Common Terminology Criteria for Adverse Events (CTCAE)

Common Terminology Criteria

for Adverse Events (CTCAE)

Version 5.0

Published: November 27, 2017

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Publish Date: November 27, 2017

Introduction

The NCI Common Terminology Criteria for

Adverse Events is a descriptive terminology which

can be utilized for Adverse Event (AE) reporting. A

grading (severity) scale is provided for each AE

term.

SOC

System Organ Class (SOC), the highest level of the

MedDRA

1

hierarchy, is identified by anatomical or

physiological system, etiology, or purpose (e.g.,

SOC Investigations for laboratory test results).

CTCAE terms are grouped by MedDRA Primary

SOCs. Within each SOC, AEs are listed and

accompanied by descriptions of severity (Grade).

CTCAE Terms

An Adverse Event (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 CTCAE v4.0 term is a MedDRA LLT (Lowest

Level Term).

1

CTCAE v5.0 incorporates certain elements of the MedDRA terminology. For further details on MedDRA refer to the MedDRA MSSO Web site (https://www.meddra.org/).

Grades

Grade refers to the severity of the AE. The CTCAE

displays Grades 1 through 5 with unique clinical

descriptions of severity for each AE based on this

general guideline:

Grade 1 Mild; asymptomatic or mild

symptoms; clinical or diagnostic

observations only; intervention

not indicated.

Grade 2 Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL*.

Grade 3 Severe or medically significant but not

immediately life-threatening;

hospitalization or prolongation

of hospitalization indicated;

disabling; limiting self care

ADL**.

Grade 4 Life-threatening consequences; urgent

intervention indicated.

Grade 5 Death related to AE.

A Semi-colon indicates ‘or’ within the description

of the grade.

A single dash (-) indicates a Grade is 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.

Definitions

A brief Definition is provided to clarify the

meaning of each AE term. A single dash (-)

indicates a Definition is not available.

Navigational Notes

A Navigational Note is used to assist the reporter

in choosing a correct AE. It may list other AEs that

should be considered in addition to or in place of

the AE in question. A single dash (-) indicates a

Navigational Note has not been defined for the AE

term.

Activities of Daily Living (ADL)

*Instrumental ADL refer to preparing meals,

shopping for groceries or clothes, using the

telephone, managing money, etc.

**Self care ADL refer to bathing, dressing and

undressing, feeding self, using the toilet, taking

medications, and not bedridden.

Table of Contents

Blood and lymphatic system disorders ....................................................................... 4

Cardiac disorders ........................................................................................................ 6

Congenital, familial and genetic disorders ................................................................ 12

Ear and labyrinth disorders ....................................................................................... 13

Endocrine disorders .................................................................................................. 15

Eye disorders ............................................................................................................ 18

Gastrointestinal disorders ........................................................................................ 24

General disorders and administration site conditions .............................................. 44

Hepatobiliary disorders ............................................................................................ 48

Immune system disorders ........................................................................................ 51

Infections and infestations ....................................................................................... 53

Injury, poisoning and procedural complications ....................................................... 70

Investigations ........................................................................................................... 84

Metabolism and nutrition disorders ......................................................................... 91

Musculoskeletal and connective tissue disorders ..................................................... 95

Neoplasms benign, malignant and unspecified (incl cysts and polyps) ................... 103

Nervous system disorders ...................................................................................... 104

Pregnancy, puerperium and perinatal conditions ................................................... 114

Psychiatric disorders ............................................................................................... 115

Renal and urinary disorders .................................................................................... 119

Reproductive system and breast disorders............................................................. 123

Respiratory, thoracic and mediastinal disorders .................................................... 131

Skin and subcutaneous tissue disorders ................................................................. 142

Social circumstances ............................................................................................... 150

Surgical and medical procedures ............................................................................ 151

Vascular disorders .................................................................................................. 152

CTCAE v5.0 – November 27, 2017 Page 4

Blood and lymphatic system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Anemia

Hemoglobin (Hgb) <LLN - 10.0

g/dL; <LLN - 6.2 mmol/L; <LLN

- 100 g/L

Hgb <10.0 - 8.0 g/dL; <6.2 - 4.9

mmol/L; <100 - 80g/L

Hgb <8.0 g/dL; <4.9 mmol/L;

<80 g/L; transfusion indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a reduction in the amount of hemoglobin in 100 ml of blood. Signs and symptoms of anemia may include pallor of the skin and mucous

membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.

Navigational Note: -

Bone marrow hypocellular

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

Aplastic persistent for longer

than 2 weeks

Death

Definition: A disorder characterized by the inability of the bone marrow to produce hematopoietic elements.

Navigational Note: -

Disseminated intravascular

coagulation

-

Laboratory findings with no

bleeding

Laboratory findings and

bleeding

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by systemic pathological activation of blood clotting mechanisms which results in clot formation throughout the body. There is an increase in the

risk of hemorrhage as the body is depleted of platelets and coagulation factors.

Navigational Note: -

Eosinophilia

>ULN and >Baseline

-

Steroids initiated

-

Definition: A disorder characterized by laboratory test results that indicate an increased number of eosinophils in the blood.

Navigational Note: -

Febrile neutropenia

-

ANC <1000/mm3 with a single

temperature of >38.3 degrees

C (101 degrees F) or a

sustained temperature of

>=38 degrees C (100.4

degrees F) for more than one

hour

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an ANC <1000/mm3 and a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees

F) for more than one hour.

Navigational Note: -

Hemolysis

Laboratory evidence of

hemolysis only (e.g., direct

antiglobulin test; DAT;

Coombs'; schistocytes;

decreased haptoglobin)

Evidence of hemolysis and

>=2 g decrease in hemoglobin

Transfusion or medical

intervention indicated (e.g.,

steroids)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by laboratory test results that indicate widespread erythrocyte cell membrane destruction.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 5

Blood and lymphatic system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hemolytic uremic syndrome

-

Laboratory findings with

clinical consequences (e.g.,

renal insufficiency, petechiae)

Life-threatening

consequences, (e.g., CNS

hemorrhage or

thrombosis/embolism or renal

failure)

Death

Definition: A disorder characterized by a form of thrombotic microangiopathy with renal failure, hemolytic anemia, and severe thrombocytopenia.

Navigational Note: -

Leukocytosis

-

>100,000/mm3

Clinical manifestations of

leucostasis; urgent

intervention indicated

Death

Definition: A disorder characterized by laboratory test results that indicate an increased number of white blood cells in the blood.

Navigational Note: -

Lymph node pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in a lymph node.

Navigational Note: -

Methemoglobinemia

-

>ULN

Requiring urgent intervention

Life-threatening consequences

Death

Definition: A disorder characterized by laboratory test results that indicate increased methemoglobin in the blood.

Navigational Note: -

Thrombotic

thrombocytopenic purpura

-

Laboratory findings with

clinical consequences (e.g.,

renal insufficiency, petechiae)

Life-threatening

consequences, (e.g., CNS

hemorrhage or

thrombosis/embolism or renal

failure)

Death

Definition: A disorder characterized by the presence of microangiopathic hemolytic anemia, thrombocytopenic purpura, fever, renal abnormalities and neurological abnormalities such

as seizures, hemiplegia, and visual disturbances. It is an acute or subacute condition.

Navigational Note: -

Blood and lymphatic system

disorders - Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 6

Cardiac disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Aortic valve disease

Asymptomatic valvular

thickening with or without

mild valvular regurgitation or

stenosis by imaging

Asymptomatic; moderate

regurgitation or stenosis by

imaging

Symptomatic; severe

regurgitation or stenosis by

imaging; symptoms controlled

with medical intervention

Life-threatening

consequences; urgent

intervention indicated (e.g.,

valve replacement,

valvuloplasty)

Death

Definition: A disorder characterized by a defect in aortic valve function or structure.

Navigational Note: -

Asystole

Periods of asystole; non-

urgent medical management

indicated

-

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a dysrhythmia without cardiac electrical activity. Typically, this is accompanied by cessation of the pumping function of the heart.

Navigational Note: -

Atrial fibrillation

Asymptomatic, intervention

not indicated

Non-urgent medical

intervention indicated

Symptomatic, urgent

intervention indicated; device

(e.g., pacemaker); ablation;

new onset

Life-threatening

consequences; embolus

requiring urgent intervention

Death

Definition: A disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular response due to multiple reentry circuits. The rhythm disturbance

originates above the ventricles.

Navigational Note: -

Atrial flutter

Asymptomatic, intervention

not indicated

Non-urgent medical

intervention indicated

Symptomatic, urgent

intervention indicated; device

(e.g., pacemaker); ablation

Life-threatening

consequences; embolus

requiring urgent intervention

Death

Definition: A disorder characterized by a dysrhythmia with organized rhythmic atrial contractions with a rate of 200-300 beats per minute. The rhythm disturbance originates in the

atria.

Navigational Note: -

Atrioventricular block

complete

-

Non-urgent intervention

indicated

Symptomatic and

incompletely controlled

medically, or controlled with

device (e.g., pacemaker); new

onset

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a dysrhythmia with complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 7

Cardiac disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Atrioventricular block first

degree

Asymptomatic, intervention

not indicated

Non-urgent intervention

indicated

-

Definition: A disorder characterized by a dysrhythmia with a delay in the time required for the conduction of an electrical impulse through the atrioventricular (AV) node beyond 0.2

seconds; prolongation of the PR interval greater than 200 milliseconds.

Navigational Note: -

Cardiac arrest

-

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by cessation of the pumping function of the heart.

Navigational Note: -

Chest pain - cardiac

Mild pain

Moderate pain; pain on

exertion; limiting instrumental

ADL; hemodynamically stable

Pain at rest; limiting self care

ADL; cardiac catheterization;

new onset cardiac chest pain;

unstable angina

-

Definition: A disorder characterized by substernal discomfort due to insufficient myocardial oxygenation e.g., angina pectoris.

Navigational Note: Also consider Cardiac disorders: Myocardial infarction.

Conduction disorder

Mild symptoms; intervention

not indicated

Non-urgent medical

intervention indicated

Symptomatic, urgent

intervention indicated

Life-threatening

consequences

Death

Definition: A disorder characterized by pathological irregularities in the cardiac conduction system.

Navigational Note: -

Cyanosis

-

Present

-

Definition: A disorder characterized by a bluish discoloration of the skin and/or mucous membranes.

Navigational Note: -

Heart failure

Asymptomatic with laboratory

(e.g., BNP [B-Natriuretic

Peptide ]) or cardiac imaging

abnormalities

Symptoms with moderate

activity or exertion

Symptoms at rest or with

minimal activity or exertion;

hospitalization; new onset of

symptoms

Life-threatening

consequences; urgent

intervention indicated (e.g.,

continuous IV therapy or

mechanical hemodynamic

support)

Death

Definition: A disorder characterized by the inability of the heart to pump blood at an adequate volume to meet tissue metabolic requirements, or, the ability to do so only at an

elevation in the filling pressure.

Navigational Note: If left sided use Cardiac disorders: Left ventricular systolic dysfunction; also consider Cardiac disorders: Restrictive cardiomyopathy, Investigations: Ejection fraction

decreased.

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 8

Cardiac disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Left ventricular systolic

dysfunction

-

Symptomatic due to drop in

ejection fraction responsive to

intervention

Refractory or poorly

controlled heart failure due to

drop in ejection fraction;

intervention such as

ventricular assist device,

intravenous vasopressor

support, or heart transplant

indicated

Death

Definition: A disorder characterized by failure of the left ventricle to produce adequate output.

Navigational Note: Also consider Investigations: Ejection fraction decreased.

Mitral valve disease

Asymptomatic valvular

thickening with or without

mild valvular regurgitation or

stenosis by imaging

Asymptomatic; moderate

regurgitation or stenosis by

imaging

Symptomatic; severe

regurgitation or stenosis by

imaging; symptoms controlled

with medical intervention

Life-threatening

consequences; urgent

intervention indicated (e.g.,

valve replacement,

valvuloplasty)

Death

Definition: A disorder characterized by a defect in mitral valve function or structure.

Navigational Note: -

Mobitz (type) II

atrioventricular block

Asymptomatic, intervention

not indicated

Symptomatic; medical

intervention indicated

Symptomatic and

incompletely controlled

medically, or controlled with

device (e.g., pacemaker); new

onset

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a dysrhythmia with relatively constant PR interval prior to the block of an atrial impulse. This is the result of intermittent failure of atrial

electrical impulse conduction through the atrioventricular (AV) node to the ventricles.

Navigational Note: -

Mobitz type I

Asymptomatic, intervention

not indicated

Symptomatic; medical

intervention indicated

Symptomatic and

incompletely controlled

medically, or controlled with

device (e.g., pacemaker)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a dysrhythmia with a progressively lengthening PR interval prior to the blocking of an atrial impulse. This is the result of intermittent failure of

atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 9

Cardiac disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Myocardial infarction

-

Asymptomatic and cardiac

enzymes minimally abnormal

and no evidence of ischemic

ECG changes

Severe symptoms; cardiac

enzymes abnormal;

hemodynamically stable; ECG

changes consistent with

infarction

Life-threatening

consequences;

hemodynamically unstable

Death

Definition: A disorder characterized by gross necrosis of the myocardium; this is due to an interruption of blood supply to the area.

Navigational Note: -

Myocarditis

-

Symptoms with moderate

activity or exertion

Severe with symptoms at rest

or with minimal activity or

exertion; intervention

indicated; new onset of

symptoms

Life-threatening

consequences; urgent

intervention indicated (e.g.,

continuous IV therapy or

mechanical hemodynamic

support)

Death

Definition: A disorder characterized by inflammation of the muscle tissue of the heart.

Navigational Note: -

Palpitations

Mild symptoms; intervention

not indicated

Intervention indicated

-

Definition: A disorder characterized by an unpleasant sensation of irregular and/or forceful beating of the heart.

Navigational Note: -

Paroxysmal atrial tachycardia

Asymptomatic, intervention

not indicated

Non-urgent medical

intervention indicated

Symptomatic, urgent

intervention indicated;

ablation

Life-threatening

consequences; incompletely

controlled medically;

cardioversion indicated

Death

Definition: A disorder characterized by a dysrhythmia with abrupt onset and sudden termination of atrial contractions with a rate of 150-250 beats per minute. The rhythm disturbance

originates in the atria.

Navigational Note: -

Pericardial effusion

-

Asymptomatic effusion size

small to moderate

Effusion with physiologic

consequences

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by fluid collection within the pericardial sac, usually due to inflammation.

Navigational Note: -

Pericardial tamponade

-

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an increase in intrapericardial pressure due to the collection of blood or fluid in the pericardium.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 10

Cardiac disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Pericarditis

Asymptomatic, ECG or

physical findings (e.g., rub)

consistent with pericarditis

Symptomatic pericarditis (e.g.,

chest pain)

Pericarditis with physiologic

consequences (e.g.,

pericardial constriction)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by irritation to the layers of the pericardium (the protective sac around the heart).

Navigational Note: -

Pulmonary valve disease

Asymptomatic valvular

thickening with or without

mild valvular regurgitation or

stenosis by imaging

Asymptomatic; moderate

regurgitation or stenosis by

imaging

Symptomatic; severe

regurgitation or stenosis by

imaging; symptoms controlled

with medical intervention

Life-threatening

consequences; urgent

intervention indicated (e.g.,

valve replacement,

valvuloplasty)

Death

Definition: A disorder characterized by a defect in pulmonary valve function or structure.

Navigational Note: -

Restrictive cardiomyopathy

Imaging findings only

Symptomatic without signs of

heart failure

Symptomatic heart failure or

other cardiac symptoms,

responsive to intervention;

new onset of symptoms

Refractory heart failure or

other poorly controlled

cardiac symptoms

Death

Definition: A disorder characterized by an inability of the ventricles to fill with blood because the myocardium (heart muscle) stiffens and loses its flexibility.

Navigational Note: -

Right ventricular dysfunction

Asymptomatic with laboratory

(e.g., BNP [B-Natriuretic

Peptide ]) or cardiac imaging

abnormalities

Symptoms with moderate

activity or exertion

Severe symptoms, associated

with hypoxia, right heart

failure; oxygen indicated

Life-threatening

consequences; urgent

intervention indicated (e.g.,

ventricular assist device);

heart transplant indicated

Death

Definition: A disorder characterized by impairment of right ventricular function associated with low ejection fraction and a decrease in motility of the right ventricular wall.

Navigational Note: -

Sick sinus syndrome

Asymptomatic, intervention

not indicated

Symptomatic, intervention

not indicated; change in

medication initiated

Symptomatic, intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a dysrhythmia with alternating periods of bradycardia and atrial tachycardia accompanied by syncope, fatigue and dizziness.

Navigational Note: -

Sinus bradycardia

Asymptomatic, intervention

not indicated

Symptomatic, intervention

not indicated; change in

medication initiated

Symptomatic, intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a dysrhythmia with a heart rate less than 60 beats per minute that originates in the sinus node.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 11

Cardiac disorders

CTCAE Term

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Sinus tachycardia

Asymptomatic, intervention

not indicated

Symptomatic; non-urgent

medical intervention indicated

Urgent medical intervention

indicated

-

Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates in the sinus node.

Navigational Note: -

Supraventricular tachycardia

Asymptomatic, intervention

not indicated

Non-urgent medical

intervention indicated

Symptomatic, urgent

intervention indicated

Life-threatening consequences

Death

Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates above the ventricles.

Navigational Note: -

Tricuspid valve disease

Asymptomatic valvular

thickening with or without

mild valvular regurgitation or

stenosis

Asymptomatic; moderate

regurgitation or stenosis by

imaging

Symptomatic; severe

regurgitation or stenosis;

symptoms controlled with

medical intervention

Life-threatening

consequences; urgent

intervention indicated (e.g.,

valve replacement,

valvuloplasty)

Death

Definition: A disorder characterized by a defect in tricuspid valve function or structure.

Navigational Note: -

Ventricular arrhythmia

Asymptomatic, intervention

not indicated

Non-urgent medical

intervention indicated

Urgent intervention indicated

Life-threatening

consequences; hemodynamic

compromise

Death

Definition: A disorder characterized by a dysrhythmia that originates in the ventricles.

Navigational Note: -

Ventricular fibrillation

-

Life-threatening

consequences; hemodynamic

compromise

Death

Definition: A disorder characterized by a dysrhythmia without discernible QRS complexes due to rapid repetitive excitation of myocardial fibers without coordinated contraction of the

ventricles.

Navigational Note: -

Ventricular tachycardia

-

Non-urgent medical

intervention indicated

Symptomatic, urgent

intervention indicated

Life-threatening

consequences; hemodynamic

compromise

Death

Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates distal to the bundle of His.

Navigational Note: -

Cardiac disorders - Other,

specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 12

Congenital, familial and genetic disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Congenital, familial and

genetic disorders - Other,

specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 13

Ear and labyrinth disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Ear pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the ear.

Navigational Note: -

External ear pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the external ear region.

Navigational Note: -

Hearing impaired

Adults enrolled on a

Monitoring Program (on a 1,

2, 4, 3, 6, and 8 kHz

audiogram): Threshold shift of

15 - 25 dB averaged at 2

contiguous test frequencies in

at least one ear;

Adults not enrolled on a

Monitoring Program:

Subjective change in hearing

in the absence of documented

hearing loss;

Pediatric (on a 1, 2, 3, 4, 6,

and 8 kHz audiogram):

Threshold shift >20 dB hearing

loss (HL) (i.e., 25 dB HL or

greater); sensorineural

hearing loss (SNHL) above 4

kHz (i.e., 6 or 8 kHz) in at least

one ear

Adults enrolled on a

Monitoring Program (on a 1,

2, 3, 4, 6, and 8 kHz

audiogram): Threshold shift of

>25 dB averaged at 2

contiguous test frequencies in

at least one ear;

Adults not enrolled on a

Monitoring Program: Hearing

loss with hearing aid or

intervention not indicated;

limiting instrumental ADL;

Pediatric (on a 1, 2, 3, 4, 6,

and 8 kHz audiogram):

Threshold shift >20 dB at 4

kHz in at least one ear

Adults enrolled on a

Monitoring Program (on a 1,

2, 3, 4, 6, and 8 kHz

audiogram): Threshold shift of

>25 dB averaged at 3

contiguous test frequencies in

at least one ear; therapeutic

intervention indicated;

Adults not enrolled on a

Monitoring Program: Hearing

loss with hearing aid or

intervention indicated;

limiting self care ADL;

Pediatric (on a 1, 2, 3, 4, 6,

and 8 kHz audiogram):

Hearing loss sufficient to

indicate therapeutic

intervention, including

hearing aids; threshold shift

>20 dB at 2 to < 4 kHz in at

least one ear

Adults: Decrease in hearing to

profound bilateral loss

(absolute threshold >80 dB HL

at 2 kHz and above);

nonservicable hearing

Pediatric: Audiologic

indication for cochlear

implant; > 40 dB HL (i.e., 45 dB

HL or more); SNHL at 2 kHz

and above

-

Definition: A disorder characterized by partial or complete loss of the ability to detect or understand sounds resulting from damage to ear structures.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 14

Ear and labyrinth disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Middle ear inflammation

Serous otitis

Serous otitis, medical

intervention indicated

Mastoiditis; necrosis of canal

soft tissue or bone

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation (physiologic response to irritation), swelling and redness to the middle ear.

Navigational Note: -

Tinnitus

Mild symptoms; intervention

not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by noise in the ears, such as ringing, buzzing, roaring or clicking.

Navigational Note: -

Vertigo

Mild symptoms

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by a sensation as if the external world were revolving around the patient (objective vertigo) or as if he himself were revolving in space (subjective

vertigo).

Navigational Note: -

Vestibular disorder

-

Symptomatic; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by dizziness, imbalance, nausea, and vision problems.

Navigational Note: -

Ear and labyrinth disorders -

Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 15

Endocrine disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Adrenal insufficiency

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; medical

intervention indicated

Severe symptoms;

hospitalization indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by the adrenal cortex not producing enough of the hormone cortisol and in some cases, the hormone aldosterone. It may be due to a disorder of

the adrenal cortex as in Addison's disease or primary adrenal insufficiency.

Navigational Note: -

Cushingoid

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated

Severe symptoms, medical

intervention or hospitalization

indicated

-

Definition: A disorder characterized by signs and symptoms that resemble Cushing's disease or syndrome: buffalo hump obesity, striations, adiposity, hypertension, diabetes, and

osteoporosis, usually due to exogenous corticosteroids.

Navigational Note: -

Delayed puberty

-

No breast development by

age 13 yrs for females; testes

volume of <3 cc or no Tanner

Stage 2 development by age

14.5 yrs for males

No breast development by

age 14 yrs for females; no

increase in testes volume or

no Tanner Stage 2 by age 16

yrs for males; hormone

replacement indicated

-

Definition: A disorder characterized by unusually late sexual maturity.

Navigational Note: -

Growth accelerated

-

>= +2 SD (standard deviation)

above mid parental height or

target height

-

Definition: A disorder characterized by greater growth than expected for age.

Navigational Note: -

Hyperparathyroidism

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated

-

Definition: A disorder characterized by an increase in production of parathyroid hormone by the parathyroid glands. This results in hypercalcemia (abnormally high levels of calcium in

the blood).

Navigational Note: -

Hyperthyroidism

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; thyroid

suppression therapy

indicated; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL; hospitalization

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by excessive levels of thyroid hormone in the body. Common causes include an overactive thyroid gland or thyroid hormone overdose.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 16

Endocrine disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hypoparathyroidism

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; medical

intervention indicated

Severe symptoms; medical

intervention or hospitalization

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a decrease in production of parathyroid hormone by the parathyroid glands.

Navigational Note: -

Hypophysitis

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation and cellular infiltration of the pituitary gland.

Navigational Note: -

Hypopituitarism

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a decrease in production of hormones from the pituitary gland.

Navigational Note: -

Hypothyroidism

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; thyroid

replacement indicated;

limiting instrumental ADL

Severe symptoms; limiting self

care ADL; hospitalization

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a decrease in production of thyroid hormone by the thyroid gland.

Navigational Note: -

Precocious puberty

Physical signs of puberty with

no biochemical markers for

females <8 years and males <9

years

Physical signs and biochemical

markers of puberty for

females <8 years and males <9

years

-

Definition: A disorder characterized by unusually early development of secondary sexual features; the onset of sexual maturation begins usually before age 8 for girls and before age 9

for boys.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 17

Endocrine disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Testosterone deficiency

Asymptomatic; mild

symptoms with no

intervention indicated

Replacement therapy initiated

-

Definition: A disorder characterized by low testosterone.

Navigational Note: -

Virilization

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated

-

Definition: A disorder characterized by inappropriate masculinization occurring in a female or prepubertal male.

Navigational Note: -

Endocrine disorders - Other,

specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 18

Eye disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Blurred vision

Intervention not indicated

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline); limiting

instrumental ADL

Symptomatic with marked

decrease in visual acuity (best

corrected visual acuity worse

than 20/40 or more than 3

lines of decreased vision from

known baseline, up to

20/200); limiting self care ADL

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by visual perception of unclear or fuzzy images.

Navigational Note: -

Cataract

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline); glare symptoms

affecting instrumental ADL

Symptomatic with marked

decrease in visual acuity (best

corrected visual acuity worse

than 20/40 or more than 3

lines of decreased vision from

known baseline, up to

20/200); limiting self care ADL

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by partial or complete opacity of the crystalline lens of one or both eyes. This results in a decrease in visual acuity and eventual blindness if

untreated.

Navigational Note: -

Corneal ulcer

-

Corneal ulcer without

perforation in the affected

eye

Perforation in the affected eye

-

Definition: A disorder characterized by an area of epithelial tissue loss on the surface of the cornea. It is associated with inflammatory cells in the cornea and anterior chamber.

