone, hyperreflexia,

positive Babinski, ↓ fine

motor coordination)

normal

asymptomatic with

abnormality on physical

examination

symptomatic or

interfering with

function but not

interfering with

activities of daily living

interfering with

activities of daily living

bedridden or disabling;

paralysis

Seizure(s) none - seizure(s) self-limited

and consciousness is

preserved

seizure(s) in which

consciousness is altered

seizures of any type

which are prolonged,

repetitive, or difficult to

control (e.g., status

epilepticus, intractable

epilepsy)

Speech impairment

(e.g., dysphasia or aphasia)

normal -

awareness of receptive

or expressive dysphasia,

not impairing ability to

communicate

receptive or expressive

dysphasia, impairing

ability to communicate

inability to

communicate

Syncope (fainting) absent - - present -

Also consider CARDIOVASCULAR (ARRHYTHMIA), Vasovagal episode, CNS cerebrovascular ischemia.

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 21 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Tremor none mild and brief or

intermittent but not

interfering with

function

moderate tremor

interfering with

function, but not

interfering with

activities of daily living

severe tremor

interfering with

activities of daily living

Vertigo none

not interfering with

function

interfering with

function, but not

interfering with

activities of daily living

interfering with

activities of daily living

bedridden or disabling

Neurology - Other

(Specify, __________)

none mild moderate severe life-threatening or

disabling

OCULAR/VISUAL

Cataract none asymptomatic symptomatic, partial

visual loss

symptomatic, visual

loss requiring treatment

or interfering with

function

Conjunctivitis none abnormal

ophthalmologic

changes, but

asymptomatic or

symptomatic without

visual impairment (i.e.,

pain and irritation)

symptomatic and

interfering with

function, but not

interfering with

activities of daily living

symptomatic and

interfering with

activities of daily living

Dry eye normal

mild, not requiring

treatment

moderate or requiring

artificial tears

Glaucoma none

increase in intraocular

pressure but no visual

loss

increase in intraocular

pressure with retinal

changes

visual impairment

unilateral or bilateral

loss of vision

(blindness)

Keratitis

(corneal inflammation/

corneal ulceration)

none

abnormal

ophthalmologic changes

but asymptomatic or

symptomatic without

visual impairment (i.e.,

pain and irritation)

symptomatic and

interfering with

function, but not

interfering with

activities of daily living

symptomatic and

interfering with

activities of daily living

unilateral or bilateral

loss of vision

(blindness)

Tearing (watery eyes) none

mild: not interfering

with function

moderate: interfering

with function, but not

interfering with

activities of daily living

interfering with

activities of daily living

Vision-blurred vision normal - symptomatic and

interfering with

function, but not

interfering with

activities of daily living

symptomatic and

interfering with

activities of daily living

Vision-double vision

(diplopia)

normal -

symptomatic and

interfering with

function, but not

interfering with

activities of daily living

symptomatic and

interfering with

activities of daily living

Vision-flashing

lights/floaters

normal

mild, not interfering

with function

symptomatic and

interfering with

function, but not

interfering with

activities of daily living

symptomatic and

interfering with

activities of daily living

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 22 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Vision-night blindness

(nyctalopia)

normal abnormal electro-

retinography but

asymptomatic

symptomatic and

interfering with

function, but not

interfering with

activities of daily living

symptomatic and

interfering with

activities of daily living

Vision-photophobia normal -

symptomatic and

interfering with

function, but not

interfering with

activities of daily living

symptomatic and

interfering with

activities of daily living

Ocular/Visual - Other

(Specify, __________)

normal mild moderate severe

unilateral or bilateral

loss of vision

(blindness)

PAIN

Abdominal pain or cramping none

mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Arthralgia

(joint pain)

none mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Arthritis (joint pain with clinical signs of inflammation) is graded in the MUSCULOSKELETAL category.

Bone pain none

mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Chest pain

(non-cardiac and non-

pleuritic)

none mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Dysmenorrhea none mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Dyspareunia none

mild pain not interfering

with function

moderate pain

interfering with sexual

activity

severe pain preventing

sexual activity

Dysuria is graded in the RENAL/GENITOURINARY category.

