Microsoft Word - CTCAEv3_PubDate

Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS

March 31, 2003 (http://ctep.cancer.gov

), Publish Date: August 9, 2006

Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Publish Date: August 9, 2006

Quick Reference

The NCI Common Terminology Criteria for Adverse Events

v3.0 is a descriptive terminology which can be utilized for

Adverse Event (AE) reporting. A grading (severity) scale is

provided for each AE term.

Components and Organization

CATEGORY

A CATEGORY is a broad classification of AEs based on

anatomy and/or pathophysiology. Within each CATEGORY,

AEs are listed accompanied by their descriptions of severity

(Grade).

Adverse Event Terms

An AE is any unfavorable and unintended sign (including an

abnormal laboratory finding), symptom, or disease temporally

associated with the use of a medical treatment or procedure

that may or may not

be considered related to the medical

treatment or procedure. An AE is a term that is a unique

representation of a specific event used for medical

documentation and scientific analyses. Each AE term is

mapped to a MedDRA term and code. AEs are listed

alphabetically within CATEGORIES.

Short AE Name

The ‘SHORT NAME’ column is new and it is used to simplify

documentation of AE names on Case Report Forms.

Supra-ordinate Terms

A supra-ordinate term is located within a CATEGORY and is a

grouping term based on disease process, signs, symptoms,

or diagnosis. A supra-ordinate term is followed by the word

‘Select’ and is accompanied by specific AEs that are all

related to the supra-ordinate term. Supra-ordinate terms

provide clustering and consistent representation of Grade for

related AEs. Supra-ordinate terms are not AEs, are not

mapped to a MedDRA term and code, cannot be graded and

cannot be used for reporting.

REMARK

A ‘REMARK’ is a clarification of an AE.

ALSO CONSIDER

An ‘ALSO CONSIDER’ indicates additional AEs that are to be

graded if they are clinically significant.

NAVIGATION NOTE

A ‘NAVIGATION NOTE’ indicates the location of an AE term

within the CTCAE document. It lists signs/symptoms

alphabetically and the CTCAE term will appear in the same

CATEGORY unless the ‘N

AVIGATION NOTE’ states differently.

Grades

Grade refers to the severity of the AE. The CTCAE v3.0

displays Grades 1 through 5 with unique clinical descriptions

of severity for each AE based on this general guideline:

Grade 1 Mild AE

Grade 2 Moderate AE

Grade 3 Severe AE

Grade 4 Life-threatening or disabling AE

Grade 5 Death related to AE

A Semi-colon indicates ‘or’ within the description of the grade.

An ‘Em dash’ (—) indicates a grade not available.

Not all Grades are appropriate for all AEs. Therefore, some

AEs are listed with fewer than five options for Grade

selection.

Grade 5

Grade 5 (Death) is not appropriate for some AEs and

therefore is not an option.

The DEATH CATEGORY is new. Only one Supra-ordinate

term is listed in this CATEGORY: ‘Death not associated with

CTCAE term – Select’ with 4 AE options: Death NOS;

Disease progression NOS; Multi-organ failure; Sudden death.

Important:

• Grade 5 is the only appropriate Grade

• This AE is to be used in the situation where

a death

1. cannot be reported using a CTCAE v3.0

term associated with Grade 5, or

2. cannot be reported within a CTCAE

CATEGORY as ‘Other (Specify)’

Contents

ALLERGY/IMMUNOLOGY ............................................ 1

AUDITORY/EAR............................................................ 2

BLOOD/BONE MARROW ............................................. 4

CARDIAC ARRHYTHMIA.............................................. 5

CARDIAC GENERAL .................................................... 7

COAGULATION .......................................................... 10

CONSTITUTIONAL SYMPTOMS................................ 11

DEATH ........................................................................ 13

DERMATOLOGY/SKIN ............................................... 14

ENDOCRINE ............................................................... 17

GASTROINTESTINAL................................................. 19

GROWTH AND DEVELOPMENT................................ 29

HEMORRHAGE/BLEEDING ....................................... 30

HEPATOBILIARY/PANCREAS ................................... 34

INFECTION................................................................. 35

LYMPHATICS ............................................................. 38

METABOLIC/LABORATORY ...................................... 40

MUSCULOSKELETAL/SOFT TISSUE........................ 43

NEUROLOGY ............................................................. 47

OCULAR/VISUAL........................................................ 52

PAIN............................................................................ 55

PULMONARY/UPPER RESPIRATORY...................... 56

RENAL/GENITOURINARY.......................................... 60

SECONDARY MALIGNANCY ..................................... 63

SEXUAL/REPRODUCTIVE FUNCTION ..................... 64

SURGERY/INTRA-OPERATIVE INJURY ................... 66

SYNDROMES ............................................................. 68

VASCULAR................................................................. 70

ALLERGY/IMMUNOLOGY Page 1 of 1

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 1 - March 31, 2003, Publish Date: August 9, 2006

Allergic reaction/

hypersensitivity

(including drug fever)

Allergic reaction Transient flushing or

rash; drug fever <38°C

(<100.4°F)

Rash; flushing; urticaria;

dyspnea; drug fever

≥38°C (≥100.4°F)

Symptomatic

bronchospasm, with or

without urticaria;

parenteral medication(s)

indicated; allergy-related

edema/angioedema;

hypotension

Anaphylaxis Death

REMARK: Urticaria with manifestations of allergic or hypersensitivity reaction is graded as Allergic reaction/hypersensitivity (including drug fever).

LSO CONSIDER: Cytokine release syndrome/acute infusion reaction.

Allergic rhinitis

(including sneezing,

nasal stuffiness,

postnasal drip)

Rhinitis Mild, intervention not

indicated

Moderate, intervention

indicated

— — —

REMARK: Rhinitis associated with obstruction or stenosis is graded as Obstruction/stenosis of airway – Select in the PULMONARY/UPPER RESPIRATORY CATEGORY.

Autoimmune reaction Autoimmune reaction Asymptomatic and

serologic or other

evidence of autoimmune

reaction, with normal

organ function and

intervention not indicated

Evidence of autoimmune

reaction involving a non-

essential organ or

function (e.g.,

hypothyroidism)

Reversible autoimmune

reaction involving function

of a major organ or other

adverse event (e.g.,

transient colitis or

anemia)

Autoimmune reaction with

life-threatening

consequences

Death

ALSO CONSIDER: Colitis; Hemoglobin; Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis); Thyroid function, low (hypothyroidism).

Serum sickness Serum sickness — — Present — Death

NAVIGATION NOTE: Splenic function is graded in the BLOOD/BONE MARROW CATEGORY.

NAVIGATION NOTE: Urticaria as an isolated symptom is graded as Urticaria (hives, welts, wheals) in the DERMATOLOGY/SKIN CATEGORY.

Vasculitis Vasculitis Mild, intervention not

indicated

Symptomatic, non-

steroidal medical

intervention indicated

Steroids indicated Ischemic changes;

amputation indicated

Death

Allergy/Immunology –

Other (Specify, __)

Allergy – Other (Specify) Mild Moderate Severe Life-threatening; disabling Death

AUDITORY/EAR Page 1 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 2 - March 31, 2003, Publish Date: August 9, 2006

NAVIGATION NOTE: Earache (otalgia) is graded as Pain – Select in the PAIN CATEGORY.

Hearing:

patients with/without

baseline audiogram and

enrolled in a monitoring

program

Hearing (monitoring

program)

Threshold shift or loss of

15 – 25 dB relative to

baseline, averaged at 2

or more contiguous test

frequencies in at least

one ear; or subjective

change in the absence of

a Grade 1 threshold shift

Threshold shift or loss of

>25 – 90 dB, averaged at

2 contiguous test

frequencies in at least

one ear

Adult only: Threshold shift

of >25 – 90 dB, averaged

at 3 contiguous test

frequencies in at least

one ear

Pediatric:

Hearing loss sufficient to

indicate therapeutic

intervention, including

hearing aids (e.g., ≥20 dB

bilateral HL in the speech

frequencies; ≥30 dB

unilateral HL; and

requiring additional

speech-language related

services)

Adult only: Profound

bilateral hearing loss

(>90 dB)

Pediatric:

Audiologic indication for

cochlear implant and

requiring additional

speech-language related

services

—

REMARK: Pediatric recommendations are identical to those for adults, unless specified. For children and adolescents (≤18 years of age) without a baseline test, pre-exposure/pre-

treatment hearing should be considered to be <5 dB loss.

Hearing:

patients without baseline

audiogram and not

enrolled in a monitoring

program

Hearing (without

monitoring program)

— Hearing loss not requiring

hearing aid or

intervention (i.e., not

interfering with ADL)

Hearing loss requiring

hearing aid or

intervention (i.e.,

interfering with ADL)

Profound bilateral hearing

loss (>90 dB)

—

REMARK: Pediatric recommendations are identical to those for adults, unless specified. For children and adolescents (≤18 years of age) without a baseline test, pre-exposure/pre-

treatment hearing should be considered to be <5 dB loss.

Otitis, external ear

(non-infectious)

Otitis, external External otitis with

erythema or dry

desquamation

External otitis with moist

desquamation, edema,

enhanced cerumen or

discharge; tympanic

membrane perforation;

tympanostomy

External otitis with

mastoiditis; stenosis or

osteomyelitis

Necrosis of soft tissue or

bone

Death

ALSO CONSIDER: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program

; Hearing: patients without baseline audiogram and not enrolled in a

monitoring program

Otitis, middle ear

(non-infectious)

Otitis, middle Serous otitis Serous otitis, medical

intervention indicated

Otitis with discharge;

mastoiditis

Necrosis of the canal soft

tissue or bone

Death

AUDITORY/EAR Page 2 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 3 - March 31, 2003, Publish Date: August 9, 2006

Tinnitus Tinnitus — Tinnitus not interfering

with ADL

Tinnitus interfering with

ADL

Disabling —

ALSO CONSIDER: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program

; Hearing: patients without baseline audiogram and not enrolled in a

monitoring program

Auditory/Ear – Other

(Specify, __)

Auditory/Ear – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

Drug-induced ototoxicity should be distinguished from age-related threshold decrements or unrelated cochlear insult. When considering whether an adverse event has occurred, it is

first necessary to classify the patient into one of two groups. (1) The patient is under standard treatment/enrolled in a clinical trial <2.5 years, and has a 15 dB or greater threshold

shift averaged across two contiguous frequencies; or (2) The patient is under standard treatment/enrolled in a clinical trial >2.5 years, and the difference between the expected age-

related and the observed threshold shifts is 15 dB or greater averaged across two contiguous frequencies. Consult standard references for appropriate age- and gender-specific

hearing norms, e.g., Morrell, et al. Age- and gender-specific reference ranges for hearing level and longitudinal changes in hearing level. Journal of the Acoustical Society of America

100:1949-1967, 1996; or Shotland, et al. Recommendations for cancer prevention trials using potentially ototoxic test agents. Journal of Clinical Oncology 19:1658-1663, 2001.

In the absence of a baseline prior to initial treatment, subsequent audiograms should be referenced to an appropriate database of normals. ANSI. (1996)

American National Standard: Determination of occupational noise exposure and estimation of noise-induced hearing impairment, ANSI S 3.44-1996. (Standard S 3.44). New York:

American National Standards Institute. The recommended ANSI S3.44 database is Annex B.

BLOOD/BONE MARROW Page 1 of 1

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 4 - March 31, 2003, Publish Date: August 9, 2006

Bone marrow cellularity Bone marrow cellularity Mildly hypocellular or

≤25% reduction from

normal cellularity for age

Moderately hypocellular

or >25 – ≤50% reduction

from normal cellularity for

age

Severely hypocellular or

>50 – ≤75% reduction

cellularity from normal for

age

— Death

CD4 count CD4 count <LLN – 500/mm

<LLN – 0.5 x 10

<500 – 200/mm

<0.5 – 0.2 x 10

<200 – 50/mm

<0.2 x 0.05 – 10

<50/mm

<0.05 x

Death

Haptoglobin Haptoglobin <LLN — Absent — Death

Hemoglobin Hemoglobin <LLN – 10.0 g/dL

<LLN – 6.2 mmol/L

<LLN – 100 g/L

<10.0 – 8.0 g/dL

<6.2 – 4.9 mmol/L

<100 – 80g/L

<8.0 – 6.5 g/dL

<4.9 – 4.0 mmol/L

<80 – 65 g/L

<6.5 g/dL

<4.0 mmol/L

<65 g/L

Death

Hemolysis (e.g., immune

hemolytic anemia, drug-

related hemolysis)

Hemolysis Laboratory evidence of

hemolysis only (e.g.,

direct antiglobulin test

[DAT, Coombs’]

schistocytes)

Evidence of red cell

destruction and ≥2 gm

decrease in hemoglobin,

no transfusion

Transfusion or medical

intervention (e.g.,

steroids) indicated

Catastrophic

consequences of

hemolysis (e.g., renal

failure, hypotension,

bronchospasm,

emergency splenectomy)

Death

ALSO CONSIDER: Haptoglobin; Hemoglobin.

Iron overload Iron overload — Asymptomatic iron

overload, intervention not

indicated

Iron overload,

intervention indicated

Organ impairment (e.g.,

endocrinopathy,

cardiopathy)

Death

Leukocytes (total WBC) Leukocytes <LLN – 3000/mm

<LLN – 3.0 x 10

<3000

–

2000/mm

<3.0 – 2.0 x 10

<2000

– 1000/mm

<2.0 – 1.0 x 10

<1000/mm

<1.0 x 10

Death

Lymphopenia Lymphopenia <LLN – 800/mm

<LLN x 0.8 – 10

<800

– 500/mm

<0.8 – 0.5 x 10

<500 – 200 mm

<0.5 – 0.2 x 10

<200/mm

<0.2 x 10

Death

Myelodysplasia Myelodysplasia — — Abnormal marrow

cytogenetics (marrow

blasts ≤5%)

RAEB or RAEB-T

(marrow blasts >5%)

Death

Neutrophils/granulocytes

(ANC/AGC)

Neutrophils <LLN – 1500/mm

<LLN – 1.5 x 10

<1500

– 1000/mm

<1.5 – 1.0 x 10

<1000 – 500/mm

<1.0 – 0.5 x 10

<500/mm

<0.5 x 10

Death

Platelets Platelets <LLN – 75,000/mm

<LLN – 75.0 x 10

<75,000 – 50,000/mm

<75.0 – 50.0 x 10

<50,000 – 25,000/mm

<50.0 – 25.0 x 10

<25,000/mm

<25.0 x 10

Death

Splenic function Splenic function Incidental findings (e.g.,

Howell-Jolly bodies)

Prophylactic antibiotics

indicated

— Life-threatening

consequences

Death

Blood/Bone Marrow –

Other (Specify, __)

Blood – Other (Specify) Mild Moderate Severe Life-threatening; disabling Death

CARDIAC ARRHYTHMIA Page 1 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 5 - March 31, 2003, Publish Date: August 9, 2006

Conduction abnormality/

atrioventricular heart

block

– Select:

Conduction abnormality

– Select

Asymptomatic,

intervention not indicated

– Asystole

– AV Block-First degree

– AV Block-Second degree Mobitz Type I (Wenckebach)

– AV Block-Second degree Mobitz Type II

– AV Block-Third degree (Complete AV block)

– Conduction abnormality NOS

– Sick Sinus Syndrome

– Stokes-Adams Syndrome

– Wolff-Parkinson-White Syndrome

Non-urgent medical

intervention indicated

Incompletely controlled

medically or controlled

with device (e.g.,

pacemaker)

Life-threatening (e.g.,

arrhythmia associated

with CHF, hypotension,

syncope, shock)

Death

Palpitations Palpitations Present Present with associated

symptoms (e.g.,

lightheadedness,

shortness of breath)

— — —

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

Prolonged QTc interval Prolonged QTc QTc >0.45 – 0.47 second QTc >0.47 – 0.50

second; ≥0.06 second

above baseline

QTc >0.50 second QTc >0.50 second; life-

threatening signs or

symptoms (e.g.,

arrhythmia, CHF,

hypotension, shock

syncope); Torsade de

pointes

Death

Supraventricular and

nodal arrhythmia

– Select:

Supraventricular

arrhythmia – Select

Asymptomatic,

intervention not indicated

Non-urgent medical

intervention indicated

– Atrial fibrillation

– Atrial flutter

– Atrial tachycardia/Paroxysmal Atrial Tachycardia

– Nodal/Junctional

– Sinus arrhythmia

– Sinus bradycardia

– Sinus tachycardia

– Supraventricular arrhythmia NOS

– Supraventricular extrasystoles (Premature Atrial Contractions; Premature Nodal/Junctional Contractions)

– Supraventricular tachycardia

Symptomatic and

incompletely controlled

medically, or controlled

with device (e.g.,

pacemaker)

Life-threatening (e.g.,

arrhythmia associated

with CHF, hypotension,

syncope, shock)

Death

NAVIGATION NOTE: Syncope is graded as Syncope (fainting) in the NEUROLOGY CATEGORY.

CARDIAC ARRHYTHMIA Page 2 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 6 - March 31, 2003, Publish Date: August 9, 2006

Vasovagal episode Vasovagal episode — Present without loss of

consciousness

Present with loss of

consciousness

Life-threatening

consequences

Death

Ventricular arrhythmia

– Select:

Ventricular arrhythmia

– Select

– Bigeminy

– Idioventricular rhythm

– PVCs

– Torsade de pointes

– Trigeminy

– Ventricular arrhythmia NOS

– Ventricular fibrillation

– Ventricular flutter

– Ventricular tachycardia

Asymptomatic, no

intervention indicated

Non-urgent medical

intervention indicated

Symptomatic and

incompletely controlled

medically or controlled

with device (e.g.,

defibrillator)

Life-threatening (e.g.,

arrhythmia associated

with CHF, hypotension,

syncope, shock)

Death

Cardiac Arrhythmia

– Other (Specify, __)

Cardiac Arrhythmia –

Other (Specify)

Mild Moderate Severe Life-threatening;

disabling

Death

CARDIAC GENERAL Page 1 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 7 - March 31, 2003, Publish Date: August 9, 2006

NAVIGATION NOTE: Angina is graded as Cardiac ischemia/infarction in the CARDIAC GENERAL CATEGORY.

Cardiac

ischemia/infarction

Cardiac

ischemia/infarction

Asymptomatic arterial

narrowing without

ischemia

Asymptomatic and testing

suggesting ischemia;

stable angina

Symptomatic and testing

consistent with ischemia;

unstable angina;

intervention indicated

Acute myocardial

infarction

Death

Cardiac troponin I (cTnI) cTnI — — Levels consistent with

unstable angina as

defined by the

manufacturer

Levels consistent with

myocardial infarction as

defined by the

manufacturer

Death

Cardiac troponin T (cTnT) cTnT 0.03 – <0.05 ng/mL 0.05 – <0.1 ng/mL 0.1 – <0.2 ng/mL 0.2 ng/mL Death

Cardiopulmonary arrest,

cause unknown

(non-fatal)

Cardiopulmonary arrest — — — Life-threatening —

REMARK: Grade 4 (non-fatal) is the only appropriate grade. CTCAE provides three alternatives for reporting Death:

1. A CTCAE term associated with Grade 5.

2. A CTCAE 'Other (Specify, __)’ within any CATEGORY.

3. Death not associated with CTCAE term – Select in the DEATH CATEGORY.

NAVIGATION NOTE: Chest pain (non-cardiac and non-pleuritic) is graded as Pain – Select in the PAIN CATEGORY.

NAVIGATION NOTE: CNS ischemia is graded as CNS cerebrovascular ischemia in the NEUROLOGY CATEGORY.