Navigational Note: -

Dry eye

Asymptomatic; clinical or

diagnostic observations only;

symptoms relieved by

lubricants

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline)

Symptomatic with marked

decrease in visual acuity (best

corrected visual acuity worse

than 20/40 or more than 3

lines of decreased vision from

known baseline, up to

20/200); limiting self care ADL

-

Definition: A disorder characterized by dryness of the cornea and conjunctiva.

Navigational Note: If corneal ulcer is present, grade under Eye disorders: Corneal ulcer.

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CTCAE v5.0 – November 27, 2017 Page 19

Eye disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Extraocular muscle paresis

Asymptomatic; clinical or

diagnostic observations only

Unilateral paresis without

double vision

Bilateral paresis or unilateral

paresis causing double vision

in peripheral gaze, but not in

central gaze

Bilateral paresis requiring

head turning to see beyond

central 60 degrees or double

vision in central gaze

-

Definition: A disorder characterized by incomplete paralysis of an extraocular muscle.

Navigational Note: -

Eye pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the eye.

Navigational Note: -

Eyelid function disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; nonoperative

intervention indicated;

limiting instrumental ADL

Limiting self care ADL;

operative intervention

indicated

-

Definition: A disorder characterized by impaired eyelid function.

Navigational Note: -

Flashing lights

Symptomatic but not limiting

ADL

Limiting instrumental ADL

Limiting self care ADL

-

Definition: A disorder characterized by a sudden or brief burst of light.

Navigational Note: Also consider Eye disorders: Retinal tear or Retinal detachment

Floaters

Symptomatic but not limiting

ADL

Limiting instrumental ADL

Limiting self care ADL

-

Definition: A disorder characterized by an individual seeing spots before their eyes. The spots are shadows of opaque cell fragments in the vitreous humor or lens.

Navigational Note: Also consider Eye disorders: Retinal tear or Retinal detachment

Glaucoma

Less than 8 mmHg of elevated

intraocular pressure (EIOP);

no visual field deficit

EIOP which can be reduced to

21 mmHg or under with

topical medications and no

visual field deficit

EIOP causing visual field

deficits

Visual field deficit within the

central 10 degrees of the

visual field in the affected eye

-

Definition: A disorder characterized by an increase in pressure in the eyeball due to obstruction of the aqueous humor outflow.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 20

Eye disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Keratitis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline)

Symptomatic with marked

decrease in visual acuity (best

corrected visual acuity worse

than 20/40 or more than 3

lines of decreased vision from

known baseline, up to

20/200); corneal ulcer;

limiting self care ADL

Perforation; best corrected

visual acuity of 20/200 or

worse in the affected eye

-

Definition: A disorder characterized by inflammation to the cornea of the eye.

Navigational Note: Also consider Eye disorders: Corneal ulcer

Night blindness

Symptomatic but not limiting

ADL

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline); limiting

instrumental ADL

Symptomatic with marked

decrease in visual acuity (best

corrected visual acuity worse

than 20/40 or more than 3

lines of decreased vision from

known baseline, up to

20/200); limiting self care ADL

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by an inability to see clearly in dim light.

Navigational Note: -

Optic nerve disorder

Asymptomatic; clinical or

diagnostic observations only

Moderate decrease in visual

acuity (best corrected visual

acuity 20/40 and better or 3

lines or less decreased vision

from known baseline)

Marked decrease in visual

acuity (best corrected visual

acuity worse than 20/40 or

more than 3 lines of

decreased vision from known

baseline, up to 20/200)

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by involvement of the optic nerve (second cranial nerve).

Navigational Note: -

Papilledema

Asymptomatic; no visual field

deficit

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline)

Symptomatic with marked

decrease in visual acuity (best

corrected visual acuity worse

than 20/40 or more than 3

lines of decreased vision from

known baseline, up to 20/200)

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by swelling around the optic disc.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 21

Eye disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Periorbital edema

Soft or non-pitting

Indurated or pitting edema;

topical intervention indicated

Edema associated with visual

disturbance; increased

intraocular pressure,

glaucoma or retinal

hemorrhage; optic neuritis;

diuretics indicated; operative

intervention indicated

-

Definition: A disorder characterized by swelling due to an excessive accumulation of fluid around the orbits of the face.

Navigational Note: -

Photophobia

Symptomatic but not limiting

ADL

Limiting instrumental ADL

Limiting self care ADL

-

Definition: A disorder characterized by fear and avoidance of light.

Navigational Note: -

Retinal detachment

-

Macular sparing

rhegmatogenous detachment

Macula-off rhegmatogenous

retinal detachment

-

Definition: A disorder characterized by the separation of the inner retina layers from the underlying pigment epithelium.

Navigational Note: -

Retinal tear

No retinal detachment and

treatment not indicated

No retinal detachment and

treatment indicated

-

Definition: A disorder characterized by a small laceration of the retina, this occurs when the vitreous separates from the retina. Symptoms include flashes and floaters.

Navigational Note: If retinal detachment is present, grade under Eye disorders: Retinal detachment

Retinal vascular disorder

-

Retinal vascular disorder

without neovascularization

Retinal vascular disorder with

neovascularization

-

Definition: A disorder characterized by pathological retinal blood vessels that adversely affects vision.

Navigational Note: If vitreous hemorrhage is present, report under Eye disorders: Vitreous hemorrhage.

Retinopathy

Asymptomatic; clinical or

diagnostic observations only

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline); limiting

instrumental ADL

Symptomatic with marked

decrease in visual acuity (best

corrected visual acuity worse

than 20/40 or more than 3

lines of decreased vision from

known baseline, up to

20/200); limiting self care ADL

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder involving the retina.

Navigational Note: If vitreous hemorrhage is present, report under Eye disorders: Vitreous hemorrhage.

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CTCAE v5.0 – November 27, 2017 Page 22

Eye disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Scleral disorder

No change in vision from

baseline

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline); limiting

instrumental ADL

Symptomatic with marked

decrease in visual acuity (best

corrected visual acuity worse

than 20/40 or more than 3

lines of decreased vision from

known baseline, up to

20/200); limiting self care ADL

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by involvement of the sclera of the eye.

Navigational Note: -

Uveitis

Anterior uveitis with trace

cells

Anterior uveitis with 1+ or 2+

cells

Anterior uveitis with 3+ or

greater cells; intermediate

posterior or pan-uveitis

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by inflammation to the uvea of the eye.

Navigational Note: -

Vision decreased

-

Moderate decrease in visual

acuity (best corrected visual

acuity 20/40 and better or 3

lines or less decreased vision

from known baseline)

Marked decrease in visual

acuity (best corrected visual

acuity worse than 20/40 or

more than 3 lines of

decreased vision from known

baseline, up to 20/200)

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by a decrease in visual acuity.

Navigational Note: If etiology is known, use a more specific CTCAE term.

Vitreous hemorrhage

Intervention not indicated

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline); limiting

instrumental ADL

Symptomatic with marked

decrease in visual acuity (best

corrected visual acuity worse

than 20/40 or more than 3

lines of decreased vision from

known baseline, up to

20/200); limiting self care

ADL; vitrectomy indicated

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by bleeding into the vitreous humor.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 23

Eye disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Watering eyes

Intervention not indicated

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline)

Marked decrease in visual

acuity (best corrected visual

acuity worse than 20/40 or

more than 3 lines of

decreased vision from known

baseline, up to 20/200)

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by excessive tearing in the eyes; it can be caused by overproduction of tears or impaired drainage of the tear duct.

Navigational Note: -

Eye disorders - Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated; no

change in vision

Moderate; minimal, local or

noninvasive intervention

indicated; limiting

instrumental ADL; best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline

Severe or medically significant

but not immediately sight-

threatening; limiting self care

ADL; decrease in visual acuity

(best corrected visual acuity

worse than 20/40 or more

than 3 lines of decreased

vision from known baseline,

up to 20/200)

Sight-threatening

consequences; urgent

intervention indicated; best

corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 24

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Abdominal distension

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; limiting

instrumental ADL

Severe discomfort; limiting

self care ADL

-

Definition: A disorder characterized by swelling of the abdomen.

Navigational Note: -

Abdominal pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the abdominal region.

Navigational Note: -

Anal fissure

Asymptomatic

Symptomatic

Invasive intervention

indicated

-

Definition: A disorder characterized by a tear in the lining of the anus.

Navigational Note: -

Anal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the opening in the anal canal to the perianal skin.

Navigational Note: -

Anal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the anal region.

Navigational Note: -

Anal mucositis

Asymptomatic or mild

symptoms; intervention not

indicated

Symptomatic; medical

intervention indicated;

limiting instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by ulceration or inflammation of the mucous membrane of the anus.

Navigational Note: Report Grade 4 and 5 as Gastrointestinal disorders: Anal ulcer

Anal necrosis

-

TPN or hospitalization

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the anal region.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 25

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Anal pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the anal region.

Navigational Note: -

Anal stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Symptomatic and severely

altered GI function; non-

emergent operative

intervention indicated; TPN or

hospitalization indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the anal canal.

Navigational Note: -

Anal ulcer

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

TPN indicated; elective

invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the anal canal.

Navigational Note: -

Ascites

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by accumulation of serous or hemorrhagic fluid in the peritoneal cavity.

Navigational Note: -

Belching

Increase from baseline

Intervention initiated

(including over the counter

medications)

-

Definition: To expel gas noisily from the mouth.

Navigational Note: Synonym: Burping

Bloating

No change in bowel function

or oral intake

Symptomatic, decreased oral

intake; change in bowel

function

-

Definition: A disorder characterized by subject-reported feeling of uncomfortable fullness of the abdomen.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 26

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Cecal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the cecum.

Navigational Note: -

Cheilitis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL; intervention

indicated

-

Definition: A disorder characterized by inflammation of the lip.

Navigational Note: -

Chylous ascites

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated (e.g.,

fat-restricted diet);

paracentesis or tube drainage

indicated

Severe symptoms; elective

operative intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by accumulation of milky fluid in the peritoneal cavity.

Navigational Note: -

Colitis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Abdominal pain; mucus or

blood in stool

Severe abdominal pain;

peritoneal signs

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation of the colon.

Navigational Note: -

Colonic fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the large intestine and another organ or anatomic site.

Navigational Note: -

Colonic hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the colon.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 27

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Colonic obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Hospitalization indicated;

invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the colon.

Navigational Note: -

Colonic perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a rupture in the colonic wall.

Navigational Note: -

Colonic stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

tube feeding or

hospitalization indicated;

elective operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the colon.

Navigational Note: -

Colonic ulcer

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

TPN indicated; elective

invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the colon.

Navigational Note: -

Constipation

Occasional or intermittent

symptoms; occasional use of

stool softeners, laxatives,

dietary modification, or

enema

Persistent symptoms with

regular use of laxatives or

enemas; limiting instrumental

ADL

Obstipation with manual

evacuation indicated; limiting

self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by irregular and infrequent or difficult evacuation of the bowels.

Navigational Note: -

Dental caries

One or more dental caries,

not involving the root

Dental caries involving the

root

Dental caries resulting in

pulpitis or periapical abscess

or resulting in tooth loss

-

Definition: A disorder characterized by the decay of a tooth, in which it becomes softened, discolored and/or porous.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 28

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

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; moderate

increase in ostomy output

compared to baseline; limiting

instrumental ADL

Increase of >=7 stools per day

over baseline; hospitalization

indicated; severe increase in

ostomy output compared to

baseline; limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an increase in frequency and/or loose or watery bowel movements.

Navigational Note: -

Dry mouth

Symptomatic (e.g., dry or

thick saliva) without

significant dietary alteration;

unstimulated saliva flow >0.2

ml/min

Moderate symptoms; oral

intake alterations (e.g.,

copious water, other

lubricants, diet limited to

purees and/or soft, moist

foods); unstimulated saliva 0.1

to 0.2 ml/min

Inability to adequately aliment

orally; tube feeding or TPN

indicated; unstimulated saliva

<0.1 ml/min

-

Definition: A disorder characterized by reduced salivary flow in the oral cavity.

Navigational Note: -

Duodenal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the duodenum and another organ or anatomic site.

Navigational Note: -

Duodenal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the duodenum.

Navigational Note: -

Duodenal obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Hospitalization indicated;

invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by blockage of the normal flow of stomach contents through the duodenum.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 29

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Duodenal perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a rupture in the duodenal wall.

Navigational Note: -

Duodenal stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

tube feeding or

hospitalization indicated;

elective operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the duodenum.

Navigational Note: -

Duodenal ulcer

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated;

limiting instrumental ADL

Severely altered GI function;

TPN indicated; elective

invasive intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the duodenal wall.

Navigational Note: -

Dyspepsia

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated

Severe symptoms; operative

intervention indicated

-

Definition: A disorder characterized by an uncomfortable, often painful feeling in the stomach, resulting from impaired digestion. Symptoms include burning stomach, bloating,

heartburn, nausea and vomiting.

Navigational Note: -

Dysphagia

Symptomatic, able to eat

regular diet

Symptomatic and altered

eating/swallowing

Severely altered

eating/swallowing; tube

feeding, TPN, or

hospitalization indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by difficulty in swallowing.

Navigational Note: -

Enterocolitis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Abdominal pain; mucus or

blood in stool

Severe or persistent

abdominal pain; fever; ileus;

peritoneal signs

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation of the small and large intestines.

Navigational Note: If reporting a known abnormality of the colon, use Gastrointestinal disorders: Colitis. If reporting a documented infection, use Infections and infestations:

Enterocolitis infectious.

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CTCAE v5.0 – November 27, 2017 Page 30

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Enterovesical fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the urinary bladder and the intestine.

Navigational Note: -

Esophageal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the esophagus and another organ or anatomic site.

Navigational Note: -

Esophageal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the esophagus.

Navigational Note: -

Esophageal necrosis

-

Inability to aliment adequately

by GI tract; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the esophageal wall.

Navigational Note: -

Esophageal obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; limiting instrumental

ADL

Hospitalization indicated;

invasive intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by blockage of the normal flow of the contents in the esophagus.

Navigational Note: -

Esophageal pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the esophageal region.

Navigational Note: -

Esophageal perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a rupture in the wall of the esophagus.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 31

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Esophageal stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

tube feeding or

hospitalization indicated;

elective operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the esophagus.

Navigational Note: -

Esophageal ulcer

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; limiting instrumental

ADL

Severely altered GI function;

TPN indicated; elective

invasive intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the esophageal wall.

Navigational Note: -

Esophageal varices

hemorrhage

-

Self-limited; intervention not

indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from esophageal varices.

Navigational Note: -

Esophagitis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered

eating/swallowing; oral

supplements indicated

Severely altered

eating/swallowing; tube

feeding, TPN, or

hospitalization indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by inflammation of the esophageal wall.

Navigational Note: -

Fecal incontinence

Occasional use of pads

required

Daily use of pads required

Severe symptoms; elective

operative intervention

indicated

-

Definition: A disorder characterized by inability to control the escape of stool from the rectum.

Navigational Note: -

Flatulence

Mild symptoms; intervention

not indicated

Moderate; persistent;

psychosocial sequelae

-

Definition: A disorder characterized by a discharge of excessive gas from the lower GI tract.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 32

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Gastric fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the stomach and another organ or anatomic site.

Navigational Note: -

Gastric hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the gastric wall.

Navigational Note: -

Gastric necrosis

-

Inability to aliment adequately

by GI tract; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the gastric wall.

Navigational Note: -

Gastric perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a rupture in the stomach wall.

Navigational Note: -

Gastric stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

tube feeding or

hospitalization indicated;

elective operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the stomach.

Navigational Note: -

Gastric ulcer

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; medical intervention

indicated; limiting

instrumental ADL

Severely altered GI function;

TPN indicated; elective

invasive intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the stomach.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 33

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Gastritis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; medical intervention

indicated

Severely altered eating or

gastric function; TPN or

hospitalization indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by inflammation of the stomach.

Navigational Note: -

Gastroesophageal reflux

disease

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated

Severe symptoms; operative

intervention indicated

-

Definition: A disorder characterized by reflux of the gastric and/or duodenal contents into the distal esophagus. It is chronic in nature and usually caused by incompetence of the lower

esophageal sphincter, and may result in injury to the esophageal mucosal. Symptoms include heartburn and acid indigestion.

Navigational Note: -

Gastrointestinal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between any part of the gastrointestinal system and another organ or anatomic site.

Navigational Note: -

Gastrointestinal pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the gastrointestinal region.

Navigational Note: -

Gastroparesis

Mild nausea, early satiety and

bloating, able to maintain

caloric intake on regular diet

Moderate symptoms; able to

maintain nutrition with

dietary and lifestyle

modifications; may need

pharmacologic intervention

Weight loss >=20% from

baseline; tube feeding or TPN

indicated; elective operative

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

-

Definition: A disorder characterized by an incomplete paralysis of the muscles of the stomach wall resulting in delayed emptying of the gastric contents into the small intestine.

Navigational Note: -

Gingival pain

Mild pain

Moderate pain interfering

with oral intake

Severe pain; inability to

aliment orally

-

Definition: A disorder characterized by a sensation of marked discomfort in the gingival region.

Navigational Note: -

Hemorrhoidal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the hemorrhoids.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 34

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hemorrhoids

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; banding or

medical intervention indicated

Severe symptoms; invasive

intervention indicated

-

Definition: A disorder characterized by the presence of dilated veins in the rectum and surrounding area.

Navigational Note: -

Ileal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the ileum and another organ or anatomic site.

Navigational Note: -

Ileal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the ileal wall.

Navigational Note: -

Ileal obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; limiting instrumental

ADL; naso-gastric tube

indicated

Hospitalization indicated;

invasive intervention

indicated; limiting self care

ADL; long intestinal tube

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the ileum.

Navigational Note: -

Ileal perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a rupture in the ileal wall.

Navigational Note: -

Ileal stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

tube feeding or

hospitalization indicated;

elective operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the ileum.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 35

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Ileal ulcer

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

TPN indicated; elective

invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the ileum.

Navigational Note: -

Ileus

Asymptomatic and radiologic

observations only

Symptomatic; altered GI

function; bowel rest indicated

Severely altered GI function;

TPN indicated; tube

placement indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by failure of the ileum to transport intestinal contents.

Navigational Note: -

Intra-abdominal hemorrhage

-

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding in the abdominal cavity.

Navigational Note: -

Jejunal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the jejunum and another organ or anatomic site.

Navigational Note: -

Jejunal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the jejunal wall.

Navigational Note: -

Jejunal obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; limiting instrumental

ADL

Hospitalization indicated;

invasive intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the jejunum.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 36

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Jejunal perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a rupture in the jejunal wall.

Navigational Note: -

Jejunal stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

tube feeding or

hospitalization indicated;

elective operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the jejunum.

Navigational Note: -

Jejunal ulcer

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

TPN indicated; elective

invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the jejunum.

Navigational Note: -

Lip pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort of the lip.

Navigational Note: -

Lower gastrointestinal

hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the lower gastrointestinal tract (small intestine, large intestine, and anus).

Navigational Note: -

Malabsorption

-

Altered diet; oral intervention

indicated

Inability to aliment

adequately; TPN indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inadequate absorption of nutrients in the small intestine. Symptoms include abdominal marked discomfort, bloating and diarrhea.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 37

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Mucositis oral

Asymptomatic or mild

symptoms; intervention not

indicated

Moderate pain or ulcer that

does not interfere with oral

intake; modified diet

indicated

Severe pain; interfering with

oral intake

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by ulceration or inflammation of the oral mucosal.

Navigational Note: -

Nausea

Loss of appetite without

alteration in eating habits

Oral intake decreased without

significant weight loss,

dehydration or malnutrition

Inadequate oral caloric or

fluid intake; tube feeding,

TPN, or hospitalization

indicated

-

Definition: A disorder characterized by a queasy sensation and/or the urge to vomit.

Navigational Note: -

Obstruction gastric

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; limiting instrumental

ADL

Hospitalization indicated;

invasive intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by blockage of the normal flow of the contents in the stomach.

Navigational Note: -

Oral cavity fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the oral cavity and another organ or anatomic site.

Navigational Note: -

Oral dysesthesia

Mild discomfort; not

interfering with oral intake

Moderate pain; interfering

with oral intake

Disabling pain; tube feeding or

TPN indicated

-

Definition: A disorder characterized by a burning or tingling sensation on the lips, tongue or entire mouth.

Navigational Note: -

Oral hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the mouth.

Navigational Note: -

Oral pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the mouth, tongue or lips.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 38

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Pancreatic duct stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

tube feeding or

hospitalization indicated;

elective operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the pancreatic duct.

Navigational Note: -

Pancreatic fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the pancreas and another organ or anatomic site.

Navigational Note: -

Pancreatic hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the pancreas.

Navigational Note: -

Pancreatic necrosis

-

Tube feeding or TPN

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the pancreas.

Navigational Note: -

Pancreatitis

-

Enzyme elevation; radiologic

findings only

Severe pain; vomiting;

medical intervention indicated

(e.g., analgesia, nutritional

support)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation of the pancreas with no documented pancreas infection.

Navigational Note: -

Periodontal disease

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

-

Definition: A disorder in the gingival tissue around the teeth.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 39

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Peritoneal necrosis

-

Tube feeding or TPN

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the peritoneum.

Navigational Note: -

Proctitis

Rectal discomfort,

intervention not indicated

Symptomatic (e.g., rectal

discomfort, passing blood or

mucus); medical intervention

indicated; limiting

instrumental ADL

Severe symptoms; fecal

urgency or stool incontinence;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation of the rectum.

Navigational Note: -

Rectal fissure

Asymptomatic

Symptomatic

Invasive intervention

indicated

-

Definition: A disorder characterized by a tear in the lining of the rectum.

Navigational Note: -

Rectal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the rectum and another organ or anatomic site.

Navigational Note: -

Rectal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the rectal wall and discharged from the anus.

Navigational Note: -

Rectal mucositis

Asymptomatic or mild

symptoms; intervention not

indicated

Symptomatic; medical

intervention indicated;

limiting instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by ulceration or inflammation of the mucous membrane of the rectum.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 40

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Rectal necrosis

-

Tube feeding or TPN

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the rectal wall.

Navigational Note: -

Rectal obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; limiting instrumental

ADL

Hospitalization indicated;

invasive intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by blockage of the normal flow of the intestinal contents in the rectum.

Navigational Note: -

Rectal pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the rectal region.

Navigational Note: -

Rectal perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a rupture in the rectal wall.

Navigational Note: -

Rectal stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Severely altered GI function;

tube feeding or

hospitalization indicated;

elective operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the rectum.

Navigational Note: -

Rectal ulcer

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function (e.g., altered dietary

habits, vomiting, diarrhea)

Severely altered GI function;

TPN indicated; elective

invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the rectum.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 41

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Retroperitoneal hemorrhage

-

Self-limited; intervention

indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the retroperitoneal area.

Navigational Note: -

Salivary duct inflammation

Slightly thickened saliva;

slightly altered taste (e.g.,

metallic)

Thick, ropy, sticky saliva;

markedly altered taste;

alteration in diet indicated;

secretion-induced symptoms;

limiting instrumental ADL

Acute salivary gland necrosis;

severe secretion-induced

symptoms (e.g., thick

saliva/oral secretions or

gagging); tube feeding or TPN

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation of the salivary duct.

Navigational Note: -

Salivary gland fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between a salivary gland and another organ or anatomic site.

Navigational Note: -

Small intestinal mucositis

Asymptomatic or mild

symptoms; intervention not

indicated

Symptomatic; medical

intervention indicated;

limiting instrumental ADL

Severe pain; interfering with

oral intake; tube feeding, TPN

or hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by ulceration or inflammation of the mucous membrane of the small intestine.

Navigational Note: -

Small intestinal obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; limiting instrumental

ADL

Hospitalization indicated;

invasive intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by blockage of the normal flow of the intestinal contents of the small intestine.

Navigational Note: -

Small intestinal perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a rupture in the small intestine wall.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 42

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Small intestinal stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function

Symptomatic and severely

altered GI function; tube

feeding, TPN or

hospitalization indicated; non-

emergent operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the small intestine.

Navigational Note: -

Small intestine ulcer

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; limiting instrumental

ADL

Severely altered GI function;

TPN indicated; elective

invasive intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the small intestine.

Navigational Note: -

Stomach pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the stomach.

Navigational Note: -

Tooth development disorder

Asymptomatic; hypoplasia of

tooth or enamel

Impairment correctable with

oral surgery

Maldevelopment with

impairment not surgically

correctable; limiting self care

ADL

-

Definition: A disorder characterized by a pathological process of the teeth occurring during tooth development.

Navigational Note: -

Tooth discoloration

Surface stains

-

Definition: A disorder characterized by a change in tooth hue or tint.

Navigational Note: -

Toothache

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the tooth.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 43

Gastrointestinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Typhlitis

-

Symptomatic (e.g., abdominal

pain, fever, change in bowel

habits with ileus); peritoneal

signs

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by necrotizing enterocolitis in neutropenic patients.

Navigational Note: Also report Investigations: Neutrophil count decreased

Upper gastrointestinal

hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the upper gastrointestinal tract (oral cavity, pharynx, esophagus, and stomach).

Navigational Note: -

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

consequences; evidence of

end organ damage; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a decrease in blood supply due to narrowing or blockage of a visceral (mesenteric) artery.

Navigational Note: -

Vomiting

Intervention not indicated

Outpatient IV hydration;

medical intervention indicated

Tube feeding, TPN, or

hospitalization indicated

Life-threatening

consequences

Death

Definition: A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.

Navigational Note: -

Gastrointestinal disorders -

Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 44

General disorders and administration site conditions

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Chills

Mild sensation of cold;

shivering; chattering of teeth

Moderate tremor of the entire

body; narcotics indicated

Severe or prolonged, not

responsive to narcotics

-

Definition: A disorder characterized by a sensation of cold that often marks a physiologic response to sweating after a fever.