Earache (otalgia) none mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Headache none

mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 23 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Hepatic pain none mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Myalgia

(muscle pain)

none

mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Neuropathic pain

(e.g., jaw pain, neurologic

pain, phantom limb pain,

post-infectious neuralgia, or

painful neuropathies)

none

mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Pain due to radiation none mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Pelvic pain none mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Pleuritic pain none

mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Rectal or perirectal pain

(proctalgia)

none mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Tumor pain

(onset or exacerbation of

tumor pain due to treatment)

none mild pain not interfering

with function

moderate pain: pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain: pain or

analgesics severely

interfering with

activities of daily living

disabling

Tumor flare is graded in the SYNDROME category.

Pain - Other

(Specify, __________)

none mild moderate severe disabling

PULMONARY

Adult Respiratory Distress

Syndrome (ARDS)

absent---present

Apnea none - - present requiring intubation

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 24 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Carbon monoxide diffusion

capacity (DL

)

≥90% of

pretreatment or

normal value

≥75 - <90% of

pretreatment or normal

value

≥50 - <75% of

pretreatment or normal

value

≥25 - <50% of

pretreatment or normal

value

<25% of pretreatment

or normal value

Cough absent

mild, relieved by non-

prescription medication

requiring narcotic

antitussive

severe cough or

coughing spasms,

poorly controlled or

unresponsive to

treatment

Dyspnea

(shortness of breath)

normal - dyspnea on exertion dyspnea at normal level

of activity

dyspnea at rest or

requiring ventilator

support

FEV

≥90% of

pretreatment or

normal value

≥75 - <90% of

pretreatment or normal

value

≥50 - <75% of

pretreatment or normal

value

≥25 - <50% of

pretreatment or normal

value

<25% of pretreatment

or normal value

Hiccoughs (hiccups,

singultus)

none mild, not requiring

treatment

moderate, requiring

treatment

severe, prolonged, and

refractory to treatment

Hypoxia normal -

decreased O

saturation

with exercise

decreased O

saturation

at rest, requiring

supplemental oxygen

decreased O

saturation,

requiring pressure

support (CPAP) or

assisted ventilation

Pleural effusion

(non-malignant)

none asymptomatic and not

requiring treatment

symptomatic, requiring

diuretics

symptomatic, requiring

or therapeutic

thoracentesis

life-threatening (e.g.,

requiring intubation)

Pleuritic pain is graded in the PAIN category.

Pneumonitis/pulmonary

infiltrates

none

radiographic changes

but asymptomatic or

symptoms not requiring

steroids

radiographic changes

and requiring steroids or

diuretics

radiographic changes

and requiring oxygen

radiographic changes

and requiring assisted

ventilation

Pneumothorax none no intervention required chest tube required sclerosis or surgery

required

life-threatening

Pulmonary embolism is graded as Thrombosis/embolism in the CARDIOVASCULAR (GENERAL) category.

Pulmonary fibrosis none radiographic changes,

but asymptomatic or

symptoms not requiring

steroids

requiring steroids or

diuretics

requiring oxygen requiring assisted

ventilation

Note: Radiation-related pulmonary fibrosis is graded in the RTOG/EORTC Late Radiation Morbidity Scoring Scheme-Lung. (See Appendix IV)

Voice changes/stridor/larynx

(e.g., hoarseness, loss of

voice, laryngitis)

normal

mild or intermittent

hoarseness

persistent hoarseness,

but able to vocalize;

may have mild to

moderate edema

whispered speech, not

able to vocalize; may

have marked edema

marked dyspnea/stridor

requiring tracheostomy

or intubation

Notes: Cough from radiation is graded as cough in the PULMONARY category.

Radiation-related hemoptysis from larynx/pharynx is graded as Grade 4 Mucositis due to radiation in the GASTROINTESTINAL category. Radiation-

related hemoptysis from the thoracic cavity is graded as Grade 4 Hemoptysis in the HEMORRHAGE category.

Pulmonary - Other

(Specify, __________)

none mild moderate severe life-threatening or

disabling

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 25 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

RENAL/GENITOURINARY

Bladder spasms absent mild symptoms, not

requiring intervention

symptoms requiring

antispasmodic

severe symptoms

requiring narcotic

Creatinine WNL >ULN - 1.5 x ULN >1.5 - 3.0 x ULN >3.0 - 6.0 x ULN >6.0 x ULN

Note: Adjust to age-appropriate levels for pediatric patients.