Hypertension Hypertension Asymptomatic, transient

(<24 hrs) increase by >20

mmHg (diastolic) or to

>150/100 if previously

WNL; intervention not

indicated

Pediatric:

Asymptomatic, transient

(<24 hrs) BP increase

>ULN; intervention not

indicated

Recurrent or persistent

(≥24 hrs) or symptomatic

increase by >20 mmHg

(diastolic) or to >150/100

if previously WNL;

monotherapy may be

indicated

Pediatric:

Recurrent or persistent

(≥24 hrs) BP >ULN;

monotherapy may be

indicated

Requiring more than one

drug or more intensive

therapy than previously

Pediatric:

Same as adult

Life-threatening

consequences (e.g.,

hypertensive crisis)

Pediatric:

Same as adult

Death

REMARK: Use age and gender-appropriate normal values >95

percentile ULN for pediatric patients.

CARDIAC GENERAL Page 2 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 8 - March 31, 2003, Publish Date: August 9, 2006

Hypotension Hypotension Changes, intervention not

indicated

Brief (<24 hrs) fluid

replacement or other

therapy; no physiologic

consequences

Sustained (≥24 hrs)

therapy, resolves without

persisting physiologic

consequences

Shock (e.g., acidemia;

impairment of vital organ

function)

Death

ALSO CONSIDER: Syncope (fainting).

Left ventricular diastolic

dysfunction

Left ventricular diastolic

dysfunction

Asymptomatic diagnostic

finding; intervention not

indicated

Asymptomatic,

intervention indicated

Symptomatic CHF

responsive to intervention

Refractory CHF, poorly

controlled; intervention

such as ventricular assist

device or heart transplant

indicated

Death

Left ventricular systolic

dysfunction

Left ventricular systolic

dysfunction

Asymptomatic, resting

ejection fraction (EF)

<60 – 50%; shortening

fraction (SF) <30 – 24%

Asymptomatic, resting

EF <50 – 40%;

SF <24 – 15%

Symptomatic CHF

responsive to

intervention;

EF <40 – 20%

SF <15%

Refractory CHF or poorly

controlled; EF <20%;

intervention such as

ventricular assist device,

ventricular reduction

surgery, or heart

transplant indicated

Death

NAVIGATION NOTE: Myocardial infarction is graded as Cardiac ischemia/infarction in the CARDIAC GENERAL CATEGORY.

Myocarditis Myocarditis — — CHF responsive to

intervention

Severe or refractory CHF Death

Pericardial effusion

(non-malignant)

Pericardial effusion Asymptomatic effusion — Effusion with physiologic

consequences

Life-threatening

consequences (e.g.,

tamponade); emergency

intervention indicated

Death

Pericarditis Pericarditis Asymptomatic, ECG or

physical exam (rub)

changes consistent with

pericarditis

Symptomatic pericarditis

(e.g., chest pain)

Pericarditis with

physiologic

consequences (e.g.,

pericardial constriction)

Life-threatening

consequences;

emergency intervention

indicated

Death

NAVIGATION NOTE: Pleuritic pain is graded as Pain – Select in the PAIN CATEGORY.

Pulmonary hypertension Pulmonary hypertension Asymptomatic without

therapy

Asymptomatic, therapy

indicated

Symptomatic

hypertension, responsive

to therapy

Symptomatic

hypertension, poorly

controlled

Death

Restrictive

cardiomyopathy

Restrictive

cardiomyopathy

Asymptomatic, therapy

not indicated

Asymptomatic, therapy

indicated

Symptomatic CHF

responsive to intervention

Refractory CHF, poorly

controlled; intervention

such as ventricular assist

device, or heart

transplant indicated

Death

CARDIAC GENERAL Page 3 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 9 - March 31, 2003, Publish Date: August 9, 2006

Right ventricular

dysfunction

(cor pulmonale)

Right ventricular

dysfunction

Asymptomatic without

therapy

Asymptomatic, therapy

indicated

Symptomatic cor

pulmonale, responsive to

intervention

Symptomatic cor

pulmonale poorly

controlled; intervention

such as ventricular assist

device, or heart

transplant indicated

Death

Valvular heart disease Valvular heart disease Asymptomatic valvular

thickening with or without

mild valvular regurgitation

or stenosis; treatment

other than endocarditis

prophylaxis not indicated

Asymptomatic; moderate

regurgitation or stenosis

by imaging

Symptomatic; severe

regurgitation or stenosis;

symptoms controlled with

medical therapy

Life-threatening;

disabling; intervention

(e.g., valve replacement,

valvuloplasty) indicated

Death

Cardiac General – Other

(Specify, __)

Cardiac General – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

COAGULATION Page 1 of 1

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 10 - March 31, 2003, Publish Date: August 9, 2006

DIC (disseminated

intravascular coagulation)

DIC — Laboratory findings with

bleeding

Laboratory findings and

bleeding

Laboratory findings, life-

threatening or disabling

consequences (e.g., CNS

hemorrhage, organ

damage, or

hemodynamically

significant blood loss)

Death

REMARK: DIC (disseminated intravascular coagulation) must have increased fibrin split products or D-dimer.

LSO CONSIDER: Platelets.

Fibrinogen Fibrinogen <1.0 – 0.75 x LLN

or <25% decrease from

baseline

<0.75 – 0.5 x LLN

or 25 – <50% decrease

from baseline

<0.5 – 0.25 x LLN

or 50 – <75% decrease

from baseline

<0.25 x LLN

or 75% decrease from

baseline or absolute

value <50 mg/dL

Death

REMARK: Use % decrease only when baseline is <LLN (local laboratory value).

INR (International

Normalized Ratio of

prothrombin time)

INR

>1 – 1.5 x ULN >1.5 – 2 x ULN >2 x ULN — —

ALSO CONSIDER: Hemorrhage, CNS; Hemorrhage, GI – Select; Hemorrhage, GU – Select; Hemorrhage, pulmonary/upper respiratory – Select.

PTT (Partial

Thromboplastin Time)

PTT >1 – 1.5 x ULN >1.5 – 2 x ULN >2 x ULN — —

ALSO CONSIDER: Hemorrhage, CNS; Hemorrhage, GI – Select; Hemorrhage, GU – Select; Hemorrhage, pulmonary/upper respiratory – Select.

Thrombotic

microangiopathy (e.g.,

thrombotic

thrombocytopenic

purpura [TTP] or

hemolytic uremic

syndrome [HUS])

Thrombotic

microangiopathy

Evidence of RBC

destruction

(schistocytosis) without

clinical consequences

— Laboratory findings

present with clinical

consequences (e.g., renal

insufficiency, petechiae)

Laboratory findings and

life-threatening or

disabling consequences,

(e.g., CNS hemorrhage/

bleeding or thrombosis/

embolism or renal failure)

Death

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

ALSO CONSIDER: Creatinine; Hemoglobin; Platelets.

Coagulation – Other

(Specify, __)

Coagulation – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

CONSTITUTIONAL SYMPTOMS Page 1 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 11 - March 31, 2003, Publish Date: August 9, 2006

Fatigue

(asthenia, lethargy,

malaise)

Fatigue Mild fatigue over baseline Moderate or causing

difficulty performing some

ADL

Severe fatigue interfering

with ADL

Disabling —

Fever

(in the absence of

neutropenia, where

neutropenia is defined as

ANC <1.0 x 10

/L)

Fever 38.0 – 39.0°C

(100.4 – 102.2°F)

>39.0 – 40.0°C

(102.3 – 104.0°F)

>40.0°C

(>104.0°F) for ≤24 hrs

>40.0°C

(>104.0°F) for >24 hrs

Death

REMARK: The temperature measurements listed are oral or tympanic.

ALSO CONSIDER: Allergic reaction/hypersensitivity (including drug fever).

NAVIGATION NOTE: Hot flashes are graded as Hot flashes/flushes in the ENDOCRINE CATEGORY.

Hypothermia Hypothermia — 35 – >32°C

95 – >89.6°F

32 – >28°C

89.6 – >82.4° F

≤28 °C

82.4°F or life-threatening

consequences (e.g.,

coma, hypotension,

pulmonary edema,

acidemia, ventricular

fibrillation)

Death

Insomnia Insomnia Occasional difficulty

sleeping, not interfering

with function

Difficulty sleeping,

interfering with function

but not interfering with

ADL

Frequent difficulty

sleeping, interfering with

ADL

Disabling —

REMARK: If pain or other symptoms interfere with sleep, do NOT grade as insomnia. Grade primary event(s) causing insomnia.

Obesity

Obesity — BMI 25 – 29.9 kg/m

BMI 30 – 39.99 kg/m

BMI ≥40 kg/m

—

REMARK: BMI = (weight [kg]) / (height [m])

Odor

(patient odor)

Patient odor Mild odor Pronounced odor — — —

Rigors/chills Rigors/chills Mild Moderate, narcotics

indicated

Severe or prolonged, not

responsive to narcotics

— —

NHLBI Obesity Task Force. "Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults," The Evidence Report, Obes Res 6:51S-

209S, 1998.

CONSTITUTIONAL SYMPTOMS Page 2 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 12 - March 31, 2003, Publish Date: August 9, 2006

Sweating

(diaphoresis)

Sweating Mild and occasional Frequent or drenching — — —

ALSO CONSIDER: Hot flashes/flushes.

Weight gain Weight gain 5 – <10% of baseline 10 – <20% of baseline

≥20% of baseline

— —

REMARK: Edema, depending on etiology, is graded in the CARDIAC GENERAL or LYMPHATICS CATEGORIES.

LSO CONSIDER: Ascites (non-malignant); Pleural effusion (non-malignant).

Weight loss Weight loss 5 to <10% from baseline;

intervention not indicated

10 – <20% from baseline;

nutritional support

indicated

≥20% from baseline; tube

feeding or TPN indicated

— —

Constitutional Symptoms

– Other (Specify, __)

Constitutional Symptoms

– Other (Specify)

Mild Moderate Severe Life-threatening; disabling Death

DEATH Page 1 of 1

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 13 - March 31, 2003, Publish Date: August 9, 2006

Death not associated with

CTCAE term

– Select:

Death not associated with

CTCAE term – Select

– Death NOS

– Disease progression NOS

– Multi-organ failure

– Sudden death

— — — — Death

REMARK: Grade 5 is the only appropriate grade. 'Death not associated with CTCAE term – Select' is to be used where a death:

1. Cannot be attributed to a CTCAE term associated with Grade 5.

2. Cannot be reported within any CATEGORY using a CTCAE 'Other (Specify, __)’.

DERMATOLOGY/SKIN Page 1 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 14 - March 31, 2003, Publish Date: August 9, 2006

Atrophy, skin Atrophy, skin Detectable Marked — — —

Atrophy, subcutaneous

fat

Atrophy, subcutaneous

fat

Detectable Marked — — —

ALSO CONSIDER: Induration/fibrosis (skin and subcutaneous tissue).

Bruising

(in absence of Grade 3 or

4 thrombocytopenia)

Bruising Localized or in a

dependent area

Generalized — — —

Burn Burn Minimal symptoms;

intervention not indicated

Medical intervention;

minimal debridement

indicated

Moderate to major

debridement or

reconstruction indicated

Life-threatening

consequences

Death

REMARK: Burn refers to all burns including radiation, chemical, etc.

Cheilitis Cheilitis Asymptomatic Symptomatic, not

interfering with ADL

Symptomatic, interfering

with ADL

— —

Dry skin Dry skin Asymptomatic Symptomatic, not

interfering with ADL

Interfering with ADL — —

Flushing Flushing Asymptomatic Symptomatic — — —

Hair loss/alopecia

(scalp or body)

Alopecia Thinning or patchy Complete — — —

Hyperpigmentation Hyperpigmentation Slight or localized Marked or generalized — — —

Hypopigmentation Hypopigmentation Slight or localized Marked or generalized — — —

Induration/fibrosis

(skin and subcutaneous

tissue)

Induration Increased density on

palpation

Moderate impairment of

function not interfering

with ADL; marked

increase in density and

firmness on palpation

with or without minimal

retraction

Dysfunction interfering

with ADL; very marked

density, retraction or

fixation

— —

ALSO CONSIDER: Fibrosis-cosmesis; Fibrosis-deep connective tissue.

Injection site reaction/

extravasation changes

Injection site reaction Pain; itching; erythema Pain or swelling, with

inflammation or phlebitis

Ulceration or necrosis

that is severe; operative

intervention indicated

— —

ALSO CONSIDER: Allergic reaction/hypersensitivity (including drug fever); Ulceration.

DERMATOLOGY/SKIN Page 2 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 15 - March 31, 2003, Publish Date: August 9, 2006

Nail changes Nail changes Discoloration; ridging

(koilonychias); pitting

Partial or complete loss of

nail(s); pain in nailbed(s)

Interfering with ADL — —

NAVIGATION NOTE: Petechiae is graded as Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) in the HEMORRHAGE/BLEEDING CATEGORY.

Photosensitivity Photosensitivity Painless erythema Painful erythema Erythema with

desquamation

Life-threatening; disabling Death

Pruritus/itching Pruritus Mild or localized Intense or widespread Intense or widespread

and interfering with ADL

— —

ALSO CONSIDER: Rash/desquamation.

Rash/desquamation Rash Macular or papular

eruption or erythema

without associated

symptoms

Macular or papular

eruption or erythema with

pruritus or other

associated symptoms;

localized desquamation

or other lesions covering

<50% of body surface

area (BSA)

Severe, generalized

erythroderma or macular,

papular or vesicular

eruption; desquamation

covering ≥50% BSA

Generalized exfoliative,

ulcerative, or bullous

dermatitis

Death

REMARK: Rash/desquamation may be used for GVHD.

Rash:

acne/acneiform

Acne Intervention not indicated Intervention indicated Associated with pain,

disfigurement, ulceration,

or desquamation

— Death

Rash:

dermatitis associated with

radiation

– Select:

– Chemoradiation

– Radiation

Dermatitis – Select Faint erythema or dry

desquamation

Moderate to brisk

erythema; patchy moist

desquamation, mostly

confined to skin folds and

creases; moderate

edema

Moist desquamation other

than skin folds and

creases; bleeding

induced by minor trauma

or abrasion

Skin necrosis or

ulceration of full thickness

dermis; spontaneous

bleeding from involved

site

Death

Rash:

erythema multiforme

(e.g., Stevens-Johnson

syndrome, toxic

epidermal necrolysis)

Erythema multiforme — Scattered, but not

generalized eruption

Severe (e.g., generalized

rash or painful stomatitis);

IV fluids, tube feedings,

or TPN indicated

Life-threatening; disabling Death

Rash:

hand-foot skin reaction

Hand-foot Minimal skin changes or

dermatitis (e.g.,

erythema) without pain

Skin changes (e.g.,

peeling, blisters,

bleeding, edema) or pain,

not interfering with

function

Ulcerative dermatitis or

skin changes with pain

interfering with function

— —

DERMATOLOGY/SKIN Page 3 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 16 - March 31, 2003, Publish Date: August 9, 2006

Skin breakdown/

decubitus ulcer

Decubitus — Local wound care;

medical intervention

indicated

Operative debridement or

other invasive

intervention indicated

(e.g., hyperbaric oxygen)

Life-threatening

consequences; major

invasive intervention

indicated (e.g., tissue

reconstruction, flap, or

grafting)

Death

REMARK: Skin breakdown/decubitus ulcer is to be used for loss of skin integrity or decubitus ulcer from pressure or as the result of operative or medical intervention.

Striae Striae Mild Cosmetically significant — — —

Telangiectasia Telangiectasia Few Moderate number Many and confluent — —

Ulceration Ulceration — Superficial ulceration

<2 cm size; local wound

care; medical intervention

indicated

Ulceration ≥2 cm size;

operative debridement,

primary closure or other

invasive intervention

indicated (e.g., hyperbaric

oxygen)

Life-threatening

consequences; major

invasive intervention

indicated (e.g., complete

resection, tissue

reconstruction, flap, or

grafting)

Death

Urticaria

(hives, welts, wheals)

Urticaria Intervention not indicated Intervention indicated for

<24 hrs

Intervention indicated for

≥24 hrs

— —

ALSO CONSIDER: Allergic reaction/hypersensitivity (including drug fever).

Wound complication,

non-infectious

Wound complication,

non-infectious

Incisional separation of

≤25% of wound, no

deeper than superficial

fascia

Incisional separation

>25% of wound with local

care; asymptomatic

hernia

Symptomatic hernia

without evidence of

strangulation; fascial

disruption/dehiscence

without evisceration;

primary wound closure or

revision by operative

intervention indicated;

hospitalization or

hyperbaric oxygen

indicated

Symptomatic hernia with

evidence of strangulation;

fascial disruption with

evisceration; major

reconstruction flap,

grafting, resection, or

amputation indicated

Death

REMARK: Wound complication, non-infectious is to be used for separation of incision, hernia, dehiscence, evisceration, or second surgery for wound revision.

Dermatology/Skin – Other

(Specify, __)

Dermatology – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

ENDOCRINE Page 1 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 17 - March 31, 2003, Publish Date: August 9, 2006

Adrenal insufficiency Adrenal insufficiency Asymptomatic,

intervention not indicated

Symptomatic, intervention

indicated

Hospitalization Life-threatening; disabling Death

REMARK: Adrenal insufficiency includes any of the following signs and symptoms: abdominal pain, anorexia, constipation, diarrhea, hypotension, pigmentation of mucous membranes,

pigmentation of skin, salt craving, syncope (fainting), vitiligo, vomiting, weakness, weight loss. Adrenal insufficiency must be confirmed by laboratory studies (low cortisol frequently

accompanied by low aldosterone).

LSO CONSIDER: Potassium, serum-high (hyperkalemia); Thyroid function, low (hypothyroidism).

Cushingoid appearance

(e.g., moon face, buffalo

hump, centripetal obesity,

cutaneous striae)

Cushingoid — Present — — —

ALSO CONSIDER: Glucose, serum-high (hyperglycemia); Potassium, serum-low (hypokalemia).

Feminization of male Feminization of male — — Present — —

NAVIGATION NOTE: Gynecomastia is graded in the SEXUAL/REPRODUCTIVE FUNCTION CATEGORY.