Navigational Note: -

Death neonatal

-

Neonatal loss of life

-

Definition: Newborn death occurring during the first 28 days after birth.

Navigational Note: -

Death NOS

-

Death

Definition: Death that cannot be attributed to a CTCAE term associated with Grade 5.

Navigational Note: If death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.

Disease progression

-

Death

Definition: Death due to disease progression that cannot be attributed to a CTCAE term associated with Grade 5.

Navigational Note: If death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.

Edema face

Localized facial edema

Moderate localized facial

edema; limiting instrumental

ADL

Severe swelling; limiting self

care ADL

-

Definition: A disorder characterized by swelling due to excessive fluid accumulation in facial tissues.

Navigational Note: -

Edema limbs

5 - 10% inter-limb discrepancy

in volume or circumference at

point of greatest visible

difference; swelling or

obscuration of anatomic

architecture on close

inspection

>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; limiting instrumental

ADL

>30% inter-limb discrepancy

in volume; gross deviation

from normal anatomic

contour; limiting self care ADL

-

Definition: A disorder characterized by swelling due to excessive fluid accumulation in the upper or lower extremities.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 45

General disorders and administration site conditions

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Edema trunk

Swelling or obscuration of

anatomic architecture on

close inspection

Readily apparent obscuration

of anatomic architecture;

obliteration of skin folds;

readily apparent deviation

from normal anatomic

contour; limiting instrumental

ADL

Gross deviation from normal

anatomic contour; limiting self

care ADL

-

Definition: A disorder characterized by swelling due to excessive fluid accumulation in the trunk area.

Navigational Note: -

Facial pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the face.

Navigational Note: -

Fatigue

Fatigue relieved by rest

Fatigue not relieved by rest;

limiting instrumental ADL

Fatigue not relieved by rest,

limiting self care ADL

-

Definition: A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.

Navigational Note: -

Fever

38.0 - 39.0 degrees C (100.4 -

102.2 degrees F)

>39.0 - 40.0 degrees C (102.3 -

104.0 degrees F)

>40.0 degrees C (>104.0

degrees F) for <=24 hrs

>40.0 degrees C (>104.0

degrees F) for >24 hrs

Death

Definition: A disorder characterized by elevation of the body's temperature above the upper limit of normal.

Navigational Note: -

Flu like symptoms

Mild flu-like symptoms

present

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by a group of symptoms similar to those observed in patients with the flu. It includes fever, chills, body aches, malaise, loss of appetite and dry

cough.

Navigational Note: Synonym: Flu, Influenza

Gait disturbance

Mild change in gait (e.g.,

wide-based, limping or

hobbling)

Moderate change in gait (e.g.,

wide-based, limping or

hobbling); assistive device

indicated; limiting

instrumental ADL

Limiting self care ADL

-

Definition: A disorder characterized by walking difficulties.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 46

General disorders and administration site conditions

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Generalized edema

Noted on exam; 1+ pitting

edema

Interfering with instrumental

ADLs; oral therapy initiated

Interferes with self care ADL;

intravenous therapy

indicated; skin breakdown

Life-threatening consequences

-

Definition: A disorder characterized by fluid accumulation in the tissues of the body including the skin.

Navigational Note: -

Hypothermia

-

35 - >32 degrees C; 95 - >89.6

degrees F

32 - >28 degrees C; 89.6 -

>82.4 degrees F

<=28 degrees C; 82.4 degrees

F; life-threatening

consequences (e.g., coma,

hypotension, pulmonary

edema, acidemia, ventricular

fibrillation)

Death

Definition: A disorder characterized by an abnormally low body temperature. Treatment is required when the body temperature is 35C (95F) or below.

Navigational Note: -

Infusion site extravasation

Painless edema

Erythema with associated

symptoms (e.g., edema, pain,

induration, phlebitis)

Ulceration or necrosis; severe

tissue damage; operative

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by leakage of the infusion into the surrounding tissue. Signs and symptoms may include induration, erythema, swelling, burning sensation and

marked discomfort at the infusion site.

Navigational Note: -

Injection site reaction

Tenderness with or without

associated symptoms (e.g.,

warmth, erythema, itching)

Pain; lipodystrophy; edema;

phlebitis

Ulceration or necrosis; severe

tissue damage; operative

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an intense adverse reaction (usually immunologic) developing at the site of an injection.

Navigational Note: -

Localized edema

Localized to dependent areas,

no disability or functional

impairment

Moderate localized edema

and intervention indicated;

limiting instrumental ADL

Severe localized edema and

intervention indicated;

limiting self care ADL

-

Definition: A disorder characterized by swelling due to excessive fluid accumulation at a specific anatomic site.

Navigational Note: Prior to using this term consider specific edema areas: General disorders and administration site conditions: Edema face, Edema limbs, Edema trunk, or Edema neck;

Nervous system disorders: Edema cerebral; Reproductive system and breast disorders: Genital edema; Respiratory, thoracic and mediastinal disorders: Laryngeal edema or Pulmonary

edema; Skin and subcutaneous tissue disorders: Periorbital edema; Vascular disorders: Lymphedema

Malaise

Uneasiness or lack of well

being

Uneasiness or lack of well

being limiting instrumental

ADL

Uneasiness or lack of well

being limiting self-care ADL

-

Definition: A disorder characterized by a feeling of general discomfort or uneasiness, an out-of-sorts feeling.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 47

General disorders and administration site conditions

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Multi-organ failure

-

Shock with azotemia and acid-

base disturbances; significant

coagulation abnormalities

Life-threatening consequences

(e.g., vasopressor dependent

and oliguric or anuric or

ischemic colitis or lactic

acidosis)

Death

Definition: A disorder characterized by progressive deterioration of the lungs, liver, kidney and clotting mechanisms.

Navigational Note: -

Neck edema

Asymptomatic localized neck

edema

Moderate neck edema; slight

obliteration of anatomic

landmarks; limiting

instrumental ADL

Generalized neck edema (e.g.,

difficulty in turning neck);

limiting self care ADL

Vascular or respiratory

impairment requiring urgent

intervention

-

Definition: A disorder characterized by swelling due to an accumulation of excessive fluid in the neck.

Navigational Note: -

Non-cardiac chest pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the chest unrelated to a heart disorder.

Navigational Note: -

Pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by the sensation of marked discomfort, distress or agony.

Navigational Note: Prior to using this term consider using a specific body part pain term found throughout the CTCAE (over 40 different pain terms).

Sudden death NOS

-

Death

Definition: An unexpected death that cannot be attributed to a CTCAE term associated with Grade 5.

Navigational Note: If death is due to an AE (ex., Cardiac disorders: Cardiac arrest), report as a Grade 5 event under that AE.

Vaccination site

lymphadenopathy

Local lymph node

enlargement

Localized ulceration;

generalized lymph node

enlargement

-

Definition: A disorder characterized by lymph node enlargement after vaccination.

Navigational Note: -

General disorders and

administration site conditions

- Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 48

Hepatobiliary disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Bile duct stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; IV fluids indicated

<24 hrs

Severely altered GI function;

invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a narrowing of the lumen of the bile duct.

Navigational Note: -

Biliary fistula

-

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the bile ducts and another organ or anatomic site.

Navigational Note: -

Budd-Chiari syndrome

-

Medical management

indicated

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

asterixis; mild encephalopathy

Life-threatening

consequences; moderate to

severe encephalopathy; coma

Death

Definition: A disorder characterized by occlusion of the hepatic veins and typically presents with abdominal pain, ascites and hepatomegaly.

Navigational Note: -

Cholecystitis

-

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by inflammation involving the gallbladder. It may be associated with the presence of gallstones.

Navigational Note: -

Gallbladder fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the gallbladder and another organ or anatomic site.

Navigational Note: -

Gallbladder necrosis

-

Life-threatening

consequences; urgent invasive

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the gallbladder.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 49

Hepatobiliary disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Gallbladder obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; altered GI

function; IV fluids indicated

<24 hrs

Symptomatic and severely

altered GI function; tube

feeding, TPN or

hospitalization indicated; non-

emergent operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by blockage of the normal flow of the contents of the gallbladder.

Navigational Note: -

Gallbladder pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the gallbladder region.

Navigational Note: -

Gallbladder perforation

-

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a rupture in the gallbladder wall.

Navigational Note: -

Hepatic failure

-

Asterixis; mild

encephalopathy; drug-

induced liver injury (DILI);

limiting self care ADL

Life-threatening

consequences; moderate to

severe encephalopathy; coma

Death

Definition: A disorder characterized by the inability of the liver to metabolize chemicals in the body. Laboratory test results reveal abnormal plasma levels of ammonia, bilirubin, lactic

dehydrogenase, alkaline phosphatase, aminotransferase, and/or prolongation of prothrombin time (INR.) Drug-induced liever injury (DILI) as defined by Hy's Law.

Navigational Note: -

Hepatic hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the liver.

Navigational Note: -

Hepatic necrosis

-

Life-threatening

consequences; urgent invasive

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the hepatic parenchyma.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 50

Hepatobiliary disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hepatic pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the liver region.

Navigational Note: -

Perforation bile duct

-

Invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a rupture in the wall of the extrahepatic or intrahepatic bile duct.

Navigational Note: -

Portal hypertension

-

Decreased portal vein flow

Reversal/retrograde portal

vein flow; associated with

varices and/or ascites

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an increase in blood pressure in the portal venous system.

Navigational Note: -

Portal vein thrombosis

-

Intervention not indicated

Medical intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by the formation of a thrombus (blood clot) in the portal vein.

Navigational Note: -

Sinusoidal obstruction

syndrome

-

Blood bilirubin 2-5 mg/dL;

minor interventions required

(i.e., blood product, diuretic,

oxygen)

Blood bilirubin >5 mg/dL;

coagulation modifier indicated

(e.g., defibrotide); reversal of

flow on ultrasound

Life-threatening

consequences (e.g.,

ventilatory support, dialysis,

plasmapheresis, peritoneal

drainage)

Death

Definition: A disorder characterized by severe hepatic injury as a result of the blood vessels of the liver becoming inflamed and/or blocked.

Navigational Note: -

Hepatobiliary disorders -

Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 51

Immune system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Allergic reaction

Systemic intervention not

indicated

Oral intervention indicated

Bronchospasm;

hospitalization indicated for

clinical sequelae; intravenous

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an adverse local or general response from exposure to an allergen.

Navigational Note: If related to infusion, use Injury, poisoning and procedural complications: Infusion related reaction. Do not report both.

Anaphylaxis

-

Symptomatic bronchospasm,

with or without urticaria;

parenteral intervention

indicated; allergy-related

edema/angioedema;

hypotension

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an acute inflammatory reaction resulting from the release of histamine and histamine-like substances from mast cells, causing a hypersensitivity

immune response. Clinically, it presents with breathing difficulty, dizziness, hypotension, cyanosis and loss of consciousness and may lead to death.

Navigational Note: -

Autoimmune disorder

Asymptomatic; serologic or

other evidence of

autoimmune reaction, with

normal organ function;

intervention not indicated

Evidence of autoimmune

reaction involving a non-

essential organ or function

(e.g., hypothyroidism)

Autoimmune reactions

involving major organ (e.g.,

colitis, anemia, myocarditis,

kidney)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by loss of function or tissue destruction of an organ or multiple organs, arising from humoral or cellular immune responses of the individual to his

own tissue constituents.

Navigational Note: Prior to using this term consider specific autoimmune AEs

Cytokine release syndrome

Fever with or without

constitutional symptoms

Hypotension responding to

fluids; hypoxia responding to

<40% O2

Hypotension managed with

one pressor; hypoxia requiring

≥ 40% O2

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by fever, tachypnea, headache, tachycardia, hypotension, rash, and/or hypoxia caused by the release of cytokines.

Navigational Note: Also consider reporting other organ dysfunctions including neurological toxicities such as: Psychiatric disorders: Hallucinations or Confusion; Nervous system

disorders: Seizure, Dysphasia, Tremor, or Headache

Serum sickness

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate arthralgia; fever,

rash, urticaria, antihistamines

indicated

Severe arthralgia or arthritis;

extensive rash; steroids or IV

fluids indicated

Life-threatening

consequences; pressor or

ventilatory support indicated

Death

Definition: A disorder characterized by a delayed-type hypersensitivity reaction to foreign proteins derived from an animal serum. It occurs approximately six to twenty-one days

following the administration of the foreign antigen. Symptoms include fever, arthralgias, myalgias, skin eruptions, lymphadenopathy, chest marked discomfort and dyspnea.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 52

Immune system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Immune system disorders -

Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 53

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Abdominal infection

-

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the abdominal cavity.

Navigational Note: -

Anorectal infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the anal area and the rectum.

Navigational Note: -

Appendicitis

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by acute inflammation to the vermiform appendix caused by a pathogenic agent.

Navigational Note: -

Appendicitis perforated

-

Medical intervention

indicated; operative

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by acute inflammation to the vermiform appendix caused by a pathogenic agent with gangrenous changes resulting in the rupture of the

appendiceal wall. The appendiceal wall rupture causes the release of inflammatory and bacterial contents from the appendiceal lumen into the abdominal cavity.

Navigational Note: -

Arteritis infective

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving an artery.

Navigational Note: -

Bacteremia

-

Blood culture positive with no

signs or symptoms

-

Definition: A disorder characterized by the presence of bacteria in the blood stream.

Navigational Note: Consider Infections and infestations: Sepsis (Grades 3, 4 & 5)

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CTCAE v5.0 – November 27, 2017 Page 54

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Biliary tract infection

-

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the biliary tract.

Navigational Note: -

Bladder infection

-

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the bladder.

Navigational Note: -

Bone infection

-

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the bones.

Navigational Note: -

Breast infection

-

Local infection with moderate

symptoms; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; severe infection;

axillary adenitis

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the breast.

Navigational Note: -

Bronchial infection

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the bronchi.

Navigational Note: -

Catheter related infection

-

Localized; local intervention

indicated; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process that arises secondary to catheter use.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 55

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Cecal infection

-

Localized; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the cecum.

Navigational Note: -

Cervicitis infection

-

Localized; local intervention

indicated (e.g., topical

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the uterine cervix.

Navigational Note: -

Conjunctivitis

Asymptomatic or mild

symptoms; intervention not

indicated

Symptomatic; moderate

decrease in visual acuity (best

corrected visual acuity 20/40

and better or 3 lines or less

decreased vision from known

baseline)

Symptomatic with marked

decrease in visual acuity (best

corrected visual acuity worse

than 20/40 or more than 3

lines of decreased vision from

known baseline, up to

20/200); limiting self care ADL

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by inflammation, swelling and redness to the conjunctiva of the eye.

Navigational Note: Consider Infections and infestations: Conjunctivitis infective if caused by infection

Conjunctivitis infective

-

Localized; local intervention

indicated (e.g., topical

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

-

Definition: A disorder characterized by an infectious process involving the conjunctiva. Clinical manifestations include pink or red color in the eyes.

Navigational Note: -

Corneal infection

-

Localized; local intervention

indicated (e.g., topical

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the cornea.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 56

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Cranial nerve infection

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving a cranial nerve.

Navigational Note: -

Cytomegalovirus infection

reactivation

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; medical

intervention indicated

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated; IV

intervention indicated

Life-threatening

consequences; urgent

intervention indicated;

blindness

Death

Definition: A disorder characterized by the reactivation of cytomegalovirus (CMV).

Navigational Note: Synonym: CMV

Device related infection

-

Oral intervention indicated

(e.g., antibiotic, antifungal)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the use of a medical device.

Navigational Note: -

Duodenal infection

-

Moderate symptoms; medical

intervention indicated (e.g.,

oral antibiotics)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the duodenum.

Navigational Note: -

Encephalitis infection

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; severe changes in

mental status; self-limited

seizure activity; focal

neurologic abnormalities

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the brain tissue.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 57

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Encephalomyelitis infection

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the brain and spinal cord tissues.

Navigational Note: -

Endocarditis infective

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the endocardial layer of the heart.

Navigational Note: -

Endophthalmitis

-

Local intervention indicated

Systemic intervention;

hospitalization indicated

Best corrected visual acuity of

20/200 or worse in the

affected eye

-

Definition: A disorder characterized by an infectious process involving the internal structures of the eye.

Navigational Note: -

Enterocolitis infectious

-

Passage of >3 unformed stools

per 24 hrs or duration of

illness >48 hrs; moderate

abdominal pain; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated;

profuse watery diarrhea with

signs of hypovolemia; bloody

diarrhea; fever; severe

abdominal pain;

hospitalization indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the small and large intestines.

Navigational Note: Includes Clostridium difficile (c. diff, c. difficile).

Epstein-Barr virus infection

reactivation

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; medical

intervention indicated

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated; IV

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by the reactivation of Epstein-Barr virus (EBV).

Navigational Note: Synonym: EBV

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CTCAE v5.0 – November 27, 2017 Page 58

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Esophageal infection

-

Local intervention indicated

(e.g., oral antibiotic,

antifungal, antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the esophagus.

Navigational Note: -

Eye infection

-

Localized; local intervention

indicated (e.g., topical

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated;

enucleation

Death

Definition: A disorder characterized by an infectious process involving the eye.

Navigational Note: -

Folliculitis

Covering <10% of the body

surface area; no intervention

indicated

Covering 10-30% of the body

surface area; topical

intervention initiated

>30% BSA; systemic

intervention indicated

-

Definition: A disorder characterized by inflammation or infection of the hair follicles.

Navigational Note: -

Fungemia

-

Moderate symptoms; medical

intervention indicated

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated

-

Definition: A disorder characterized by the presence of fungus in the blood stream.

Navigational Note: -

Gallbladder infection

-

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the gallbladder.

Navigational Note: -

Gum infection

Local therapy indicated (swish

and swallow)

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the gums.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 59

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hepatic infection

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the liver.

Navigational Note: -

Hepatitis B reactivation

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; medical

intervention indicated

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated; IV

intervention indicated

Life-threatening

consequences; urgent

intervention indicated; severe

decompensated liver function

(e.g., coagulopathy,

encephalopathy, coma)

Death

Definition: A disorder characterized by the reactivation of hepatitis B virus.

Navigational Note: -

Hepatitis viral

Asymptomatic, intervention

not indicated

Moderate symptoms; medical

intervention indicated

Symptomatic liver

dysfunction; fibrosis by

biopsy; compensated

cirrhosis; hospitalization or

prolongation of existing

hospitalization indicated

Life-threatening

consequences; severe

decompensated liver function

(e.g., coagulopathy,

encephalopathy, coma)

Death

Definition: A disorder characterized by a viral pathologic process involving the liver parenchyma.

Navigational Note: -

Herpes simplex reactivation

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; medical

intervention indicated

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated; IV

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by the reactivation of Herpes simplex virus.

Navigational Note: -

Infective myositis

-

Localized; local intervention

indicated (e.g., topical

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the skeletal muscles.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 60

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Joint infection

-

Localized; local intervention

indicated; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral);

needle aspiration indicated

(single or multiple)

Arthroscopic intervention

indicated (e.g., drainage) or

arthrotomy (e.g., open

surgical drainage)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving a joint.

Navigational Note: -

Kidney infection

-

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the kidney.

Navigational Note: -

Laryngitis

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an inflammatory process involving the larynx.

Navigational Note: For symptoms and no intervention, consider Respiratory, thoracic and mediastinal disorders: Sore throat or Hoarseness.

Lip infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

-

Definition: A disorder characterized by an infectious process involving the lips.

Navigational Note: -

Lung infection

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the lungs, including pneumonia.

Navigational Note: If infection is due to aspiration, consider reporting Respiratory, thoracic and mediastinal disorders: Apiration

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 61

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Lymph gland infection

-

Localized; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the lymph nodes.

Navigational Note: -

Mediastinal infection

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the mediastinum.

Navigational Note: -

Meningitis

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated; focal

neurologic deficit

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by acute inflammation of the meninges of the brain and/or spinal cord.

Navigational Note: -

Mucosal infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving a mucosal surface.

Navigational Note: -

Myelitis

Asymptomatic; mild signs

(e.g., Babinski's reflex or

Lhermitte's sign)

Moderate weakness or

sensory loss; limiting

instrumental ADL

Severe weakness or sensory

loss; limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation involving the spinal cord. Symptoms include weakness, paresthesia, sensory loss, marked discomfort and incontinence.

Navigational Note: -

Nail infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

-

Definition: A disorder characterized by an infectious process involving the nail.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 62

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Otitis externa

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the outer ear and ear canal. Contributory factors include excessive water exposure (swimmer's ear infection) and

cuts in the ear canal. Symptoms include fullness, itching, swelling and marked discomfort in the ear and ear drainage.

Navigational Note: Changes associated with radiation to external ear (pinnae) are graded under Injury, poisoning and procedural complications: Dermatitis radiation

Otitis media

-

Localized; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the middle ear.

Navigational Note: -

Ovarian infection

-

Localized; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the ovary.

Navigational Note: -

Pancreas infection

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the pancreas.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 63

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Papulopustular rash

Papules and/or pustules

covering <10% BSA, which

may or may not be associated

with symptoms of pruritus or

tenderness

Papules and/or pustules

covering 10-30% BSA, which

may or may not be associated

with symptoms of pruritus or

tenderness; associated with

psychosocial impact; limiting

instrumental ADL; papules

and/or pustules covering >

30% BSA with or without mild

symptoms

Papules and/or pustules

covering >30% BSA with

moderate or severe

symptoms; limiting self-care

ADL; IV antibiotics indicated

Life-threatening

consequences

Death

Definition: A disorder characterized by an eruption consisting of papules (a small, raised pimple) and pustules (a small pus filled blister), typically appearing in face, scalp, and upper

chest and back. Unlike acne, this rash does not present with whiteheads or blackheads, and can be symptomatic, with itchy or tender lesions.

Navigational Note: -

Paronychia

Nail fold edema or erythema;

disruption of the cuticle

Local intervention indicated;

oral intervention indicated

(e.g., antibiotic, antifungal,

antiviral); nail fold edema or

erythema with pain;

associated with discharge or

nail plate separation; limiting

instrumental ADL

Operative intervention

indicated; IV antibiotics

indicated; limiting self care

ADL

-

Definition: A disorder characterized by an infectious process involving the soft tissues around the nail.

Navigational Note: -

Pelvic infection

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the pelvic cavity.

Navigational Note: -

Penile infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the penis.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 64

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Periorbital infection

-

Localized; local intervention

indicated (e.g., topical

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the orbit of the eye.

Navigational Note: -

Peripheral nerve infection

-

Localized; local intervention

indicated (e.g., topical

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the peripheral nerves.

Navigational Note: -

Peritoneal infection

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the peritoneum.

Navigational Note: -

Pharyngitis

-

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation of the throat.

Navigational Note: For Grade 1 Consider Respiratory, thoracic and mediastinal disorders: Sore throat

Phlebitis infective

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the vein. Clinical manifestations include erythema, marked discomfort, swelling, and induration along the course

of the infected vein.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 65

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Pleural infection

-

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the pleura.

Navigational Note: -

Prostate infection

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the prostate gland.

Navigational Note: -

Rash pustular

-

Localized; local intervention

indicated (e.g., topical

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

-

Definition: A disorder characterized by a circumscribed and elevated skin lesion filled with pus.

Navigational Note: Synonym: Boil

Rhinitis infective

-

Localized; local intervention

indicated

-

Definition: A disorder characterized by an infectious process involving the nasal mucosal.

Navigational Note: -

Salivary gland infection

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the salivary gland.

Navigational Note: -

Scrotal infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the scrotum.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 66

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Sepsis

-

Blood culture positive with

signs or symptoms; treatment

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause a rapidly progressing systemic reaction that may lead to shock.

Navigational Note: Includes SIRS. Also consider Infections and infestations: Bacteremia (Grade 2)

Shingles

Localized, local intervention

indicated

Local infection with moderate

symptoms; oral intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated; IV

intervention indicated;

limiting self-care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by the reactivation of herpes zoster virus.

Navigational Note: Synonym: Herpes zoster

Sinusitis

-

Localized; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the mucous membranes of the paranasal sinuses.

Navigational Note: -

Skin infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the skin such as cellulitis.

Navigational Note: -

Small intestine infection

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the small intestine.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 67

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Soft tissue infection

-

Localized; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving soft tissues.

Navigational Note: -

Splenic infection

-

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the spleen.

Navigational Note: -

Stoma site infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving a stoma (surgically created opening on the surface of the body).

Navigational Note: -

Thrush

Asymptomatic; local

symptomatic management

Oral intervention indicated

(e.g., antifungal)

IV antifungal intervention

indicated

-

Definition: A disorder characterized by a suspected candidal infection involving an oral mucosal surface.

Navigational Note: -

Tooth infection

-

Localized; local intervention

indicated (e.g., topical

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving a tooth.

Navigational Note: -

Tracheitis

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the trachea.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 68

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Upper respiratory infection

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea).

Navigational Note: -

Urethral infection

-

Localized; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the urethra.

Navigational Note: -

Urinary tract infection

-

Localized; oral intervention

indicated (e.g., antibiotic,

antifungal, or antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra.

Navigational Note: -

Uterine infection

-

Moderate symptoms; oral

intervention indicated (e.g.,

antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the endometrium. It may extend to the myometrium and parametrial tissues.

Navigational Note: -

Vaginal infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the vagina.

Navigational Note: -

Viremia

-

Moderate symptoms; medical

intervention indicated

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated

-

Definition: A disorder characterized by the presence of a virus in the blood stream.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 69

Infections and infestations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Vulval infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the vulva.

Navigational Note: -

Wound infection

Localized, local intervention

indicated

Oral intervention indicated

(e.g., antibiotic, antifungal, or

antiviral)

IV antibiotic, antifungal, or

antiviral intervention

indicated; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an infectious process involving the wound.