Dysuria

(painful urination)

none

mild symptoms

requiring no

intervention

symptoms relieved with

therapy

symptoms not relieved

despite therapy

Fistula or GU fistula

(e.g., vaginal, vesicovaginal)

none - - requiring intervention requiring surgery

Hemoglobinuria - present - - -

Hematuria (in the absence of vaginal bleeding) is graded in the HEMORRHAGE category.

Incontinence none with coughing,

sneezing, etc.

spontaneous, some

control

no control (in the

absence of fistula)

Operative injury to bladder

and/or ureter

none - injury of bladder with

primary repair

sepsis, fistula, or

obstruction requiring

secondary surgery; loss

of one kidney; injury

requiring anastomosis

or re-implantation

septic obstruction of

both kidneys or

vesicovaginal fistula

requiring diversion

Proteinuria normal or <0.15

g/24 hours

1+ or 0.15 - 1.0 g/24

hours

2+ to 3+ or 1.0 - 3.5

g/24 hours

4+ or >3.5 g/24 hours nephrotic syndrome

Note: If there is an inconsistency between absolute value and dip stick reading, use the absolute value for grading.

Renal failure none - - requiring dialysis, but

reversible

requiring dialysis and

irreversible

Ureteral obstruction none

unilateral, not requiring

surgery

bilateral, not requiring

surgery

stent, nephrostomy

tube, or surgery

Urinary electrolyte wasting

(e.g., Fanconi’s syndrome,

renal tubular acidosis)

none

asymptomatic, not

requiring treatment

mild, reversible and

manageable with oral

replacement

reversible but requiring

IV replacement

irreversible, requiring

continued replacement

Also consider Acidosis, Bicarbonate, Hypocalcemia, Hypophosphatemia.

Urinary frequency/urgency normal increase in frequency or

nocturia up to 2 x

normal

increase >2 x normal

but <hourly

hourly or more with

urgency, or requiring

catheter

Urinary retention normal hesitancy or dribbling,

but no significant

residual urine; retention

occurring during the

immediate

postoperative period

hesitancy requiring

medication or

occasional in/out

catheterization (<4 x per

week), or operative

bladder atony requiring

indwelling catheter

beyond immediate

postoperative period but

for <6 weeks

requiring frequent

in/out catheterization

(≥4 x per week) or

urological intervention

(e.g., TURP, suprapubic

tube, urethrotomy)

bladder rupture

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 26 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Urine color change

(not related to other dietary

or physiologic cause e.g.,

bilirubin, concentrated urine,

hematuria)

normal asymptomatic, change

in urine color

---

Vaginal bleeding is graded in the HEMORRHAGE category.

Vaginitis

(not due to infection)

none mild, not requiring

treatment

moderate, relieved with

treatment

severe, not relieved

with treatment, or

ulceration not requiring

surgery

ulceration requiring

surgery

Renal/Genitourinary - Other

(Specify, __________)

none mild moderate severe

life-threatening or

disabling

SECONDARY MALIGNANCY

Secondary Malignancy -

Other

(Specify type, __________)

excludes metastasis from

initial primary

none---present

SEXUAL/REPRODUCTIVE FUNCTION

Dyspareunia is graded in the PAIN category.

Dysmenorrhea is graded in the PAIN category.

Erectile impotence normal mild (erections

impaired but

satisfactory)

moderate (erections

impaired, unsatisfactory

for intercourse)

no erections -

Female sterility normal - - sterile -

Feminization of male is graded in the ENDOCRINE category.

Irregular menses

(change from baseline)

normal

occasionally irregular or

lengthened interval, but

continuing menstrual

cycles

very irregular, but

continuing menstrual

cycles

persistent amenorrhea -

Libido normal decrease in interest severe loss of interest - -

Male infertility - -

oligospermia

(low sperm count)

azoospermia

(no sperm)

Masculinization of female is graded in the ENDOCRINE category.

Vaginal dryness normal mild

requiring treatment

and/or interfering with

sexual function,

dyspareunia

Sexual/Reproductive

Function - Other

(Specify, __________)

none mild moderate severe disabling

SYNDROMES (not included in previous categories)

Acute vascular leak syndrome is graded in the CARDIOVASCULAR (GENERAL) category.

ARDS (Adult Respiratory Distress Syndrome) is graded in the PULMONARY category.

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 27 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Grade

Adverse Event 0 1 2 3 4

Autoimmune reactions are graded in the ALLERGY/IMMUNOLOGY category.

