* CTCAE v4.0 incorporates certain elements of the MedDRA terminology. For further details on MedDRA, refer to the MedDRA MSSO website ( http://www.meddramsso.com ).
(version 4.0)
U.S. Department of Health and Human Services
National Institutes of Health, National Cancer Institute
Published May 28, 2009 (v4.03: June 14, 2010)
For the complete table containing common terminology criteria for adverse events, please go to expertconsult.com . To access your account, look for your activation instructions on the inside front cover of this book.
Quick Reference
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events is a descriptive terminology that can be used for adverse event (AE) reporting. A grading (severity) scale is provided for each AE term.
Components and Organization
System Organ Class
System Organ Class (SOC), the highest level of the Medical Dictionary for Regulatory Activities (MedDRA) hierarchy, is identified by anatomic or physiologic system, etiology, or purpose (eg, 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 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).
Definitions
A brief definition is provided to clarify the meaning of each AE term.
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.
- 1.
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
- 2.
Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental ADLs. †
- 3.
Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADLs. ‡
- 4.
Grade 4: Life-threatening consequences; urgent intervention indicated.
- 5.
Grade 5: Death related to AE
† Instrumental ADLs refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, and so on.
‡ Self-care ADLs refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not being bedridden.
A semicolon 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.
Activities of Daily Living
| Blood and Lymphatic System Disorders | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 5 | |
| Anemia | 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; <100–80 g/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. | |||||
| 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 >2 weeks | Death |
| Definition: A disorder characterized by the inability of the bone marrow to produce hematopoietic elements | |||||
| 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 pathologic activation of blood clotting mechanisms that result 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. | |||||
| Febrile neutropenia | — | — | ANC <1000/mm 3 with a single temperature of >38.3°C (101°F) or a sustained temperature of ≥38°C (100.4°F) for >1 hour | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an ANC <1000/mm 3 and a single temperature of >38.3°C (101°F) or a sustained temperature of ≥38°C (100.4°F) for >1 hour | |||||
| Hemolysis | Laboratory evidence of hemolysis only (eg, direct antiglobulin test; DAT; Coombs; schistocytes; decreased haptoglobin) | Evidence of hemolysis and ≥2 g decrease in hemoglobin. | Transfusion or medical intervention indicated (eg, steroids) | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by laboratory test results that indicate widespread erythrocyte cell membrane destruction | |||||
| Hemolytic uremic syndrome | Evidence of RBC destruction (schistocytosis) without clinical consequences | — | Laboratory findings with clinical consequences (eg, renal insufficiency, petechiae) | Life-threatening consequences (eg, CNS hemorrhage or thrombosis or embolism, renal failure) | Death |
| Definition: A disorder characterized by a form of thrombotic microangiopathy with renal failure, hemolytic anemia, and severe thrombocytopenia | |||||
| Leukocytosis | — | — | >100,000/mm 3 | Clinical manifestations of leukostasis; urgent intervention indicated | Death |
| Definition: A disorder characterized by laboratory test results that indicate an increased number of white blood cells in the blood | |||||
| Lymph node pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in a lymph node | |||||
| Spleen disorder | Incidental findings (eg, Howell-Jolly bodies); mild degree of thrombocytosis and leukocytosis | Prophylactic antibiotics indicated | — | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder of the spleen | |||||
| Thrombotic thrombocytopenic purpura | Evidence of RBC destruction (schistocytosis) without clinical consequences | — | Laboratory findings with clinical consequences (eg, renal insufficiency, petechiae) | Life-threatening consequences (eg, CNS hemorrhage or thrombosis or embolism, renal failure) | Death |
| Definition: A disorder characterized by the presence of microangiopathic hemolytic anemia, thrombocytopenic purpura, fever, renal abnormalities, and neurologic abnormalities such as seizures, hemiplegia, and visual disturbances. It is an acute or subacute condition. | |||||
| 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 ADLs | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
ADL, Activity of daily living; ANC, absolute neutrophil count, CNS, central nervous system, DAT, direct antiglobulin test, Hgb, hemoglobin, LLN, lower limit of normal, RBC, red blood cell.