Navigational Note: -

Infections and infestations -

Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 70

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Ankle fracture

Mild; non-operative

intervention indicated

Limiting instrumental ADL;

outpatient operative

intervention indicated

Limiting self care ADL; elective

operative intervention

indicated requiring

hospitalization

-

Definition: A finding of damage to the ankle joint characterized by a break in the continuity of the ankle bone. Symptoms include marked discomfort, swelling and difficulty moving the

affected leg and foot.

Navigational Note: -

Aortic injury

-

Operative intervention not

indicated

Severe symptoms; limiting self

care ADL; repair or revision

indicated

Life-threatening

consequences; evidence of

end organ damage; urgent

operative intervention

indicated

Death

Definition: A finding of damage to the aorta.

Navigational Note: -

Arterial injury

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; repair or

revision not indicated

Severe symptoms; limiting self

care ADL; repair or revision

indicated

Life-threatening

consequences; evidence of

end organ damage; urgent

operative intervention

indicated

Death

Definition: A finding of damage to an artery.

Navigational Note: -

Biliary anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage of bile due to breakdown of a biliary anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Bladder anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage of urine due to breakdown of a bladder anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Bruising

Localized or in a dependent

area

Generalized

-

Definition: A finding of injury of the soft tissues or bone characterized by leakage of blood into surrounding tissues.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 71

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Burn

Minimal symptoms;

intervention not indicated

Medical intervention; minimal

debridement indicated

Moderate to major

debridement or

reconstruction indicated

Life-threatening

consequences

Death

Definition: A finding of impaired integrity to the anatomic site of an adverse thermal reaction. Burns can be caused by exposure to chemicals, direct heat, electricity, flames and

radiation. The extent of damage depends on the length and intensity of exposure and time until provision of treatment.

Navigational Note: -

Dermatitis radiation

Faint erythema or dry

desquamation

Moderate to brisk erythema;

patchy moist desquamation,

mostly confined to skin folds

and creases; moderate edema

Moist desquamation in areas

other than skin folds and

creases; bleeding induced by

minor trauma or abrasion

Life-threatening

consequences; skin necrosis

or ulceration of full thickness

dermis; spontaneous bleeding

from involved site; skin graft

indicated

Death

Definition: A finding of cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.

Navigational Note: Synonym: Radiation induced skin toxicities (CTCAE v3.0 )

Esophageal anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of an esophageal anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Fall

Minor with no resultant

injuries; intervention not

indicated

Symptomatic; noninvasive

intervention indicated

Hospitalization indicated;

invasive intervention

indicated

-

Definition: A finding of sudden movement downward, usually resulting in injury.

Navigational Note: -

Fallopian tube anastomotic

leak

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a fallopian tube anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 72

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Fallopian tube perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated (e.g., organ

resection)

Death

Definition: A disorder characterized by a rupture of the fallopian tube wall.

Navigational Note: -

Fracture

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic but non-

displaced; immobilization

indicated

Severe symptoms; displaced

or open wound with bone

exposure; limiting self care

ADL; operative intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of traumatic injury to the bone in which the continuity of the bone is broken.

Navigational Note: Prior to using this term consider specific fracture areas: Injury, poisoning and procedural complications: Ankle fracture, Hip fracture, Spinal fracture, or Wrist

fracture

Gastric anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a gastric anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Gastrointestinal anastomotic

leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a gastrointestinal anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Gastrointestinal stoma

necrosis

-

Superficial necrosis;

intervention not indicated

Severe symptoms;

hospitalization indicated;

elective operative

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the gastrointestinal tract stoma.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 73

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hip fracture

-

Hairline fracture; mild pain;

limiting instrumental ADL;

non-operative intervention

indicated

Severe pain; hospitalization or

intervention indicated for pain

control (e.g., traction);

operative intervention

indicated

Life-threatening

consequences; symptoms

associated with neurovascular

compromise

-

Definition: A finding of traumatic injury to the hip in which the continuity of either the femoral head, femoral neck, intertrochanteric or subtrochanteric regions is broken.

Navigational Note: -

Infusion related reaction

Mild transient reaction;

infusion interruption not

indicated; intervention not

indicated

Therapy or infusion

interruption indicated but

responds promptly to

symptomatic treatment (e.g.,

antihistamines, NSAIDS,

narcotics, IV fluids);

prophylactic medications

indicated for <=24 hrs

Prolonged (e.g., not rapidly

responsive to symptomatic

medication and/or brief

interruption of infusion);

recurrence of symptoms

following initial improvement;

hospitalization indicated for

clinical sequelae

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by adverse reaction to the infusion of pharmacological or biological substances.

Navigational Note: -

Injury to carotid artery

-

Repair or revision not

indicated

Severe symptoms; limiting self

care ADL (e.g., transient

cerebral ischemia); repair or

revision indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the carotid artery.

Navigational Note: -

Injury to inferior vena cava

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; repair or

revision not indicated

Severe symptoms; limiting self

care ADL; repair or revision

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the inferior vena

cava.

Navigational Note: -

Injury to jugular vein

-

Repair or revision not

indicated

Symptomatic limiting self care

ADL; repair or revision

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the jugular vein.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 74

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Injury to superior vena cava

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; repair or

revision not indicated

Severe symptoms; limiting self

care ADL; repair or revision

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the superior vena cava.

Navigational Note: -

Intestinal stoma leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage of contents from an intestinal stoma (surgically created opening on the surface of the body).

Navigational Note: -

Intestinal stoma obstruction

-

Self-limited; intervention not

indicated

Severe symptoms; IV fluids,

tube feeding, or TPN indicated

>=24 hrs; elective operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by blockage of the normal flow of the contents of the intestinal stoma.

Navigational Note: -

Intestinal stoma site bleeding

Minimal bleeding identified

on clinical exam; intervention

not indicated

Moderate bleeding; medical

intervention indicated

Transfusion indicated;

invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the intestinal stoma.

Navigational Note: -

Intraoperative arterial injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to an artery during a surgical procedure.

Navigational Note: -

Intraoperative breast injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the breast parenchyma during a surgical procedure.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 75

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Intraoperative cardiac injury

-

Primary repair of injured

organ/structure indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the heart during a surgical procedure.

Navigational Note: -

Intraoperative ear injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL (e.g.,

impaired hearing; impaired

balance)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the ear during a surgical procedure.

Navigational Note: -

Intraoperative endocrine

injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the endocrine gland during a surgical procedure.

Navigational Note: -

Intraoperative gastrointestinal

injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the gastrointestinal system during a surgical procedure.

Navigational Note: -

Intraoperative head and neck

injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the head and neck during a surgical procedure.

Navigational Note: -

Intraoperative hemorrhage

-

Postoperative invasive

intervention indicated;

hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of uncontrolled bleeding during a surgical procedure.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 76

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Intraoperative hepatobiliary

injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the hepatic parenchyma and/or biliary tract during a surgical procedure.

Navigational Note: -

Intraoperative

musculoskeletal injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the musculoskeletal system during a surgical procedure.

Navigational Note: -

Intraoperative neurological

injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the nervous system during a surgical procedure.

Navigational Note: -

Intraoperative ocular injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the eye during a surgical procedure.

Navigational Note: -

Intraoperative renal injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the kidney during a surgical procedure.

Navigational Note: -

Intraoperative reproductive

tract injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the reproductive organs during a surgical procedure.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 77

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Intraoperative respiratory

injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the respiratory system during a surgical procedure.

Navigational Note: -

Intraoperative splenic injury

-

Primary repair of injured

organ/structure indicated

Resection or reconstruction of

injured organ/structure

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the spleen during a surgical procedure.

Navigational Note: -

Intraoperative urinary injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to the urinary system during a surgical procedure.

Navigational Note: -

Intraoperative venous injury

Primary repair of injured

organ/structure indicated

Partial resection of injured

organ/structure indicated

Complete resection or

reconstruction of injured

organ/structure indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of damage to a vein during a surgical procedure.

Navigational Note: -

Kidney anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage of urine due to breakdown of a kidney anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Large intestinal anastomotic

leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of an anastomosis (surgical connection of two separate anatomic structures) in the large intestine.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 78

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Pancreatic anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a pancreatic anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Pharyngeal anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a pharyngeal anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Postoperative hemorrhage

Mild symptoms; intervention

not indicated

Moderate bleeding requiring

transfusion < 2 units (10 cc/kg

for pediatrics) of pRBCs

Transfusion indicated of >=2

units (10 cc/kg for pediatrics)

pRBCs; invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding occurring after a surgical procedure.

Navigational Note: -

Postoperative thoracic

procedure complication

-

Extubated within 24 - 72 hrs

postoperatively

Extubated >72 hrs

postoperatively, but before

tracheostomy indicated

Life-threatening airway

compromise; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A finding of a previously undocumented problem that occurs after a thoracic procedure.

Navigational Note: -

Prolapse of intestinal stoma

Asymptomatic; reducible

Recurrent after manual

reduction; local irritation or

stool leakage; difficulty to fit

appliance; limiting

instrumental ADL

Severe symptoms; elective

operative intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of protrusion of the intestinal stoma (surgically created opening on the surface of the body) above the abdominal surface.

Navigational Note: -

Prolapse of urostomy

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Local care or maintenance;

minor revision indicated

Dysfunctional stoma; elective

operative intervention or

major stomal revision

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A finding of displacement of the urostomy.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 79

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Radiation recall reaction

(dermatologic)

Faint erythema or dry

desquamation

Moderate to brisk erythema;

patchy moist desquamation,

mostly confined to skin folds

and creases; moderate edema

Moist desquamation in areas

other than skin folds and

creases; bleeding induced by

minor trauma or abrasion

Life-threatening

consequences; skin necrosis

or ulceration of full thickness

dermis; spontaneous bleeding

from involved site; skin graft

indicated

Death

Definition: A finding of acute skin inflammatory reaction caused by drugs, especially chemotherapeutic agents, for weeks or months following radiotherapy. The inflammatory reaction

is confined to the previously irradiated skin and the symptoms disappear after the removal of the pharmaceutical agent.

Navigational Note: -

Rectal anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a rectal anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Seroma

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; simple

aspiration indicated

Symptomatic, elective

invasive intervention

indicated

-

Definition: A finding of tumor-like collection of serum in the tissues.

Navigational Note: -

Small intestinal anastomotic

leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of an anastomosis (surgical connection of two separate anatomic structures) in the small bowel.

Navigational Note: -

Spermatic cord anastomotic

leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a spermatic cord anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 80

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Spinal fracture

Mild back pain;

nonprescription analgesics

indicated

Moderate back pain;

prescription analgesics

indicated; limiting

instrumental ADL

Severe back pain;

hospitalization or intervention

indicated for pain control

(e.g., vertebroplasty); limiting

self care ADL; disability

Life-threatening

consequences; symptoms

associated with neurovascular

compromise

Death

Definition: A finding of traumatic injury to the spine in which the continuity of a vertebral bone is broken.

Navigational Note: -

Stenosis of gastrointestinal

stoma

-

Symptomatic; IV fluids

indicated <24 hrs; manual

dilation at bedside

Severely altered GI function;

tube feeding, TPN or

hospitalization indicated;

elective operative

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of narrowing of the gastrointestinal stoma (surgically created opening on the surface of the body).

Navigational Note: -

Stomal ulcer

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated

Severe symptoms; elective

operative intervention

indicated

-

Definition: A disorder characterized by a circumscribed, erosive lesion on the jejunal mucosal surface close to the anastomosis site following a gastroenterostomy procedure.

Navigational Note: -

Tracheal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the trachea.

Navigational Note: -

Tracheal obstruction

Partial asymptomatic

obstruction on examination

(e.g., visual, radiologic or

endoscopic)

Symptomatic (e.g., noisy

airway breathing), no

respiratory distress; medical

intervention indicated (e.g.,

steroids); limiting

instrumental ADL

Stridor or respiratory distress

limiting self care ADL; invasive

intervention indicated (e.g.,

stent, laser)

Life-threatening airway

compromise; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A disorder characterized by blockage of the lumen of the trachea.

Navigational Note: -

Tracheostomy site bleeding

Minimal bleeding identified

on clinical exam; intervention

not indicated

Moderate bleeding; medical

intervention indicated

Transfusion indicated;

invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the tracheostomy site.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 81

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Ureteric anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a ureteral anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Urethral anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a urethral anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Urostomy leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage of contents from a urostomy.

Navigational Note: -

Urostomy obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; dilation or

endoscopic repair or stent

placement indicated

Altered organ function (e.g.,

sepsis or hydronephrosis, or

renal dysfunction); elective

operative intervention

indicated

Life-threatening

consequences; organ failure;

urgent operative intervention

indicated

Death

Definition: A disorder characterized by blockage of the urostomy.

Navigational Note: -

Urostomy site bleeding

Minimal bleeding identified

on clinical exam; intervention

not indicated

Moderate bleeding; medical

intervention indicated

Transfusion indicated;

invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the urostomy site.

Navigational Note: -

Urostomy stenosis

-

Symptomatic but no

hydronephrosis, sepsis, or

renal dysfunction; dilation or

endoscopic repair or stent

placement indicated

Symptomatic (e.g.,

hydronephrosis, or renal

dysfunction); elective

operative intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of narrowing of the opening of a urostomy.

Navigational Note: -

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 82

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Uterine anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a uterine anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Uterine perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a rupture in the uterine wall.

Navigational Note: -

Vaccination complication

Mild pain; erythema 2.5-5cm;

induration/swelling 2.5-5cm;

does not interfere with

activity

Moderate pain; Erythema 5.1-

10 cm; Induration/swelling

5.1-10 cm; lipodystrophy;

limiting instrumental ADL

Severe pain; Erythema > 10

cm; Induration/swelling > 10

cm; necrosis; limiting self care

ADL

Life-threatening

consequences; urgent

intervention indicated

-

Definition: A disorder that occurs after the injection of a substance with antigenic properties, administered to activate the immune system.

Navigational Note: For systemic vaccination complications, consider Immune system disorders: Allergic reaction or Anaphylaxis.

Vaginal anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a vaginal anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Vas deferens anastomotic leak

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A finding of leakage due to breakdown of a vas deferens anastomosis (surgical connection of two separate anatomic structures).

Navigational Note: -

Vascular access complication

TPA administration into line

with no intent for systemic

therapy indicated

Device dislodgement,

blockage, leak, or malposition;

device replacement indicated

Pulmonary embolism, deep

vein or cardiac thrombosis;

intervention indicated (e.g.,

anticoagulation, lysis, filter,

invasive procedure)

Life-threatening

consequences with

hemodynamic or neurologic

instability

Death

Definition: A finding of a previously undocumented problem related to the vascular access site.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 83

Injury, poisoning and procedural complications

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Venous injury

Asymptomatic diagnostic

finding; intervention not

indicated

Symptomatic (e.g.,

claudication); repair or

revision not indicated

Severe symptoms; limiting self

care ADL; repair or revision

indicated

Life-threatening

consequences; evidence of

end organ damage; urgent

operative intervention

indicated

Death

Definition: A finding of damage to a vein.

Navigational Note: -

Wound complication

Observation only; topical

intervention indicated

Bedside local care indicated

Operative intervention

indicated

Life-threatening

consequences

Death

Definition: A finding of development of a new problem at the site of an existing wound.

Navigational Note: Prior to using this term consider Injury, poisoning and procedural complications: Wound dehiscence or Infections and infestations: Wound infection

Wound dehiscence

Incisional separation,

intervention not indicated

Incisional separation, local

care (e.g., suturing) or medical

intervention indicated (e.g.,

analgesic)

Fascial disruption or

dehiscence without

evisceration; revision by

operative intervention

indicated

Life-threatening

consequences; symptomatic

hernia with evidence of

strangulation; fascial

disruption with evisceration;

major reconstruction flap,

grafting, resection, or

amputation indicated

Death

Definition: A finding of separation of the approximated margins of a surgical wound.

Navigational Note: Also consider Infections and infestations: Wound infection

Wrist fracture

Mild; non-operative

intervention indicated

Limiting instrumental ADL;

outpatient operative

intervention indicated

Limiting self care ADL; elective

operative intervention

indicated requiring

hospitalization

-

Definition: A finding of traumatic injury to the wrist joint in which the continuity of a wrist bone is broken.

Navigational Note: -

Injury, poisoning and

procedural complications -

Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 84

Investigations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Activated partial

thromboplastin time

prolonged

>ULN - 1.5 x ULN

>1.5 - 2.5 x ULN

>2.5 x ULN; bleeding

-

Definition: A finding based on laboratory test results in which the partial thromboplastin time is found to be greater than the control value. As a possible indicator of coagulopathy, a

prolonged partial thromboplastin time (PTT) may occur in a variety of diseases and disorders, both primary and related to treatment.

Navigational Note: -

Alanine aminotransferase

increased

>ULN - 3.0 x ULN if baseline

was normal; 1.5 - 3.0 x

baseline if baseline was

abnormal

>3.0 - 5.0 x ULN if baseline

was normal; >3.0 - 5.0 x

baseline if baseline was

abnormal

>5.0 - 20.0 x ULN if baseline

was normal; >5.0 - 20.0 x

baseline if baseline was

abnormal

>20.0 x ULN if baseline was

normal; >20.0 x baseline if

baseline was abnormal

-

Definition: A finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen.

Navigational Note: Also consider Hepatobiliary disorders: Hepatic failure

Alkaline phosphatase

increased

>ULN - 2.5 x ULN if baseline

was normal; 2.0 - 2.5 x

baseline if baseline was

abnormal

>2.5 - 5.0 x ULN if baseline

was normal; >2.5 - 5.0 x

baseline if baseline was

abnormal

>5.0 - 20.0 x ULN if baseline

was normal; >5.0 - 20.0 x

baseline if baseline was

abnormal

>20.0 x ULN if baseline was

normal; >20.0 x baseline if

baseline was abnormal

-

Definition: A finding based on laboratory test results that indicate an increase in the level of alkaline phosphatase in a blood specimen.

Navigational Note: -

Aspartate aminotransferase

increased

>ULN - 3.0 x ULN if baseline

was normal; 1.5 - 3.0 x

baseline if baseline was

abnormal

>3.0 - 5.0 x ULN if baseline

was normal; >3.0 - 5.0 x

baseline if baseline was

abnormal

>5.0 - 20.0 x ULN if baseline

was normal; >5.0 - 20.0 x

baseline if baseline was

abnormal

>20.0 x ULN if baseline was

normal; >20.0 x baseline if

baseline was abnormal

-

Definition: A finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen.

Navigational Note: Also consider Hepatobiliary disorders: Hepatic failure

Blood antidiuretic hormone

abnormal

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated

Hospitalization indicated

-

Definition: A finding based on laboratory test results that indicate abnormal levels of antidiuretic hormone in the blood specimen.

Navigational Note: -

Blood bicarbonate decreased

<LLN and no intervention

initiated

-

Definition: A finding based on laboratory test results that indicate a decrease in levels of bicarbonate in a venous blood specimen.

Navigational Note: Also consider Metabolism and nutrition disorders: Acidosis or Alkalosis

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 85

Investigations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Blood bilirubin increased

>ULN - 1.5 x ULN if baseline

was normal; > 1.0 - 1.5 x

baseline if baseline was

abnormal

>1.5 - 3.0 x ULN if baseline

was normal; >1.5 - 3.0 x

baseline if baseline was

abnormal

>3.0 - 10.0 x ULN if baseline

was normal; >3.0 - 10.0 x

baseline if baseline was

abnormal

>10.0 x ULN if baseline was

normal; >10.0 x baseline if

baseline was abnormal

-

Definition: A finding based on laboratory test results that indicate an abnormally high level of bilirubin in the blood. Excess bilirubin is associated with jaundice.

Navigational Note: Also consider Hepatobiliary disorders: Hepatic failure

Blood corticotrophin

decreased

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated

Hospitalization indicated

-

Definition: A finding based on laboratory test results that indicate an decrease in levels of corticotrophin in a blood specimen.

Navigational Note: -

Blood gonadotrophin

abnormal

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated;

limiting instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A finding based on laboratory test results that indicate abnormal levels of gonadotrophin hormone in a blood specimen.

Navigational Note: -

Blood lactate dehydrogenase

increased

>ULN

-

Definition: A finding based on laboratory test results that indicate increased levels of lactate dehydrogenase in the blood specimen.

Navigational Note: -

Blood prolactin abnormal

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

-

Definition: A finding based on laboratory test results that indicate abnormal levels of prolactin hormone in a blood specimen.

Navigational Note: -

Carbon monoxide diffusing

capacity decreased

3 - 5 units below LLN; for

follow-up, a decrease of 3 - 5

units (ml/min/mm Hg) below

the baseline value;

asymptomatic and

intervention not indicated

6 - 8 units below LLN; for

follow-up, an asymptomatic

decrease of >5 - 8 units

(ml/min/mm Hg) below the

baseline value; symptomatic

and intervention not indicated

Asymptomatic decrease of >8

units drop; >5 units drop

along with the presence of

pulmonary symptoms (e.g.,

>Grade 2 hypoxia or >Grade 2

dyspnea); intervention

indicated

-

Definition: A finding based on lung function test results that indicate a decrease in the lung capacity to absorb carbon monoxide.

Navigational Note: Also consider Respiratory, thoracic and mediastinal disorders: Respiratory failure or Dyspnea

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 86

Investigations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Cardiac troponin I increased

Levels above the upper limit

of normal and below the level

of myocardial infarction as

defined by the manufacturer

-

Levels consistent with

myocardial infarction as

defined by the manufacturer

-

Definition: A finding based on laboratory test results that indicate increased levels of cardiac troponin I in a biological specimen.

Navigational Note: Also consider Cardiac disorders: Heart failure or Cardiac disorders: Myocardial infarction. Report Cardiac disorders: Heart failure or Cardiac disorders: Myocardial

infarction if same grade event.

Cardiac troponin T increased

Levels above the upper limit

of normal and below the level

of myocardial infarction as

defined by the manufacturer

-

Levels consistent with

myocardial infarction as

defined by the manufacturer

-

Definition: A finding based on laboratory test results that indicate increased levels of cardiac troponin T in a biological specimen.

Navigational Note: Also consider Cardiac disorders: Heart failure or Cardiac disorders: Myocardial infarction. Report Cardiac disorders: Heart failure or Cardiac disorders: Myocardial

infarction if same grade event.

CD4 lymphocytes decreased

<LLN - 500/mm3; <LLN - 0.5 x

10e9 /L

<500 - 200/mm3; <0.5 - 0.2 x

10e9 /L

<200 - 50/mm3; <0.2 x 0.05 -

10e9 /L

<50/mm3; <0.05 x 10e9 /L

-

Definition: A finding based on laboratory test results that indicate an decrease in levels of CD4 lymphocytes in a blood specimen.

Navigational Note: -

Cholesterol high

>ULN - 300 mg/dL; >ULN -

7.75 mmol/L

>300 - 400 mg/dL; >7.75 -

10.34 mmol/L

>400 - 500 mg/dL; >10.34 -

12.92 mmol/L

>500 mg/dL; >12.92 mmol/L

-

Definition: A finding based on laboratory test results that indicate higher than normal levels of cholesterol in a blood specimen.

Navigational Note: -

CPK increased

>ULN - 2.5 x ULN

>2.5 x ULN - 5 x ULN

>5 x ULN - 10 x ULN

>10 x ULN

-

Definition: A finding based on laboratory test results that indicate an increase in levels of creatine phosphokinase in a blood specimen.

Navigational Note: Also consider Cardiac disorders: Heart failure or Cardiac disorders: Myocardial infarction. Report Cardiac disorders: Heart failure or Cardiac disorders: Myocardial

infarction if same grade event.

Creatinine increased

>ULN - 1.5 x ULN

>1.5 - 3.0 x baseline; >1.5 - 3.0

x ULN

>3.0 x baseline; >3.0 - 6.0 x

ULN

>6.0 x ULN

-

Definition: A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen.

Navigational Note: Also consider Renal and urinary disorders: Acute kidney injury

Back to TOC

CTCAE v5.0 – November 27, 2017 Page 87

Investigations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Ejection fraction decreased

-

Resting ejection fraction (EF)

50 - 40%; 10 - 19% drop from

baseline

Resting ejection fraction (EF)

39 - 20%; >=20% drop from

baseline

Resting ejection fraction (EF)

<20%

-

Definition: The percentage computed when the amount of blood ejected during a ventricular contraction of the heart is compared to the amount that was present prior to the

contraction.

Navigational Note: Also consider Cardiac disorders: Left ventricular systolic dysfunction. Report Cardiac disorders: Left ventricular systolic dysfunction if same grade event.

Electrocardiogram QT

corrected interval prolonged

Average QTc 450 - 480 ms

Average QTc 481 - 500 ms

Average QTc >= 501 ms; >60

ms change from baseline

Torsade de pointes;

polymorphic ventricular

tachycardia; signs/symptoms

of serious arrhythmia

-

Definition: A finding of a cardiac dysrhythmia characterized by an abnormally long corrected QT interval.

Navigational Note: -

Electrocardiogram T wave

abnormal

T wave flattening

Nonspecific ST segment

change

-

Definition: A disorder characterized by Electrocardiogram T wave amplitude changes.

Navigational Note: -

Fibrinogen decreased

<1.0 - 0.75 x LLN; if abnormal,

<25% decrease from baseline

<0.75 - 0.5 x LLN; if abnormal,

25 - <50% decrease from

baseline

<0.5 - 0.25 x LLN; if abnormal,

50 - <75% decrease from

baseline

<0.25 x LLN; if abnormal, 75%

decrease from baseline;

absolute value <50 mg/dL

-

Definition: A finding based on laboratory test results that indicate an decrease in levels of fibrinogen in a blood specimen.

Navigational Note: -

Forced expiratory volume

decreased

FEV1% (percentages of

observed FEV1 and FVC

related to their respective

predicted values) 99 - 70%

predicted

FEV1 60 - 69%

50 - 59%

<= 49%

-

Definition: A finding based on test results that indicate a relative decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.