DIC (disseminated intravascular coagulation) is graded in the COAGULATION category.

Fanconi’s syndrome is graded as Urinary electrolyte wasting in the RENAL/GENITOURINARY category.

Renal tubular acidosis is graded as Urinary electrolyte wasting in the RENAL/GENITOURINARY category.

Stevens-Johnson syndrome (erythema multiforme) is graded in the DERMATOLOGY/SKIN category.

SIADH (syndrome of inappropriate antidiuretic hormone) is graded in the ENDOCRINE category.

Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTP or hemolytic uremic syndrome/HUS) is graded in the COAGULATION category.

Tumor flare none

mild pain not interfering

with function

moderate pain; pain or

analgesics interfering

with function, but not

interfering with

activities of daily living

severe pain; pain or

analgesics interfering

with function and

interfering with

activities of daily living

Disabling

Also consider Hypercalcemia.

Note: Tumor flare is characterized by a constellation of symptoms and signs in direct relation to initiation of therapy (e.g., anti-estrogens/androgens or additional

hormones). The symptoms/signs include tumor pain, inflammation of visible tumor, hypercalcemia, diffuse bone pain, and other electrolyte disturbances.

Tumor lysis syndrome absent - - present -

Also consider Hyperkalemia, Creatinine.

Urinary electrolyte wasting (e.g., Fanconi’s syndrome, renal tubular acidosis) is graded in the RENAL/GENITOURINARY category.

Syndromes - Other

(Specify, __________)

none mild moderate severe

life-threatening or

disabling

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 28 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Appendix I

Adverse Event Module

To be implemented at the request of the study sponsor or principal investigator in the protocol or by protocol

amendment when more detailed information is considered pertinent.

Adverse Event: Date of Treatment: Course Number:

Date of onset: Grade at onset:

Date of first change in grade: Grade:

Date of next change in grade: Grade:

Did adverse event resolve? Yes______ No______

If so, date of resolution of adverse event:

Date of last observation (if prior to

recovery):

Reason(s) observations stopped (if prior

to recovery):

Was patient retreated? Yes______ No______

If yes, was treatment delayed for

recovery? Yes______ No______

Date of next treatment?

Dose reduced for next treatment? Yes______ No______

Additional Comments:

________________________________________________________________________________________________________

If module is being activated for new adverse event not currently in CTC, please provide definitions for adverse event grading:

Grade 0 = ____________________________________________________________________

Grade 1 = ____________________________________________________________________

Grade 2 = ____________________________________________________________________

Grade 3 = ____________________________________________________________________

Grade 4 = ____________________________________________________________________

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 29 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Appendix II

Infection Module

To be implemented at the request of the study sponsor or principal investigator in the protocol or by protocol

amendment when more detailed information is considered pertinent.

Use the Common Toxicity Criteria definitions to grade the severity of the infection.

Specify type of infection from the following (CHOOSE ONE):

BACTERIAL FUNGAL PROTOZOAL VIRAL UNKNOWN

Specify site of infection from the following (CHOOSE ALL THAT APPLY):

BLOOD CULTURE POSITIVE

BONE INFECTION

CATHETER (intravenous)

CATHETER (intravenous), tunnel infection

CENTRAL NERVOUS SYSTEM INFECTION

EAR INFECTION

EYE INFECTION

GASTROINTESTINAL INFECTION

ORAL INFECTION

PNEUMONIA

SKIN INFECTION

UPPER RESPIRATORY INFECTION

URINARY TRACT INFECTION

VAGINAL INFECTION

INFECTION, not otherwise specified (Specify site, __________)

Specify organism, if known: _______________.

Prophylactic antibiotic, antifungal, or antiviral therapy administration

Yes_______ No_______

If prophylaxis was given prior to infection, please specify below:

Antibiotic prophylaxis _____________________________________________________

Antifungal prophylaxis ____________________________________________________

Antiviral prophylaxis ______________________________________________________

Other prophylaxis ________________________________________________________

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 30 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Appendix III

Performance Status Scales/Scores

PERFORMANCE STATUS CRITERIA

Karnofsky and Lansky performance scores are intended to be multiples of 10

ECOG (Zubrod) Karnofsky Lansky*

Score Description Score Description Score Description

100 Normal, no complaints, no

evidence of disease.