Hot flashes/flushes

Hot flashes Mild Moderate Interfering with ADL — —

Masculinization of female Masculinization of female — — Present — —

Neuroendocrine:

ACTH deficiency

ACTH Asymptomatic Symptomatic, not

interfering with ADL;

intervention indicated

Symptoms interfering with

ADL; hospitalization

indicated

Life-threatening

consequences (e.g.,

severe hypotension)

Death

Neuroendocrine:

ADH secretion

abnormality (e.g., SIADH

or low ADH)

ADH Asymptomatic Symptomatic, not

interfering with ADL;

intervention indicated

Symptoms interfering with

ADL

Life-threatening

consequences

Death

Neuroendocrine:

gonadotropin secretion

abnormality

Gonadotropin Asymptomatic Symptomatic, not

interfering with ADL;

intervention indicated

Symptoms interfering with

ADL; osteopenia;

fracture; infertility

— —

Neuroendocrine:

growth hormone

secretion abnormality

Growth hormone Asymptomatic Symptomatic, not

interfering with ADL;

intervention indicated

— — —

Neuroendocrine:

prolactin hormone

secretion abnormality

Prolactin Asymptomatic Symptomatic, not

interfering with ADL;

intervention indicated

Symptoms interfering with

ADL; amenorrhea;

galactorrhea

— Death

Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl HJ, "Methodologic Lessons Learned from Hot Flash Studies," J Clin Oncol 2001 Dec 1;19(23):4280-90

ENDOCRINE Page 2 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 18 - March 31, 2003, Publish Date: August 9, 2006

Pancreatic endocrine:

glucose intolerance

Diabetes Asymptomatic,

intervention not indicated

Symptomatic; dietary

modification or oral agent

indicated

Symptoms interfering with

ADL; insulin indicated

Life-threatening

consequences (e.g.,

ketoacidosis,

hyperosmolar non-ketotic

coma)

Death

Parathyroid function, low

(hypoparathyroidism)

Hypoparathyroidism Asymptomatic,

intervention not indicated

Symptomatic; intervention

indicated

— — —

Thyroid function, high

(hyperthyroidism,

thyrotoxicosis)

Hyperthyroidism Asymptomatic,

intervention not indicated

Symptomatic, not

interfering with ADL;

thyroid suppression

therapy indicated

Symptoms interfering with

ADL; hospitalization

indicated

Life-threatening

consequences (e.g.,

thyroid storm)

Death

Thyroid function, low

(hypothyroidism)

Hypothyroidism Asymptomatic,

intervention not indicated

Symptomatic, not

interfering with ADL;

thyroid replacement

indicated

Symptoms interfering with

ADL; hospitalization

indicated

Life-threatening

myxedema coma

Death

Endocrine – Other

(Specify, __)

Endocrine – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

GASTROINTESTINAL Page 1 of 10

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 19 - March 31, 2003, Publish Date: August 9, 2006

NAVIGATION NOTE: Abdominal pain or cramping is graded as Pain – Select in the PAIN CATEGORY.

Anorexia Anorexia Loss of appetite without

alteration in eating habits

Oral intake altered

without significant weight

loss or malnutrition; oral

nutritional supplements

indicated

Associated with

significant weight loss or

malnutrition (e.g.,

inadequate oral caloric

and/or fluid intake); IV

fluids, tube feedings or

TPN indicated

Life-threatening

consequences

Death

ALSO CONSIDER: Weight loss.

Ascites (non-malignant) Ascites Asymptomatic Symptomatic, medical

intervention indicated

Symptomatic, invasive

procedure indicated

Life-threatening

consequences

Death

REMARK: Ascites (non-malignant) refers to documented non-malignant ascites or unknown etiology, but unlikely malignant, and includes chylous ascites.

Colitis Colitis Asymptomatic, pathologic

or radiographic findings

only

Abdominal pain; mucus

or blood in stool

Abdominal pain, fever,

change in bowel habits

with ileus; peritoneal

signs

Life-threatening

consequences (e.g.,

perforation, bleeding,

ischemia, necrosis, toxic

megacolon)

Death

ALSO CONSIDER: Hemorrhage, GI – Select.

Constipation Constipation Occasional or intermittent

symptoms; occasional

use of stool softeners,

laxatives, dietary

modification, or enema

Persistent symptoms with

regular use of laxatives

or enemas indicated

Symptoms interfering

with ADL; obstipation

with manual evacuation

indicated

Life-threatening

consequences (e.g.,

obstruction, toxic

megacolon)

Death

ALSO CONSIDER: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation); Obstruction, GI – Select.

Dehydration Dehydration Increased oral fluids

indicated; dry mucous

membranes; diminished

skin turgor

IV fluids indicated <24

hrs

IV fluids indicated ≥24 hrs

Life-threatening

consequences (e.g.,

hemodynamic collapse)

Death

ALSO CONSIDER: Diarrhea; Hypotension; Vomiting.

Dental:

dentures or prosthesis

Dentures Minimal discomfort, no

restriction in activities

Discomfort preventing

use in some activities

(e.g., eating), but not

others (e.g., speaking)

Unable to use dentures

or prosthesis at any time

— —

GASTROINTESTINAL Page 2 of 10

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 20 - March 31, 2003, Publish Date: August 9, 2006

Dental:

periodontal disease

Periodontal Gingival recession or

gingivitis; limited bleeding

on probing; mild local

bone loss

Moderate gingival

recession or gingivitis;

multiple sites of bleeding

on probing; moderate

bone loss

Spontaneous bleeding;

severe bone loss with or

without tooth loss;

osteonecrosis of maxilla

or mandible

— —

REMARK: Severe periodontal disease leading to osteonecrosis is graded as Osteonecrosis (avascular necrosis) in the MUSCULOSKELETAL CATEGORY.

Dental:

teeth

Teeth Surface stains; dental

caries; restorable, without

extractions

Less than full mouth

extractions; tooth fracture

or crown amputation or

repair indicated

Full mouth extractions

indicated

— —

Dental:

teeth development

Teeth development Hypoplasia of tooth or

enamel not interfering

with function

Functional impairment

correctable with oral

surgery

Maldevelopment with

functional impairment not

surgically correctable

— —

Diarrhea Diarrhea Increase of <4 stools per

day over baseline; mild

increase in ostomy output

compared to baseline

Increase of 4 – 6 stools

per day over baseline; IV

fluids indicated <24hrs;

moderate increase in

ostomy output compared

to baseline; not

interfering with ADL

Increase of ≥7 stools per

day over baseline;

incontinence; IV fluids

≥24 hrs; hospitalization;

severe increase in

ostomy output compared

to baseline; interfering

with ADL

Life-threatening

consequences (e.g.,

hemodynamic collapse)

Death

REMARK: Diarrhea includes diarrhea of small bowel or colonic origin, and/or ostomy diarrhea.

ALSO CONSIDER: Dehydration; Hypotension.

Distension/bloating,

abdominal

Distension Asymptomatic Symptomatic, but not

interfering with GI

function

Symptomatic, interfering

with GI function

— —

ALSO CONSIDER: Ascites (non-malignant); Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation); Obstruction, GI – Select.

GASTROINTESTINAL Page 3 of 10

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 21 - March 31, 2003, Publish Date: August 9, 2006

Dry mouth/salivary gland

(xerostomia)

Dry mouth Symptomatic (dry or thick

saliva) without significant

dietary alteration;

unstimulated saliva flow

>0.2 ml/min

Symptomatic and

significant oral intake

alteration (e.g., copious

water, other lubricants,

diet limited to purees

and/or soft, moist foods);

unstimulated saliva

0.1 to 0.2 ml/min

Symptoms leading to

inability to adequately

aliment orally; IV fluids,

tube feedings, or TPN

indicated; unstimulated

saliva <0.1 ml/min

— —

REMARK: Dry mouth/salivary gland (xerostomia) includes descriptions of grade using both subjective and objective assessment parameters. Record this event consistently throughout

a patient’s participation on study. If salivary flow measurements are used for initial assessment, subsequent assessments must use salivary flow.

LSO CONSIDER: Salivary gland changes/saliva.

Dysphagia

(difficulty swallowing)

Dysphagia Symptomatic, able to eat

regular diet

Symptomatic and altered

eating/swallowing (e.g.,

altered dietary habits,

oral supplements); IV

fluids indicated <24 hrs

Symptomatic and

severely altered

eating/swallowing (e.g.,

inadequate oral caloric or

fluid intake); IV fluids,

tube feedings, or TPN

indicated ≥24 hrs

Life-threatening

consequences (e.g.,

obstruction, perforation)

Death

REMARK: Dysphagia (difficulty swallowing) is to be used for swallowing difficulty from oral, pharyngeal, esophageal, or neurologic origin. Dysphagia requiring dilation is graded as

Stricture/stenosis (including anastomotic), GI – Select.

LSO CONSIDER: Dehydration; Esophagitis.

Enteritis

(inflammation of the small

bowel)

Enteritis Asymptomatic, pathologic

or radiographic findings

only

Abdominal pain; mucus

or blood in stool

Abdominal pain, fever,

change in bowel habits

with ileus; peritoneal

signs

Life-threatening

consequences (e.g.,

perforation, bleeding,

ischemia, necrosis)

Death

ALSO CONSIDER: Hemorrhage, GI – Select; Typhlitis (cecal inflammation).

Esophagitis Esophagitis Asymptomatic pathologic,

radiographic, or

endoscopic findings only

Symptomatic; altered

eating/swallowing (e.g.,

altered dietary habits,

oral supplements); IV

fluids indicated <24 hrs

Symptomatic and

severely altered

eating/swallowing (e.g.,

inadequate oral caloric or

fluid intake); IV fluids,

tube feedings, or TPN

indicated ≥24 hrs

Life-threatening

consequences

Death

REMARK: Esophagitis includes reflux esophagitis.

LSO CONSIDER: Dysphagia (difficulty swallowing).

GASTROINTESTINAL Page 4 of 10

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 22 - March 31, 2003, Publish Date: August 9, 2006

Fistula, GI

– Select:

Fistula, GI – Select

– Abdomen NOS

– Anus

– Biliary tree

– Colon/cecum/appendix

– Duodenum

– Esophagus

– Gallbladder

– Ileum

– Jejunum

– Oral cavity

– Pancreas

– Pharynx

– Rectum

– Salivary gland

– Small bowel NOS

– Stomach

Asymptomatic,

radiographic findings only

Symptomatic; altered GI

function (e.g., altered

dietary habits, diarrhea,

or GI fluid loss); IV fluids

indicated <24 hrs

Symptomatic and

severely altered GI

function (e.g., altered

dietary habits, diarrhea,

or GI fluid loss); IV fluids,

tube feedings, or TPN

indicated ≥24 hrs

Life-threatening

consequences

Death

REMARK: A fistula is defined as an abnormal communication between two body cavities, potential spaces, and/or the skin. The site indicated for a fistula should be the site from which

the abnormal process is believed to have originated. For example, a tracheo-esophageal fistula arising in the context of a resected or irradiated esophageal cancer is graded as

Fistula, GI – esophagus.

Flatulence Flatulence Mild Moderate — — —

Gastritis (including bile

reflux gastritis)

Gastritis Asymptomatic

radiographic or

endoscopic findings only

Symptomatic; altered

gastric function (e.g.,

inadequate oral caloric or

fluid intake); IV fluids

indicated <24 hrs

Symptomatic and

severely altered gastric

function (e.g., inadequate

oral caloric or fluid

intake); IV fluids, tube

feedings, or TPN

indicated ≥24 hrs

Life-threatening

consequences; operative

intervention requiring

complete organ resection

(e.g., gastrectomy)

Death

ALSO CONSIDER: Hemorrhage, GI – Select; Ulcer, GI – Select.

NAVIGATION NOTE: Head and neck soft tissue necrosis is graded as Soft tissue necrosis – Select in the MUSCULOSKELETAL/SOFT TISSUE CATEGORY.

Heartburn/dyspepsia Heartburn Mild Moderate Severe — —

Hemorrhoids Hemorrhoids Asymptomatic Symptomatic; banding or

medical intervention

indicated

Interfering with ADL;

interventional radiology,

endoscopic, or operative

intervention indicated

Life-threatening

consequences

Death

GASTROINTESTINAL Page 5 of 10

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 23 - March 31, 2003, Publish Date: August 9, 2006

Ileus, GI (functional

obstruction of bowel, i.e.,

neuroconstipation)

Ileus Asymptomatic,

radiographic findings only

Symptomatic; altered GI

function (e.g., altered

dietary habits); IV fluids

indicated <24 hrs

Symptomatic and

severely altered GI

function; IV fluids, tube

feeding, or TPN indicated

≥24 hrs

Life-threatening

consequences

Death

REMARK: Ileus, GI is to be used for altered upper or lower GI function (e.g., delayed gastric or colonic emptying).

ALSO CONSIDER: Constipation; Nausea; Obstruction, GI – Select; Vomiting.

Incontinence, anal Incontinence, anal Occasional use of pads

required

Daily use of pads

required

Interfering with ADL;

operative intervention

indicated

Permanent bowel

diversion indicated

Death

REMARK: Incontinence, anal is to be used for loss of sphincter control as sequelae of operative or therapeutic intervention.

Leak (including

anastomotic), GI

– Select:

– Biliary tree

– Esophagus

– Large bowel

– Leak NOS

– Pancreas

– Pharynx

– Rectum

– Small bowel

– Stoma

– Stomach

Leak, GI – Select Asymptomatic

radiographic findings only

Symptomatic; medical

intervention indicated

Symptomatic and

interfering with GI

function; invasive or

endoscopic intervention

indicated

Life-threatening

consequences

Death

REMARK: Leak (including anasomotic), GI – Select is to be used for clinical signs/symptoms or radiographic confirmation of anastomotic or conduit leak (e.g., biliary, esophageal,

intestinal, pancreatic, pharyngeal, rectal), but without development of fistula.

Malabsorption Malabsorption — Altered diet; oral

therapies indicated (e.g.,

enzymes, medications,

dietary supplements)

Inability to aliment

adequately via GI tract

(i.e., TPN indicated)

Life-threatening

consequences

Death

GASTROINTESTINAL Page 6 of 10

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 24 - March 31, 2003, Publish Date: August 9, 2006

Mucositis/stomatitis

(clinical exam)

– Select:

– Anus

– Esophagus

– Large bowel

– Larynx

– Oral cavity

– Pharynx

– Rectum

– Small bowel

– Stomach

– Trachea

Mucositis (clinical exam)

– Select

Erythema of the mucosa Patchy ulcerations or

pseudomembranes

Confluent ulcerations or

pseudomembranes;

bleeding with minor

trauma

Tissue necrosis;

significant spontaneous

bleeding; life-threatening

consequences

Death

REMARK: Mucositis/stomatitis (functional/symptomatic) may be used for mucositis of the upper aero-digestive tract caused by radiation, agents, or GVHD.

Mucositis/stomatitis

(functional/symptomatic)

– Select:

– Anus

– Esophagus

– Large bowel

– Larynx

– Oral cavity

– Pharynx

– Rectum

– Small bowel

– Stomach

– Trachea

Mucositis (functional/

symptomatic) – Select

Upper aerodigestive tract

sites: Minimal symptoms,

normal diet; minimal

respiratory symptoms but

not interfering with

function

Lower GI sites:

Minimal discomfort,

intervention not indicated

Upper aerodigestive tract

sites: Symptomatic but

can eat and swallow

modified diet; respiratory

symptoms interfering with

function but not

interfering with ADL

Lower GI sites:

Symptomatic, medical

intervention indicated but

not interfering with ADL

Upper aerodigestive tract

sites: Symptomatic and

unable to adequately

aliment or hydrate orally;

respiratory symptoms

interfering with ADL

Lower GI sites:

Stool incontinence or

other symptoms

interfering with ADL

Symptoms associated

with life-threatening

consequences

Death

Nausea Nausea Loss of appetite without

alteration in eating habits

Oral intake decreased

without significant weight

loss, dehydration or

malnutrition; IV fluids

indicated <24 hrs

Inadequate oral caloric or

fluid intake; IV fluids, tube

feedings, or TPN

indicated ≥24 hrs

Life-threatening

consequences

Death

ALSO CONSIDER: Anorexia; Vomiting.

GASTROINTESTINAL Page 7 of 10

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 25 - March 31, 2003, Publish Date: August 9, 2006

Necrosis, GI

– Select:

Necrosis, GI – Select

– Anus

– Colon/cecum/appendix

– Duodenum

– Esophagus

– Gallbladder

– Hepatic

– Ileum

– Jejunum

– Oral

– Pancreas

– Peritoneal cavity

– Pharynx

– Rectum

– Small bowel NOS

– Stoma

– Stomach

— — Inability to aliment

adequately by GI tract

(e.g., requiring enteral or

parenteral nutrition);

interventional radiology,

endoscopic, or operative

intervention indicated

Life-threatening

consequences; operative

intervention requiring

complete organ resection

(e.g., total colectomy)

Death

ALSO CONSIDER: Visceral arterial ischemia (non-myocardial).

Obstruction, GI

– Select:

– Cecum

– Colon

– Duodenum

– Esophagus

– Gallbladder

– Ileum

– Jejunum

– Rectum

– Small bowel NOS

– Stoma

– Stomach

Obstruction, GI – Select Asymptomatic

radiographic findings only

Symptomatic; altered GI

function (e.g., altered

dietary habits, vomiting,

diarrhea, or GI fluid loss);

IV fluids indicated <24

hrs

Symptomatic and

severely altered GI

function (e.g., altered

dietary habits, vomiting,

diarrhea, or GI fluid loss);

IV fluids, tube feedings,

or TPN indicated ≥24 hrs;

operative intervention

indicated

Life-threatening

consequences; operative

intervention requiring

complete organ resection

(e.g., total colectomy)

Death

NAVIGATION NOTE: Operative injury is graded as Intra-operative injury – Select Organ or Structure in the SURGERY/INTRA-OPERATIVE INJURY CATEGORY.

NAVIGATION NOTE: Pelvic pain is graded as Pain – Select in the PAIN CATEGORY.

GASTROINTESTINAL Page 8 of 10

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 26 - March 31, 2003, Publish Date: August 9, 2006

Perforation, GI

– Select:

– Appendix

– Biliary tree

– Cecum

– Colon

– Duodenum

– Esophagus

– Gallbladder

– Ileum

– Jejunum

– Rectum

– Small bowel NOS

– Stomach

Perforation, GI – Select Asymptomatic

radiographic findings only

Medical intervention

indicated; IV fluids

indicated <24 hrs

IV fluids, tube feedings,

or TPN indicated ≥24 hrs;

operative intervention

indicated

Life-threatening

consequences

Death

Proctitis Proctitis Rectal discomfort,

intervention not indicated

Symptoms not interfering

with ADL; medical

intervention indicated

Stool incontinence or

other symptoms

interfering with ADL;

operative intervention

indicated

Life-threatening

consequences (e.g.,

perforation)

Death

Prolapse of stoma, GI Prolapse of stoma, GI Asymptomatic Extraordinary local care

or maintenance; minor

revision indicated

Dysfunctional stoma;

major revision indicated

Life-threatening

consequences

Death

REMARK: Other stoma complications may be graded as Fistula, GI – Select; Leak (including anastomotic), GI – Select; Obstruction, GI – Select; Perforation, GI – Select;

Stricture/stenosis (including anastomotic), GI – Select.

NAVIGATION NOTE: Rectal or perirectal pain (proctalgia) is graded as Pain – Select in the PAIN CATEGORY.

Salivary gland

changes/saliva

Salivary gland changes Slightly thickened saliva;

slightly altered taste (e.g.,

metallic)

Thick, ropy, sticky saliva;

markedly altered taste;

alteration in diet

indicated; secretion-

induced symptoms not

interfering with ADL

Acute salivary gland

necrosis; severe

secretion-induced

symptoms interfering with

ADL

Disabling —

ALSO CONSIDER: Dry mouth/salivary gland (xerostomia); Mucositis/stomatitis (clinical exam) – Select; Mucositis/stomatitis (functional/symptomatic) – Select; Taste alteration

(dysgeusia).

NAVIGATION NOTE: Splenic function is graded in the BLOOD/BONE MARROW CATEGORY.

GASTROINTESTINAL Page 9 of 10

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 27 - March 31, 2003, Publish Date: August 9, 2006

Stricture/stenosis

(including anastomotic),

– Select:

Stricture, GI – Select

– Anus

– Biliary tree

– Cecum

– Colon

– Duodenum

– Esophagus

– Ileum

– Jejunum

– Pancreas/pancreatic duct

– Pharynx

– Rectum

– Small bowel NOS

– Stoma

– Stomach

Asymptomatic

radiographic findings only

Symptomatic; altered GI

function (e.g., altered

dietary habits, vomiting,

bleeding, diarrhea); IV

fluids indicated <24 hrs

Symptomatic and

severely altered GI

function (e.g., altered

dietary habits, diarrhea,

or GI fluid loss); IV fluids,

tube feedings, or TPN

indicated ≥24 hrs;

operative intervention

indicated

Life-threatening

consequences; operative

intervention requiring

complete organ resection

(e.g., total colectomy)

Death

Taste alteration

(dysgeusia)

Taste alteration Altered taste but no

change in diet

Altered taste with change

in diet (e.g., oral

supplements); noxious or

unpleasant taste; loss of

taste

— — —

Typhlitis

(cecal inflammation)

Typhlitis Asymptomatic, pathologic

or radiographic findings

only

Abdominal pain; mucus

or blood in stool

Abdominal pain, fever,

change in bowel habits

with ileus; peritoneal

signs

Life-threatening

consequences (e.g.,

perforation, bleeding,

ischemia, necrosis);

operative intervention

indicated

Death

ALSO CONSIDER: Colitis; Hemorrhage, GI – Select ; Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation).