Navigational Note: Also consider Respiratory, thoracic and mediastinal disorders: Respiratory failure or Dyspnea

GGT increased

>ULN - 2.5 x ULN if baseline

was normal; 2.0 - 2.5 x

baseline if baseline was

abnormal

>2.5 - 5.0 x ULN if baseline

was normal; >2.5 - 5.0 x

baseline if baseline was

abnormal

>5.0 - 20.0 x ULN if baseline

was normal; >5.0 - 20.0 x

baseline if baseline was

abnormal

>20.0 x ULN if baseline was

normal; >20.0 x baseline if

baseline was abnormal

-

Definition: A finding based on laboratory test results that indicate higher than normal levels of the enzyme gamma-glutamyltransferase in the blood specimen. GGT (gamma-

glutamyltransferase ) catalyzes the transfer of a gamma glutamyl group from a gamma glutamyl peptide to another peptide, amino acids or water.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 88

Investigations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Growth hormone abnormal

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated;

limiting instrumental ADL

-

Definition: A finding based on laboratory test results that indicate abnormal levels of growth hormone in a biological specimen.

Navigational Note: -

Haptoglobin decreased

<LLN

-

Definition: A finding based on laboratory test results that indicate an decrease in levels of haptoglobin in a blood specimen.

Navigational Note: -

Hemoglobin increased

Increase in >0 - 2 g/dL

Increase in >2 - 4 g/dL

Increase in >4 g/dL

-

Definition: A finding based on laboratory test results that indicate increased levels of hemoglobin above normal.

Navigational Note: -

INR increased

>1.2 - 1.5; >1 - 1.5 x baseline if

on anticoagulation;

monitoring only indicated

>1.5 - 2.5; >1.5 - 2.5 x baseline

if on anticoagulation; dose

adjustment indicated

>2.5; >2.5 x baseline if on

anticoagulation; bleeding

-

Definition: A finding based on laboratory test results that indicate an increase in the ratio of the patient's prothrombin time to a control sample in the blood.

Navigational Note: -

Lipase increased

>ULN - 1.5 x ULN

>1.5 - 2.0 x ULN; >2.0 - 5.0 x

ULN and asymptomatic

>2.0 - 5.0 x ULN with signs or

symptoms; >5.0 x ULN and

asymptomatic

>5.0 x ULN and with signs or

symptoms

-

Definition: A finding based on laboratory test results that indicate an increase in the level of lipase in a biological specimen.

Navigational Note: -

Lymphocyte count decreased

<LLN - 800/mm3; <LLN - 0.8 x

10e9/L

<800 - 500/mm3; <0.8 - 0.5 x

10e9 /L

<500 - 200/mm3; <0.5 - 0.2 x

10e9 /L

<200/mm3; <0.2 x 10e9 /L

-

Definition: A finding based on laboratory test results that indicate a decrease in number of lymphocytes in a blood specimen.

Navigational Note: -

Lymphocyte count increased

-

>4000/mm3 - 20,000/mm3

>20,000/mm3

-

Definition: A finding based on laboratory test results that indicate an abnormal increase in the number of lymphocytes in the blood, effusions or bone marrow.

Navigational Note: -

Neutrophil count decreased

<LLN - 1500/mm3; <LLN - 1.5 x

10e9 /L

<1500 - 1000/mm3; <1.5 - 1.0

x 10e9 /L

<1000 - 500/mm3; <1.0 - 0.5 x

10e9 /L

<500/mm3; <0.5 x 10e9 /L

-

Definition: A finding based on laboratory test results that indicate a decrease in number of neutrophils in a blood specimen.

Navigational Note: -

Pancreatic enzymes

decreased

<LLN and asymptomatic

Increase in stool frequency,

bulk, or odor; steatorrhea

Sequelae of absorption

deficiency

-

Definition: A finding based on laboratory test results that indicate an decrease in levels of pancreatic enzymes in a biological specimen.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 89

Investigations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Platelet count decreased

<LLN - 75,000/mm3; <LLN -

75.0 x 10e9 /L

<75,000 - 50,000/mm3; <75.0

- 50.0 x 10e9 /L

<50,000 - 25,000/mm3; <50.0

- 25.0 x 10e9 /L

<25,000/mm3; <25.0 x 10e9 /L

-

Definition: A finding based on laboratory test results that indicate a decrease in number of platelets in a blood specimen.

Navigational Note: -

Serum amylase increased

>ULN - 1.5 x ULN

>1.5 - 2.0 x ULN; >2.0 - 5.0 x

ULN and asymptomatic

>2.0 - 5.0 x ULN with signs or

symptoms; >5.0 x ULN and

asymptomatic

>5.0 x ULN and with signs or

symptoms

-

Definition: A finding based on laboratory test results that indicate an increase in the levels of amylase in a serum specimen.

Navigational Note: -

Thyroid stimulating hormone

increased

TSH increased and no

intervention initiated

-

Definition: A disorder characterized by an increase in thyroid stimulating hormone.

Navigational Note: If intervention initiated or symptomatic, report as Endocrine disorders: Hypothyroidism.

Urine output decreased

-

Adult: Oliguria (<80 ml in 8

hr);

Infants: < 0.5 mL/kg per hour

for 24 hours;

Children: < 500 mL/1.73 m2

body surface area per day

Adult: Anuria (<240 ml in 24

hr);

Pediatric: No urine output

over 12 hours

-

Definition: A finding based on test results that indicate urine production is less relative to previous output.

Navigational Note: -

Vital capacity abnormal

90 - 75% of predicted value

<75 - 50% of predicted value;

limiting instrumental ADL

<50% of predicted value;

limiting self care ADL

-

Definition: A finding based on pulmonary function test results that indicate an abnormal vital capacity (amount of exhaled after a maximum inhalation) when compared to the

predicted value.

Navigational Note: Also consider Investigations: Forced Expiratory Volume; Respiratory, thoracic and mediastinal disorders: Respiratory failure or Dyspnea

Weight gain

5 - <10% from baseline

10 - <20% from baseline

>=20% from baseline

-

Definition: A finding characterized by an unexpected or abnormal increase in overall body weight; for pediatrics, greater than the baseline growth curve.

Navigational Note: Do not use Metabolism and nutrition disorders: Obesity, this term is being retired.

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

-

Definition: A finding characterized by a decrease in overall body weight; for pediatrics, less than the baseline growth curve.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 90

Investigations

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

White blood cell decreased

<LLN - 3000/mm3; <LLN - 3.0 x

10e9 /L

<3000 - 2000/mm3; <3.0 - 2.0

x 10e9 /L

<2000 - 1000/mm3; <2.0 - 1.0

x 10e9 /L

<1000/mm3; <1.0 x 10e9 /L

-

Definition: A finding based on laboratory test results that indicate an decrease in number of white blood cells in a blood specimen.

Navigational Note: -

Investigations - Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 91

Metabolism and nutrition disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Acidosis

pH <normal, but >=7.3

-

pH <7.3

Life-threatening

consequences

Death

Definition: A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues.

Navigational Note: -

Alcohol intolerance

-

Present

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an increase in sensitivity to the adverse effects of alcohol, which can include nasal congestion, skin flushes, heart dysrhythmias, nausea,

vomiting, indigestion and headaches.

Navigational Note: -

Alkalosis

pH >normal, but <=7.5

-

pH >7.5

Life-threatening

consequences

Death

Definition: A disorder characterized by abnormally high alkalinity (low hydrogen-ion concentration) of the blood and other body tissues.

Navigational Note: -

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); tube

feeding or TPN indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a loss of appetite.

Navigational Note: -

Dehydration

Increased oral fluids indicated;

dry mucous membranes;

diminished skin turgor

IV fluids indicated

Hospitalization indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis.

Navigational Note: -

Glucose intolerance

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; dietary

modification or oral agent

indicated

Severe symptoms; insulin

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an inability to properly metabolize glucose.

Navigational Note: -

Hypercalcemia

Corrected serum calcium of

>ULN - 11.5 mg/dL; >ULN - 2.9

mmol/L; Ionized calcium >ULN

- 1.5 mmol/L

Corrected serum calcium of

>11.5 - 12.5 mg/dL; >2.9 - 3.1

mmol/L; Ionized calcium >1.5

- 1.6 mmol/L; symptomatic

Corrected serum calcium of

>12.5 - 13.5 mg/dL; >3.1 - 3.4

mmol/L; Ionized calcium >1.6

- 1.8 mmol/L; hospitalization

indicated

Corrected serum calcium of

>13.5 mg/dL; >3.4 mmol/L;

Ionized calcium >1.8 mmol/L;

life-threatening consequences

Death

Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of calcium (corrected for albumin) in blood.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 92

Metabolism and nutrition disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hyperglycemia

Abnormal glucose above

baseline with no medical

intervention

Change in daily management

from baseline for a diabetic;

oral antiglycemic agent

initiated; workup for diabetes

Insulin therapy initiated;

hospitalization indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of blood sugar. It is usually an indication of diabetes mellitus or glucose

intolerance.

Navigational Note: -

Hyperkalemia

>ULN - 5.5 mmol/L

>5.5 - 6.0 mmol/L;

intervention initiated

>6.0 - 7.0 mmol/L;

hospitalization indicated

>7.0 mmol/L; life-threatening

consequences

Death

Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of potassium in the blood; associated with kidney failure or sometimes

with the use of diuretic drugs.

Navigational Note: -

Hyperlipidemia

Requiring diet changes

Requiring pharmaceutical

intervention

Hospitalization; pancreatitis

Life-threatening

consequences

-

Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of lipids in blood.

Navigational Note: -

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;

life-threatening consequences

Death

Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of magnesium in the blood.

Navigational Note: -

Hypernatremia

>ULN - 150 mmol/L

>150 - 155 mmol/L;

intervention initiated

>155 - 160 mmol/L;

hospitalization indicated

>160 mmol/L; life-threatening

consequences

Death

Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of sodium in the blood.

Navigational Note: -

Hyperphosphatemia

Laboratory finding only and

intervention not indicated

Noninvasive intervention

indicated

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated

Life-threatening

consequences; urgent

intervention indicated (e.g.,

dialysis)

Death

Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of phosphate in a blood.

Navigational Note: -

Hypertriglyceridemia

150 mg/dL - 300 mg/dL; 1.71

mmol/L - 3.42 mmol/L

>300 mg/dL - 500 mg/dL;

>3.42 mmol/L - 5.7 mmol/L

>500 mg/dL - 1000 mg/dL;

>5.7 mmol/L - 11.4 mmol/L

>1000 mg/dL; >11.4 mmol/L;

life-threatening consequences

Death

Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of triglyceride concentration in the blood.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 93

Metabolism and nutrition disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hyperuricemia

>ULN without physiologic

consequences

-

>ULN with physiologic

consequences

Life-threatening

consequences

Death

Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of uric acid.

Navigational Note: -

Hypoalbuminemia

<LLN - 3 g/dL; <LLN - 30 g/L

<3 - 2 g/dL; <30 - 20 g/L

<2 g/dL; <20 g/L

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by laboratory test results that indicate a low concentration of albumin in the blood.

Navigational Note: -

Hypocalcemia

Corrected serum calcium of

<LLN - 8.0 mg/dL; <LLN - 2.0

mmol/L; Ionized calcium <LLN

- 1.0 mmol/L

Corrected serum calcium of

<8.0 - 7.0 mg/dL; <2.0 - 1.75

mmol/L; Ionized calcium <1.0

- 0.9 mmol/L; symptomatic

Corrected serum calcium of

<7.0 - 6.0 mg/dL; <1.75 - 1.5

mmol/L; Ionized calcium <0.9

- 0.8 mmol/L; hospitalization

indicated

Corrected serum calcium of

<6.0 mg/dL; <1.5 mmol/L;

Ionized calcium <0.8 mmol/L;

life-threatening consequences

Death

Definition: A disorder characterized by laboratory test results that indicate a low concentration of calcium (corrected for albumin) in the blood.

Navigational Note: -

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; life-

threatening consequences;

seizures

Death

Definition: A disorder characterized by laboratory test results that indicate a low concentration of glucose in the blood.

Navigational Note: -

Hypokalemia

<LLN - 3.0 mmol/L

Symptomatic with <LLN - 3.0

mmol/L; intervention

indicated

<3.0 - 2.5 mmol/L;

hospitalization indicated

<2.5 mmol/L; life-threatening

consequences

Death

Definition: A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood.

Navigational Note: -

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; life-

threatening consequences

Death

Definition: A disorder characterized by laboratory test results that indicate a low concentration of magnesium in the blood.

Navigational Note: -

Hyponatremia

<LLN - 130 mmol/L

125-129 mmol/L and

asymptomatic

125-129 mmol/L

symptomatic; 120-124

mmol/L regardless of

symptoms

<120 mmol/L; life-threatening

consequences

Death

Definition: A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 94

Metabolism and nutrition disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hypophosphatemia

Laboratory finding only and

intervention not indicated

Oral replacement therapy

indicated

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated

Life-threatening

consequences

Death

Definition: A disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood.

Navigational Note: -

Iron overload

-

Moderate symptoms;

intervention not indicated

Severe symptoms;

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by accumulation of iron in the tissues.

Navigational Note: -

Obesity

-

BMI 25 - 29.9 kg/m2

BMI 30 - 39.9 kg/m2

BMI >=40 kg/m2

-

Definition: A disorder characterized by having a high amount of body fat.

Navigational Note: Use term Investigations: Weight

gain

Tumor lysis syndrome

-

Present

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by metabolic abnormalities that result from a spontaneous or therapy-related cytolysis of tumor cells.

Navigational Note: -

Metabolism and nutrition

disorders - Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 95

Musculoskeletal and connective tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Abdominal soft tissue necrosis

-

Local wound care; medical

intervention indicated (e.g.,

dressings or topical

medications)

Operative debridement or

other invasive intervention

indicated (e.g., tissue

reconstruction, flap, or

grafting)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the abdominal wall.

Navigational Note: -

Arthralgia

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in a joint.

Navigational Note: -

Arthritis

Mild pain with inflammation,

erythema, or joint swelling

Moderate pain associated

with signs of inflammation,

erythema, or joint swelling;

limiting instrumental ADL

Severe pain associated with

signs of inflammation,

erythema, or joint swelling;

irreversible joint damage;

limiting self care ADL

-

Definition: A disorder characterized by inflammation involving a joint.

Navigational Note: -

Avascular necrosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL; elective operative

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by necrotic changes in the bone tissue due to interruption of blood supply. Most often affecting the epiphysis of the long bones, the necrotic

changes result in the collapse and the destruction of the bone structure.

Navigational Note: Use new term: Musculoskeletal and connective tissue disorders: Osteonecrosis

Back pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the back region.

Navigational Note: -

Bone pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the bones.

Navigational Note: -

Buttock pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the buttocks.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 96

Musculoskeletal and connective tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Chest wall necrosis

-

Local wound care; medical

intervention indicated (e.g.,

dressings or topical

medications)

Operative debridement or

other invasive intervention

indicated (e.g., tissue

reconstruction, flap, or

grafting)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the chest wall including breast.

Navigational Note: -

Chest wall pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the chest wall.

Navigational Note: -

Exostosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL; elective operative

intervention indicated

-

Definition: A disorder characterized by non-neoplastic overgrowth of bone.

Navigational Note: -

Fibrosis deep connective

tissue

Mild induration, able to move

skin parallel to plane (sliding)

and perpendicular to skin

(pinching up)

Moderate induration, able to

slide skin, unable to pinch

skin; limiting instrumental ADL

Severe induration; unable to

slide or pinch skin; limiting

joint or orifice movement

(e.g., mouth, anus); limiting

self care ADL

Generalized; associated with

signs or symptoms of impaired

breathing or feeding

Death

Definition: A disorder characterized by fibrotic degeneration of the deep connective tissues.

Navigational Note: -

Flank pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort on the lateral side of the body in the region below the ribs and above the hip.

Navigational Note: -

Generalized muscle weakness

Symptomatic; perceived by

patient but not evident on

physical exam

Symptomatic; evident on

physical exam; limiting

instrumental ADL

Limiting self care ADL

-

Definition: A disorder characterized by a reduction in the strength of muscles in multiple anatomic sites.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 97

Musculoskeletal and connective tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Growth suppression

Reduction in growth velocity

by 10 - 29% ideally measured

over the period of a year

Reduction in growth velocity

by 30 - 49% ideally measured

over the period of a year or 0 -

49% reduction in growth from

the baseline growth curve

Reduction in growth velocity

of >=50% ideally measured

over the period of a year

-

Definition: A disorder characterized by stature that is smaller than normal as expected for age.

Navigational Note: -

Head soft tissue necrosis

-

Local wound care; medical

intervention indicated (e.g.,

dressings or topical

medications)

Operative debridement or

other invasive intervention

indicated (e.g., tissue

reconstruction, flap, or

grafting)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the head.

Navigational Note: -

Joint effusion

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL; invasive

intervention indicated

-

Definition: A disorder characterized by excessive fluid in a joint, usually as a result of joint inflammation.

Navigational Note: -

Joint range of motion

decreased

<=25% loss of ROM (range of

motion); decreased ROM

limiting athletic activity

>25 - 50% decrease in ROM;

limiting instrumental ADL

>50% decrease in ROM;

limiting self care ADL

-

Definition: A disorder characterized by a decrease in joint flexibility of any joint.

Navigational Note: -

Joint range of motion

decreased cervical spine

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

-

Definition: A disorder characterized by a decrease in flexibility of a cervical spine joint.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 98

Musculoskeletal and connective tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Joint range of motion

decreased lumbar spine

Stiffness; difficulty bending to

the floor to pick up a very light

object but able to do athletic

activity

Pain with range of motion

(ROM) in lumbar spine;

requires a reaching aid to pick

up a very light object from the

floor

<50% lumbar spine flexion;

associated with symptoms of

ankylosis or fused over

multiple segments with no L-

spine flexion (e.g., unable to

reach to floor to pick up a very

light object)

-

Definition: A disorder characterized by a decrease in flexibility of a lumbar spine joint.

Navigational Note: -

Kyphosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate accentuation;

limiting instrumental ADL

Severe accentuation;

operative intervention

indicated; limiting self care

ADL

-

Definition: A disorder characterized by an abnormal increase in the curvature of the thoracic portion of the spine.

Navigational Note: -

Lordosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate accentuation;

limiting instrumental ADL

Severe accentuation;

operative intervention

indicated; limiting self care

ADL

-

Definition: A disorder characterized by an abnormal increase in the curvature of the lumbar portion of the spine.

Navigational Note: -

Muscle cramp

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by marked cramping sensation originating from a muscle or group of muscles.

Navigational Note: Synonym: Muscle spasm

Muscle weakness lower limb

Symptomatic; perceived by

patient but not evident on

physical exam

Symptomatic; evident on

physical exam; limiting

instrumental ADL

Limiting self care ADL

-

Definition: A disorder characterized by a reduction in the strength of the lower limb muscles.

Navigational Note: -

Muscle weakness trunk

Symptomatic; perceived by

patient but not evident on

physical exam

Symptomatic; evident on

physical exam; limiting

instrumental ADL

Limiting self care ADL

-

Definition: A disorder characterized by a reduction in the strength of the trunk muscles.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 99

Musculoskeletal and connective tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Muscle weakness upper limb

Symptomatic; perceived by

patient but not evident on

physical exam

Symptomatic; evident on

physical exam; limiting

instrumental ADL

Limiting self care ADL

-

Definition: A disorder characterized by a reduction in the strength of the upper limb muscles.

Navigational Note: -

Musculoskeletal deformity

Cosmetically and functionally

insignificant hypoplasia

Deformity, hypoplasia, or

asymmetry able to be

remediated by prosthesis

(e.g., shoe insert) or covered

by clothing

Significant deformity,

hypoplasia, or asymmetry,

unable to be remediated by

prosthesis or covered by

clothing; limiting self care ADL

-

Definition: A disorder characterized by a malformation of the musculoskeletal system.

Navigational Note: -

Myalgia

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by marked discomfort sensation originating from a muscle or group of muscles.

Navigational Note: -

Myositis

Mild pain

Moderate pain associated

with weakness; pain limiting

instrumental ADL

Pain associated with severe

weakness; limiting self care

ADL

Life-threatening

consequences; urgent

intervention indicated

-

Definition: A disorder characterized by inflammation involving the skeletal muscles.

Navigational Note: -

Neck pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the neck area.

Navigational Note: -

Neck soft tissue necrosis

-

Local wound care; medical

intervention indicated (e.g.,

dressings or topical

medications)

Operative debridement or

other invasive intervention

indicated (e.g., tissue

reconstruction, flap, or

grafting)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the neck.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 100

Musculoskeletal and connective tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Osteonecrosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated (e.g.,

analgesics or

bisphosphonates); limiting

instrumental ADL

Severe symptoms; limiting self

care ADL; elective operative

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by necrotic changes in the bone tissue due to interruption of blood supply. Most often affecting the epiphysis of the long bones, the necrotic

changes result in the collapse and the destruction of the bone structure.

Navigational Note: -

Osteonecrosis of jaw

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated (e.g.,

topical agents); limiting

instrumental ADL

Severe symptoms; limiting self

care ADL; elective operative

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the bone of the mandible.

Navigational Note: -

Osteoporosis

Adult: Radiologic evidence of

osteoporosis or Bone Mineral

Density (BMD) t-score -1 to -

2.5 (osteopenia);

Pediatric: Radiologic evidence

of low BMD with z score of <=

-2.0 and no history of

significant fractures

Adult: BMD t-score < -2.5; loss

of height <2 cm; therapy to

improve BMD indicated;

limiting instrumental ADL;

Pediatric: Low BMD (z-score

<= -2.0) and significant

fracture history (defined as a

long bone fracture of the

lower extremity, vertebral

compression, 2 or more long

bone fractures of the upper

extremities); therapy to

improve BMD indicated

Adult: Loss of height >=2 cm;

hospitalization indicated;

limiting self care ADL;

Pediatric: Limiting self care

ADL

-

Definition: A disorder characterized by reduced bone mass, with a decrease in cortical thickness and in the number and size of the trabeculae of cancellous bone (but normal chemical

composition), resulting in increased fracture incidence.

Navigational Note: -

Pain in extremity

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the upper or lower extremities.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 101

Musculoskeletal and connective tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Pelvic soft tissue necrosis

-

Local wound care; medical

intervention indicated (e.g.,

dressings or topical

medications)

Operative debridement or

other invasive intervention

indicated (e.g., tissue

reconstruction, flap, or

grafting)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the pelvis.

Navigational Note: -

Rhabdomyolysis

Asymptomatic, intervention

not indicated; laboratory

findings only

Non-urgent intervention

indicated

Symptomatic, urgent

intervention indicated

Life-threatening

consequences; dialysis

Death

Definition: A disorder characterized by the breakdown of muscle tissue resulting in the release of muscle fiber contents into the bloodstream.

Navigational Note: -

Rotator cuff injury

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting

instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

-

Definition: A disorder characterized by an injury of the rotator cuff.

Navigational Note: -

Scoliosis

<20 degrees; clinically

undetectable

>20 - 45 degrees; visible by

forward flexion; limiting

instrumental ADL

>45 degrees; scapular

prominence in forward

flexion; operative intervention

indicated; limiting self care

ADL

-

Definition: A disorder characterized by a malformed, lateral curvature of the spine.

Navigational Note: -

Soft tissue necrosis lower limb

-

Local wound care; medical

intervention indicated (e.g.,

dressings or topical

medications)

Operative debridement or

other invasive intervention

indicated (e.g., tissue

reconstruction, flap, or

grafting)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the lower extremity.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 102

Musculoskeletal and connective tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Soft tissue necrosis upper limb

-

Local wound care; medical

intervention indicated (e.g.,

dressings or topical

medications)

Operative debridement or

other invasive intervention

indicated (e.g., tissue

reconstruction, flap, or

grafting)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the soft tissues of the upper extremity.

Navigational Note: -

Superficial soft tissue fibrosis

Mild induration, able to move

skin parallel to plane (sliding)

and perpendicular to skin

(pinching up)

Moderate induration, able to

slide skin, unable to pinch

skin; limiting instrumental ADL

Severe induration; unable to

slide or pinch skin; limiting

joint or orifice movement

(e.g., mouth, anus); limiting

self care ADL

Generalized; associated with

signs or symptoms of impaired

breathing or feeding

Death

Definition: A disorder characterized by fibrotic degeneration of the superficial soft tissues.

Navigational Note: -

Trismus

Decreased ROM (range of

motion) without impaired

eating

Decreased ROM requiring

small bites, soft foods or

purees

Decreased ROM with inability

to adequately aliment or

hydrate orally

-

Definition: A disorder characterized by lack of ability to open the mouth fully due to a decrease in the range of motion of the muscles of mastication.

Navigational Note: -

Unequal limb length

Mild length discrepancy <2 cm

Moderate length discrepancy

2 - 5 cm; shoe lift indicated;

limiting instrumental ADL

Severe length discrepancy >5

cm; limiting self care ADL;

operative intervention

indicated

-

Definition: A disorder characterized by a discrepancy between the lengths of the lower or upper extremities.

Navigational Note: -

Musculoskeletal and

connective tissue disorder -

Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 103

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Leukemia secondary to

oncology chemotherapy

-

Present

Death

Definition: A disorder characterized by leukemia arising as a result of the mutagenic effect of chemotherapy agents.

Navigational Note: -

Myelodysplastic syndrome

-

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by insufficiently healthy hematapoietic cell production by the bone marrow.

Navigational Note: -

Skin papilloma

Asymptomatic; intervention

not indicated

Intervention initiated

-

Definition: A disorder characterized by the presence of one or more warts.

Navigational Note: -

Treatment related secondary

malignancy

-

Non life-threatening

secondary malignancy

Acute life-threatening

secondary malignancy; blast

crisis in leukemia

Death

Definition: A disorder characterized by development of a malignancy most probably as a result of treatment for a previously existing malignancy.