100 Fully active, normal.

Fully active, able to carry on

all pre-disease performance

without restriction.

90 Able to carry on normal

activity; minor signs or

symptoms of disease.

90 Minor restrictions in physically

strenuous activity.

80 Normal activity with effort;

some signs or symptoms of

disease.

80 Active, but tires more quickly

Restricted in physically

strenuous activity but

ambulatory and able to carry

out work of a light or

sedentary nature, e.g., light

housework, office work.

70 Cares for self, unable to carry

on normal activity or do active

work.

70 Both greater restriction of and less time

spent in play activity.

60 Requires occasional

assistance, but is able to care

for most of his/her needs.

60 Up and around, but minimal active play;

keeps busy with quieter activities.

Ambulatory and capable of all

selfcare but unable to carry

out any work activities. Up

and about more than 50% of

waking hours.

50 Requires considerable

assistance and frequent

medical care.

50 Gets dressed, but lies around much of

the day; no active play; able to

participate in all quiet play and

activities.

40 Disabled, requires special care

and assistance.

40 Mostly in bed; participates in quiet

activities.

Capable of only limited

selfcare, confined to bed or

chair more than 50% of

waking hours.

30 Severely disabled,

hospitalization indicated.

Death not imminent.

30 In bed; needs assistance even for quiet

play.

20 Very sick, hospitalization

indicated. Death not imminent.

20 Often sleeping; play entirely limited to

very passive activities.

Completely disabled. Cannot

carry on any selfcare. Totally

confined to bed or chair.

10 Moribund, fatal processes

progressing rapidly.

10 No play; does not get out of bed.

*The conversion of the Lansky to ECOG scales is intended for NCI reporting purposes only.

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 31 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Appendix IV

RTOG/EORTC Late Radiation Morbidity Scoring Scheme

Use for adverse event occurring greater than 90 days after radiation therapy.

Grade

Adverse Event 0 1 2 3 4

Bladder-

Late RT Morbidity Scoring

No change from

baseline

Slight epithelial

atrophy/minor

telangiectasia

(microscopic hematuria)

Moderate frequency/

generalized

telangiectasia/

intermittent

macroscopic hematuria

Severe frequency and

dysuria/severe

generalized

telangiectasia (often

with petechiae);

frequent hematuria;

reduction in bladder

capacity (<150 mL)

Necrosis/contracted

bladder (capacity <100

mL)/severe

hemorrhagic cystitis

Bone-

Late RT Morbidity Scoring

No change from

baseline

Asymptomatic; no

growth retardation;

reduced bone density

Moderate pain or

tenderness; growth

retardation; irregular

bone sclerosis

Severe pain or

tenderness; complete

arrest of bone growth;

dense bone sclerosis

Necrosis/

spontaneous fracture

Brain-

Late RT Morbidity Scoring

No change from

baseline

Mild headache; slight

lethargy

Moderate headache;

great lethargy

Severe headaches;

severe CNS dysfunction

(partial loss of power or

dyskinesia)

Seizures or paralysis;

coma

Esophagus-

Late RT Morbidity Scoring

No change from

baseline

Mild fibrosis; slight

difficulty in swallowing

solids; no pain on

swallowing

Unable to take solid

food normally;

swallowing semi-solid

food; dilation may be

indicated

Severe fibrosis; able to

swallow only liquids;

may have pain on

swallowing; dilation

required

Necrosis/

perforation; fistula

Eye-

Late RT Morbidity Scoring

No change from

baseline

Asymptomatic cataract;

minor corneal

ulceration or keratitis

Symptomatic cataract;

moderate corneal

ulceration; minor

retinopathy or glaucoma

Severe keratitis; severe

retinopathy or

detachment; severe

glaucoma

Panophthalmitis;

blindness

Heart-

Late RT Morbidity Scoring

No change from

baseline

Asymptomatic or mild

symptoms; transient T

wave inversion and ST

changes; sinus

tachycardia >110 (at

rest)

Moderate angina on

effort; mild pericarditis;

normal heart size;

persistent abnormal T

wave and ST changes;

low QRS

Severe angina;

pericardial effusion;

constrictive pericarditis;

moderate heart failure;

cardiac enlargement;