GASTROINTESTINAL Page 10 of 10

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 28 - March 31, 2003, Publish Date: August 9, 2006

Ulcer, GI

– Select:

– Anus

– Cecum

– Colon

– Duodenum

– Esophagus

– Ileum

– Jejunum

– Rectum

– Small bowel NOS

– Stoma

– Stomach

Ulcer, GI – Select Asymptomatic,

radiographic or

endoscopic findings only

Symptomatic; altered GI

function (e.g., altered

dietary habits, oral

supplements); IV fluids

indicated <24 hrs

Symptomatic and

severely altered GI

function (e.g., inadequate

oral caloric or fluid

intake); IV fluids, tube

feedings, or TPN

indicated ≥24 hrs

Life-threatening

consequences

Death

ALSO CONSIDER: Hemorrhage, GI – Select.

Vomiting Vomiting 1 episode in 24 hrs 2 – 5 episodes in 24 hrs;

IV fluids indicated

<24 hrs

≥6 episodes in 24 hrs; IV

fluids, or TPN indicated

≥24 hrs

Life-threatening

consequences

Death

ALSO CONSIDER: Dehydration.

Gastrointestinal – Other

(Specify, __)

GI – Other (Specify) Mild Moderate Severe Life-threatening;

disabling

Death

GROWTH AND DEVELOPMENT Page 1 of 1

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 29 - March 31, 2003, Publish Date: August 9, 2006

Bone age

(alteration in bone age)

Bone age — +2 SD (standard

deviation) from normal

— — —

Bone growth:

femoral head; slipped

capital femoral epiphysis

Femoral head growth Mild valgus/varus

deformity

Moderate valgus/varus

deformity, symptomatic,

interfering with function

but not interfering with

ADL

Mild slipped capital

femoral epiphysis;

operative intervention

(e.g., fixation) indicated;

interfering with ADL

Disabling; severe slipped

capital femoral epiphysis

>60%; avascular necrosis

—

Bone growth:

limb length discrepancy

Limb length Mild length discrepancy

<2 cm

Moderate length

discrepancy 2 – 5 cm;

shoe lift indicated

Severe length

discrepancy >5 cm;

operative intervention

indicated; interfering with

ADL

Disabling; epiphysiodesis —

Bone growth:

spine kyphosis/lordosis

Kyphosis/lordosis Mild radiographic

changes

Moderate accentuation;

interfering with function

but not interfering with

ADL

Severe accentuation;

operative intervention

indicated; interfering with

ADL

Disabling (e.g., cannot lift

head)

—

Growth velocity

(reduction in growth

velocity)

Reduction in growth

velocity

10 – 29% reduction in

growth from the baseline

growth curve

30 – 49% reduction in

growth from the baseline

growth curve

≥50% reduction in growth

from the baseline growth

curve

— —

Puberty (delayed) Delayed puberty — No breast development

by age 13 yrs for females;

no Tanner Stage 2

development by age 14.5

yrs for males

No sexual development

by age 14 yrs for girls,

age 16 yrs for boys;

hormone replacement

indicated

— —

REMARK: Do not use testicular size for Tanner Stage in male cancer survivors.

Puberty (precocious) Precocious puberty — Physical signs of puberty

<7 years for females,

<9 years for males

— — —

Short stature Short stature Beyond two standard

deviations of age and

gender mean height

Altered ADL — — —

REMARK: Short stature is secondary to growth hormone deficiency.

LSO CONSIDER: Neuroendocrine: growth hormone secretion abnormality.

Growth and Development

– Other (Specify, __)

Growth and Development

– Other (Specify)

Mild Moderate Severe Life-threatening; disabling Death

HEMORRHAGE/BLEEDING Page 1 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 30 - March 31, 2003, Publish Date: August 9, 2006

Hematoma Hematoma Minimal symptoms,

invasive intervention not

indicated

Minimally invasive

evacuation or aspiration

indicated

Transfusion,

interventional radiology,

or operative intervention

indicated

Life-threatening

consequences; major

urgent intervention

indicated

Death

REMARK: Hematoma refers to extravasation at wound or operative site or secondary to other intervention. Transfusion implies pRBC.

LSO CONSIDER: Fibrinogen; INR (International Normalized Ratio of prothrombin time); Platelets; PTT (Partial Thromboplastin Time).

Hemorrhage/bleeding

associated with surgery,

intra-operative or

postoperative

Hemorrhage with surgery — — Requiring transfusion of

2 units non-autologous

(10 cc/kg for pediatrics)

pRBCs beyond protocol

specification;

postoperative

interventional radiology,

endoscopic, or operative

intervention indicated

Life-threatening

consequences

Death

REMARK: Postoperative period is defined as ≤72 hours after surgery. Verify protocol-specific acceptable guidelines regarding pRBC transfusion.

ALSO CONSIDER: Fibrinogen; INR (International Normalized Ratio of prothrombin time); Platelets; PTT (Partial Thromboplastin Time).

Hemorrhage, CNS CNS hemorrhage Asymptomatic,

radiographic findings only

Medical intervention

indicated

Ventriculostomy, ICP

monitoring,

intraventricular

thrombolysis, or operative

intervention indicated

Life-threatening

consequences;

neurologic deficit or

disability

Death

ALSO CONSIDER: Fibrinogen; INR (International Normalized Ratio of prothrombin time); Platelets; PTT (Partial Thromboplastin Time).

HEMORRHAGE/BLEEDING Page 2 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 31 - March 31, 2003, Publish Date: August 9, 2006

Hemorrhage, GI

– Select:

– Abdomen NOS

– Anus

– Biliary tree

– Cecum/appendix

– Colon

– Duodenum

– Esophagus

– Ileum

– Jejunum

– Liver

– Lower GI NOS

– Oral cavity

– Pancreas

– Peritoneal cavity

– Rectum

– Stoma

– Stomach

– Upper GI NOS

– Varices (esophageal)

– Varices (rectal)

Hemorrhage, GI – Select Mild, intervention (other

than iron supplements)

not indicated

Symptomatic and medical

intervention or minor

cauterization indicated

Transfusion,

interventional radiology,

endoscopic, or operative

intervention indicated;

radiation therapy (i.e.,

hemostasis of bleeding

site)

Life-threatening

consequences; major

urgent intervention

indicated

Death

REMARK: Transfusion implies pRBC.

ALSO CONSIDER: Fibrinogen; INR (International Normalized Ratio of prothrombin time); Platelets; PTT (Partial Thromboplastin Time).

HEMORRHAGE/BLEEDING Page 3 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 32 - March 31, 2003, Publish Date: August 9, 2006

Hemorrhage, GU

– Select:

– Bladder

– Fallopian tube

– Kidney

– Ovary

– Prostate

– Retroperitoneum

– Spermatic cord

– Stoma

– Testes

– Ureter

– Urethra

– Urinary NOS

– Uterus

– Vagina

– Vas deferens

Hemorrhage, GU – Select Minimal or microscopic

bleeding; intervention not

indicated

Gross bleeding, medical

intervention, or urinary

tract irrigation indicated

Transfusion,

interventional radiology,

endoscopic, or operative

intervention indicated;

radiation therapy (i.e.,

hemostasis of bleeding

site)

Life-threatening

consequences; major

urgent intervention

indicated

Death

REMARK: Transfusion implies pRBC.

LSO CONSIDER: Fibrinogen; INR (International Normalized Ratio of prothrombin time); Platelets; PTT (Partial Thromboplastin Time).

Hemorrhage, pulmonary/

upper respiratory

– Select:

Hemorrhage pulmonary

– Select

– Bronchopulmonary NOS

– Bronchus

– Larynx

– Lung

– Mediastinum

– Nose

– Pharynx

– Pleura

– Respiratory tract NOS

– Stoma

– Trachea

Mild, intervention not

indicated

Symptomatic and

medical intervention

indicated

Transfusion,

interventional radiology,

endoscopic, or operative

intervention indicated;

radiation therapy (i.e.,

hemostasis of bleeding

site)

Life-threatening

consequences; major

urgent intervention

indicated

Death

REMARK: Transfusion implies pRBC.

LSO CONSIDER: Fibrinogen; INR (International Normalized Ratio of prothrombin time); Platelets; PTT (Partial Thromboplastin Time).

Petechiae/purpura

(hemorrhage/bleeding

into skin or mucosa)

Petechiae Few petechiae Moderate petechiae;

purpura

Generalized petechiae or

purpura

— —

ALSO CONSIDER: Fibrinogen; INR (International Normalized Ratio of prothrombin time); Platelets; PTT (Partial Thromboplastin Time).

HEMORRHAGE/BLEEDING Page 4 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 33 - March 31, 2003, Publish Date: August 9, 2006

NAVIGATION NOTE: Vitreous hemorrhage is graded in the OCULAR/VISUAL CATEGORY.

Hemorrhage/Bleeding –

Other (Specify, __)

Hemorrhage – Other

(Specify)

Mild without transfusion — Transfusion indicated Catastrophic bleeding,

requiring major non-

elective intervention

Death

HEPATOBILIARY/PANCREAS Page 1 of 1

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 34 - March 31, 2003, Publish Date: August 9, 2006

NAVIGATION NOTE: Biliary tree damage is graded as Fistula, GI – Select; Leak (including anastomotic), GI – Select; Necrosis, GI – Select; Obstruction, GI – Select; Perforation, GI –

Select; Stricture/stenosis (including anastomotic), GI – Select in the GASTROINTESTINAL CATEGORY.

Cholecystitis Cholecystitis Asymptomatic,

radiographic findings only

Symptomatic, medical

intervention indicated

Interventional radiology,

endoscopic, or operative

intervention indicated

Life-threatening

consequences (e.g.,

sepsis or perforation)

Death

ALSO CONSIDER: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils – Select; Infection with normal ANC or Grade 1 or 2 neutrophils – Select; Infection

with unknown ANC – Select.

Liver dysfunction/failure

(clinical)

Liver dysfunction — Jaundice Asterixis Encephalopathy or coma Death

REMARK: Jaundice is not an AE, but occurs when the liver is not working properly or when a bile duct is blocked. It is graded as a result of liver dysfunction/failure or elevated bilirubin.

LSO CONSIDER: Bilirubin (hyperbilirubinemia).

Pancreas, exocrine

enzyme deficiency

Pancreas, exocrine

enzyme deficiency

— Increase in stool

frequency, bulk, or odor;

steatorrhea

Sequelae of absorption

deficiency (e.g., weight

loss)

Life-threatening

consequences

Death

ALSO CONSIDER: Diarrhea.

Pancreatitis Pancreatitis Asymptomatic, enzyme

elevation and/or

radiographic findings

Symptomatic, medical

intervention indicated

Interventional radiology or

operative intervention

indicated

Life-threatening

consequences

(e.g., circulatory failure,

hemorrhage, sepsis)

Death

ALSO CONSIDER: Amylase.

NAVIGATION NOTE: Stricture (biliary tree, hepatic or pancreatic) is graded as Stricture/stenosis (including anastomotic), GI – Select in the GASTROINTESTINAL CATEGORY.

Hepatobiliary/Pancreas –

Other (Specify, __)

Hepatobiliary – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

INFECTION Page 1 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 35 - March 31, 2003, Publish Date: August 9, 2006

Colitis, infectious

(e.g., Clostridium difficile)

Colitis, infectious Asymptomatic, pathologic

or radiographic findings

only

Abdominal pain with

mucus and/or blood in

stool

IV antibiotics or TPN

indicated

Life-threatening

consequences (e.g.,

perforation, bleeding,

ischemia, necrosis or

toxic megacolon);

operative resection or

diversion indicated

Death

ALSO CONSIDER: Hemorrhage, GI – Select; Typhlitis (cecal inflammation).

Febrile neutropenia

(fever of unknown origin

without clinically or

microbiologically

documented infection)

(ANC <1.0 x 10

/L, fever

≥38.5°C)

Febrile neutropenia — — Present Life-threatening

consequences (e.g.,

septic shock,

hypotension, acidosis,

necrosis)

Death

ALSO CONSIDER: Neutrophils/granulocytes (ANC/AGC).

Infection

(documented clinically or

microbiologically) with

Grade 3 or 4 neutrophils

(ANC <1.0 x 10

/L)

– Select

‘Select’ AEs appear at the

end of the CATEGORY.

Infection (documented

clinically) with Grade 3 or

4 ANC – Select

— Localized, local

intervention indicated

IV antibiotic, antifungal, or

antiviral intervention

indicated; interventional

radiology or operative

intervention indicated

Life-threatening

consequences (e.g.,

septic shock,

hypotension, acidosis,

necrosis)

Death

REMARK: Fever with Grade 3 or 4 neutrophils in the absence of documented infection is graded as Febrile neutropenia (fever of unknown origin without clinically or microbiologically

documented infection).

LSO CONSIDER: Neutrophils/granulocytes (ANC/AGC).

Infection with normal

ANC or Grade 1 or 2

neutrophils

– Select

‘Select’ AEs appear at the

end of the CATEGORY.

Infection with normal

ANC – Select

— Localized, local

intervention indicated

IV antibiotic, antifungal, or

antiviral intervention

indicated; interventional

radiology or operative

intervention indicated

Life-threatening

consequences (e.g.,

septic shock,

hypotension, acidosis,

necrosis)

Death

INFECTION Page 2 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 36 - March 31, 2003, Publish Date: August 9, 2006

Infection with unknown

ANC

– Select

‘Select’ AEs appear at the

end of the CATEGORY.

Infection with unknown

ANC – Select

— Localized, local

intervention indicated

IV antibiotic, antifungal, or

antiviral intervention

indicated; interventional

radiology or operative

intervention indicated

Life-threatening

consequences (e.g.,

septic shock,

hypotension, acidosis,

necrosis)

Death

REMARK: Infection with unknown ANC – Select is to be used in the rare case when ANC is unknown.

Opportunistic infection

associated with ≥Grade 2

Lymphopenia

Opportunistic infection — Localized, local

intervention indicated

IV antibiotic, antifungal, or

antiviral intervention

indicated; interventional

radiology or operative

intervention indicated

Life-threatening

consequences (e.g.,

septic shock,

hypotension, acidosis,

necrosis)

Death

ALSO CONSIDER: Lymphopenia.

Viral hepatitis Viral hepatitis Present; transaminases

and liver function normal

Transaminases

abnormal, liver function

normal

Symptomatic liver

dysfunction; fibrosis by

biopsy; compensated

cirrhosis

Decompensated liver

function (e.g., ascites,

coagulopathy,

encephalopathy, coma)

Death

REMARK: Non-viral hepatitis is graded as Infection – Select.

ALSO CONSIDER: Albumin, serum-low (hypoalbuminemia); ALT, SGPT (serum glutamic pyruvic transaminase); AST, SGOT (serum glutamic oxaloacetic transaminase); Bilirubin

(hyperbilirubinemia); Encephalopathy.

Infection – Other

(Specify, __)

Infection – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

INFECTION – SELECT Page 3 of 3

CTCAE v3.0 - 37 - March 31, 2003, Publish Date: August 9, 2006

AUDITORY/EAR

– External ear (otitis externa)

– Middle ear (otitis media)

CARDIOVASCULAR

– Artery

– Heart (endocarditis)

– Spleen

– Vein

DERMATOLOGY/SKIN

– Lip/perioral

– Peristomal

– Skin (cellulitis)

– Ungual (nails)

GASTROINTESTINAL

– Abdomen NOS

– Anal/perianal

– Appendix

– Cecum

– Colon

– Dental-tooth

– Duodenum

– Esophagus

– Ileum

– Jejunum

– Oral cavity-gums (gingivitis)

– Peritoneal cavity

– Rectum

– Salivary gland

– Small bowel NOS

– Stomach

GENERAL

– Blood

– Catheter-related

– Foreign body (e.g., graft, implant,

prosthesis, stent)

– Wound

HEPATOBILIARY/PANCREAS

– Biliary tree

– Gallbladder (cholecystitis)

– Liver

– Pancreas

LYMPHATIC

– Lymphatic

MUSCULOSKELETAL

– Bone (osteomyelitis)

– Joint

– Muscle (infection myositis)

– Soft tissue NOS

NEUROLOGY

– Brain (encephalitis, infectious)

– Brain + Spinal cord (encephalomyelitis)

– Meninges (meningitis)

– Nerve-cranial

– Nerve-peripheral

– Spinal cord (myelitis)

OCULAR

– Conjunctiva

– Cornea

– Eye NOS

– Lens

PULMONARY/UPPER RESPIRATORY

– Bronchus

– Larynx

– Lung (pneumonia)

– Mediastinum NOS

– Mucosa

– Neck NOS

– Nose

– Paranasal

– Pharynx

– Pleura (empyema)

– Sinus

– Trachea

– Upper aerodigestive NOS

– Upper airway NOS

RENAL/GENITOURINARY

– Bladder (urinary)

– Kidney

– Prostate

– Ureter

– Urethra

– Urinary tract NOS

SEXUAL/REPRODUCTIVE FUNCTION

– Cervix

– Fallopian tube

– Pelvis NOS

– Penis

– Scrotum

– Uterus

– Vagina

– Vulva

LYMPHATICS Page 1 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 38 - March 31, 2003, Publish Date: August 9, 2006

Chyle or lymph leakage Chyle or lymph leakage Asymptomatic, clinical or

radiographic findings

Symptomatic, medical

intervention indicated

Interventional radiology

or operative intervention

indicated

Life-threatening

complications

Death

ALSO CONSIDER: Chylothorax.

Dermal change

lymphedema,

phlebolymphedema

Dermal change Trace thickening or faint

discoloration

Marked discoloration;

leathery skin texture;

papillary formation

— — —

REMARK: Dermal change lymphedema, phlebolymphedema refers to changes due to venous stasis.

ALSO CONSIDER: Ulceration.