Navigational Note: -

Tumor hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding in a tumor.

Navigational Note: -

Tumor pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort from a neoplasm that may be pressing on a nerve, blocking blood vessels, inflamed or fractured from

metastasis.

Navigational Note: -

Neoplasms benign, malignant

and unspecified (incl cysts and

polyps) - Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 104

Nervous system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Abducens nerve disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by dysfunction of the abducens nerve (sixth cranial nerve).

Navigational Note: -

Accessory nerve disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by dysfunction of the accessory nerve (eleventh cranial nerve).

Navigational Note: -

Acoustic nerve disorder NOS

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by dysfunction of the acoustic nerve (eighth cranial nerve).

Navigational Note: -

Akathisia

Mild restlessness or increased

motor activity

Moderate restlessness or

increased motor activity;

limiting instrumental ADL

Severe restlessness or

increased motor activity;

limiting self care ADL

-

Definition: A disorder characterized by an uncomfortable feeling of inner restlessness and inability to stay still; this is a side effect of some psychotropic drugs.

Navigational Note: -

Amnesia

Mild; transient memory loss

Moderate; short term

memory loss; limiting

instrumental ADL

Severe; long term memory

loss; limiting self care ADL

-

Definition: A disorder characterized by systematic and extensive loss of memory.

Navigational Note: -

Anosmia

Present

-

Definition: A disorder characterized by a change in the sense of smell.

Navigational Note: Also consider Olfactory nerve disorder

Aphonia

-

Voicelessness; unable to

speak

-

Definition: A disorder characterized by the inability to speak. It may result from injuries to the vocal cords or may be functional (psychogenic).

Navigational Note: -

Arachnoiditis

Mild symptoms

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation of the arachnoid membrane and adjacent subarachnoid space.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 105

Nervous system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Ataxia

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL; mechanical

assistance indicated

-

Definition: A disorder characterized by lack of coordination of muscle movements resulting in the impairment or inability to perform voluntary activities.

Navigational Note: -

Brachial plexopathy

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by regional paresthesia of the brachial plexus, marked discomfort and muscle weakness, and limited movement in the arm or hand.

Navigational Note: -

Central nervous system

necrosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms;

corticosteroids indicated

Severe symptoms; medical

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the brain and/or spinal cord.

Navigational Note: -

Cerebrospinal fluid leakage

Post-craniotomy:

asymptomatic; Post-lumbar

puncture: transient headache;

postural care indicated

Post-craniotomy: moderate

symptoms; medical

intervention indicated; Post-

lumbar puncture: persistent

moderate symptoms; blood

patch indicated

Severe symptoms; medical

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by loss of cerebrospinal fluid into the surrounding tissues.

Navigational Note: -

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

-

Definition: A disorder characterized by a conspicuous change in cognitive function.

Navigational Note: -

Concentration impairment

Mild inattention or decreased

level of concentration

Moderate impairment in

attention or decreased level

of concentration; limiting

instrumental ADL

Severe impairment in

attention or decreased level

of concentration; limiting self

care ADL

-

Definition: A disorder characterized by a deterioration in the ability to concentrate.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 106

Nervous system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Depressed level of

consciousness

Decreased level of alertness

Sedation; slow response to

stimuli; limiting instrumental

ADL

Difficult to arouse

Life-threatening

consequences; coma; urgent

intervention indicated

Death

Definition: A disorder characterized by a decrease in ability to perceive and respond.

Navigational Note: -

Dizziness

Mild unsteadiness or

sensation of movement

Moderate unsteadiness or

sensation of movement;

limiting instrumental ADL

Severe unsteadiness or

sensation of movement;

limiting self care ADL

-

Definition: A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking.

Navigational Note: -

Dysarthria

Mild slurred speech

Moderate impairment of

articulation or slurred speech

Severe impairment of

articulation or slurred speech

-

Definition: A disorder characterized by slow and slurred speech resulting from an inability to coordinate the muscles used in speech.

Navigational Note: -

Dysesthesia

Mild sensory alteration

Moderate sensory alteration;

limiting instrumental ADL

Severe sensory alteration;

limiting self care ADL

-

Definition: A disorder characterized by distortion of sensory perception, resulting in an abnormal and unpleasant sensation.

Navigational Note: -

Dysgeusia

Altered taste but no change in

diet

Altered taste with change in

diet (e.g., oral supplements);

noxious or unpleasant taste;

loss of taste

-

Definition: A disorder characterized by abnormal sensual experience with the taste of foodstuffs; it can be related to a decrease in the sense of smell.

Navigational Note: -

Dysphasia

Awareness of receptive or

expressive characteristics; not

impairing ability to

communicate

Moderate receptive or

expressive characteristics;

impairing ability to

communicate spontaneously

Severe receptive or expressive

characteristics; impairing

ability to read, write or

communicate intelligibly

-

Definition: A disorder characterized by impairment of verbal communication skills, often resulting from brain damage.

Navigational Note: -

Edema cerebral

-

New onset; worsening from

baseline

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by swelling due to an excessive accumulation of fluid in the brain.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 107

Nervous system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Encephalopathy

Mild symptoms

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a pathologic process involving the brain.

Navigational Note: -

Extrapyramidal disorder

Mild involuntary movements

Moderate involuntary

movements; limiting

instrumental ADL

Severe involuntary

movements or torticollis;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by abnormal, repetitive, involuntary muscle movements, frenzied speech and extreme restlessness.

Navigational Note: Synonym: Restless legs

Facial muscle weakness

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by a reduction in the strength of the facial muscles.

Navigational Note: -

Facial nerve disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by dysfunction of the facial nerve (seventh cranial nerve).

Navigational Note: -

Glossopharyngeal nerve

disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by dysfunction of the glossopharyngeal nerve (ninth cranial nerve).

Navigational Note: -

Guillain-Barre syndrome

Mild symptoms

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated;

intubation

Death

Definition: A disorder characterized by the body's immune system attacking the peripheral nervous system causing ascending paralysis.

Navigational Note: -

Headache

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 108

Nervous system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hydrocephalus

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms;

intervention not indicated

Severe symptoms or

neurological deficit;

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal increase of cerebrospinal fluid in the ventricles of the brain.

Navigational Note: -

Hypersomnia

Mild increased need for sleep

Moderate increased need for

sleep

Severe increased need for

sleep

-

Definition: A disorder characterized by characterized by excessive sleepiness during the daytime.

Navigational Note: -

Hypoglossal nerve disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by dysfunction of the hypoglossal nerve (twelfth cranial nerve).

Navigational Note: -

Intracranial hemorrhage

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms;

intervention indicated

Ventriculostomy, ICP

monitoring, intraventricular

thrombolysis, or invasive

intervention indicated;

hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the cranium.

Navigational Note: -

Ischemia cerebrovascular

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms

-

Definition: A disorder characterized by a decrease or absence of blood supply to the brain caused by obstruction (thrombosis or embolism) of an artery resulting in neurological

damage.

Navigational Note: Prior to using this term consider Nervous system disorder: TIA or Stroke

Lethargy

Mild symptoms; reduced

alertness and awareness

Moderate symptoms; limiting

instrumental ADL

-

Definition: A disorder characterized by a decrease in consciousness characterized by mental and physical inertness.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 109

Nervous system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Leukoencephalopathy

Asymptomatic; small focal

T2/FLAIR hyperintensities;

involving periventricular white

matter or <1/3 of susceptible

areas of cerebrum +/- mild

increase in subarachnoid

space (SAS) and/or mild

ventriculomegaly

Moderate symptoms; focal

T2/FLAIR hyperintensities,

involving periventricular white

matter extending into

centrum semiovale or

involving 1/3 to 2/3 of

susceptible areas of cerebrum

+/- moderate increase in SAS

and/or moderate

ventriculomegaly

Severe symptoms; extensive

T2/FLAIR hyperintensities,

involving periventricular white

matter involving 2/3 or more

of susceptible areas of

cerebrum +/- moderate to

severe increase in SAS and/or

moderate to severe

ventriculomegaly

Life-threatening

consequences; extensive

T2/FLAIR hyperintensities,

involving periventricular white

matter involving most of

susceptible areas of cerebrum

+/- moderate to severe

increase in SAS and/or

moderate to severe

ventriculomegaly

Death

Definition: A disorder characterized by diffuse reactive astrocytosis with multiple areas of necrotic foci without inflammation.

Navigational Note: -

Memory impairment

Mild memory impairment

Moderate memory

impairment; limiting

instrumental ADL

Severe memory impairment;

limiting self care ADL

-

Definition: A disorder characterized by a deterioration in memory function.

Navigational Note: -

Meningismus

Mild symptoms

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by neck stiffness, headache, and photophobia resulting from irritation of the cerebral meninges.

Navigational Note: -

Movements involuntary

Mild symptoms

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by uncontrolled and purposeless movements.

Navigational Note: -

Muscle weakness left-sided

Symptomatic; perceived by

patient but not evident on

physical exam

Symptomatic; evident on

physical exam; limiting

instrumental ADL

Limiting self care ADL

-

Definition: A disorder characterized by a reduction in the strength of the muscles on the left side of the body.

Navigational Note: -

Muscle weakness right-sided

Symptomatic; perceived by

patient but not evident on

physical exam

Symptomatic; evident on

physical exam; limiting

instrumental ADL

Limiting self care ADL

-

Definition: A disorder characterized by a reduction in the strength of the muscles on the right side of the body.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 110

Nervous system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Myasthenia gravis

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by weakness and rapid fatigue of any of the skeletal muscles.

Navigational Note: -

Neuralgia

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by intense painful sensation along a nerve or group of nerves.

Navigational Note: -

Nystagmus

-

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by involuntary movements of the eyeballs.

Navigational Note: -

Oculomotor nerve disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by dysfunction of the oculomotor nerve (third cranial nerve).

Navigational Note: -

Olfactory nerve disorder

-

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by dysfunction of the olfactory nerve (first cranial nerve).

Navigational Note: -

Paresthesia

Mild symptoms

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by functional disturbances of sensory neurons resulting in abnormal cutaneous sensations of tingling, numbness, pressure, cold, and/or warmth.

Navigational Note: -

Peripheral motor neuropathy

Asymptomatic; clinical or

diagnostic observations only

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by damage or dysfunction of the peripheral motor nerves.

Navigational Note: Also consider Nervous system disroders: Peripheral sensory neuropathy

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CTCAE v5.0 – November 27, 2017 Page 111

Nervous system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Peripheral sensory

neuropathy

Asymptomatic

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

-

Definition: A disorder characterized by damage or dysfunction of the peripheral sensory nerves.

Navigational Note: -

Phantom pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort related to a limb or an organ that is removed from or is not physically part of the body.

Navigational Note: -

Presyncope

-

Present (e.g., near fainting)

-

Definition: A disorder characterized by an episode of lightheadedness and dizziness which may precede an episode of syncope.

Navigational Note: -

Pyramidal tract syndrome

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by dysfunction of the corticospinal (pyramidal) tracts of the spinal cord. Symptoms include an increase in the muscle tone in the lower extremities,

hyperreflexia, positive Babinski and a decrease in fine motor coordination.

Navigational Note: -

Radiculitis

Mild symptoms

Moderate symptoms; medical

intervention indicated;

limiting instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by inflammation involving a nerve root. Patients experience marked discomfort radiating along a nerve path because of spinal pressure on the

connecting nerve root.

Navigational Note: -

Recurrent laryngeal nerve

palsy

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms

Severe symptoms; medical

intervention indicated (e.g.,

thyroplasty, vocal cord

injection)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by paralysis of the recurrent laryngeal nerve.

Navigational Note: -

Reversible posterior

leukoencephalopathy

syndrome

-

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL; hospitalization

Life-threatening

consequences

Death

Definition: A disorder characterized by headaches, mental status changes, visual disturbances, and/or seizures associated with imaging findings of posterior leukoencephalopathy. It

has been observed in association with hypertensive encephalopathy, eclampsia, and immunosuppressive and cytotoxic drug treatment. It is an acute or subacute reversible condition.

Also known as posterior reversible encephalopathy syndrome (PRES).

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 112

Nervous system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Seizure

Brief partial seizure and no

loss of consciousness

Brief generalized seizure

New onset seizures (partial or

generalized); multiple seizures

despite medical intervention

Life-threatening

consequences; prolonged

repetitive seizures

Death

Definition: A disorder characterized by a sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.

Navigational Note: -

Somnolence

Mild but more than usual

drowsiness or sleepiness

Moderate sedation; limiting

instrumental ADL

Obtundation or stupor

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by characterized by excessive sleepiness and drowsiness.

Navigational Note: -

Spasticity

Mild or slight increase in

muscle tone

Moderate increase in muscle

tone and increase in

resistance through range of

motion

Severe increase in muscle

tone and increase in

resistance through range of

motion

Life-threatening

consequences; unable to

move active or passive range

of motion

Death

Definition: A disorder characterized by increased involuntary muscle tone that affects the regions interfering with voluntary movement. It results in gait, movement, and speech

disturbances.

Navigational Note: -

Spinal cord compression

-

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by pressure on the spinal cord.

Navigational Note: -

Stroke

Incidental radiographic

findings only

Mild to moderate neurologic

deficit; limiting instrumental

ADL

Severe neurologic deficit;

limiting self care ADL;

hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a decrease or absence of blood supply to the brain caused by obstruction (thrombosis or embolism) of an artery resulting in neurological

damage.

Navigational Note: -

Syncope

-

Fainting; orthostatic collapse

-

Definition: A disorder characterized by spontaneous loss of consciousness caused by insufficient blood supply to the brain.

Navigational Note: -

Tendon reflex decreased

Ankle reflex reduced

Ankle reflex absent; other

reflexes reduced

Absence of all reflexes

-

Definition: A disorder characterized by less than normal deep tendon reflexes.

Navigational Note: Also consider Nervous system disorders: Peripheral motor neuropathy or Peripheral sensory neuropathy

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CTCAE v5.0 – November 27, 2017 Page 113

Nervous system disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Transient ischemic attacks

Mild neurologic deficit with or

without imaging confirmation

Moderate neurologic deficit

with or without imaging

confirmation

-

Definition: A disorder characterized by a brief attack (less than 24 hours) of cerebral dysfunction of vascular origin, with no persistent neurological deficit.

Navigational Note: If >24 hours, Consider Nervous system disorders: Stroke

Tremor

Mild symptoms

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by the uncontrolled shaking movement of the whole body or individual parts.

Navigational Note: -

Trigeminal nerve disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by dysfunction of the trigeminal nerve (fifth cranial nerve).

Navigational Note: -

Trochlear nerve disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by dysfunction of the trochlear nerve (fourth cranial nerve).

Navigational Note: -

Vagus nerve disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by dysfunction of the vagus nerve (tenth cranial nerve).

Navigational Note: -

Vasovagal reaction

-

Present

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a sudden drop of the blood pressure, bradycardia, and peripheral vasodilation that may lead to loss of consciousness. It results from an increase

in the stimulation of the vagus nerve.

Navigational Note: -

Nervous system disorders -

Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 114

Pregnancy, puerperium and perinatal conditions

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Fetal growth retardation

-

<10% percentile of weight for

gestational age

<5% percentile of weight for

gestational age

<1% percentile of weight for

gestational age

-

Definition: A disorder characterized by inhibition of fetal growth resulting in the inability of the fetus to achieve its potential weight.

Navigational Note: -

Pregnancy loss

-

Fetal loss at any gestational

age

-

Definition: Death in utero.

Navigational Note: -

Premature delivery

Delivery of a liveborn infant at

>34 to 37 weeks gestation

Delivery of a liveborn infant at

>28 to 34 weeks gestation

Delivery of a liveborn infant at

24 to 28 weeks gestation

Delivery of a liveborn infant at

24 weeks of gestation or less

-

Definition: A disorder characterized by delivery of a viable infant before the normal end of gestation. Typically, viability is achievable between the twentieth and thirty-seventh week of

gestation.

Navigational Note: -

Pregnancy, puerperium and

perinatal conditions - Other,

specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 115

Psychiatric disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Agitation

Mild mood alteration

Moderate mood alteration

Severe agitation;

hospitalization not indicated

Life-threatening

consequences; urgent

intervention indicated

-

Definition: A disorder characterized by a state of restlessness associated with unpleasant feelings of irritability and tension.

Navigational Note: -

Anorgasmia

Inability to achieve orgasm

not adversely affecting

relationship

Inability to achieve orgasm

adversely affecting

relationship

-

Definition: A disorder characterized by an inability to achieve orgasm.

Navigational Note: -

Anxiety

Mild symptoms; intervention

not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL; hospitalization

indicated

Life-threatening

consequences; urgent

intervention indicated

-

Definition: A disorder characterized by apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus.

Navigational Note: -

Confusion

Mild disorientation

Moderate disorientation;

limiting instrumental ADL

Severe disorientation; limiting

self care ADL

Life-threatening

consequences; urgent

intervention indicated

-

Definition: A disorder characterized by a lack of clear and orderly thought and behavior.

Navigational Note: -

Delayed orgasm

Delay in achieving orgasm not

adversely affecting

relationship

Delay in achieving orgasm

adversely affecting

relationship

-

Definition: A disorder characterized by sexual dysfunction characterized by a delay in climax.

Navigational Note: -

Delirium

Mild acute confusional state

Moderate and acute

confusional state; limiting

instrumental ADL

Severe and acute confusional

state; limiting self care ADL;

urgent intervention indicated;

new onset

Life-threatening

consequences, threats of

harm to self or others; urgent

intervention indicated

Death

Definition: A disorder characterized by the acute and sudden development of confusion, illusions, movement changes, inattentiveness, agitation, and hallucinations. Usually, it is a

reversible condition.

Navigational Note: -

Delusions

-

Moderate delusional

symptoms

Severe delusional symptoms;

hospitalization not indicated;

new onset

Life-threatening

consequences, threats of

harm to self or others;

hospitalization indicated

Death

Definition: A disorder characterized by false personal beliefs held contrary to reality, despite contradictory evidence and common sense.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 116

Psychiatric disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Depression

Mild depressive symptoms

Moderate depressive

symptoms; limiting

instrumental ADL

Severe depressive symptoms;

limiting self care ADL;

hospitalization not indicated

Life-threatening

consequences, threats of

harm to self or others;

hospitalization indicated

Death

Definition: A disorder characterized by melancholic feelings of grief or unhappiness.

Navigational Note: -

Euphoria

Mild mood elevation

Moderate mood elevation

Severe mood elevation (e.g.,

hypomania)

-

Definition: A disorder characterized by an exaggerated feeling of well-being which is disproportionate to events and stimuli.

Navigational Note: -

Hallucinations

Mild hallucinations (e.g.,

perceptual distortions)

Moderate hallucinations

Severe hallucinations;

hospitalization not indicated

Life-threatening

consequences, threats of

harm to self or others;

hospitalization indicated

Death

Definition: A disorder characterized by a false sensory perception in the absence of an external stimulus.

Navigational Note: -

Insomnia

Mild difficulty falling asleep,

staying asleep or waking up

early

Moderate difficulty falling

asleep, staying asleep or

waking up early

Severe difficulty in falling

asleep, staying asleep or

waking up early

-

Definition: A disorder characterized by difficulty in falling asleep and/or remaining asleep.

Navigational Note: -

Irritability

Mild; easily consolable

Moderate; limiting

instrumental ADL; increased

attention indicated

Severe abnormal or excessive

response; limiting self care

ADL; inconsolable; medical or

psychiatric intervention

indicated

-

Definition: A disorder characterized by an abnormal responsiveness to stimuli or physiological arousal; may be in response to pain, fright, a drug, an emotional situation or a medical

condition.

Navigational Note: -

Libido decreased

Decrease in sexual interest

not adversely affecting

relationship

Decrease in sexual interest

adversely affecting

relationship

-

Definition: A disorder characterized by a decrease in sexual desire.

Navigational Note: -

Libido increased

Present

-

Definition: A disorder characterized by an increase in sexual desire.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 117

Psychiatric disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Mania

Mild manic symptoms (e.g.,

elevated mood, rapid

thoughts, rapid speech,

decreased need for sleep)

Moderate manic symptoms

(e.g., relationship and work

difficulties; poor hygiene)

Severe manic symptoms (e.g.,

hypomania; major sexual or

financial indiscretions);

hospitalization not indicated;

new onset

Life-threatening

consequences, threats of

harm to self or others;

hospitalization indicated

Death

Definition: A disorder characterized by excitement of psychotic proportions manifested by mental and physical hyperactivity, disorganization of behavior and elevation of mood.

Navigational Note: -

Personality change

Mild personality change

Moderate personality change

Severe personality change;

hospitalization not indicated

Life-threatening

consequences, threats of

harm to self or others;

hospitalization indicated

-

Definition: A disorder characterized by a conspicuous change in a person's behavior and thinking.

Navigational Note: -

Psychosis

Mild psychotic symptoms

Moderate psychotic

symptoms (e.g., disorganized

speech; impaired reality

testing)

Severe psychotic symptoms

(e.g., paranoid, extreme

disorganization);

hospitalization not indicated;

new onset

Life-threatening

consequences, threats of

harm to self or others;

hospitalization indicated

Death

Definition: A disorder characterized by personality change, impaired functioning, and loss of touch with reality. It may be a manifestation of schizophrenia, bipolar disorder or brain

tumor.

Navigational Note: -

Restlessness

Mild symptoms; intervention

not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by an inability to rest, relax or be still.

Navigational Note: -

Suicidal ideation

Increased thoughts of death

but no wish to kill oneself

Suicidal ideation with no

specific plan or intent

Specific plan to commit

suicide without serious intent

to die which may not require

hospitalization

Specific plan to commit

suicide with serious intent to

die which requires

hospitalization

-

Definition: A disorder characterized by thoughts of taking one's own life.

Navigational Note: -

Suicide attempt

-

Suicide attempt or gesture

without intent to die

Suicide attempt with intent to

die which requires

hospitalization

Death

Definition: A disorder characterized by self-inflicted harm in an attempt to end one's own life.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 118

Psychiatric disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Psychiatric disorders - Other,

specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; limiting self care

ADL

Life-threatening

consequences; hospitalization

or urgent intervention

indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 119

Renal and urinary disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Acute kidney injury

-

Hospitalization indicated

Life-threatening

consequences; dialysis

indicated

Death

Definition: A disorder characterized by the acute loss of renal function (within 2 weeks) and is traditionally classified as pre-renal (low blood flow into kidney), renal (kidney damage)

and post-renal causes (ureteral or bladder outflow obstruction).

Navigational Note: Also consider Investigations: Creatinine increased

Bladder perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; organ failure;

urgent operative intervention

indicated

Death

Definition: A disorder characterized by a rupture in the bladder wall.

Navigational Note: -

Bladder spasm

Intervention not indicated

Antispasmodics indicated

Hospitalization indicated

-

Definition: A disorder characterized by a sudden and involuntary contraction of the bladder wall.

Navigational Note: -

Chronic kidney disease

eGFR (estimated Glomerular

Filtration Rate) or CrCl

(creatinine clearance) <LLN -

60 ml/min/1.73 m2 or

proteinuria 2+ present; urine

protein/creatinine >0.5

eGFR or CrCl 59 - 30

ml/min/1.73 m2

eGFR or CrCl 29 - 15

ml/min/1.73 m2

eGFR or CrCl <15 ml/min/1.73

m2; dialysis or renal

transplant indicated

Death

Definition: A disorder characterized by gradual and usually permanent loss of kidney function resulting in renal failure.

Navigational Note: -

Cystitis noninfective

Microscopic hematuria;

minimal increase in

frequency, urgency, dysuria,

or nocturia; new onset of

incontinence

Moderate hematuria;

moderate increase in

frequency, urgency, dysuria,

nocturia or incontinence;

urinary catheter placement or

bladder irrigation indicated;

limiting instrumental ADL

Gross hematuria; transfusion,

IV medications, or

hospitalization indicated;

elective invasive intervention

indicated

Life-threatening

consequences; urgent invasive

intervention indicated

Death

Definition: A disorder characterized by inflammation of the bladder which is not caused by an infection of the urinary tract.

Navigational Note: -

Dysuria

Present

-

Definition: A disorder characterized by painful urination.

Navigational Note: If associated with an infection, report the infection. For grades higher than Grade 1, consider Renal and urinary disorders: Bladder spasm or Cystitis noninfective;

Infections and infestations: Urinary tract infection.

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CTCAE v5.0 – November 27, 2017 Page 120

Renal and urinary disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Glucosuria

Present

-

Definition: A disorder characterized by laboratory test results that indicate glucose in the urine.

Navigational Note: -

Hematuria

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; urinary catheter

or bladder irrigation indicated;

limiting instrumental ADL

Gross hematuria; transfusion,

IV medications, or

hospitalization indicated;

elective invasive intervention

indicated; limiting self care

ADL

Life-threatening

consequences; urgent invasive

intervention indicated

Death

Definition: A disorder characterized by laboratory test results that indicate blood in the urine.

Navigational Note: -

Hemoglobinuria

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

-

Definition: A disorder characterized by laboratory test results that indicate the presence of free hemoglobin in the urine.

Navigational Note: Report underlying AE if > Grade 1

Nephrotic syndrome

-

Not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by symptoms that include severe edema, proteinuria, and hypoalbuminemia; it is indicative of renal dysfunction.

Navigational Note: -

Proteinuria

1+ proteinuria; urinary protein

≥ULN - <1.0 g/24 hrs

Adult: 2+ and 3+ proteinuria;

urinary protein 1.0 - <3.5 g/24

hrs;

Pediatric: Urine P/C

(Protein/Creatinine) ratio 0.5 -

1.9

Adult: Urinary protein >=3.5

g/24 hrs; 4+ proteinuria;

Pediatric: Urine P/C

(Protein/Creatinine) ratio >1.9

-

Definition: A disorder characterized by laboratory test results that indicate the presence of excessive protein in the urine. It is predominantly albumin, but also globulin.