EKG abnormalities

Tamponade/severe heart

failure/severe

constrictive pericarditis

Joint-

Late RT Morbidity Scoring

No change from

baseline

Mild joint stiffness;

slight limitation of

movement

Moderate stiffness;

intermittent or moderate

joint pain; moderate

limitation of movement

Severe joint stiffness;

pain with severe

limitation of movement

Necrosis/complete

fixation

Kidney-

Late RT Morbidity Scoring

No change from

baseline

Transient albuminuria;

no hypertension; mild

impairment of renal

function; urea 25 - 35

mg%; creatinine 1.5 -

2.0 mg%; creatinine

clearance >75%

Persistent moderate

albuminuria (2+); mild

hypertension; no related

anemia; moderate

impairment of renal

function; urea >36 - 60

mg%; creatinine

clearance >50 - 74%

Severe albuminuria;

severe hypertension;

persistent anemia (<10

g%); severe renal

failure; urea >60 mg%;

creatinine >4 mg%;

creatinine clearance

<50%

Malignant hypertension;

uremic coma/urea

>100%

Larynx-

Late RT Morbidity Scoring

No change from

baseline

Hoarseness; slight

arytenoid edema

Moderate arytenoid

edema; chondritis

Severe edema; severe

chondritis

Necrosis

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 32 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Appendix IV (continued)

RTOG/EORTC Late Radiation Morbidity Scoring Scheme

Use for adverse event occurring greater than 90 days after radiation therapy.

Grade

Adverse Event 0 1 2 3 4

Liver-

Late RT Morbidity Scoring

No change from

baseline

Mild lassitude; nausea;

dyspepsia; slightly

abnormal liver function

Moderate symptoms;

some abnormal liver

function tests; serum

albumin normal

Disabling hepatic

insufficiency; liver

function tests grossly

abnormal; low albumin;

edema or ascites

Necrosis/hepatic coma

or encephalopathy

Lung-

Late RT Morbidity Scoring

No change from

baseline

Asymptomatic or mild

symptoms (dry cough);

slight radiographic

appearances

Moderate symptomatic

fibrosis or pneumonitis

(severe cough); low

grade fever; patchy

radiographic

appearances

Severe symptomatic

fibrosis or pneumonitis;

dense radiographic

changes

Severe respiratory

insufficiency/

continuous O

/assisted

ventilation

Mucous membrane-

Late RT Morbidity Scoring

No change from

baseline

Slight atrophy and

dryness

Moderate atrophy and

telangiectasia; little

mucus

Marked atrophy with

complete dryness;

severe telangiectasia

Ulceration

Salivary glands-

Late RT Morbidity Scoring

No change from

baseline

Slight dryness of

mouth; good response

on stimulation

Moderate dryness of

mouth; poor response

on stimulation

Complete dryness of

mouth; no response on

stimulation

Fibrosis

Skin-

Late RT Morbidity Scoring

No change from

baseline

Slight atrophy;

pigmentation change;

some hair loss

Patchy atrophy;

moderate telangiectasia;

total hair loss

Marked atrophy; gross

telangiectasia

Ulceration

Small/Large intestine-

Late RT Morbidity Scoring

No change from

baseline

Mild diarrhea; mild

cramping; bowel

movement 5 x daily;

slight rectal discharge

or bleeding

Moderate diarrhea and

colic; bowel movement

>5 x daily; excessive

rectal mucus or

intermittent bleeding

Obstruction or bleeding,

requiring surgery

Necrosis/perforation

fistula

Spinal cord-

Late RT Morbidity Scoring

No change from

baseline

Mild Lhermitte’s

syndrome

Severe Lhermitte’s

syndrome

Objective neurological

findings at or below

cord level treatment

Mono-, para-,

quadriplegia

Subcutaneous tissue-

Late RT Morbidity Scoring

No change from

baseline

Slight induration

(fibrosis) and loss of

subcutaneous fat

Moderate fibrosis but

asymptomatic; slight

field contracture; <10%

linear reduction

Severe induration and

loss of subcutaneous

tissue; field contracture

>10% linear

measurement

Necrosis

Radiation - Other

(Specify, __________)

None Mild Moderate Severe Life-threatening or

disabling

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 33 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Appendix V

BMT-Specific Adverse Events

Summary of BMT-Specific Adverse Events that may be used

if specified by the protocol

. These differ

from the standard CTC and may be more relevant to the transplant setting. They are listed here for the

convenience of investigators writing transplant protocols. They are also included in the CTC document.