Edema:

head and neck

Edema: head and neck Localized to dependent

areas, no disability or

functional impairment

Localized facial or neck

edema with functional

impairment

Generalized facial or

neck edema with

functional impairment

(e.g., difficulty in turning

neck or opening mouth

compared to baseline)

Severe with ulceration or

cerebral edema;

tracheotomy or feeding

tube indicated

Death

Edema:

limb

Edema: limb 5 – 10% inter-limb

discrepancy in volume or

circumference at point of

greatest visible

difference; swelling or

obscuration of anatomic

architecture on close

inspection; pitting edema

>10 – 30% inter-limb

discrepancy in volume or

circumference at point of

greatest visible

difference; readily

apparent obscuration of

anatomic architecture;

obliteration of skin folds;

readily apparent

deviation from normal

anatomic contour

>30% inter-limb

discrepancy in volume;

lymphorrhea; gross

deviation from normal

anatomic contour;

interfering with ADL

Progression to

malignancy (i.e.,

lymphangiosarcoma);

amputation indicated;

disabling

Death

Edema:

trunk/genital

Edema: trunk/genital Swelling or obscuration

of anatomic architecture

on close inspection;

pitting edema

Readily apparent

obscuration of anatomic

architecture; obliteration

of skin folds; readily

apparent deviation from

normal anatomic contour

Lymphorrhea; interfering

with ADL; gross deviation

from normal anatomic

contour

Progression to

malignancy (i.e.,

lymphangiosarcoma);

disabling

Death

Edema:

viscera

Edema: viscera Asymptomatic; clinical or

radiographic findings only

Symptomatic; medical

intervention indicated

Symptomatic and unable

to aliment adequately

orally; interventional

radiology or operative

intervention indicated

Life-threatening

consequences

Death

LYMPHATICS Page 2 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 39 - March 31, 2003, Publish Date: August 9, 2006

Lymphedema-related

fibrosis

Lymphedema-related

fibrosis

Minimal to moderate

redundant soft tissue,

unresponsive to elevation

or compression, with

moderately firm texture or

spongy feel

Marked increase in

density and firmness,

with or without tethering

Very marked density and

firmness with tethering

affecting ≥40% of the

edematous area

— —

Lymphocele Lymphocele Asymptomatic, clinical or

radiographic findings only

Symptomatic; medical

intervention indicated

Symptomatic and

interventional radiology

or operative intervention

indicated

— —

Phlebolymphatic cording Phlebolymphatic cording Asymptomatic, clinical

findings only

Symptomatic; medical

intervention indicated

Symptomatic and leading

to contracture or reduced

range of motion

— —

Lymphatics – Other

(Specify, __)

Lymphatics – Other

(Specify)

Mild Moderate Severe Life-threatening;

disabling

Death

METABOLIC/LABORATORY Page 1 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 40 - March 31, 2003, Publish Date: August 9, 2006

Acidosis

(metabolic or respiratory)

Acidosis

pH <normal, but ≥7.3

— pH <7.3 pH <7.3 with life-

threatening

consequences

Death

Albumin, serum-low

(hypoalbuminemia)

Hypoalbuminemia <LLN – 3 g/dL

<LLN – 30 g/L

<3 – 2 g/dL

<30 – 20 g/L

<2 g/dL

<20 g/L

— Death

Alkaline phosphatase Alkaline phosphatase >ULN – 2.5 x ULN >2.5 – 5.0 x ULN >5.0 – 20.0 x ULN >20.0 x ULN —

Alkalosis

(metabolic or respiratory)

Alkalosis

pH >normal, but ≤7.5

— pH >7.5 pH >7.5 with life-

threatening

consequences

Death

ALT, SGPT

(serum glutamic pyruvic

transaminase)

ALT >ULN – 2.5 x ULN >2.5 – 5.0 x ULN >5.0 – 20.0 x ULN >20.0 x ULN —

Amylase Amylase >ULN – 1.5 x ULN >1.5 – 2.0 x ULN >2.0 – 5.0 x ULN >5.0 x ULN —

AST, SGOT

(serum glutamic

oxaloacetic

transaminase)

AST >ULN – 2.5 x ULN >2.5 – 5.0 x ULN >5.0 – 20.0 x ULN >20.0 x ULN —

Bicarbonate, serum-low Bicarbonate, serum-low <LLN – 16 mmol/L <16 – 11 mmol/L <11 – 8 mmol/L <8 mmol/L Death

Bilirubin

(hyperbilirubinemia)

Bilirubin >ULN – 1.5 x ULN >1.5 – 3.0 x ULN >3.0 – 10.0 x ULN >10.0 x ULN —

REMARK: Jaundice is not an AE, but may be a manifestation of liver dysfunction/failure or elevated bilirubin. If jaundice is associated with elevated bilirubin, grade bilirubin.

Calcium, serum-low

(hypocalcemia)

Hypocalcemia <LLN – 8.0 mg/dL

<LLN – 2.0 mmol/L

Ionized calcium:

<LLN – 1.0 mmol/L

<8.0 – 7.0 mg/dL

<2.0 – 1.75 mmol/L

Ionized calcium:

<1.0 – 0.9 mmol/L

<7.0 – 6.0 mg/dL

<1.75 – 1.5 mmol/L

Ionized calcium:

<0.9 – 0.8 mmol/L

<6.0 mg/dL

<1.5 mmol/L

Ionized calcium:

<0.8 mmol/L

Death

REMARK: Calcium can be falsely low if hypoalbuminemia is present. Serum albumin is <4.0 g/dL, hypocalcemia is reported after the following corrective calculation has been

performed: Corrected Calcium (mg/dL) = Total Calcium (mg/dL) – 0.8 [Albumin (g/dL) – 4]

. Alternatively, direct measurement of ionized calcium is the definitive method to diagnose

metabolically relevant alterations in serum calcium.

Crit Rev Clin Lab Sci 1984;21(1):51-97

METABOLIC/LABORATORY Page 2 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 41 - March 31, 2003, Publish Date: August 9, 2006

Calcium, serum-high

(hypercalcemia)

Hypercalcemia >ULN – 11.5 mg/dL

>ULN – 2.9 mmol/L

Ionized calcium:

>ULN – 1.5 mmol/L

>11.5 – 12.5 mg/dL

>2.9 – 3.1 mmol/L

Ionized calcium:

>1.5 – 1.6 mmol/L

>12.5 – 13.5 mg/dL

>3.1 – 3.4 mmol/L

Ionized calcium:

>1.6 – 1.8 mmol/L

>13.5 mg/dL

>3.4 mmol/L

Ionized calcium:

>1.8 mmol/L

Death

Cholesterol, serum-high

(hypercholesteremia)

Cholesterol >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

Death

CPK (creatine

phosphokinase)

CPK >ULN – 2.5 x ULN >2.5 x ULN – 5 x ULN >5 x ULN – 10 x ULN >10 x ULN Death

Creatinine Creatinine >ULN – 1.5 x ULN >1.5 – 3.0 x ULN >3.0 – 6.0 x ULN >6.0 x ULN Death

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

LSO CONSIDER: Glomerular filtration rate.

GGT (γ-Glutamyl

transpeptidase)

GGT >ULN – 2.5 x ULN >2.5 – 5.0 x ULN >5.0 – 20.0 x ULN >20.0 x ULN —

Glomerular filtration rate GFR <75 – 50% LLN <50 – 25% LLN <25% LLN, chronic

dialysis not indicated

Chronic dialysis or renal

transplant indicated

Death

ALSO CONSIDER: Creatinine.

Glucose, serum-high

(hyperglycemia)

Hyperglycemia >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

Death

REMARK: Hyperglycemia, in general, is defined as fasting unless otherwise specified in protocol.

Glucose, serum-low

(hypoglycemia)

Hypoglycemia <LLN – 55 mg/dL

<LLN – 3.0 mmol/L

<55 – 40 mg/dL

<3.0 – 2.2 mmol/L

<40 – 30 mg/dL

<2.2 – 1.7 mmol/L

<30 mg/dL

<1.7 mmol/L

Death

Hemoglobinuria Hemoglobinuria Present — — — Death

Lipase Lipase >ULN – 1.5 x ULN >1.5 – 2.0 x ULN >2.0 – 5.0 x ULN >5.0 x ULN —

Magnesium, serum-high

(hypermagnesemia)

Hypermagnesemia >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

Death

Magnesium, serum-low

(hypomagnesemia)

Hypomagnesemia <LLN – 1.2 mg/dL

<LLN – 0.5 mmol/L

<1.2 – 0.9 mg/dL

<0.5 – 0.4 mmol/L

<0.9 – 0.7 mg/dL

<0.4 – 0.3 mmol/L

<0.7 mg/dL

<0.3 mmol/L

Death

Phosphate, serum-low

(hypophosphatemia)

Hypophosphatemia <LLN – 2.5 mg/dL

<LLN – 0.8 mmol/L

<2.5 – 2.0 mg/dL

<0.8 – 0.6 mmol/L

<2.0 – 1.0 mg/dL

<0.6 – 0.3 mmol/L

<1.0 mg/dL

<0.3 mmol/L

Death

Potassium, serum-high

(hyperkalemia)

Hyperkalemia >ULN – 5.5 mmol/L >5.5 – 6.0 mmol/L >6.0 – 7.0 mmol/L >7.0 mmol/L Death

METABOLIC/LABORATORY Page 3 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 42 - March 31, 2003, Publish Date: August 9, 2006

Potassium, serum-low

(hypokalemia)

Hypokalemia <LLN – 3.0 mmol/L — <3.0 – 2.5 mmol/L <2.5 mmol/L Death

Proteinuria Proteinuria 1+ or

0.15 – 1.0 g/24 hrs

2+ to 3+ or

>1.0 – 3.5 g/24 hrs

4+ or

>3.5 g/24 hrs

Nephrotic syndrome Death

Sodium, serum-high

(hypernatremia)

Hypernatremia >ULN – 150 mmol/L >150 – 155 mmol/L >155 – 160 mmol/L >160 mmol/L Death

Sodium, serum-low

(hyponatremia)

Hyponatremia <LLN – 130 mmol/L — <130 – 120 mmol/L <120 mmol/L Death

Triglyceride, serum-high

(hypertriglyceridemia)

Hypertriglyceridemia >ULN – 2.5 x ULN >2.5 – 5.0 x ULN >5.0 – 10 x ULN >10 x ULN Death

Uric acid, serum-high

(hyperuricemia)

Hyperuricemia

>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

Death

ALSO CONSIDER: Creatinine; Potassium, serum-high (hyperkalemia); Renal failure; Tumor lysis syndrome.

Metabolic/Laboratory –

Other (Specify, __)

Metabolic/Lab – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

MUSCULOSKELETAL/SOFT TISSUE Page 1 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 43 - March 31, 2003, Publish Date: August 9, 2006

Arthritis (non-septic) Arthritis 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

ADL

Severe pain with

inflammation, erythema,

or joint swelling and

interfering with ADL

Disabling Death

REMARK: Report only when the diagnosis of arthritis (e.g., inflammation of a joint or a state characterized by inflammation of joints) is made. Arthralgia (sign or symptom of pain in a

joint, especially non-inflammatory in character) is graded as Pain – Select in the PAIN CATEGORY.

Bone:

spine-scoliosis

Scoliosis

≤20 degrees; clinically

undetectable

>20 – 45 degrees; visible

by forward flexion;

interfering with function

but not interfering with

ADL

>45 degrees; scapular

prominence in forward

flexion; operative

intervention indicated;

interfering with ADL

Disabling (e.g., interfering

with cardiopulmonary

function)

Death

Cervical spine-range of

motion

Cervical spine ROM Mild restriction of rotation

or flexion between

60 – 70 degrees

Rotation <60 degrees to

right or left; <60 degrees

of flexion

Ankylosed/fused over

multiple segments with

no C-spine rotation

— —

REMARK: 60 – 65 degrees of rotation is required for reversing a car; 60 – 65 degrees of flexion is required to tie shoes.

Exostosis Exostosis Asymptomatic Involving multiple sites;

pain or interfering with

function

Excision indicated Progression to

malignancy (i.e.,

chondrosarcoma)

Death

Extremity-lower

(gait/walking)

Gait/walking Limp evident only to

trained observer and able

to walk ≥1 kilometer;

cane indicated for

walking

Noticeable limp, or

limitation of limb function,

but able to walk ≥0.1

kilometer (1 city block);

quad cane indicated for

walking

Severe limp with stride

modified to maintain

balance (widened base of

support, marked

reduction in step length);

ambulation limited to

walker; crutches

indicated

Unable to walk —

ALSO CONSIDER: Ataxia (incoordination); Muscle weakness, generalized or specific area (not due to neuropathy) – Select.

Extremity-upper

(function)

Extremity-upper

(function)

Able to perform most

household or work

activities with affected

limb

Able to perform most

household or work

activities with

compensation from

unaffected limb

Interfering with ADL Disabling; no function of

affected limb

—

Fibrosis-cosmesis Fibrosis-cosmesis Visible only on close

examination

Readily apparent but not

disfiguring

Significant disfigurement;

operative intervention

indicated if patient

chooses

— —

MUSCULOSKELETAL/SOFT TISSUE Page 2 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 44 - March 31, 2003, Publish Date: August 9, 2006

Fibrosis-deep connective

tissue

Fibrosis-deep connective

tissue

Increased density,

“spongy” feel

Increased density with

firmness or tethering

Increased density with

fixation of tissue;

operative intervention

indicated; interfering with

ADL

Life-threatening;

disabling; loss of limb;

interfering with vital organ

function

Death

ALSO CONSIDER: Induration/fibrosis (skin and subcutaneous tissue); Muscle weakness, generalized or specific area (not due to neuropathy) – Select; Neuropathy: motor; Neuropathy:

sensory.

Fracture Fracture Asymptomatic,

radiographic findings only

(e.g., asymptomatic rib

fracture on plain x-ray,

pelvic insufficiency

fracture on MRI, etc.)

Symptomatic but non-

displaced; immobilization

indicated

Symptomatic and

displaced or open wound

with bone exposure;

operative intervention

indicated

Disabling; amputation

indicated

Death

Joint-effusion Joint-effusion Asymptomatic, clinical or

radiographic findings only

Symptomatic; interfering

with function but not

interfering with ADL

Symptomatic and

interfering with ADL

Disabling Death

ALSO CONSIDER: Arthritis (non-septic).

Joint-function

Joint-function Stiffness interfering with

athletic activity; ≤25%

loss of range of motion

(ROM)

Stiffness interfering with

function but not

interfering with ADL;

>25 – 50% decrease in

ROM

Stiffness interfering with

ADL; >50 – 75%

decrease in ROM

Fixed or non-functional

joint (arthrodesis);

>75% decrease in ROM

—

ALSO CONSIDER: Arthritis (non-septic).

Local complication –

device/prosthesis-related

Device/prosthesis Asymptomatic Symptomatic, but not

interfering with ADL; local

wound care; medical

intervention indicated

Symptomatic, interfering

with ADL; operative

intervention indicated

(e.g., hardware/device

replacement or removal,

reconstruction)

Life-threatening;

disabling; loss of limb or

organ

Death

Lumbar spine-range of

motion

Lumbar spine ROM Stiffness and difficulty

bending to the floor to

pick up a very light object

but able to do activity

Some lumbar spine

flexion but requires a

reaching aid to pick up a

very light object from the

floor

Ankylosed/fused over

multiple segments with

no L-spine flexion (i.e.,

unable to reach to floor to

pick up a very light

— —

Adapted from the International SFTR Method of Measuring and Recording Joint Motion, International Standard Orthopedic Measurements (ISOM), Jon J. Gerhardt and Otto A.

Russee, Bern, Switzerland, Han Huber 9 Publisher), 1975.

MUSCULOSKELETAL/SOFT TISSUE Page 3 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 45 - March 31, 2003, Publish Date: August 9, 2006

object)

Muscle weakness,

generalized or specific

area (not due to

neuropathy)

– Select:

Muscle weakness

– Select

– Extraocular

– Extremity-lower

– Extremity-upper

– Facial

– Left-sided

– Ocular

– Pelvic

– Right-sided

– Trunk

– Whole body/generalized

Asymptomatic, weakness

on physical exam

Symptomatic and

interfering with function,

but not interfering with

ADL

Symptomatic and

interfering with ADL

Life-threatening; disabling Death

ALSO CONSIDER: Fatigue (asthenia, lethargy, malaise).

Muscular/skeletal

hypoplasia

Muscular/skeletal

hypoplasia

Cosmetically and

functionally insignificant

hypoplasia

Deformity, hypoplasia, or

asymmetry able to be

remediated by prosthesis

(e.g., shoe insert) or

covered by clothing

Functionally significant

deformity, hypoplasia, or

asymmetry, unable to be

remediated by prosthesis

or covered by clothing

Disabling —

Myositis

(inflammation/damage of

muscle)

Myositis Mild pain, not interfering

with function

Pain interfering with

function, but not

interfering with ADL

Pain interfering with ADL Disabling Death

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

LSO CONSIDER: CPK (creatine phosphokinase); Pain – Select.

Osteonecrosis

(avascular necrosis)

Osteonecrosis Asymptomatic,

radiographic findings only

Symptomatic and

interfering with function,

but not interfering with

ADL; minimal bone

removal indicated (i.e.,

minor sequestrectomy)

Symptomatic and

interfering with ADL;

operative intervention or

hyperbaric oxygen

indicated

Disabling Death

MUSCULOSKELETAL/SOFT TISSUE Page 4 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 46 - March 31, 2003, Publish Date: August 9, 2006

Osteoporosis

Osteoporosis Radiographic evidence of

osteoporosis or Bone

Mineral Density (BMD)

t-score –1 to –2.5

(osteopenia) and no loss

of height or therapy

indicated

BMD t-score < –2.5; loss

of height <2 cm; anti-

osteoporotic therapy

indicated

Fractures; loss of height

≥2 cm

Disabling Death

Seroma Seroma Asymptomatic Symptomatic; medical

intervention or simple

aspiration indicated

Symptomatic,

interventional radiology

or operative intervention

indicated

— —

Soft tissue necrosis

– Select:

– Abdomen

– Extremity-lower

– Extremity-upper

– Head

– Neck

– Pelvic

– Thorax

Soft tissue necrosis

– Select

— Local wound care;

medical intervention

indicated

Operative debridement or

other invasive

intervention indicated

(e.g., hyperbaric oxygen)

Life-threatening

consequences; major

invasive intervention

indicated (e.g., tissue

reconstruction, flap, or

grafting)

Death

Trismus (difficulty,

restriction or pain when

opening mouth)

Trismus Decreased range of

motion without impaired

eating

Decreased range of

motion requiring small

bites, soft foods or

purees

Decreased range of

motion with inability to

adequately aliment or

hydrate orally

— —

NAVIGATION NOTE: Wound-infectious is graded as Infection – Select in the INFECTION CATEGORY.

NAVIGATION NOTE: Wound non-infectious is graded as Wound complication, non-infectious in the DERMATOLOGY/SKIN CATEGORY.

Musculoskeletal/Soft

Tissue – Other

(Specify, __)

Musculoskeletal – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

"Assessment of Fracture Risk and its Application to Screening for Postmenopausal Osteoporosis," Report of a WHO Study Group Technical Report Series, No. 843, 1994, v + 129

pages [C*, E, F, R, S], ISBN 92 4 120843 0, Sw.fr. 22.-/US $19.80; in developing countries: Sw.fr. 15.40, Order no. 1100843

NEUROLOGY Page 1 of 5

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 47 - March 31, 2003, Publish Date: August 9, 2006

NAVIGATION NOTE: ADD (Attention Deficit Disorder) is graded as Cognitive disturbance.

NAVIGATION NOTE: Aphasia, receptive and/or expressive, is graded as Speech impairment (e.g., dysphasia or aphasia).

Apnea Apnea — — Present Intubation indicated Death

Arachnoiditis/

meningismus/radiculitis

Arachnoiditis Symptomatic, not

interfering with function;

medical intervention

indicated

Symptomatic (e.g.,

photophobia, nausea)

interfering with function

but not interfering with

ADL

Symptomatic, interfering

with ADL

Life-threatening; disabling

(e.g., paraplegia)

Death

ALSO CONSIDER: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10

/L); Infection (documented clinically or microbiologically) with Grade 3 or 4

neutrophils (ANC <1.0 x 109/L) – Select; Infection with normal ANC or Grade 1 or 2 neutrophils – Select; Infection with unknown ANC – Select; Pain – Select; Vomiting.

Ataxia (incoordination) Ataxia Asymptomatic Symptomatic, not

interfering with ADL

Symptomatic, interfering

with ADL; mechanical

assistance indicated

Disabling Death

REMARK: Ataxia (incoordination) refers to the consequence of medical or operative intervention.