Navigational Note: 24-hour urine collection takes precedence over dipstick

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CTCAE v5.0 – November 27, 2017 Page 121

Renal and urinary disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Renal calculi

Asymptomatic or mild

symptoms; occasional use of

nonprescription analgesics

indicated

Symptomatic; oral antiemetics

indicated; around the clock

nonprescription analgesics or

any oral narcotic analgesics

indicated

Hospitalization indicated; IV

intervention (e.g., analgesics,

antiemetics); elective invasive

intervention indicated

Life-threatening

consequences; urgent invasive

intervention indicated

Death

Definition: A disorder characterized by the formation of crystals/kidney stones in the pelvis of the kidney.

Navigational Note: -

Renal colic

Mild pain not interfering with

activity; nonprescription

medication indicated

Moderate pain; limiting

instrumental ADL;

prescription medication

indicated

Hospitalization indicated;

limiting self care ADL

-

Definition: A disorder characterized by paroxysmal and severe flank marked discomfort radiating to the inguinal area. Often, the cause is the passage of crystals/kidney stones.

Navigational Note: -

Renal hemorrhage

Mild symptoms; intervention

not indicated

Analgesics and hematocrit

monitoring indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the kidney.

Navigational Note: -

Urinary fistula

-

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent invasive

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between any part of the urinary system and another organ or anatomic site.

Navigational Note: -

Urinary frequency

Present

Limiting instrumental ADL;

medical management

indicated

-

Definition: A disorder characterized by urination at short intervals.

Navigational Note: -

Urinary incontinence

Occasional (e.g., with

coughing, sneezing, etc.), pads

not indicated

Spontaneous; pads indicated;

limiting instrumental ADL

Intervention indicated (e.g.,

clamp, collagen injections);

operative intervention

indicated; limiting self care

ADL

-

Definition: A disorder characterized by inability to control the flow of urine from the bladder.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 122

Renal and urinary disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Urinary retention

Urinary, suprapubic or

intermittent catheter

placement not indicated; able

to void with some residual

Placement of urinary,

suprapubic or intermittent

catheter placement indicated;

medication indicated

Elective invasive intervention

indicated; substantial loss of

affected kidney function or

mass

Life-threatening

consequences; organ failure;

urgent operative intervention

indicated

Death

Definition: A disorder characterized by accumulation of urine within the bladder because of the inability to urinate.

Navigational Note: -

Urinary tract obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic but no

hydronephrosis, sepsis, or

renal dysfunction; urethral

dilation, urinary or suprapubic

catheter indicated

Altered organ function (e.g.,

hydronephrosis or renal

dysfunction); invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by blockage of the normal flow of contents of the urinary tract.

Navigational Note: -

Urinary tract pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the urinary tract.

Navigational Note: -

Urinary urgency

Present

Limiting instrumental ADL;

medical management

indicated

-

Definition: A disorder characterized by a sudden compelling urge to urinate.

Navigational Note: -

Urine discoloration

Present

-

Definition: A disorder characterized by a change in the color of the urine.

Navigational Note: -

Renal and urinary disorders -

Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 123

Reproductive system and breast disorders

CTCAE Term

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Amenorrhea

-

Present

-

Definition: A disorder characterized by the abnormal absence of menses for at least three consecutive menstrual cycles.

Navigational Note: -

Azoospermia

-

Absence of sperm in ejaculate

-

Definition: A disorder characterized by laboratory test results that indicate complete absence of spermatozoa in the semen.

Navigational Note: -

Breast atrophy

Minimal asymmetry; minimal

atrophy

Moderate asymmetry;

moderate atrophy

Asymmetry >1/3 of breast

volume; severe atrophy

-

Definition: A disorder characterized by underdevelopment of the breast.

Navigational Note: -

Breast pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the breast region.

Navigational Note: -

Dysmenorrhea

Mild symptoms; intervention

not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by abnormally painful abdominal cramps during menses.

Navigational Note: -

Dyspareunia

Mild discomfort or pain

associated with vaginal

penetration; discomfort

relieved with use of vaginal

lubricants or estrogen

Moderate discomfort or pain

associated with vaginal

penetration; discomfort or

pain partially relieved with

use of vaginal lubricants or

estrogen

Severe discomfort or pain

associated with vaginal

penetration; discomfort or

pain unrelieved by vaginal

lubricants or estrogen

-

Definition: A disorder characterized by painful or difficult coitus.

Navigational Note: -

Ejaculation disorder

Diminished ejaculation

Anejaculation or retrograde

ejaculation

-

Definition: A disorder characterized by problems related to ejaculation. This category includes premature, delayed, retrograde and painful ejaculation.

Navigational Note: -

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Reproductive system and breast disorders

CTCAE Term

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Erectile dysfunction

Decrease in erectile function

(frequency or rigidity of

erections) but intervention

not indicated (e.g., medication

or use of mechanical device,

penile pump)

Decrease in erectile function

(frequency/rigidity of

erections), erectile

intervention indicated, (e.g.,

medication or mechanical

devices such as penile pump)

Decrease in erectile function

(frequency/rigidity of

erections) but erectile

intervention not helpful (e.g.,

medication or mechanical

devices such as penile pump);

placement of a permanent

penile prosthesis indicated

(not previously present)

-

Definition: A disorder characterized by the persistent or recurrent inability to achieve or to maintain an erection during sexual activity.

Navigational Note: -

Fallopian tube obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; elective

intervention indicated

Severe symptoms; invasive

intervention indicated

-

Definition: A disorder characterized by blockage of the normal flow of the contents in the fallopian tube.

Navigational Note: -

Feminization acquired

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated

-

Definition: A disorder characterized by the development of secondary female sex characteristics in males due to extrinsic factors.

Navigational Note: -

Genital edema

Mild swelling or obscuration

of anatomic architecture on

close inspection

Readily apparent obscuration

of anatomic architecture;

obliteration of skin folds;

readily apparent deviation

from normal anatomic

contour

Lymphorrhea; gross deviation

from normal anatomic

contour; limiting self care ADL

-

Definition: A disorder characterized by swelling due to an excessive accumulation of fluid in the genitals.

Navigational Note: -

Gynecomastia

Asymptomatic

Symptomatic (e.g., pain or

psychosocial impact)

Severe symptoms; elective

operative intervention

indicated

-

Definition: A disorder characterized by excessive development of the breasts in males.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 125

Reproductive system and breast disorders

CTCAE Term

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Hematosalpinx

Minimal bleeding identified

on imaging study or

laparoscopy; intervention not

indicated

Moderate bleeding; medical

intervention indicated

Transfusion indicated;

invasive intervention

indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by the presence of blood in a fallopian tube.

Navigational Note: -

Irregular menstruation

Intermittent/irregular menses

for no more than 3

consecutive menstrual cycles

Intermittent/irregular menses

for more than 3 consecutive

menstrual cycles

-

Definition: A disorder characterized by a change in cycle or duration of menses from baseline.

Navigational Note: Also consider Reproductive system and breast disorders: Premature menopause, Amenorrhea.

Lactation disorder

Mild changes in lactation, not

significantly affecting

production or expression of

breast milk

Changes in lactation,

significantly affecting breast

production or expression of

breast milk

-

Definition: A disorder characterized by disturbances of milk secretion. It is not necessarily related to pregnancy that is observed in females and can be observed in males.

Navigational Note: -

Menorrhagia

Mild; iron supplements

indicated

Moderate symptoms; medical

intervention indicated (e.g.,

hormones)

Severe; transfusion indicated;

operative intervention

indicated (e.g., hysterectomy)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by abnormally heavy vaginal bleeding during menses.

Navigational Note: -

Nipple deformity

Asymptomatic; asymmetry

with slight retraction and/or

thickening of the nipple

areolar complex

Symptomatic; asymmetry of

nipple areolar complex with

moderate retraction and/or

thickening of the nipple

areolar complex

-

Definition: A disorder characterized by a malformation of the nipple.

Navigational Note: -

Oligospermia

Sperm concentration > 0 to <

15 million/ml

-

Definition: A disorder characterized by a decrease in the number of spermatozoa in the semen.

Navigational Note: -

Ovarian hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the ovary.

Navigational Note: -

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Reproductive system and breast disorders

CTCAE Term

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Ovarian rupture

Asymptomatic clinical or

diagnostic observations only;

intervention not indicated

Symptomatic and intervention

not indicated

Transfusion; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by tearing or disruption of the ovarian tissue.

Navigational Note: -

Ovulation pain

-

Present

-

Definition: A disorder characterized by a sensation of marked discomfort in one side of the abdomen between menstrual cycles, around the time of the discharge of the ovum from the

ovarian follicle.

Navigational Note: -

Pelvic floor muscle weakness

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic, not interfering

with bladder, bowel, or

vaginal function; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by a reduction in the strength of the muscles of the pelvic floor.

Navigational Note: -

Pelvic pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the pelvis.

Navigational Note: -

Penile pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the penis.

Navigational Note: -

Perineal pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the area between the genital organs and the anus.

Navigational Note: -

Premature menopause

-

Present

-

Definition: A disorder characterized by premature ovarian failure. Symptoms may include hot flashes, night sweats, mood swings, and a decrease in sex drive. Laboratory findings

include elevated luteinizing hormone (LH) and follicle-stimulating hormone (FSH.)

Navigational Note: -

Prostatic hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the prostate gland.

Navigational Note: -

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Reproductive system and breast disorders

CTCAE Term

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Prostatic obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; elective

intervention indicated

Severe symptoms; invasive

intervention indicated

-

Definition: A disorder characterized by compression of the urethra secondary to enlargement of the prostate gland. This results in voiding difficulties (straining to void, slow urine

stream, and incomplete emptying of the bladder).

Navigational Note: -

Prostatic pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the prostate gland.

Navigational Note: -

Scrotal pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the scrotal area.

Navigational Note: -

Spermatic cord hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the spermatic cord.

Navigational Note: -

Spermatic cord obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; elective

intervention indicated

Severe symptoms; invasive

intervention indicated

-

Definition: A disorder characterized by blockage of the normal flow of the contents of the spermatic cord.

Navigational Note: -

Testicular disorder

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic but not

interfering with sexual

function; intervention not

indicated; limiting

instrumental ADL

Severe symptoms; interfering

with sexual function; limiting

self care ADL; intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

-

Definition: A disorder characterized by abnormal function or appearance of the testis.

Navigational Note: Also consider Reproductive system and breast disorders: Genital edema or other AE terms in the Renal and urinary disorders SOC or Reproductive system and breast

disorders SOC.

Testicular hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the testis.

Navigational Note: -

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Reproductive system and breast disorders

CTCAE Term

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Testicular pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the testis.

Navigational Note: -

Uterine fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the uterus and another organ or anatomic site.

Navigational Note: -

Uterine hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the uterus.

Navigational Note: -

Uterine obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; elective

intervention indicated

Severe symptoms; invasive

intervention indicated

-

Definition: A disorder characterized by blockage of the uterine outlet.

Navigational Note: -

Uterine pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the uterus.

Navigational Note: -

Vaginal discharge

Mild vaginal discharge

(greater than baseline for

patient)

Moderate to heavy vaginal

discharge; use of perineal pad

or tampon indicated

-

Definition: A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years.

Navigational Note: -

Vaginal dryness

Mild vaginal dryness not

interfering with sexual

function

Moderate vaginal dryness

interfering with sexual

function or causing frequent

discomfort

Severe vaginal dryness

resulting in dyspareunia or

severe discomfort

-

Definition: A disorder characterized by an uncomfortable feeling of itching and burning in the vagina.

Navigational Note: -

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Reproductive system and breast disorders

CTCAE Term

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Vaginal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the vagina and another organ or anatomic site.

Navigational Note: -

Vaginal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the vagina.

Navigational Note: -

Vaginal inflammation

Mild discomfort or pain,

edema, or redness

Moderate discomfort or pain,

edema, or redness; limiting

instrumental ADL

Severe discomfort or pain,

edema, or redness; limiting

self care ADL; small areas of

mucosal ulceration

Life-threatening

consequences; widespread

areas of mucosal ulceration;

urgent intervention indicated

-

Definition: A disorder characterized by inflammation involving the vagina. Symptoms may include redness, edema, marked discomfort and an increase in vaginal discharge.

Navigational Note: -

Vaginal obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; elective

intervention indicated

Severe symptoms; invasive

intervention indicated

-

Definition: A disorder characterized by blockage of vaginal canal.

Navigational Note: -

Vaginal pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the vagina.

Navigational Note: -

Vaginal perforation

-

Invasive intervention not

indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a rupture in the vaginal wall.

Navigational Note: -

Vaginal stricture

Asymptomatic; mild vaginal

shortening or narrowing

Vaginal narrowing and/or

shortening not interfering

with physical examination

Vaginal narrowing and/or

shortening interfering with

the use of tampons, sexual

activity or physical

examination

-

Death

Definition: A disorder characterized by a narrowing of the vaginal canal.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 130

Reproductive system and breast disorders

CTCAE Term

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Reproductive system and

breast disorders - Other,

specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 131

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Adult respiratory distress

syndrome

-

Present with radiologic

findings; intubation not

indicated

Life-threatening respiratory or

hemodynamic compromise;

intubation or urgent

intervention indicated

Death

Definition: A disorder characterized by progressive and life-threatening pulmonary distress in the absence of an underlying pulmonary condition, usually following major trauma or

surgery.

Navigational Note: -

Allergic rhinitis

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated

-

Definition: A disorder characterized by an inflammation of the nasal mucous membranes caused by an IgE-mediated response to external allergens. The inflammation may also involve

the mucous membranes of the sinuses, eyes, middle ear, and pharynx. Symptoms include sneezing, nasal congestion, rhinorrhea and itching.

Navigational Note: -

Apnea

-

Present; medical intervention

indicated

Life-threatening respiratory or

hemodynamic compromise;

intubation or urgent

intervention indicated

Death

Definition: A disorder characterized by cessation of breathing.

Navigational Note: -

Aspiration

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Altered eating habits;

coughing or choking episodes

after eating or swallowing;

medical intervention indicated

(e.g., suction or oxygen)

Dyspnea and pneumonia

symptoms (e.g., aspiration

pneumonia); hospitalization

indicated; unable to aliment

orally

Life-threatening respiratory or

hemodynamic compromise;

intubation or urgent

intervention indicated

Death

Definition: A disorder characterized by inhalation of solids or liquids into the lungs.

Navigational Note: -

Atelectasis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic (e.g., dyspnea,

cough); medical intervention

indicated (e.g., chest

physiotherapy, suctioning);

bronchoscopic suctioning

Supplemental oxygen

indicated; hospitalization or

elective operative

intervention indicated (e.g.,

stent, laser)

Life-threatening respiratory or

hemodynamic compromise;

intubation or urgent

intervention indicated

Death

Definition: A disorder characterized by the collapse of part or the entire lung.

Navigational Note: -

Bronchial fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the bronchus and another organ or anatomic site.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 132

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Bronchial obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic (e.g., mild

wheezing); endoscopic

evaluation indicated;

radiographic evidence of

atelectasis/lobar collapse;

medical management

indicated (e.g., steroids,

bronchodilators)

Shortness of breath with

stridor; endoscopic

intervention indicated (e.g.,

laser, stent placement)

Life-threatening respiratory or

hemodynamic compromise;

intubation or urgent

intervention indicated

Death

Definition: A disorder characterized by blockage of a bronchus passage, most often by bronchial secretions and exudates.

Navigational Note: -

Bronchial stricture

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic (e.g., rhonchi or

wheezing) but without

respiratory distress; medical

intervention indicated (e.g.,

steroids, bronchodilators)

Shortness of breath with

stridor; endoscopic

intervention indicated (e.g.,

laser, stent placement)

Life-threatening respiratory or

hemodynamic compromise;

intubation or urgent

intervention indicated

Death

Definition: A disorder characterized by a narrowing of the bronchial tube.

Navigational Note: -

Bronchopleural fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Hospitalization; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between a bronchus and the pleural cavity.

Navigational Note: -

Bronchopulmonary

hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms; invasive

intervention not indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; intubation or

urgent intervention indicated

Death

Definition: A disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.

Navigational Note: -

Bronchospasm

Mild symptoms; intervention

not indicated

Symptomatic; medical

intervention indicated;

limiting instrumental ADL

Limiting self care ADL;

supplemental oxygen

indicated

Life-threatening respiratory or

hemodynamic compromise;

intubation or urgent

intervention indicated

Death

Definition: A disorder characterized by a sudden contraction of the smooth muscles of the bronchial wall.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 133

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Chylothorax

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated (e.g.,

fat-restricted diet);

thoracentesis or tube

drainage indicated

Severe symptoms; elective

operative intervention

indicated

Life-threatening respiratory or

hemodynamic compromise;

intubation or urgent

intervention indicated

Death

Definition: A disorder characterized by milky pleural effusion (abnormal collection of fluid) resulting from accumulation of lymph fluid in the pleural cavity.

Navigational Note: -

Cough

Mild symptoms;

nonprescription intervention

indicated

Moderate symptoms, medical

intervention indicated;

limiting instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied

by a distinctive sound.

Navigational Note: -

Dyspnea

Shortness of breath with

moderate exertion

Shortness of breath with

minimal exertion; limiting

instrumental ADL

Shortness of breath at rest;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an uncomfortable sensation of difficulty breathing.

Navigational Note: -

Epistaxis

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated (e.g.,

nasal packing, cauterization;

topical vasoconstrictors)

Transfusion; invasive

intervention indicated (e.g.,

hemostasis of bleeding site)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the nose.

Navigational Note: -

Hiccups

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated;

limiting instrumental ADL

Severe symptoms; interfering

with sleep; limiting self care

ADL

-

Definition: A disorder characterized by repeated gulp sounds that result from an involuntary opening and closing of the glottis. This is attributed to a spasm of the diaphragm.

Navigational Note: -

Hoarseness

Mild or intermittent voice

change; fully understandable;

self-resolves

Moderate or persistent voice

changes; may require

occasional repetition but

understandable on telephone;

medical evaluation indicated

Severe voice changes

including predominantly

whispered speech

-

Definition: A disorder characterized by harsh and raspy voice arising from or spreading to the larynx.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 134

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hypoxia

-

Decreased oxygen saturation

with exercise (e.g., pulse

oximeter <88%); intermittent

supplemental oxygen

Decreased oxygen saturation

at rest (e.g., pulse oximeter

<88% or PaO2 <=55 mm Hg)

Life-threatening airway

compromise; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A disorder characterized by a decrease in the level of oxygen in the body.

Navigational Note: -

Laryngeal edema

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated (e.g.,

dexamethasone, epinephrine,

antihistamines)

Stridor; respiratory distress;

hospitalization indicated

Life-threatening airway

compromise; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A disorder characterized by swelling due to an excessive accumulation of fluid in the larynx.

Navigational Note: -

Laryngeal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the larynx and another organ or anatomic site.

Navigational Note: -

Laryngeal hemorrhage

Mild cough or trace

hemoptysis; laryngoscopic

findings

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A disorder characterized by bleeding from the larynx.

Navigational Note: -

Laryngeal inflammation

Mild sore throat; raspy voice

Moderate sore throat;

analgesics indicated

Severe throat pain;

endoscopic intervention

indicated

-

Definition: A disorder characterized by an inflammation involving the larynx.

Navigational Note: -

Laryngeal mucositis

Endoscopic findings only; mild

discomfort with normal intake

Moderate pain, analgesics

indicated; altered oral intake;

limiting instrumental ADL

Severe pain; severely altered

eating/swallowing; medical

intervention indicated

Life-threatening airway

compromise; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A disorder characterized by ulceration or inflammation involving the mucous membrane of the larynx.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 135

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Laryngeal obstruction

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic (e.g., noisy

airway breathing), no

respiratory distress; medical

intervention indicated (e.g.,

steroids); limiting

instrumental ADL

Limiting self care ADL; stridor;

endoscopic intervention

indicated (e.g., stent, laser)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by blockage of the laryngeal airway.

Navigational Note: -

Laryngeal stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic (e.g., noisy

airway breathing), no

respiratory distress; medical

intervention indicated (e.g.,

steroids); limiting

instrumental ADL

Limiting self care ADL; stridor;

endoscopic intervention

indicated (e.g., stent, laser)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a narrowing of the laryngeal airway.

Navigational Note: -

Laryngopharyngeal

dysesthesia

Mild symptoms; no anxiety;

intervention not indicated

Moderate symptoms; mild

anxiety, but no dyspnea; short

duration of observation

and/or anxiolytic indicated;

limiting instrumental ADL

Severe symptoms; dyspnea

and swallowing difficulty;

limiting self care ADL

Life-threatening

consequences

Death

Definition: A disorder characterized by an uncomfortable persistent sensation in the area of the laryngopharynx.

Navigational Note: -

Laryngospasm

-

Transient episode;

intervention not indicated

Recurrent episodes;

noninvasive intervention

indicated (e.g., breathing

technique, pressure point

massage)

Persistent or severe episodes

associated with syncope;

urgent intervention indicated

(e.g., fiberoptic laryngoscopy,

intubation, botox injection)

Death

Definition: A disorder characterized by paroxysmal spasmodic muscular contraction of the vocal cords.

Navigational Note: -

Mediastinal hemorrhage

Mild symptoms; intervention

not indicated; radiologic

evidence only

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by bleeding from the mediastinum.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 136

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Nasal congestion

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated

Associated with bloody nasal

discharge or epistaxis

-

Definition: A disorder characterized by obstruction of the nasal passage due to mucosal edema.

Navigational Note: -

Oropharyngeal pain

Mild pain

Moderate pain; altered oral

intake; non-narcotics

initiated; topical analgesics

initiated

Severe pain; severely altered

eating/swallowing; narcotics

initiated; requires parenteral

nutrition

-

Definition: A disorder characterized by a sensation of marked discomfort in the oropharynx.

Navigational Note: -

Pharyngeal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the pharynx and another organ or anatomic site.

Navigational Note: -

Pharyngeal hemorrhage

Mild symptoms; intervention

not indicated

Moderate symptoms;

intervention indicated

Transfusion indicated;

invasive intervention

indicated; hospitalization

Life-threatening

consequences; intubation or

urgent intervention indicated

Death

Definition: A disorder characterized by bleeding from the pharynx.

Navigational Note: -

Pharyngeal mucositis

Endoscopic findings only;

minimal symptoms with

normal oral intake; mild pain

but analgesics not indicated

Moderate pain, analgesics

indicated; altered oral intake;

limiting instrumental ADL

Severe pain; unable to

adequately aliment or hydrate

orally; limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by ulceration or inflammation involving the mucous membrane of the pharynx.

Navigational Note: -

Pharyngeal necrosis

-

Inability to aliment adequately

by GI tract; invasive

intervention indicated; tube

feeding or TPN indicated

Life-threatening

consequences; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by a necrotic process occurring in the pharynx.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 137

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Pharyngeal stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic (e.g., noisy

airway breathing), no

respiratory distress; medical

intervention indicated (e.g.,

steroids); limiting

instrumental ADL

Limiting self care ADL; stridor;

endoscopic intervention

indicated (e.g., stent, laser)

Life-threatening airway

compromise; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A disorder characterized by a narrowing of the pharyngeal airway.

Navigational Note: -

Pharyngolaryngeal pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the pharyngolaryngeal region.

Navigational Note: -

Pleural effusion

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; intervention

indicated (e.g., diuretics or

therapeutic thoracentesis)

Symptomatic with respiratory

distress and hypoxia;

operative intervention

including chest tube or

pleurodesis indicated

Life-threatening respiratory or

hemodynamic compromise;

intubation or urgent

intervention indicated

Death

Definition: A disorder characterized by an increase in amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough and marked chest discomfort.

Navigational Note: -

Pleural hemorrhage

Asymptomatic; mild

hemorrhage confirmed by

thoracentesis

Symptomatic or associated

with pneumothorax; chest

tube drainage indicated

>1000 ml of blood evacuated;

persistent bleeding (150-200

ml/hr for 2 - 4 hr); persistent

transfusion indicated; elective

operative intervention

indicated; hospitalization

Life-threatening

consequences; intubation or

urgent intervention indicated

Death

Definition: A disorder characterized by bleeding from the pleural cavity.

Navigational Note: -

Pleuritic pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the pleura.

Navigational Note: -

Pneumonitis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated;

limiting instrumental ADL

Severe symptoms; limiting self

care ADL; oxygen indicated

Life-threatening respiratory

compromise; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 138

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Pneumothorax

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; intervention

indicated

Sclerosis and/or operative

intervention indicated;

hospitalization indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by abnormal presence of air in the pleural cavity resulting in the collapse of the lung.

Navigational Note: -

Postnasal drip

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated

-

Definition: A disorder characterized by excessive mucous secretion in the back of the nasal cavity or throat, causing sore throat and/or coughing.

Navigational Note: -

Productive cough

Occasional/minimal

production of sputum with

cough

Moderate sputum production;

limiting instrumental ADL

Persistent or copious

production of sputum; limiting

self care ADL

-

Definition: A disorder characterized by expectorated secretions upon coughing.

Navigational Note: -

Pulmonary edema

Radiologic findings only;

minimal dyspnea on exertion

Moderate dyspnea on

exertion; medical intervention

indicated; limiting

instrumental ADL

Severe dyspnea or dyspnea at

rest; oxygen indicated;

limiting self care ADL

Life-threatening respiratory

compromise; urgent

intervention or intubation

with ventilatory support

indicated

Death

Definition: A disorder characterized by accumulation of fluid in the lung tissues that causes a disturbance of the gas exchange that may lead to respiratory failure.