Grade

Adverse Event 0 1 2 3 4

Bilirubin associated with

graft versus host disease for

BMT studies .

normal

≥2 - <3 mg/100 mL ≥3 - <6 mg/100 mL ≥6 - <15 mg/100 mL ≥15 mg/100 mL

Diarrhea associated with

graft versus host disease

(GVHD) for BMT studies.

none

>500 - ≤1000mL of

diarrhea/day

>1000 - ≤1500mL of

diarrhea/day

>1500mL of

diarrhea/day

severe abdominal pain

with or without ileus

Diarrhea for pediatric BMT

studies.

>5 -

≤

10 mL/kg of

diarrhea/day

>10 -

≤

15 mL/kg of

diarrhea/day

>15 mL/kg of

diarrhea/day

Hepatic enlargement absent - - present -

Leukocytes (total WBC) for

BMT studies.

WNL

≥2.0 - <3.0 X 10

≥2000 - <3000/mm

≥1.0 - <2.0 x 10

≥1000 - <2000/mm

≥0.5 - <1.0 x 10

≥500 - <1000/mm

<0.5 x 10

<500/mm

Leukocytes (total WBC) for

pediatric BMT studies (using

age, race and sex normal

values).

≥

75 - <100% LLN

≥

50 - <75% LLN

≥

25 - 50% LLN

<25% LLN

Lymphopenia for pediatric

BMT studies (using age,

race and sex normal values).

≥

75-<100%LLN

≥

50-<75%LLN

≥

25-<50%LLN

<25%LLN

Neutrophils/granulocytes

(ANC/AGC) for BMT

studies.

WNL

≥1.0 - <1.5 x 10

≥1000 - <1500/mm

≥0.5 - <1.0 x 10

≥500 - <1000/mm

≥0.1 - <0.5 x 10

≥100 - <500/mm

<0.1 x 10

<100/mm

Platelets for BMT studies. WNL

≥50.0 - <75.0 x 10

≥50,000 - <75,000/mm

≥20.0 - <50.0 x 10

≥20,000 - <50,000/mm

≥10.0 - <20.0 x 10

≥10,000 - <20,000/mm

<10.0 x 10

<10,000/mm

Rash/dermatitis associated

with high-dose

chemotherapy or BMT

studies.

none

faint erythema or dry

desquamation

moderate to brisk

erythema or a patchy

moist desquamation,

mostly confined to skin

folds and creases;

moderate edema

confluent moist

desquamation, ≥1.5 cm

diameter, not confined

to skin folds; pitting

edema

skin necrosis or

ulceration of full

thickness dermis; may

include spontaneous

bleeding not induced by

minor trauma or

abrasion

Rash/desquamation

associated with graft versus

host disease (GVHD) for

BMT studies.

none macular or papular

eruption or erythema

covering <25% of body

surface area without

associated symptoms

macular or papular

eruption or erythema

with pruritus or other

associated symptoms

covering ≥25 - <50% of

body surface or

localized desquamation

or other lesions

covering ≥25 - <50% of

body surface area

symptomatic

generalized

erythroderma or

symptomatic macular,

papular or vesicular

eruption, with bullous

formation, or

desquamation covering

≥50% of body surface

area

generalized exfoliative

dermatitis or ulcerative

dermatitis or bullous

formation

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 34 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Appendix V (Continued)

BMT-Specific Adverse Events

Summary of BMT-Specific Adverse Events that may be used

if specified by the protocol

. These differ

from the standard CTC and may be more relevant to the transplant setting. They are listed here for the

convenience of investigators writing transplant protocols. They are also included in the CTC document.

Grade

Adverse Event 0 1 2 3 4

Stomatitis/pharyngitis

(oral/pharyngeal mucositis)

for BMT studies.

none painless ulcers,

erythema, or mild

soreness in the absence

of lesions

painful erythema,

edema or ulcers but can

swallow

painful erythema,

edema, or ulcers

preventing swallowing

or requiring hydration

or parenteral (or enteral)

nutritional support

severe ulceration

requiring prophylactic

intubation or resulting

in documented

aspiration pneumonia

Transfusion: Platelets for

BMT studies.

none 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)

Transfusion: pRBCs for

BMT studies.