Brachial plexopathy Brachial plexopathy Asymptomatic Symptomatic, not

interfering with ADL

Symptomatic, interfering

with ADL

Disabling Death

CNS cerebrovascular

ischemia

CNS ischemia — Asymptomatic,

radiographic findings only

Transient ischemic event

or attack (TIA) ≤24 hrs

duration

Cerebral vascular

accident (CVA, stroke),

neurologic deficit

>24 hrs

Death

NAVIGATION NOTE: CNS hemorrhage/bleeding is graded as Hemorrhage, CNS in the HEMORRHAGE/BLEEDING CATEGORY.

CNS necrosis/cystic

progression

CNS necrosis Asymptomatic,

radiographic findings only

Symptomatic, not

interfering with ADL;

medical intervention

indicated

Symptomatic and

interfering with ADL;

hyperbaric oxygen

indicated

Life-threatening;

disabling; operative

intervention indicated to

prevent or treat CNS

necrosis/cystic

progression

Death

Cognitive disturbance Cognitive disturbance Mild cognitive disability;

not interfering with

work/school/life

performance; specialized

educational

services/devices not

indicated

Moderate cognitive

disability; interfering with

work/school/life

performance but capable

of independent living;

specialized resources on

part-time basis indicated

Severe cognitive

disability; significant

impairment of

work/school/life

performance

Unable to perform ADL;

full-time specialized

resources or

institutionalization

indicated

Death

REMARK: Cognitive disturbance may be used for Attention Deficit Disorder (ADD).

NEUROLOGY Page 2 of 5

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 48 - March 31, 2003, Publish Date: August 9, 2006

Confusion Confusion

Transient confusion,

disorientation, or attention

deficit

Confusion, disorientation,

or attention deficit

interfering with function,

but not interfering with

ADL

Confusion or delirium

interfering with ADL

Harmful to others or self;

hospitalization indicated

Death

REMARK: Attention Deficit Disorder (ADD) is graded as Cognitive disturbance.

NAVIGATION NOTE: Cranial neuropathy is graded as Neuropathy-cranial – Select.

Dizziness Dizziness With head movements or

nystagmus only; not

interfering with function

Interfering with function,

but not interfering with

ADL

Interfering with ADL Disabling —

REMARK: Dizziness includes disequilibrium, lightheadedness, and vertigo.

ALSO CONSIDER: Neuropathy: cranial – Select; Syncope (fainting).

NAVIGATION NOTE: Dysphasia, receptive and/or expressive, is graded as Speech impairment (e.g., dysphasia or aphasia).

Encephalopathy Encephalopathy — Mild signs or symptoms;

not interfering with ADL

Signs or symptoms

interfering with ADL;

hospitalization indicated

Life-threatening; disabling Death

ALSO CONSIDER: Cognitive disturbance; Confusion; Dizziness; Memory impairment; Mental status; Mood alteration – Select; Psychosis (hallucinations/delusions);

Somnolence/depressed level of consciousness.

Extrapyramidal/

involuntary movement/

restlessness

Involuntary movement Mild involuntary

movements not

interfering with function

Moderate involuntary

movements interfering

with function, but not

interfering with ADL

Severe involuntary

movements or torticollis

interfering with ADL

Disabling

Death

NAVIGATION NOTE: Headache/neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies) is graded as Pain – Select in the

PAIN CATEGORY.

Hydrocephalus Hydrocephalus Asymptomatic,

radiographic findings only

Mild to moderate

symptoms not interfering

with ADL

Severe symptoms or

neurological deficit

interfering with ADL

Disabling Death

Irritability (children <3

years of age)

Irritability Mild; easily consolable Moderate; requiring

increased attention

Severe; inconsolable — —

Laryngeal nerve

dysfunction

Laryngeal nerve Asymptomatic, weakness

on clinical

examination/testing only

Symptomatic, but not

interfering with ADL;

intervention not indicated

Symptomatic, interfering

with ADL; intervention

indicated (e.g.,

thyroplasty, vocal cord

injection)

Life-threatening;

tracheostomy indicated

Death

NEUROLOGY Page 3 of 5

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 49 - March 31, 2003, Publish Date: August 9, 2006

Leak, cerebrospinal fluid

(CSF)

CSF leak Transient headache;

postural care indicated

Symptomatic, not

interfering with ADL;

blood patch indicated

Symptomatic, interfering

with ADL; operative

intervention indicated

Life-threatening; disabling Death

REMARK: Leak, cerebrospinal fluid (CSF) may be used for CSF leak associated with operation and persisting >72 hours.

Leukoencephalopathy

(radiographic findings)

Leukoencephalopathy Mild increase in

subarachnoid space

(SAS); mild

ventriculomegaly; small

(+/- multiple) focal T2

hyperintensities, involving

periventricular white

matter or <1/3 of

susceptible areas of

cerebrum

Moderate increase in

SAS; moderate

ventriculomegaly; 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)

— —

REMARK: Leukoencephalopathy is a diffuse white matter process, specifically NOT associated with necrosis. Leukoencephalopathy (radiographic findings) does not include lacunas,

which are areas that become void of neural tissue.

Memory impairment Memory impairment Memory impairment not

interfering with function

Memory impairment

interfering with function,

but not interfering with

ADL

Memory impairment

interfering with ADL

Amnesia —

Mental status

Mental status — 1 – 3 point below age

and educational norm in

Folstein Mini-Mental

Status Exam (MMSE)

>3 point below age and

educational norm in

Folstein MMSE

— —

Mood alteration

– Select:

– Agitation

– Anxiety

– Depression

– Euphoria

Mood alteration – Select Mild mood alteration not

interfering with function

Moderate mood alteration

interfering with function,

but not interfering with

ADL; medication

indicated

Severe mood alteration

interfering with ADL

Suicidal ideation; danger

to self or others

Death

Myelitis Myelitis Asymptomatic, mild signs

(e.g., Babinski’s or

Lhermitte’s sign)

Weakness or sensory

loss not interfering with

ADL

Weakness or sensory

loss interfering with ADL

Disabling Death

Folstein MF, Folstein, SE and McHugh PR (1975) "Mini-Mental State: A Practical Method for Grading the State of Patients for the Clinician," Journal of Psychiatric Research, 12:

189-198

NEUROLOGY Page 4 of 5

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 50 - March 31, 2003, Publish Date: August 9, 2006

NAVIGATION NOTE: Neuropathic pain is graded as Pain – Select in the PAIN CATEGORY.

Neuropathy:

cranial

– Select:

Neuropathy: cranial

– Select

Asymptomatic, detected

on exam/testing only

– CN I Smell

– CN II Vision

– CN III Pupil, upper eyelid, extra ocular movements

– CN IV Downward, inward movement of eye

– CN V Motor-jaw muscles; Sensory-facial

– CN VI Lateral deviation of eye

– CN VII Motor-face; Sensory-taste

– CN VIII Hearing and balance

– CN IX Motor-pharynx; Sensory-ear, pharynx, tongue

– CN X Motor-palate; pharynx, larynx

– CN XI Motor-sternomastoid and trapezius

– CN XII Motor-tongue

Symptomatic, not

interfering with ADL

Symptomatic, interfering

with ADL

Life-threatening; disabling Death

Neuropathy:

motor

Neuropathy-motor Asymptomatic, weakness

on exam/testing only

Symptomatic weakness

interfering with function,

but not interfering with

ADL

Weakness interfering with

ADL; bracing or

assistance to walk (e.g.,

cane or walker) indicated

Life-threatening; disabling

(e.g., paralysis)

Death

REMARK: Cranial nerve motor neuropathy is graded as Neuropathy: cranial – Select.

ALSO CONSIDER: Laryngeal nerve dysfunction; Phrenic nerve dysfunction.

Neuropathy:

sensory

Neuropathy-sensory Asymptomatic; loss of

deep tendon reflexes or

paresthesia (including

tingling) but not

interfering with function

Sensory alteration or

paresthesia (including

tingling), interfering with

function, but not

interfering with ADL

Sensory alteration or

paresthesia interfering

with ADL

Disabling Death

REMARK: Cranial nerve sensory neuropathy is graded as Neuropathy: cranial – Select.

Personality/behavioral Personality Change, but not

adversely affecting

patient or family

Change, adversely

affecting patient or family

Mental health intervention

indicated

Change harmful to others

or self; hospitalization

indicated

Death

Phrenic nerve dysfunction Phrenic nerve Asymptomatic weakness

on exam/testing only

Symptomatic but not

interfering with ADL;

intervention not indicated

Significant dysfunction;

intervention indicated

(e.g., diaphragmatic

plication)

Life-threatening

respiratory compromise;

mechanical ventilation

indicated

Death

Psychosis (hallucinations/

delusions)

Psychosis — Transient episode Interfering with ADL;

medication, supervision

Harmful to others or self;

life-threatening

Death

NEUROLOGY Page 5 of 5

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 51 - March 31, 2003, Publish Date: August 9, 2006

or restraints indicated consequences

Pyramidal tract

dysfunction (e.g., ↑ tone,

hyperreflexia, positive

Babinski, ↓ fine motor

coordination)

Pyramidal tract

dysfunction

Asymptomatic,

abnormality on exam or

testing only

Symptomatic; interfering

with function but not

interfering with ADL

Interfering with ADL Disabling; paralysis Death

Seizure Seizure — One brief generalized

seizure; seizure(s) well

controlled by

anticonvulsants or

infrequent focal motor

seizures not interfering

with ADL

Seizures in which

consciousness is altered;

poorly controlled seizure

disorder, with

breakthrough generalized

seizures despite medical

intervention

Seizures of any kind

which are prolonged,

repetitive, or difficult to

control (e.g., status

epilepticus, intractable

epilepsy)

Death

Somnolence/depressed

level of consciousness

Somnolence — Somnolence or sedation

interfering with function,

but not interfering with

ADL

Obtundation or stupor;

difficult to arouse;

interfering with ADL

Coma Death

Speech impairment

(e.g., dysphasia or

aphasia)

Speech impairment — Awareness of receptive

or expressive dysphasia,

not impairing ability to

communicate

Receptive or expressive

dysphasia, impairing

ability to communicate

Inability to communicate —

REMARK: Speech impairment refers to a primary CNS process, not neuropathy or end organ dysfunction.

ALSO CONSIDER: Laryngeal nerve dysfunction; Voice changes/dysarthria (e.g., hoarseness, loss, or alteration in voice, laryngitis).

Syncope (fainting) Syncope (fainting) — — Present Life-threatening

consequences

Death

ALSO CONSIDER: CNS cerebrovascular ischemia; Conduction abnormality/atrioventricular heart block – Select; Dizziness; Supraventricular and nodal arrhythmia – Select; Vasovagal

episode; Ventricular arrhythmia – Select.

NAVIGATION NOTE: Taste alteration (CN VII, IX) is graded as Taste alteration (dysgeusia) in the GASTROINTESTINAL CATEGORY.

Tremor Tremor Mild and brief or

intermittent but not

interfering with function

Moderate tremor

interfering with function,

but not interfering with

ADL

Severe tremor interfering

with ADL

Disabling —

Neurology – Other

(Specify, __)

Neurology – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

OCULAR/VISUAL Page 1 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 52 - March 31, 2003, Publish Date: August 9, 2006

Cataract Cataract Asymptomatic, detected

on exam only

Symptomatic, with

moderate decrease in

visual acuity

(20/40 or better);

decreased visual function

correctable with glasses

Symptomatic with marked

decrease in visual acuity

(worse than 20/40);

operative intervention

indicated (e.g., cataract

surgery)

— —

Dry eye syndrome Dry eye Mild, intervention not

indicated

Symptomatic, interfering

with function but not

interfering with ADL;

medical intervention

indicated

Symptomatic or decrease

in visual acuity interfering

with ADL; operative

intervention indicated

— —

Eyelid dysfunction Eyelid dysfunction Asymptomatic Symptomatic, interfering

with function but not ADL;

requiring topical agents or

epilation

Symptomatic; interfering

with ADL; surgical

intervention indicated

— —

REMARK: Eyelid dysfunction includes canalicular stenosis, ectropion, entropion, erythema, madarosis, symblepharon, telangiectasis, thickening, and trichiasis.

LSO CONSIDER: Neuropathy: cranial – Select.

Glaucoma Glaucoma Elevated intraocular

pressure (EIOP) with

single topical agent for

intervention; no visual

field deficit

EIOP causing early visual

field deficit (i.e., nasal

step or arcuate deficit);

multiple topical or oral

agents indicated

EIOP causing marked

visual field deficits (i.e.,

involving both superior

and inferior visual fields);

operative intervention

indicated

EIOP resulting in

blindness (20/200 or

worse); enucleation

indicated

—

Keratitis (corneal

inflammation/corneal

ulceration)

Keratitis Abnormal ophthalmologic

changes only;

intervention not indicated

Symptomatic and

interfering with function,

but not interfering with

ADL

Symptomatic and

interfering with ADL;

operative intervention

indicated

Perforation or blindness

(20/200 or worse)

—

NAVIGATION NOTE: Ocular muscle weakness is graded as Muscle weakness, generalized or specific area (not due to neuropathy) – Select in the MUSCULOSKELETAL/SOFT TISSUE

CATEGORY.

Night blindness

(nyctalopia)

Nyctalopia Symptomatic, not

interfering with function

Symptomatic and

interfering with function

but not interfering with

ADL

Symptomatic and

interfering with ADL

Disabling —

OCULAR/VISUAL Page 2 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 53 - March 31, 2003, Publish Date: August 9, 2006

Nystagmus Nystagmus Asymptomatic Symptomatic and

interfering with function

but not interfering with

ADL

Symptomatic and

interfering with ADL

Disabling —

ALSO CONSIDER: Neuropathy: cranial – Select; Ophthalmoplegia/diplopia (double vision).

Ocular surface disease Ocular surface disease Asymptomatic or

minimally symptomatic

but not interfering with

function

Symptomatic, interfering

with function but not

interfering with ADL;

topical antibiotics or other

topical intervention

indicated

Symptomatic, interfering

with ADL; operative

intervention indicated

— —

REMARK: Ocular surface disease includes conjunctivitis, keratoconjunctivitis sicca, chemosis, keratinization, and palpebral conjunctival epithelial metaplasia.

Ophthalmoplegia/

diplopia (double vision)

Diplopia Intermittently

symptomatic, intervention

not indicated

Symptomatic and

interfering with function

but not interfering with

ADL

Symptomatic and

interfering with ADL;

surgical intervention

indicated

Disabling —

ALSO CONSIDER: Neuropathy: cranial – Select.

Optic disc edema Optic disc edema Asymptomatic Decreased visual acuity

(20/40 or better); visual

field defect present

Decreased visual acuity

(worse than 20/40);

marked visual field defect

but sparing the central 20

degrees

Blindness

(20/200 or worse)

—

ALSO CONSIDER: Neuropathy: cranial – Select.

Proptosis/enophthalmos Proptosis/enophthalmos Asymptomatic,

intervention not indicated

Symptomatic and

interfering with function,

but not interfering with

ADL

Symptomatic and

interfering with ADL

— —

Retinal detachment Retinal detachment Exudative; no central

vision loss; intervention

not indicated

Exudative and visual

acuity 20/40 or better but

intervention not indicated

Rhegmatogenous or

exudative detachment;

operative intervention

indicated

Blindness

(20/200 or worse)

—

Retinopathy Retinopathy Asymptomatic Symptomatic with

moderate decrease in

visual acuity

(20/40 or better)

Symptomatic with marked

decrease in visual acuity

(worse than 20/40)

Blindness

(20/200 or worse)

—

OCULAR/VISUAL Page 3 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 54 - March 31, 2003, Publish Date: August 9, 2006

Scleral necrosis/melt Scleral necrosis Asymptomatic or

symptomatic but not

interfering with function

Symptomatic, interfering

with function but not

interfering with ADL;

moderate decrease in

visual acuity (20/40 or

better); medical

intervention indicated

Symptomatic, interfering

with ADL; marked

decrease in visual acuity

(worse than 20/40);

operative intervention

indicated

Blindness (20/200 or

worse); painful eye with

enucleation indicated

—

Uveitis Uveitis Asymptomatic Anterior uveitis; medical

intervention indicated

Posterior or pan-uveitis;

operative intervention

indicated

Blindness

(20/200 or worse)

—

Vision-blurred vision Blurred vision Symptomatic not

interfering with function

Symptomatic and

interfering with function,

but not interfering with

ADL

Symptomatic and

interfering with ADL

Disabling —

Vision-flashing

lights/floaters

Flashing lights Symptomatic not

interfering with function

Symptomatic and

interfering with function,

but not interfering with

ADL

Symptomatic and

interfering with ADL

Disabling —

Vision-photophobia Photophobia Symptomatic not

interfering with function

Symptomatic and

interfering with function,

but not interfering with

ADL

Symptomatic and

interfering with ADL

Disabling —

Vitreous hemorrhage Vitreous hemorrhage Asymptomatic, clinical

findings only

Symptomatic, interfering

with function, but not

interfering with ADL;

intervention not indicated

Symptomatic, interfering

with ADL; vitrectomy

indicated

— —

Watery eye (epiphora,

tearing)

Watery eye Symptomatic, intervention

not indicated

Symptomatic, interfering

with function but not

interfering with ADL

Symptomatic, interfering

with ADL

— —

Ocular/Visual – Other

(Specify, __)

Ocular – Other

(Specify)

Symptomatic not

interfering with function

Symptomatic and

interfering with function,

but not interfering with

ADL

Symptomatic and

interfering with ADL

Blindness

(20/200 or worse)

Death

PAIN Page 1 of 1

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 55 - March 31, 2003, Publish Date: August 9, 2006

Pain

– Select:

‘Select’ AEs appear at the

end of the CATEGORY.

Pain – Select Mild pain not interfering

with function

Moderate pain; pain or

analgesics interfering with

function, but not

interfering with ADL

Severe pain; pain or

analgesics severely

interfering with ADL

Disabling —

Pain – Other

(Specify, __)

Pain – Other (Specify) Mild pain not interfering

with function

Moderate pain; pain or

analgesics interfering with

function, but not

interfering with ADL

Severe pain; pain or

analgesics severely

interfering with ADL

Disabling —

PAIN – SELECT

AUDITORY/EAR

– External ear

– Middle ear

CARDIOVASCULAR

– Cardiac/heart

– Pericardium

DERMATOLOGY/SKIN

– Face

– Lip

– Oral-gums

– Scalp

– Skin

GASTROINTESTINAL

– Abdomen NOS

– Anus

– Dental/teeth/peridontal

– Esophagus

– Oral cavity

– Peritoneum

– Rectum

– Stomach

GENERAL

– Pain NOS

– Tumor pain

HEPATOBILIARY/PANCREAS

– Gallbladder

– Liver

LYMPHATIC

– Lymph node

MUSCULOSKELETAL

– Back

– Bone

– Buttock

– Extremity-limb

– Intestine

– Joint

– Muscle

– Neck

– Phantom (pain associated with missing limb)

NEUROLOGY

– Head/headache

– Neuralgia/peripheral nerve

OCULAR

– Eye

PULMONARY/UPPER RESPIRATORY

– Chest wall

– Chest/thorax NOS

PULMONARY/UPPER RESPIRATORY

(continued)

– Larynx

– Pleura

– Sinus

– Throat/pharynx/larynx

RENAL/GENITOURINARY

– Bladder

– Kidney

SEXUAL/REPRODUCTIVE FUNCTION

– Breast

– Ovulatory

– Pelvis

– Penis

– Perineum

– Prostate

– Scrotum

– Testicle

– Urethra

– Uterus

– Vagina

PULMONARY/UPPER RESPIRATORY Page 1 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 56 - March 31, 2003, Publish Date: August 9, 2006

Adult Respiratory

Distress Syndrome

(ARDS)

ARDS — — Present, intubation not

indicated

Present, intubation

indicated

Death

ALSO CONSIDER: Dyspnea (shortness of breath); Hypoxia; Pneumonitis/pulmonary infiltrates.