Navigational Note: -

Pulmonary fibrosis

Radiologic pulmonary fibrosis

<25% of lung volume

associated with hypoxia

Evidence of pulmonary

hypertension; radiographic

pulmonary fibrosis 25 - 50%

associated with hypoxia

Severe hypoxia; evidence of

right-sided heart failure;

radiographic pulmonary

fibrosis >50 - 75%

Life-threatening

consequences (e.g.,

hemodynamic/pulmonary

complications); intubation

with ventilatory support

indicated; radiographic

pulmonary fibrosis >75% with

severe honeycombing

Death

Definition: A disorder characterized by the replacement of the lung tissue by connective tissue, leading to progressive dyspnea, respiratory failure or right heart failure.

Navigational Note: -

Pulmonary fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the lung and another organ or anatomic site.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 139

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Pulmonary hypertension

Minimal dyspnea; findings on

physical exam or other

evaluation

Moderate dyspnea, cough;

requiring evaluation by

cardiac catheterization and

medical intervention

Severe symptoms, associated

with hypoxia, right heart

failure; oxygen indicated

Life-threatening airway

consequences; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A disorder characterized by an increase in pressure within the pulmonary circulation due to lung or heart disorder.

Navigational Note: -

Respiratory failure

-

Life-threatening

consequences; urgent

intervention, intubation, or

ventilatory support indicated

Death

Definition: A disorder characterized by impaired gas exchange by the respiratory system resulting in hypoxia and a decrease in oxygenation of the tissues that may be associated with

an increase in arterial levels of carbon dioxide.

Navigational Note: -

Retinoic acid syndrome

Fluid retention; <3 kg of

weight gain; intervention with

fluid restriction and/or

diuretics indicated

Moderate signs or symptoms;

steroids indicated

Severe symptoms;

hospitalization indicated

Life-threatening

consequences; ventilatory

support indicated

Death

Definition: A disorder characterized by weight gain, dyspnea, pleural and pericardial effusions, leukocytosis and/or renal failure originally described in patients treated with all-trans

retinoic acid.

Navigational Note: -

Rhinorrhea

Present

-

Definition: A disorder characterized by excessive mucous secretions draining from the nose.

Navigational Note: -

Sinus disorder

Asymptomatic mucosal

crusting; blood-tinged

secretions

Symptomatic stenosis or

edema/narrowing interfering

with airflow; limiting

instrumental ADL

Stenosis with significant nasal

obstruction; limiting self care

ADL

Necrosis of soft tissue or

bone; urgent operative

intervention indicated

Death

Definition: A disorder characterized by involvement of the paranasal sinuses.

Navigational Note: -

Sinus pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the face, between the eyes, or upper teeth originating from the sinuses.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 140

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Sleep apnea

Snoring and nocturnal sleep

arousal without apneic

periods

Moderate apnea and oxygen

desaturation; excessive

daytime sleepiness; medical

evaluation indicated; limiting

instrumental ADL

Oxygen desaturation;

associated with pulmonary

hypertension; medical

intervention indicated;

limiting self care ADL

Cardiovascular or

neuropsychiatric symptoms;

urgent operative intervention

indicated

Death

Definition: A disorder characterized by cessation of breathing for short periods during sleep.

Navigational Note: -

Sneezing

Mild symptoms; intervention

not indicated

Moderate symptoms; medical

intervention indicated

-

Definition: A disorder characterized by the involuntary expulsion of air from the nose.

Navigational Note: -

Sore throat

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL; limiting ability to

swallow

-

Definition: A disorder characterized by marked discomfort in the throat.

Navigational Note: -

Stridor

-

Respiratory distress limiting

self care ADL; medical

intervention indicated

Life-threatening airway

compromise; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A disorder characterized by a high pitched breathing sound due to laryngeal or upper airway obstruction.

Navigational Note: -

Tracheal fistula

Asymptomatic

Symptomatic, invasive

intervention not indicated

Invasive intervention

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an abnormal communication between the trachea and another organ or anatomic site.

Navigational Note: -

Tracheal mucositis

Endoscopic findings only;

minimal hemoptysis, pain, or

respiratory symptoms

Moderate symptoms; medical

intervention indicated;

limiting instrumental ADL

Severe pain; hemorrhage or

respiratory symptoms;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an inflammation or ulceration involving the mucous membrane of the trachea.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 141

Respiratory, thoracic and mediastinal disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Tracheal stenosis

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic (e.g., noisy

airway breathing), no

respiratory distress; medical

intervention indicated (e.g.,

steroids); limiting

instrumental ADL

Stridor or respiratory distress

limiting self care ADL; invasive

intervention indicated (e.g.,

stent, laser)

Life-threatening airway

compromise; urgent

intervention indicated (e.g.,

tracheotomy or intubation)

Death

Definition: A disorder characterized by a narrowing of the trachea.

Navigational Note: -

Voice alteration

Mild or intermittent change

from normal voice

Moderate or persistent

change from normal voice;

still understandable

Severe voice changes

including predominantly

whispered speech; may

require frequent repetition or

face-to-face contact for

understandability; may

require assistive technology

-

Definition: A disorder characterized by a change in the sound and/or speed of the voice.

Navigational Note: -

Wheezing

Detectable airway noise with

minimal symptoms

Moderate symptoms; medical

intervention indicated;

limiting instrumental ADL

Severe respiratory symptoms

limiting self care ADL; oxygen

therapy or hospitalization

indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a high-pitched, whistling sound during breathing. It results from the narrowing or obstruction of the respiratory airways.

Navigational Note: -

Respiratory, thoracic and

mediastinal disorders - Other,

specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 142

Skin and subcutaneous tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Alopecia

Hair loss of <50% of normal

for that individual that is not

obvious from a distance but

only on close inspection; a

different hair style may be

required to cover the hair loss

but it does not require a wig

or hair piece to camouflage

Hair loss of >=50% normal for

that individual that is readily

apparent to others; a wig or

hair piece is necessary if the

patient desires to completely

camouflage the hair loss;

associated with psychosocial

impact

-

Definition: A disorder characterized by a decrease in density of hair compared to normal for a given individual at a given age and body location.

Navigational Note: -

Body odor

Mild odor; physician

intervention not indicated;

self care interventions

Pronounced odor;

psychosocial impact; patient

seeks medical intervention

-

Definition: A disorder characterized by an abnormal body smell resulting from the growth of bacteria on the body.

Navigational Note: -

Bullous dermatitis

Asymptomatic; blisters

covering <10% BSA

Blisters covering 10 - 30%

BSA; painful blisters; limiting

instrumental ADL

Blisters covering >30% BSA;

limiting self care ADL

Blisters covering >30% BSA;

associated with fluid or

electrolyte abnormalities; ICU

care or burn unit indicated

Death

Definition: A disorder characterized by inflammation of the skin characterized by the presence of bullae which are filled with fluid.

Navigational Note: If infectious, consider Infections and infestations: Rash pustular or other site-specific Infections and infestations term.

Dry skin

Covering <10% BSA and no

associated erythema or

pruritus

Covering 10 - 30% BSA and

associated with erythema or

pruritus; limiting instrumental

ADL

Covering >30% BSA and

associated with pruritus;

limiting self care ADL

-

Definition: A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture.

Navigational Note: -

Eczema

Asymptomatic or mild

symptoms; additional medical

intervention over baseline not

indicated

Moderate; topical or oral

intervention indicated;

additional medical

intervention over baseline

indicated

Severe or medically significant

but not immediately life-

threatening; IV intervention

indicated

-

Definition: A disorder characterized by skin which becomes itchy, red, inflamed, crusty, thick, scaly, and/or forms blisters.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 143

Skin and subcutaneous tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Erythema multiforme

Target lesions covering <10%

BSA and not associated with

skin tenderness

Target lesions covering 10 -

30% BSA and associated with

skin tenderness

Target lesions covering >30%

BSA and associated with oral

or genital erosions

Target lesions covering >30%

BSA; associated with fluid or

electrolyte abnormalities; ICU

care or burn unit indicated

Death

Definition: A disorder characterized by target lesions (a pink-red ring around a pale center).

Navigational Note: -

Erythroderma

-

Erythema covering >90% BSA

without associated symptoms;

limiting instrumental ADL

Erythema covering >90% BSA

with associated symptoms

(e.g., pruritus or tenderness);

limiting self care ADL

Erythema covering >90% BSA

with associated fluid or

electrolyte abnormalities; ICU

care or burn unit indicated

Death

Definition: A disorder characterized by generalized inflammatory erythema and exfoliation. The inflammatory process involves > 90% of the body surface area.

Navigational Note: -

Fat atrophy

Covering <10% BSA and

asymptomatic

Covering 10 - 30% BSA and

associated with erythema or

tenderness; limiting

instrumental ADL

Covering >30% BSA;

associated with erythema or

tenderness; limiting self-care

ADL

-

Definition: A disorder characterized by shrinking of adipose tissue.

Navigational Note: -

Hair color changes

Present

-

Definition: A disorder characterized by change in hair color or loss of normal pigmentation.

Navigational Note: -

Hair texture abnormal

Present

-

Definition: A disorder characterized by a change in the way the hair feels.

Navigational Note: -

Hirsutism

In women, increase in length,

thickness or density of hair in

a male distribution that the

patient is able to camouflage

by periodic shaving, bleaching,

or removal of hair

In women, increase in length,

thickness or density of hair in

a male distribution that

requires daily shaving or

consistent destructive means

of hair removal to

camouflage; associated with

psychosocial impact

-

Definition: A disorder characterized by the presence of excess hair growth in women in anatomic sites where growth is considered to be a secondary male characteristic and under

androgen control (beard, moustache, chest, abdomen).

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 144

Skin and subcutaneous tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hyperhidrosis

Limited to one site (palms,

soles, or axillae); self care

interventions

Involving >1 site; patient seeks

medical intervention;

associated with psychosocial

impact

Associated with

electrolyte/hemodynamic

imbalance

-

Definition: A disorder characterized by excessive sweating.

Navigational Note: Synonym: Night sweats,

diaphoresis

Hyperkeratosis

Present

-

Limiting self-care ADLs

-

Definition: A disorder characterized by a thickening of the outer layer of the skin.

Navigational Note: -

Hypertrichosis

Increase in length, thickness

or density of hair that the

patient is either able to

camouflage by periodic

shaving or removal of hairs or

is not concerned enough

about the overgrowth to use

any form of hair removal

Increase in length, thickness

or density of hair at least on

the usual exposed areas of the

body [face (not limited to

beard/moustache area)

plus/minus arms] that

requires frequent shaving or

use of destructive means of

hair removal to camouflage;

associated with psychosocial

impact

-

Definition: A disorder characterized by hair density or length beyond the accepted limits of normal in a particular body region, for a particular age or race.

Navigational Note: -

Hypohidrosis

-

Symptomatic; limiting

instrumental ADL

Increase in body temperature;

limiting self care ADL

Heat stroke

Death

Definition: A disorder characterized by reduced sweating.

Navigational Note: -

Lipohypertrophy

Asymptomatic and covering

<10% BSA

Covering 10 - 30% BSA and

associated tenderness;

limiting instrumental ADL

Covering >30% BSA and

associated tenderness and

narcotics or NSAIDs indicated;

lipohypertrophy; limiting self

care ADL

-

Definition: A disorder characterized by hypertrophy of the subcutaneous adipose tissue at the site of multiple subcutaneous injections of insulin.

Navigational Note: -

Nail changes

Present

-

Definition: A disorder characterized by a change in the nails.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 145

Skin and subcutaneous tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Nail discoloration

Asymptomatic; clinical or

diagnostic observations only

-

Definition: A disorder characterized by a change in the color of the nail plate.

Navigational Note: -

Nail loss

Asymptomatic separation of

the nail bed from the nail

plate or nail loss

Symptomatic separation of

the nail bed from the nail

plate or nail loss; limiting

instrumental ADL

-

Definition: A disorder characterized by loss of all or a portion of the nail.

Navigational Note: -

Nail ridging

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

-

Definition: A disorder characterized by vertical or horizontal ridges on the nails.

Navigational Note: -

Pain of skin

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the skin.

Navigational Note: -

Palmar-plantar

erythrodysesthesia syndrome

Minimal skin changes or

dermatitis (e.g., erythema,

edema, or hyperkeratosis)

without pain

Skin changes (e.g., peeling,

blisters, bleeding, fissures,

edema, or hyperkeratosis)

with pain; limiting

instrumental ADL

Severe skin changes (e.g.,

peeling, blisters, bleeding,

fissures, edema, or

hyperkeratosis) with pain;

limiting self care ADL

-

Definition: A disorder characterized by redness, marked discomfort, swelling, and tingling in the palms of the hands or the soles of the feet. Also known as Hand-Foot Syndrome.

Navigational Note: -

Photosensitivity

Painless erythema and

erythema covering <10% BSA

Tender erythema covering 10

- 30% BSA

Erythema covering >30% BSA

and erythema with blistering;

photosensitivity; oral

corticosteroid therapy

indicated; pain control

indicated (e.g., narcotics or

NSAIDs)

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by an increase in sensitivity of the skin to light.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 146

Skin and subcutaneous tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Pruritus

Mild or localized; topical

intervention indicated

Widespread and intermittent;

skin changes from scratching

(e.g., edema, papulation,

excoriations, lichenification,

oozing/crusts); oral

intervention indicated;

limiting instrumental ADL

Widespread and constant;

limiting self care ADL or sleep;

systemic corticosteroid or

immunosuppressive therapy

indicated

-

Definition: A disorder characterized by an intense itching sensation.

Navigational Note: -

Purpura

Combined area of lesions

covering <10% BSA

Combined area of lesions

covering 10 - 30% BSA;

bleeding with trauma

Combined area of lesions

covering >30% BSA;

spontaneous bleeding

-

Definition: A disorder characterized by hemorrhagic areas of the skin and mucous membrane. Newer lesions appear reddish in color. Older lesions are usually a darker purple color and

eventually become a brownish-yellow color.

Navigational Note: -

Rash acneiform

Papules and/or pustules

covering <10% BSA, which

may or may not be associated

with symptoms of pruritus or

tenderness

Papules and/or pustules

covering 10 - 30% BSA, which

may or may not be associated

with symptoms of pruritus or

tenderness; associated with

psychosocial impact; limiting

instrumental ADL; papules

and/or pustules covering >

30% BSA with or without mild

symptoms

Papules and/or pustules

covering >30% BSA with

moderate or severe

symptoms; limiting self-care

ADL; associated with local

superinfection with oral

antibiotics indicated

Life-threatening

consequences; papules and/or

pustules covering any % BSA,

which may or may not be

associated with symptoms of

pruritus or tenderness and are

associated with extensive

superinfection with IV

antibiotics indicated

Death

Definition: A disorder characterized by an eruption of papules and pustules, typically appearing in face, scalp, upper chest and back.

Navigational Note: -

Rash maculo-papular

Macules/papules covering

<10% BSA with or without

symptoms (e.g., pruritus,

burning, tightness)

Macules/papules covering 10 -

30% BSA with or without

symptoms (e.g., pruritus,

burning, tightness); limiting

instrumental ADL; rash

covering > 30% BSA with or

without mild symptoms

Macules/papules covering

>30% BSA with moderate or

severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by the presence of macules (flat) and papules (elevated). Also known as morbillform rash, it is one of the most common cutaneous adverse events,

frequently affecting the upper trunk, spreading centripetally and associated with pruritis.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 147

Skin and subcutaneous tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Scalp pain

Mild pain

Moderate pain; limiting

instrumental ADL

Severe pain; limiting self care

ADL

-

Definition: A disorder characterized by a sensation of marked discomfort in the skin covering the top and the back of the head.

Navigational Note: -

Skin atrophy

Covering <10% BSA;

associated with

telangiectasias or changes in

skin color

Covering 10 - 30% BSA;

associated with striae or

adnexal structure loss

Covering >30% BSA;

associated with ulceration

-

Definition: A disorder characterized by the degeneration and thinning of the epidermis and dermis.

Navigational Note: -

Skin hyperpigmentation

Hyperpigmentation covering

<10% BSA; no psychosocial

impact

Hyperpigmentation covering

>10% BSA; associated

psychosocial impact

-

Definition: A disorder characterized by darkening of the skin due to excessive melanin deposition.

Navigational Note: -

Skin hypopigmentation

Hypopigmentation or

depigmentation covering

<10% BSA; no psychosocial

impact

Hypopigmentation or

depigmentation covering

>10% BSA; associated

psychosocial impact

-

Definition: A disorder characterized by loss of skin pigment (e.g., vitiligo).

Navigational Note: -

Skin induration

Mild induration, able to move

skin parallel to plane (sliding)

and perpendicular to skin

(pinching up)

Moderate induration, able to

slide skin, unable to pinch

skin; limiting instrumental ADL

Severe induration; unable to

slide or pinch skin; limiting

joint or orifice movement

(e.g., mouth, anus); limiting

self care ADL

Generalized; associated with

signs or symptoms of impaired

breathing or feeding

Death

Definition: A disorder characterized by an area of hardness in the skin.

Navigational Note: -

Skin ulceration

Combined area of ulcers <1

cm; nonblanchable erythema

of intact skin with associated

warmth or edema

Combined area of ulcers 1 - 2

cm; partial thickness skin loss

involving skin or

subcutaneous fat

Combined area of ulcers >2

cm; full-thickness skin loss

involving damage to or

necrosis of subcutaneous

tissue that may extend down

to fascia

Any size ulcer with extensive

destruction, tissue necrosis, or

damage to muscle, bone, or

supporting structures with or

without full thickness skin loss

Death

Definition: A disorder characterized by a circumscribed, erosive lesion on the skin.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 148

Skin and subcutaneous tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Stevens-Johnson syndrome

-

Skin sloughing covering <10%

BSA with associated signs

(e.g., erythema, purpura,

epidermal detachment, and

mucous membrane

detachment)

Skin sloughing covering 10 -

30% BSA with associated signs

(e.g., erythema, purpura,

epidermal detachment and

mucous membrane

detachment)

Death

Definition: A disorder characterized by less than 10% total body skin area separation of dermis. The syndrome is thought to be a hypersensitivity complex affecting the skin and the

mucous membranes.

Navigational Note: -

Subcutaneous emphysema

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

-

Definition: A disorder characterized by air in the subcutaneous tissue.

Navigational Note: -

Telangiectasia

Telangiectasias covering <10%

BSA

Telangiectasias covering

>=10% BSA; associated with

psychosocial impact

-

Definition: A disorder characterized by local dilatation of small vessels resulting in red discoloration of the skin or mucous membranes.

Navigational Note: -

Toxic epidermal necrolysis

-

Skin sloughing covering >=30%

BSA with associated

symptoms (e.g., erythema,

purpura, or epidermal

detachment)

Death

Definition: A disorder characterized by greater than 30% total body skin area separation of dermis. The syndrome is thought to be a hypersensitivity complex affecting the skin and the

mucous membranes.

Navigational Note: -

Urticaria

Urticarial lesions covering

<10% BSA; topical

intervention indicated

Urticarial lesions covering 10 -

30% BSA; oral intervention

indicated

Urticarial lesions covering

>30% BSA; IV intervention

indicated

-

Definition: A disorder characterized by an itchy skin eruption characterized by wheals with pale interiors and well-defined red margins.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 149

Skin and subcutaneous tissue disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Skin and subcutaneous tissue

disorders - Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 150

Social circumstances

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Social circumstances - Other,

specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 151

Surgical and medical procedures

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Surgical and medical

procedures - Other, specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 152

Vascular disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Arterial thromboembolism

-

Urgent intervention indicated

Life-threatening

consequences; hemodynamic

or neurologic instability; organ

damage; loss of extremity(ies)

Death

Definition: A disorder characterized by occlusion of an arterial vessel by a blood clot that develops in an artery.

Navigational Note: Consider Nervous system disorders: TIA or Stroke for CNS-related events or Cardiac disorders: Myocardial infarction

Capillary leak syndrome

Asymptomatic

Symptomatic; medical

intervention indicated

Severe symptoms;

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by leakage of intravascular fluids into the extravascular space. This syndrome is observed in patients who demonstrate a state of generalized leaky

capillaries following shock syndromes, low-flow states, ischemia-reperfusion injuries, toxemias, medications, or poisoning. It can lead to generalized edema and multiple organ failure.

Navigational Note: -

Flushing

Asymptomatic; clinical or

diagnostic observations only

Moderate symptoms; limiting

instrumental ADL

Symptomatic, associated with

hypotension and/or

tachycardia; limiting self care

ADL

-

Definition: A disorder characterized by episodic reddening of the skin, especially face, neck, or chest.

Navigational Note: -

Hematoma

Mild symptoms; intervention

not indicated

Minimally invasive evacuation

or aspiration indicated

Transfusion; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by a localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall of a blood vessel.

Navigational Note: -

Hot flashes

Mild symptoms; intervention

not indicated

Moderate symptoms; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by an uncomfortable and temporary sensation of intense body warmth, flushing, sometimes accompanied by sweating upon cooling.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 153

Vascular disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Hypertension

Adult: Systolic BP 120 - 139

mm Hg or diastolic BP 80 - 89

mm Hg;

Pediatric: Systolic/diastolic BP

>90th percentile but< 95th

percentile;

Adolescent: BP ≥120/80 even

if < 95th percentile

Adult: Systolic BP 140 - 159

mm Hg or diastolic BP 90 - 99

mm Hg if previously WNL;

change in baseline medical

intervention indicated;

recurrent or persistent (>=24

hrs); symptomatic increase by

>20 mm Hg (diastolic) or to

>140/90 mm Hg;

monotherapy indicated

initiated;

Pediatric and adolescent:

Recurrent or persistent (>=24

hrs) BP >ULN; monotherapy

indicated; systolic and /or

diastolic BP between the 95th

percentile and 5 mmHg above

the 99th percentile;

Adolescent: Systolic between

130-139 or diastolic between

80-89 even if < 95th percentile

Adult: Systolic BP >=160 mm

Hg or diastolic BP >=100 mm

Hg; medical intervention

indicated; more than one drug

or more intensive therapy

than previously used

indicated;

Pediatric and adolescent:

Systolic and/or diastolic > 5

mmHg above the 99th

percentile

Adult and Pediatric: Life-

threatening consequences

(e.g., malignant hypertension,

transient or permanent

neurologic deficit,

hypertensive crisis); urgent

intervention indicated

Death

Definition: A disorder characterized by a pathological increase in blood pressure.

Navigational Note: -

Hypotension

Asymptomatic, intervention

not indicated

Non-urgent medical

intervention indicated

Medical intervention

indicated; hospitalization

indicated

Life-threatening

consequences and urgent

intervention indicated

Death

Definition: A disorder characterized by a blood pressure that is below the normal expected for an individual in a given environment.

Navigational Note: -

Lymph leakage

-

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: A disorder characterized by the loss of lymph fluid into the surrounding tissue or body cavity.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 154

Vascular disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Lymphedema

Trace thickening or faint

discoloration

Marked discoloration;

leathery skin texture; papillary

formation; limiting

instrumental ADL

Severe symptoms; limiting self

care ADL

-

Definition: A disorder characterized by excessive fluid collection in tissues that causes swelling.

Navigational Note: -

Lymphocele

Asymptomatic; clinical or

diagnostic observations only;

intervention not indicated

Symptomatic; medical

intervention indicated

Severe symptoms; invasive

intervention indicated

-

Definition: A disorder characterized by a cystic lesion containing lymph.

Navigational Note: -

Peripheral 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

consequences; evidence of

end organ damage; urgent

operative intervention

indicated

Death

Definition: A disorder characterized by impaired circulation to an extremity.

Navigational Note: -

Phlebitis

-

Present

-

Definition: A disorder characterized by inflammation of the wall of a vein.

Navigational Note: -

Superficial thrombophlebitis

-

Present

-

Definition: A disorder characterized by a blood clot and inflammation involving a superficial vein of the extremities.

Navigational Note: -

Superior vena cava syndrome

Asymptomatic; incidental

finding of SVC thrombosis

Symptomatic; medical

intervention indicated (e.g.,

anticoagulation, radiation or

chemotherapy)

Severe symptoms; multi-

modality intervention

indicated (e.g.,

anticoagulation,

chemotherapy, radiation,

stenting)

Life-threatening

consequences; urgent multi-

modality intervention

indicated (e.g., lysis,

thrombectomy, surgery)

Death

Definition: A disorder characterized by obstruction of the blood flow in the superior vena cava. Signs and symptoms include swelling and cyanosis of the face, neck, and upper arms,

cough, orthopnea and headache.

Navigational Note: -

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CTCAE v5.0 – November 27, 2017 Page 155

Vascular disorders

CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Thromboembolic event

Medical intervention not

indicated (e.g., superficial

thrombosis)

Medical intervention

indicated

Urgent medical intervention

indicated (e.g., pulmonary

embolism or intracardiac

thrombus)

Life-threatening

consequences with

hemodynamic or neurologic

instability

Death

Definition: A disorder characterized by occlusion of a vessel by a thrombus that has migrated from a distal site via the blood stream.

Navigational Note: Consider Nervous system disorders: TIA or Stroke for CNS-related events. Use Vascular disorders: Arterial thromboembolism for arterial thrombi.

Vasculitis

Asymptomatic, intervention

not indicated

Moderate symptoms, medical

intervention indicated

Severe symptoms, medical

intervention indicated (e.g.,

steroids)

Life-threatening

consequences; evidence of

peripheral or visceral

ischemia; urgent intervention

indicated

Death

Definition: A disorder characterized by inflammation involving the wall of a vessel.

Navigational Note: -

Vascular disorders - Other,

specify

Asymptomatic or mild

symptoms; clinical or

diagnostic observations only;

intervention not indicated

Moderate; minimal, local or

noninvasive intervention

indicated; limiting age-

appropriate instrumental ADL

Severe or medically significant

but not immediately life-

threatening; hospitalization or

prolongation of existing

hospitalization indicated;

limiting self care ADL

Life-threatening

consequences; urgent

intervention indicated

Death

Definition: -

Navigational Note: -

Back to TOC