none

≤2 u pRBC in 24 hours

elective or planned

3 u pRBC in 24 hours

elective or planned

≥4 u pRBC in 24 hours

hemorrhage or

hemolysis associated

with life-threatening

anemia; medical

intervention required to

improve hemoglobin

Transfusion: pRBCs for

pediatric BMT studies.

none

≤

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

improve hemoglobin

Thrombotic

microangiopathy (e.g.,

thrombotic

thrombocytopenic

purpura/TTP or hemolytic

uremic syndrome/HUS) for

BMT studies.

evidence of RBC

destruction

(schistocytosis) without

clinical consequences

evidence of RBC

destruction with

elevated creatinine (≤3

x ULN)

evidence of RBC

destruction with

creatinine (>3 x ULN)

not requiring dialysis

evidence of RBC

destruction with renal

failure requiring

dialysis and/or

encephalopathy

Weight gain associated with

Veno-Occlusive Disease

(VOD) for BMT studies.

<2%

≥2 - <5% ≥5 - <10% ≥10% or as ascites

≥10% or fluid retention

resulting in pulmonary

failure

CTC Version 2.0

Publish Date: April 30, 1999

Cancer Therapy Evaluation Program 35 Revised March 23, 1998

Common Toxicity Criteria, Version 2.0

DCTD, NCI, NIH, DHHS March 1998

Appendix VI

BMT Complex/Multicomponent Events

Grade

Adverse Event 0 1 2 3 4

Note: The grading of Complex/Multicomponent Events in bone marrow transplant will be defined in the protocol. The grading scale must use the CTC criteria for

grading the specific component events (adverse events).

Failure to engraft absent mild moderate severe life-threatening

Also consider Hemoglobin, Neutrophils/granulocytes (ANC/AGC), Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol, Platelets,

Platelets for BMT studies, if specified in the protocol

Graft versus host disease absent mild moderate severe life-threatening

Also consider Fatigue, Rash/desquamation, Rash/desquamation associated with graft versus host disease (GVHD) for BMT studies, if specified in the protocol,

Diarrhea for patients without colostomy, Diarrhea for patients with colostomy, Diarrhea associated with graft versus host disease (GVHD) for BMT studies, if

specified in the protocol, Diarrhea for pediatric BMT studies, if specified in the protocol, Bilirubin, Bilirubin associated with graft versus host disease (GVHD) for

BMT studies, if specified in the protocol

Stem cell infusion

complications

absent mild moderate severe life-threatening

Also consider Allergic reaction/hypersensitivity, Conduction abnormality/Atrioventricular heart block, Nodal/junctional arrhythmia/dysrhythmia, Prolonged QTc

interval (QTc >0.48 seconds), Sinus bradycardia, Sinus tachycardia, Supraventricular arrhythmias (SVT/atrial fibrillation/flutter), Vasovagal episode, Ventricular

arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia), Cardiovascular/Arrhythmia - Other (Specify, ___________), Hypertension, Hypotension, Fever (in

the absence of neutropenia, where neutropenia is defined as AGC <1.0 x 10

/L), Rigors/chills, Sweating (diaphoresis), Rash/desquamation, Rash/desquamation

associated with graft versus host disease (GVHD) for BMT studies, if specified in the protocol, Urticaria (hives, welts, wheals), Diarrhea for patients without

colostomy, Diarrhea for patients with colostomy, Diarrhea associated with graft versus host disease (GVHD) for BMT studies, if specified in the protocol, Diarrhea

for pediatric BMT studies, if specified in the protocol, Nausea, Vomiting, Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia, Hemorrhage/bleeding without

grade 3 or 4 thrombocytopenia, Hemoptysis, Alkaline phosphatase, Bilirubin, Bilirubin associated with graft versus host disease (GVHD) for BMT studies, if

specified in the protocol, GGT, SGOT (AST), SGPT (ALT), Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x

/L), Infection without neutropenia, Hyperkalemia, Hypernatremia, Hypokalemia, Depressed level of consciousness, Seizures, Abdominal pain, Headache,

Creatinine, Hemoglobinuria

Veno-Occlusive Disease

(VOD)

absent mild moderate severe life-threatening

Also consider Weight gain associated with Veno-Occlusive Disease (VOD) for BMT studies, if specified in the protocol, Bilirubin, Bilirubin associated with graft

versus host disease (GVHD) for BMT studies, if specified in the protocol, Depressed level of consciousness, Hepatic pain, Renal failure, Hepatic enlargement