Aspiration Aspiration Asymptomatic (“silent

aspiration”); endoscopy

or radiographic (e.g.,

barium swallow) findings

Symptomatic (e.g.,

altered eating habits,

coughing or choking

episodes consistent with

aspiration); medical

intervention indicated

(e.g., antibiotics, suction

or oxygen)

Clinical or radiographic

signs of pneumonia or

pneumonitis; unable to

aliment orally

Life-threatening (e.g.,

aspiration pneumonia or

pneumonitis)

Death

ALSO CONSIDER: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10

/L) – Select; Infection with normal ANC or Grade 1 or 2 neutrophils

– Select; Infection with unknown ANC – Select; Laryngeal nerve dysfunction; Neuropathy: cranial – Select; Pneumonitis/pulmonary infiltrates.

Atelectasis Atelectasis Asymptomatic Symptomatic (e.g.,

dyspnea, cough), medical

intervention indicated

(e.g., bronchoscopic

suctioning, chest

physiotherapy,

suctioning)

Operative (e.g., stent,

laser) intervention

indicated

Life-threatening

respiratory compromise

Death

ALSO CONSIDER: Adult Respiratory Distress Syndrome (ARDS); Cough; Dyspnea (shortness of breath); Hypoxia; Infection (documented clinically or microbiologically) with Grade 3 or 4

neutrophils (ANC <1.0 x 109/L) – Select; Infection with normal ANC or Grade 1 or 2 neutrophils – Select; Infection with unknown ANC – Select; Obstruction/stenosis of airway –

Select; Pneumonitis/pulmonary infiltrates; Pulmonary fibrosis (radiographic changes).

Bronchospasm,

wheezing

Bronchospasm Asymptomatic Symptomatic not

interfering with function

Symptomatic interfering

with function

Life-threatening Death

ALSO CONSIDER: Allergic reaction/hypersensitivity (including drug fever); Dyspnea (shortness of breath).

Carbon monoxide

diffusion capacity (DL

)

90 – 75% of predicted

value

<75 – 50% of predicted

value

<50 – 25% of predicted

value

<25% of predicted value Death

ALSO CONSIDER: Hypoxia; Pneumonitis/pulmonary infiltrates; Pulmonary fibrosis (radiographic changes).

Chylothorax Chylothorax Asymptomatic Symptomatic;

thoracentesis or tube

drainage indicated

Operative intervention

indicated

Life-threatening (e.g.,

hemodynamic instability

or ventilatory support

indicated)

Death

Cough Cough Symptomatic, non-

narcotic medication only

indicated

Symptomatic and

narcotic medication

indicated

Symptomatic and

significantly interfering

with sleep or ADL

— —

PULMONARY/UPPER RESPIRATORY Page 2 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 57 - March 31, 2003, Publish Date: August 9, 2006

Dyspnea (shortness of

breath)

Dyspnea Dyspnea on exertion, but

can walk 1 flight of stairs

without stopping

Dyspnea on exertion but

unable to walk 1 flight of

stairs or 1 city block

(0.1km) without stopping

Dyspnea with ADL Dyspnea at rest;

intubation/ventilator

indicated

Death

ALSO CONSIDER: Hypoxia; Neuropathy: motor; Pneumonitis/pulmonary infiltrates; Pulmonary fibrosis (radiographic changes).

Edema, larynx Edema, larynx Asymptomatic edema by

exam only

Symptomatic edema, no

respiratory distress

Stridor; respiratory

distress; interfering with

ADL

Life-threatening airway

compromise;

tracheotomy, intubation,

or laryngectomy indicated

Death

ALSO CONSIDER: Allergic reaction/hypersensitivity (including drug fever).

FEV

90 – 75% of predicted

value

<75 – 50% of predicted

value

<50 – 25% of predicted

value

<25% of predicted Death

Fistula, pulmonary/upper

respiratory

– Select:

– Bronchus

– Larynx

– Lung

– Oral cavity

– Pharynx

– Pleura

– Trachea

Fistula, pulmonary

– Select

Asymptomatic,

radiographic findings only

Symptomatic, tube

thoracostomy or medical

management indicated;

associated with altered

respiratory function but

not interfering with ADL

Symptomatic and

associated with altered

respiratory function

interfering with ADL; or

endoscopic (e.g., stent)

or primary closure by

operative intervention

indicated

Life-threatening

consequences; operative

intervention with

thoracoplasty, chronic

open drainage or multiple

thoracotomies indicated

Death

REMARK: A fistula is defined as an abnormal communication between two body cavities, potential spaces, and/or the skin. The site indicated for a fistula should be the site from which

the abnormal process is believed to have arisen. For example, a tracheo-esophageal fistula arising in the context of a resected or irradiated esophageal cancer should be graded as

Fistula, GI – esophagus in the GASTROINTESTINAL CATEGORY.

NAVIGATION NOTE: Hemoptysis is graded as Hemorrhage, pulmonary/upper respiratory – Select in the HEMORRHAGE/BLEEDING CATEGORY.

Hiccoughs (hiccups,

singultus)

Hiccoughs Symptomatic,

intervention not indicated

Symptomatic,

intervention indicated

Symptomatic,

significantly interfering

with sleep or ADL

— —

Hypoxia Hypoxia — Decreased O

saturation

with exercise (e.g., pulse

oximeter <88%);

intermittent supplemental

oxygen

Decreased O

saturation

at rest; continuous

oxygen indicated

Life-threatening;

intubation or ventilation

indicated

Death

PULMONARY/UPPER RESPIRATORY Page 3 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 58 - March 31, 2003, Publish Date: August 9, 2006

Nasal cavity/paranasal

sinus reactions

Nasal/paranasal

reactions

Asymptomatic mucosal

crusting, blood-tinged

secretions

Symptomatic stenosis or

edema/narrowing

interfering with airflow

Stenosis with significant

nasal obstruction;

interfering with ADL

Necrosis of soft tissue or

bone

Death

ALSO CONSIDER: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10

/L) – Select; Infection with normal ANC or Grade 1 or 2 neutrophils

– Select; Infection with unknown ANC – Select.

Obstruction/stenosis of

airway

– Select:

– Bronchus

– Larynx

– Pharynx

– Trachea

Airway obstruction

– Select

Asymptomatic obstruction

or stenosis on exam,

endoscopy, or radiograph

Symptomatic (e.g., noisy

airway breathing), but

causing no respiratory

distress; medical

management indicated

(e.g., steroids)

Interfering with ADL;

stridor or endoscopic

intervention indicated

(e.g., stent, laser)

Life-threatening airway

compromise; tracheotomy

or intubation indicated

Death

Pleural effusion

(non-malignant)

Pleural effusion Asymptomatic Symptomatic,

intervention such as

diuretics or up to 2

therapeutic

thoracenteses indicated

Symptomatic and

supplemental oxygen,

>2 therapeutic

thoracenteses, tube

drainage, or pleurodesis

indicated

Life-threatening (e.g.,

causing hemodynamic

instability or ventilatory

support indicated)

Death

ALSO CONSIDER: Atelectasis; Cough; Dyspnea (shortness of breath); Hypoxia; Pneumonitis/pulmonary infiltrates; Pulmonary fibrosis (radiographic changes).

NAVIGATION NOTE: Pleuritic pain is graded as Pain – Select in the PAIN CATEGORY.

Pneumonitis/pulmonary

infiltrates

Pneumonitis Asymptomatic,

radiographic findings only

Symptomatic, not

interfering with ADL

Symptomatic, interfering

with ADL; O

indicated

Life-threatening;

ventilatory support

indicated

Death

ALSO CONSIDER: Adult Respiratory Distress Syndrome (ARDS); Cough; Dyspnea (shortness of breath); Hypoxia; Infection (documented clinically or microbiologically) with Grade 3 or 4

neutrophils (ANC <1.0 x 10

/L) – Select; Infection with normal ANC or Grade 1 or 2 neutrophils – Select; Infection with unknown ANC – Select; Pneumonitis/pulmonary infiltrates;

Pulmonary fibrosis (radiographic changes).

Pneumothorax Pneumothorax Asymptomatic,

radiographic findings only

Symptomatic;

intervention indicated

(e.g., hospitalization for

observation, tube

placement without

sclerosis)

Sclerosis and/or

operative intervention

indicated

Life-threatening, causing

hemodynamic instability

(e.g., tension

pneumothorax);

ventilatory support

indicated

Death

Prolonged chest tube

drainage or air leak after

pulmonary resection

Chest tube drainage or

leak

— Sclerosis or additional

tube thoracostomy

indicated

Operative intervention

indicated (e.g.,

thoracotomy with stapling

or sealant application)

Life-threatening;

debilitating; organ

resection indicated

Death

PULMONARY/UPPER RESPIRATORY Page 4 of 4

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 59 - March 31, 2003, Publish Date: August 9, 2006

Prolonged intubation

after pulmonary resection

(>24 hrs after surgery)

Prolonged intubation — Extubated within

24 – 72 hrs

postoperatively

Extubated >72 hrs

postoperatively, but

before tracheostomy

indicated

Tracheostomy indicated Death

NAVIGATION NOTE: Pulmonary embolism is graded as Grade 4 either as Thrombosis/embolism (vascular access-related) or Thrombosis/thrombus/embolism in the VASCULAR

CATEGORY.

Pulmonary fibrosis

(radiographic changes)

Pulmonary fibrosis Minimal radiographic

findings (or patchy or bi-

basilar changes) with

estimated radiographic

proportion of total lung

volume that is fibrotic of

<25%

Patchy or bi-basilar

changes with estimated

radiographic proportion of

total lung volume that is

fibrotic of 25 – <50%

Dense or widespread

infiltrates/consolidation

with estimated

radiographic proportion of

total lung volume that is

fibrotic of 50 – <75%

Estimated radiographic

proportion of total lung

volume that is fibrotic is

≥75%; honeycombing

Death

REMARK: Fibrosis is usually a “late effect” seen >3 months after radiation or combined modality therapy (including surgery). It is thought to represent scar/fibrotic lung tissue. It may be

difficult to distinguish from pneumonitis that is generally seen within 3 months of radiation or combined modality therapy.

LSO CONSIDER: Adult Respiratory Distress Syndrome (ARDS); Cough; Dyspnea (shortness of breath); Hypoxia; Infection (documented clinically or microbiologically) with Grade 3 or 4

neutrophils (ANC <1.0 x 10

/L) – Select; Infection with normal ANC or Grade 1 or 2 neutrophils – Select; Infection with unknown ANC – Select.

NAVIGATION NOTE: Recurrent laryngeal nerve dysfunction is graded as Laryngeal nerve dysfunction in the NEUROLOGY CATEGORY.

Vital capacity Vital capacity 90 – 75% of predicted

value

<75 – 50% of predicted

value

<50 – 25% of predicted

value

<25% of predicted value Death

Voice changes/dysarthria

(e.g., hoarseness, loss or

alteration in voice,

laryngitis)

Voice changes Mild or intermittent

hoarseness or voice

change, but fully

understandable

Moderate or persistent

voice changes, may

require occasional

repetition but

understandable on

telephone

Severe voice changes

including predominantly

whispered speech; may

require frequent repetition

or face-to-face contact for

understandability;

requires voice aid (e.g.,

electrolarynx) for ≤50% of

communication

Disabling;

non-understandable voice

or aphonic; requires voice

aid (e.g., electrolarynx)

for >50% of

communication or

requires >50% written

communication

Death

ALSO CONSIDER: Laryngeal nerve dysfunction; Speech impairment (e.g., dysphasia or aphasia).

Pulmonary/Upper

Respiratory – Other

(Specify, __)

Pulmonary – Other

(Specify)

Mild Moderate Severe Life-threatening;

disabling

Death

RENAL/GENITOURINARY Page 1 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 60 - March 31, 2003, Publish Date: August 9, 2006

Bladder spasms Bladder spasms Symptomatic, intervention

not indicated

Symptomatic,

antispasmodics indicated

Narcotics indicated Major surgical

intervention indicated

(e.g., cystectomy)

—

Cystitis Cystitis Asymptomatic Frequency with dysuria;

macroscopic hematuria

Transfusion; IV pain

medications; bladder

irrigation indicated

Catastrophic bleeding;

major non-elective

intervention indicated

Death

ALSO CONSIDER: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 109/L) – Select; Infection with normal ANC or Grade 1 or 2 neutrophils

– Select; Infection with unknown ANC – Select; Pain – Select.

Fistula, GU

– Select:

– Bladder

– Genital tract-female

– Kidney

– Ureter

– Urethra

– Uterus

– Vagina

Fistula, GU – Select Asymptomatic,

radiographic findings only

Symptomatic;

noninvasive intervention

indicated

Symptomatic interfering

with ADL; invasive

intervention indicated

Life-threatening

consequences; operative

intervention requiring

partial or full organ

resection; permanent

urinary diversion

Death

REMARK: A fistula is defined as an abnormal communication between two body cavities, potential spaces, and/or the skin. The site indicated for a fistula should be the site from which

the abnormal process is believed to have originated.

Incontinence, urinary Incontinence, urinary Occasional (e.g., with

coughing, sneezing, etc.),

pads not indicated

Spontaneous, pads

indicated

Interfering with ADL;

intervention indicated

(e.g., clamp, collagen

injections)

Operative intervention

indicated (e.g.,

cystectomy or permanent

urinary diversion)

—

Leak (including

anastomotic), GU

– Select:

– Bladder

– Fallopian tube

– Kidney

– Spermatic cord

– Stoma

– Ureter

– Urethra

– Uterus

– Vagina

– Vas deferens

Leak, GU – Select Asymptomatic,

radiographic findings only

Symptomatic; medical

intervention indicated

Symptomatic, interfering

with GU function; invasive

or endoscopic

intervention indicated

Life-threatening Death

REMARK: Leak (including anastomotic), GU – Select refers to clinical signs and symptoms or radiographic confirmation of anastomotic leak but without development of fistula.

RENAL/GENITOURINARY Page 2 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 61 - March 31, 2003, Publish Date: August 9, 2006

Obstruction, GU

– Select:

– Bladder

– Fallopian tube

– Prostate

– Spermatic cord

– Stoma

– Testes

– Ureter

– Urethra

– Uterus

– Vagina

– Vas deferens

Obstruction, GU – Select Asymptomatic,

radiographic or

endoscopic findings only

Symptomatic but no

hydronephrosis, sepsis or

renal dysfunction; dilation

or endoscopic repair or

stent placement indicated

Symptomatic and altered

organ function (e.g.,

sepsis or hydronephrosis,

or renal dysfunction);

operative intervention

indicated

Life-threatening

consequences; organ

failure or operative

intervention requiring

complete organ resection

indicated

Death

NAVIGATION NOTE: Operative injury is graded as Intra-operative injury – Select Organ or Structure in the SURGERY/INTRA-OPERATIVE INJURY CATEGORY.

Perforation, GU

– Select:

– Bladder

– Fallopian tube

– Kidney

– Ovary

– Prostate

– Spermatic cord

– Stoma

– Testes

– Ureter

– Urethra

– Uterus

– Vagina

– Vas deferens

Perforation, GU – Select Asymptomatic

radiographic findings only

Symptomatic, associated

with altered renal/GU

function

Symptomatic, operative

intervention indicated

Life-threatening

consequences or organ

failure; operative

intervention requiring

organ resection indicated

Death

Prolapse of stoma, GU Prolapse stoma, GU Asymptomatic; special

intervention,

extraordinary care not

indicated

Extraordinary local care

or maintenance; minor

revision under local

anesthesia indicated

Dysfunctional stoma;

operative intervention or

major stomal revision

indicated

Life-threatening

consequences

Death

REMARK: Other stoma complications may be graded as Fistula, GU – Select; Leak (including anastomotic), GU – Select; Obstruction, GU – Select; Perforation, GU – Select;

Stricture/stenosis (including anastomotic), GU – Select.

Renal failure Renal failure — — Chronic dialysis not

indicated

Chronic dialysis or renal

transplant indicated

Death

ALSO CONSIDER: Glomerular filtration rate.

RENAL/GENITOURINARY Page 3 of 3

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 62 - March 31, 2003, Publish Date: August 9, 2006

Stricture/stenosis

(including anastomotic),

– Select:

– Bladder

– Fallopian tube

– Prostate

– Spermatic cord

– Stoma

– Testes

– Ureter

– Urethra

– Uterus

– Vagina

– Vas deferens

Stricture, anastomotic,

GU – Select

Asymptomatic,

radiographic or

endoscopic findings only

Symptomatic but no

hydronephrosis, sepsis or

renal dysfunction; dilation

or endoscopic repair or

stent placement indicated

Symptomatic and altered

organ function (e.g.,

sepsis or hydronephrosis,

or renal dysfunction);

operative intervention

indicated

Life-threatening

consequences; organ

failure or operative

intervention requiring

organ resection indicated

Death

ALSO CONSIDER: Obstruction, GU – Select.

Urinary electrolyte

wasting (e.g., Fanconi’s

syndrome, renal tubular

acidosis)

Urinary electrolyte

wasting

Asymptomatic,

intervention not indicated

Mild, reversible and

manageable with

replacement

Irreversible, requiring

continued replacement

— —

ALSO CONSIDER: Acidosis (metabolic or respiratory); Bicarbonate, serum-low; Calcium, serum-low (hypocalcemia); Phosphate, serum-low (hypophosphatemia).

Urinary

frequency/urgency

Urinary frequency Increase in frequency or

nocturia up to 2 x normal;

enuresis

Increase >2 x normal but

<hourly

≥1 x/hr; urgency; catheter

indicated

— —

Urinary retention

(including neurogenic

bladder)

Urinary retention Hesitancy or dribbling, no

significant residual urine;

retention occurring during

the immediate

postoperative period

Hesitancy requiring

medication; or operative

bladder atony requiring

indwelling catheter

beyond immediate

postoperative period but

for <6 weeks

More than daily

catheterization indicated;

urological intervention

indicated (e.g., TURP,

suprapubic tube,

urethrotomy)

Life-threatening

consequences; organ

failure (e.g., bladder

rupture); operative

intervention requiring

organ resection indicated

Death

REMARK: The etiology of retention (if known) is graded as Obstruction, GU – Select; Stricture/stenosis (including anastomotic), GU – Select.

LSO CONSIDER: Obstruction, GU – Select; Stricture/stenosis (including anastomotic), GU – Select.

Urine color change Urine color change Present — — — —

REMARK: Urine color refers to change that is not related to other dietary or physiologic cause (e.g., bilirubin, concentrated urine, and hematuria).

Renal/Genitourinary –

Other (Specify, __)

Renal – Other (Specify) Mild Moderate Severe Life-threatening; disabling Death

SECONDARY MALIGNANCY Page 1 of 1

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 63 - March 31, 2003, Publish Date: August 9, 2006

Secondary Malignancy –

possibly related to cancer

treatment (Specify, __)

Secondary Malignancy

(possibly related to

cancer treatment)

— — Non-life-threatening basal

or squamous cell

carcinoma of the skin

Solid tumor, leukemia or

lymphoma

Death

REMARK: Secondary malignancy excludes metastasis from initial primary. Any malignancy possibly related to cancer treatment (including AML/MDS) should be reported via the routine

reporting mechanisms outlined in each protocol. Important: Secondary Malignancy is an exception to NCI Expedited Adverse Event Reporting Guidelines. Secondary Malignancy is

“Grade 4, present” but NCI does not require AdEERS Expedited Reporting for any (related or unrelated to treatment) Secondary Malignancy. A diagnosis of AML/MDS following

treatment with an NCI-sponsored investigational agent is to be reported using the form available from the CTEP Web site at http://ctep.cancer.gov. Cancers not suspected of being

treatment-related are not to be reported here.

SEXUAL/REPRODUCTIVE FUNCTION Page 1 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 64 - March 31, 2003, Publish Date: August 9, 2006

Breast function/lactation Breast function Mammary abnormality,

not functionally significant

Mammary abnormality,

functionally significant

— — —

Breast nipple/areolar

deformity

Nipple/areolar Limited areolar

asymmetry with no

change in nipple/areolar

projection

Asymmetry of nipple

areolar complex with

slight deviation in nipple

projection

Marked deviation of

nipple projection

— —

Breast volume/hypoplasia Breast Minimal asymmetry;

minimal hypoplasia

Asymmetry exists, ≤1/3 of

the breast volume;

moderate hypoplasia

Asymmetry exists, >1/3 of

the breast volume; severe

hypoplasia

— —

REMARK: Breast volume is referenced with both arms straight overhead.

NAVIGATION NOTE: Dysmenorrhea is graded as Pain – Select in the PAIN CATEGORY.

NAVIGATION NOTE: Dyspareunia is graded as Pain – Select in the PAIN CATEGORY.

NAVIGATION NOTE: Dysuria (painful urination) is graded as Pain – Select in the PAIN CATEGORY.

Erectile dysfunction Erectile dysfunction Decrease in erectile

function

(frequency/rigidity of

erections) but erectile

aids not indicated

Decrease in erectile

function

(frequency/rigidity of

erections), erectile aids

indicated

Decrease in erectile

function

(frequency/rigidity of

erections) but erectile

aids not helpful; penile

prosthesis indicated

— —

Ejaculatory dysfunction Ejaculatory dysfunction Diminished ejaculation Anejaculation or

retrograde ejaculation

— — —

NAVIGATION NOTE: Feminization of male is graded in the ENDOCRINE CATEGORY.

Gynecomastia Gynecomastia — Asymptomatic breast

enlargement

Symptomatic breast

enlargement; intervention

indicated

— —

ALSO CONSIDER: Pain – Select.

Infertility/sterility Infertility/sterility — Male: oligospermia/low

sperm count

Female: diminished

fertility/ovulation

Male: sterile/azoospermia

Female: infertile/

anovulatory

— —

Irregular menses

(change from baseline)

Irregular menses 1 – 3 months without

menses

>3 – 6 months without

menses but continuing

menstrual cycles

Persistent amenorrhea

for >6 months

— —

SEXUAL/REPRODUCTIVE FUNCTION Page 2 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 65 - March 31, 2003, Publish Date: August 9, 2006

Libido Libido Decrease in interest but

not affecting relationship;

intervention not indicated

Decrease in interest and

adversely affecting

relationship; intervention

indicated

— — —

NAVIGATION NOTE: Masculinization of female is graded in the ENDOCRINE CATEGORY.

Orgasmic dysfunction Orgasmic function Transient decrease Decrease in orgasmic

response requiring

intervention

Complete inability of

orgasmic response; not

responding to intervention

— —

NAVIGATION NOTE: Pelvic pain is graded as Pain – Select in the PAIN CATEGORY.

NAVIGATION NOTE: Ulcers of the labia or perineum are graded as Ulceration in DERMATOLOGY/SKIN CATEGORY.

Vaginal discharge

(non-infectious)

Vaginal discharge Mild Moderate to heavy; pad

use indicated

— — —

Vaginal dryness Vaginal dryness Mild Interfering with sexual

function; dyspareunia;

intervention indicated

— — —

ALSO CONSIDER: Pain – Select.

Vaginal mucositis Vaginal mucositis Erythema of the mucosa;

minimal symptoms

Patchy ulcerations;

moderate symptoms or

dyspareunia

Confluent ulcerations;

bleeding with trauma;

unable to tolerate vaginal

exam, sexual intercourse

or tampon placement

Tissue necrosis;

significant spontaneous

bleeding; life-threatening

consequences

—

Vaginal stenosis/length Vaginal stenosis Vaginal narrowing and/or

shortening not interfering

with function

Vaginal narrowing and/or

shortening interfering with

function

Complete obliteration; not

surgically correctable

— —

Vaginitis (not due to

infection)

Vaginitis Mild, intervention not

indicated

Moderate, intervention

indicated

Severe, not relieved with

treatment; ulceration, but

operative intervention not

indicated

Ulceration and operative

intervention indicated

—

Sexual/Reproductive

Function – Other

(Specify, __)

Sexual – Other (Specify) Mild Moderate Severe Disabling Death

SURGERY/INTRA-OPERATIVE INJURY Page 1 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 66 - March 31, 2003, Publish Date: August 9, 2006

NAVIGATION NOTE: Intra-operative hemorrhage is graded as Hemorrhage/bleeding associated with surgery, intra-operative or postoperative in the HEMORRHAGE/BLEEDING

CATEGORY.

Intra-operative injury

– Select Organ or

Structure

‘Select’ AEs appear at the

end of the CATEGORY.

Intraop injury – Select Primary repair of injured

organ/structure indicated

Partial resection of

injured organ/structure

indicated

Complete resection or

reconstruction of injured

organ/structure indicated

Life threatening

consequences; disabling

—

REMARK: The ‘Select’ AEs are defined as significant, unanticipated injuries that are recognized at the time of surgery. These AEs do not refer to additional surgical procedures that

must be performed because of a change in the operative plan based on intra-operative findings. Any sequelae resulting from the intra-operative injury that result in an adverse

outcome for the patient must also be recorded and graded under the relevant CTCAE Term.

Intra-operative Injury –

Other (Specify, __)

Intraop Injury – Other

(Specify)

Primary repair of injured

organ/structure indicated

Partial resection of

injured organ/structure

indicated

Complete resection or

reconstruction of injured

organ/structure indicated

Life threatening

consequences; disabling

—

REMARK: Intra-operative Injury – Other (Specify, __) is to be used only to report an organ/structure not included in the ‘Select’ AEs found at the end of the CATEGORY. Any sequelae

resulting from the intra-operative injury that result in an adverse outcome for the patient must also be recorded and graded under the relevant CTCAE Term.

SURGERY/INTRA-OPERATIVE INJURY – SELECT Page 2 of 2

CTCAE v3.0 - 67 - March 31, 2003, Publish Date: August 9, 2006

AUDITORY/EAR

– Inner ear

– Middle ear

– Outer ear NOS

– Outer ear-Pinna

CARDIOVASCULAR

– Artery-aorta

– Artery-carotid

– Artery-cerebral

– Artery-extremity (lower)

– Artery-extremity (upper)

– Artery-hepatic

– Artery-major visceral artery

– Artery-pulmonary

– Artery NOS

– Heart

– Spleen

– Vein-extremity (lower)

– Vein-extremity (upper)

– Vein-hepatic

– Vein-inferior vena cava

– Vein-jugular

– Vein-major visceral vein

– Vein-portal vein

– Vein-pulmonary

– Vein-superior vena cava

– Vein NOS

DERMATOLOGY/SKIN

– Breast

– Nails

– Skin

ENDOCRINE

– Adrenal gland

– Parathyroid

– Pituitary

ENDOCRINE

(continued)

– Thyroid

HEAD AND NECK

– Gingiva

– Larynx

– Lip/perioral area

– Face NOS

– Nasal cavity

– Nasopharynx

– Neck NOS

– Nose

– Oral cavity NOS

– Parotid gland

– Pharynx

– Salivary duct

– Salivary gland

– Sinus

– Teeth

– Tongue

– Upper aerodigestive NOS

GASTROINTESTINAL

– Abdomen NOS

– Anal sphincter

– Anus

– Appendix

– Cecum

– Colon

– Duodenum

– Esophagus

– Ileum

– Jejunum

– Oral

– Peritoneal cavity

– Rectum

– Small bowel NOS

GASTROINTESTINAL

(continued)

– Stoma (GI)

– Stomach

HEPATOBILIARY/ PANCREAS

– Biliary tree-common bile

duct

– Biliary tree-common hepatic

duct

– Biliary tree-left hepatic duct

– Biliary tree-right hepatic duct

– Biliary tree NOS

– Gallbladder

– Liver

– Pancreas

– Pancreatic duct

MUSCULOSKELETAL

– Bone

– Cartilage

– Extremity-lower

– Extremity-upper

– Joint

– Ligament

– Muscle

– Soft tissue NOS

– Tendon

NEUROLOGY

– Brain

– Meninges

– Spinal cord

NERVES:

– Brachial plexus

– CN I (olfactory)

– CN II (optic)

– CN III (oculomotor)

– CN IV (trochlear)

NEUROLOGY

(continued)

NERVES:

– CN V (trigeminal) motor

– CN V (trigeminal) sensory

– CN VI (abducens)

– CN VII (facial) motor-face

– CN VII (facial) sensory-

taste

– CN VIII (vestibulocochlear)

– CN IX (glossopharyngeal)

motor pharynx

– CN IX (glossopharyngeal)

sensory ear-pharynx-

tongue

– CN X (vagus)

– CN XI (spinal accessory)

– CN XII (hypoglossal)

– Cranial nerve or branch

NOS

– Lingual

– Lung thoracic

– Peripheral motor NOS

– Peripheral sensory NOS

– Recurrent laryngeal

– Sacral plexus

– Sciatic

– Thoracodorsal

OCULAR

– Conjunctiva

– Cornea

– Eye NOS

– Lens

– Retina

PULMONARY/UPPER

RESPIRATORY

– Bronchus

– Lung

– Mediastinum

– Pleura

– Thoracic duct

– Trachea

– Upper airway NOS

RENAL/GENITOURINARY

– Bladder

– Cervix

– Fallopian tube

– Kidney

– Ovary

– Pelvis NOS

– Penis

– Prostate

– Scrotum

– Testis

– Ureter

– Urethra

– Urinary conduit

– Urinary tract NOS

– Uterus

– Vagina

– Vulva

SYNDROMES Page 1 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 68 - March 31, 2003, Publish Date: August 9, 2006

NAVIGATION NOTE: Acute vascular leak syndrome is graded in the VASCULAR CATEGORY.

NAVIGATION NOTE: Adrenal insufficiency is graded in the ENDOCRINE CATEGORY.

NAVIGATION NOTE: Adult Respiratory Distress Syndrome (ARDS) is graded in the PULMONARY/UPPER RESPIRATORY CATEGORY.

Alcohol intolerance

syndrome (antabuse-like

syndrome)

Alcohol intolerance

syndrome

— — Present — Death

REMARK: An antabuse-like syndrome occurs with some new anti-androgens (e.g., nilutamide) when patient also consumes alcohol.

NAVIGATION NOTE: Autoimmune reaction is graded as Autoimmune reaction/hypersensitivity (including drug fever) in the ALLERGY/IMMUNOLOGY CATEGORY.

Cytokine release

syndrome/acute infusion

reaction

Cytokine release

syndrome

Mild reaction; infusion

interruption not indicated;

intervention not indicated

Requires therapy or

infusion interruption but

responds promptly to

symptomatic treatment

(e.g., antihistamines,

NSAIDS, narcotics, IV

fluids); prophylactic

medications indicated

for ≤24 hrs

Prolonged (i.e., not

rapidly responsive to

symptomatic medication

and/or brief interruption of

infusion); recurrence of

symptoms following initial

improvement;

hospitalization indicated

for other clinical sequelae

(e.g., renal impairment,

pulmonary infiltrates)

Life-threatening; pressor

or ventilatory support

indicated

Death

REMARK: Cytokine release syndromes/acute infusion reactions are different from Allergic/hypersensitive reactions, although some of the manifestations are common to both AEs. An

acute infusion reaction may occur with an agent that causes cytokine release (e.g., monoclonal antibodies or other biological agents). Signs and symptoms usually develop during or

shortly after drug infusion and generally resolve completely within 24 hrs of completion of infusion. Signs/symptoms may include: Allergic reaction/hypersensitivity (including drug

fever); Arthralgia (joint pain); Bronchospasm; Cough; Dizziness; Dyspnea (shortness of breath); Fatigue (asthenia, lethargy, malaise); Headache; Hypertension; Hypotension; Myalgia

(muscle pain); Nausea; Pruritis/itching; Rash/desquamation; Rigors/chills; Sweating (diaphoresis); Tachycardia; Tumor pain (onset or exacerbation of tumor pain due to treatment);

Urticaria (hives, welts, wheals); Vomiting.

LSO CONSIDER: Allergic reaction/hypersensitivity (including drug fever); Bronchospasm, wheezing; Dyspnea (shortness of breath); Hypertension; Hypotension; Hypoxia; Prolonged

QTc interval; Supraventricular and nodal arrhythmia – Select; Ventricular arrhythmia – Select.

NAVIGATION NOTE: Disseminated intravascular coagulation (DIC) is graded in the COAGULATION CATEGORY.

NAVIGATION NOTE: Fanconi’s syndrome is graded as Urinary electrolyte wasting (e.g., Fanconi’s syndrome, renal tubular acidosis) in the RENAL/GENITOURINARY CATEGORY.

Flu-like syndrome Flu-like syndrome Symptoms present but

not interfering with

function

Moderate or causing

difficulty performing some

ADL

Severe symptoms

interfering with ADL

Disabling Death

REMARK: Flu-like syndrome represents a constellation of symptoms which may include cough with catarrhal symptoms, fever, headache, malaise, myalgia, prostration, and is to be

used when the symptoms occur in a cluster consistent with one single pathophysiological process.

NAVIGATION NOTE: Renal tubular acidosis is graded as Urinary electrolyte wasting (e.g., Fanconi’s syndrome, renal tubular acidosis) in the RENAL/GENITOURINARY CATEGORY.

SYNDROMES Page 2 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 69 - March 31, 2003, Publish Date: August 9, 2006

“Retinoic acid syndrome” “Retinoic acid syndrome” Fluid retention; less than

3 kg of weight gain;

intervention with fluid

restriction and/or diuretics

indicated

Mild to moderate signs/

symptoms; steroids

indicated

Severe signs/symptoms;

hospitalization indicated

Life-threatening;

ventilatory support

indicated

Death

REMARK: Patients with acute promyelocytic leukemia may experience a syndrome similar to “retinoic acid syndrome” in association with other agents such as arsenic trioxide. The

syndrome is usually manifested by otherwise unexplained fever, weight gain, respiratory distress, pulmonary infiltrates and/or pleural effusion, with or without leukocytosis.

LSO CONSIDER: Acute vascular leak syndrome; Pleural effusion (non-malignant); Pneumonitis/pulmonary infiltrates.

NAVIGATION NOTE: SIADH is graded as Neuroendocrine: ADH secretion abnormality (e.g., SIADH or low ADH) in the ENDOCRINE CATEGORY.

NAVIGATION NOTE: Stevens-Johnson syndrome is graded as Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) in the DERMATOLOGY/SKIN

CATEGORY.

NAVIGATION NOTE: Thrombotic microangiopathy is graded as Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) in

the COAGULATION CATEGORY.

Tumor flare Tumor flare Mild pain not interfering

with function

Moderate pain; pain or

analgesics interfering with

function, but not

interfering with ADL

Severe pain; pain or

analgesics interfering with

function and interfering

with ADL

Disabling Death

REMARK: Tumor flare is characterized by a constellation of signs and symptoms 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.

LSO CONSIDER: Calcium, serum-high (hypercalcemia).

Tumor lysis syndrome Tumor lysis syndrome — — Present — Death

ALSO CONSIDER: Creatinine; Potassium, serum-high (hyperkalemia).

Syndromes – Other

(Specify, __)

Syndromes – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death

VASCULAR Page 1 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 70 - March 31, 2003, Publish Date: August 9, 2006

Acute vascular leak

syndrome

Acute vascular leak

syndrome

— Symptomatic, fluid

support not indicated

Respiratory compromise

or fluids indicated

Life-threatening; pressor

support or ventilatory

support indicated

Death

Peripheral arterial

ischemia

Peripheral arterial

ischemia

— Brief (<24 hrs) episode of

ischemia managed non-

surgically and without

permanent deficit

Recurring or prolonged

(≥24 hrs) and/or invasive

intervention indicated

Life-threatening, disabling

and/or associated with

end organ damage

(e.g., limb loss)

Death

Phlebitis (including

superficial thrombosis)

Phlebitis — Present — — —

ALSO CONSIDER: Injection site reaction/extravasation changes.

Portal vein flow Portal flow — Decreased portal vein

flow

Reversal/retrograde

portal vein flow

— —

Thrombosis/embolism

(vascular access-related)

Thrombosis/embolism

(vascular access)

— Deep vein thrombosis or

cardiac thrombosis;

intervention (e.g.,

anticoagulation, lysis,

filter, invasive procedure)

not indicated

Deep vein thrombosis or

cardiac thrombosis;

intervention (e.g.,

anticoagulation, lysis,

filter, invasive procedure)

indicated

Embolic event including

pulmonary embolism or

life-threatening thrombus

Death

Thrombosis/thrombus/

embolism

Thrombosis/thrombus/

embolism

— Deep vein thrombosis or

cardiac thrombosis;

intervention (e.g.,

anticoagulation, lysis,

filter, invasive procedure)

not indicated

Deep vein thrombosis or

cardiac thrombosis;

intervention (e.g.,

anticoagulation, lysis,

filter, invasive procedure)

indicated

Embolic event including

pulmonary embolism or

life-threatening thrombus

Death

Vessel injury-artery

– Select:

– Aorta

– Carotid

– Extremity-lower

– Extremity-upper

– Other NOS

– Visceral

Artery injury – Select Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic (e.g.,

claudication); not

interfering with ADL;

repair or revision not

indicated

Symptomatic interfering

with ADL; repair or

revision indicated

Life-threatening;

disabling; evidence of

end organ damage (e.g.,

stroke, MI, organ or limb

loss)

Death

NAVIGATION NOTE: Vessel injury to an artery intra-operatively is graded as Intra-operative injury – Select Organ or Structure in the SURGERY/INTRA-OPERATIVE INJURY

CATEGORY.

VASCULAR Page 2 of 2

Grade

Adverse Event Short Name 1 2 3 4 5

CTCAE v3.0 - 71 - March 31, 2003, Publish Date: August 9, 2006

Vessel injury-vein

– Select:

– Extremity-lower

– Extremity-upper

– IVC

– Jugular

– Other NOS

– SVC

– Viscera

Vein injury – Select Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic (e.g.,

claudication); not

interfering with ADL;

repair or revision not

indicated

Symptomatic interfering

with ADL; repair or

revision indicated

Life-threatening;

disabling; evidence of

end organ damage

Death

NAVIGATION NOTE: Vessel injury to a vein intra-operatively is graded as Intra-operative injury – Select Organ or Structure in the SURGERY/INTRA-OPERATIVE INJURY CATEGORY.

Visceral arterial ischemia

(non-myocardial)

Visceral arterial ischemia — Brief (<24 hrs) episode of

ischemia managed

medically and without

permanent deficit

Prolonged (≥24 hrs) or

recurring symptoms

and/or invasive

intervention indicated

Life-threatening;

disabling; evidence of

end organ damage

Death

ALSO CONSIDER: CNS cerebrovascular ischemia.

Vascular – Other

(Specify, __)

Vascular – Other

(Specify)

Mild Moderate Severe Life-threatening; disabling Death