| Cardiac Disorders | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 5 | |
| Acute coronary syndrome | — | Symptomatic, progressive angina; cardiac enzymes normal; hemodynamically stable | Symptomatic, unstable angina or acute myocardial infarction, cardiac enzymes abnormal, hemodynamically stable | Symptomatic, unstable angina or acute myocardial infarction, cardiac enzymes abnormal, hemodynamically unstable | Death |
| Definition: A disorder characterized by signs and symptoms related to acute ischemia of the myocardium secondary to coronary artery disease. The clinical presentation covers a spectrum of heart diseases from unstable angina to myocardial infarction. | |||||
| 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 (eg, valve replacement, valvuloplasty) | Death |
| Definition: A disorder characterized by a defect in aortic valve function or structure | |||||
| 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. | |||||
| Atrial fibrillation | Asymptomatic; intervention not indicated | Non-urgent medical intervention indicated | Symptomatic and incompletely controlled medically, or controlled with device (eg, pacemaker), or ablation | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular response resulting from multiple reentry circuits. The rhythm disturbance originates above the ventricles. | |||||
| Atrial flutter | Asymptomatic; intervention not indicated | Non-urgent medical intervention indicated | Symptomatic and incompletely controlled medically, or controlled with device (eg, pacemaker), or ablation | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by a dysrhythmia with organized rhythmic atrial contractions with a rate of 200 to 300 beats/min. The rhythm disturbance originates in the atria. | |||||
| AV block complete | — | Non-urgent intervention indicated | Symptomatic and incompletely controlled medically, or controlled with device (eg, pacemaker) | 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. | |||||
| AV 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 AV node beyond 0.2 seconds; prolongation of the PR interval greater than 200 msec. | |||||
| Cardiac arrest | — | — | — | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by cessation of the pumping function of the heart | |||||
| Chest pain—cardiac | Mild pain | Moderate pain; limiting instrumental ADLs | Pain at rest; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by substernal discomfort caused by insufficient myocardial oxygenation | |||||
| Conduction disorder | Mild symptoms; intervention not indicated | Moderate symptoms | Severe symptoms; intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by pathologic irregularities in the cardiac conduction system | |||||
| Constrictive pericarditis | — | — | Symptomatic heart failure or other cardiac symptoms, responsive to intervention | Refractory heart failure or other poorly controlled cardiac symptoms | Death |
| Definition: A disorder characterized by a thickened and fibrotic pericardial sac; these fibrotic changes impede normal myocardial function by restricting myocardial muscle action | |||||
| Heart failure | Asymptomatic with laboratory (eg, BNP) or cardiac imaging abnormalities | Symptoms with mild to moderate activity or exertion | Severe with symptoms at rest or with minimal activity or exertion; intervention indicated | Life-threatening consequences; urgent intervention indicated (eg, 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 | |||||
| Left ventricular systolic dysfunction | — | — | Symptomatic because of drop in ejection fraction; responsive to intervention | Refractory or poorly controlled heart failure caused by drop in ejection fraction; intervention such as ventricular assist device, IV vasopressor support, or heart transplant indicated | Death |
| Definition: A disorder characterized by failure of the left ventricle to produce adequate output despite an increase in distending pressure and in end-diastolic volume. Clinical manifestations may include dyspnea, orthopnea, and other signs and symptoms of pulmonary congestion and edema. | |||||
| 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 (eg, valve replacement, valvuloplasty) | Death |
| Definition: A disorder characterized by a defect in mitral valve function or structure | |||||
| Mobitz (type) II atrioventricular block | Asymptomatic; intervention not indicated | Symptomatic; medical intervention indicated | Symptomatic and incompletely controlled medically or controlled with device (eg, pacemaker) | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by a dysrhythmia with relatively constant PR interval before the block of an atrial impulse. This is the result of intermittent failure of atrial electrical impulse conduction through the AV node to the ventricles. | |||||
| Mobitz type I | Asymptomatic; intervention not indicated | Symptomatic; medical intervention indicated | Symptomatic and incompletely controlled medically, or controlled with device (eg, pacemaker) | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by a dysrhythmia with a progressively lengthening PR interval before the blocking of an atrial impulse. This is the result of intermittent failure of atrial electrical impulse conduction through the AV node to the ventricles. | |||||
| Myocardial infarction | — | Asymptomatic and cardiac enzymes minimally abnormal; 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 caused by an interruption of blood supply to the area | |||||
| Myocarditis | Asymptomatic with laboratory (eg, BNP[) or cardiac imaging abnormalities | Symptoms with mild to moderate activity or exertion | Severe with symptoms at rest or with minimal activity or exertion; intervention indicated | Life-threatening consequences; urgent intervention indicated (eg, continuous IV therapy or mechanical hemodynamic support) | Death |
| Definition: A disorder characterized by inflammation of the muscle tissue of the heart | |||||
| Palpitations | Mild symptoms; intervention not indicated | Intervention indicated | — | — | — |
| Definition: A disorder characterized by an unpleasant sensation of irregular or forceful beating of the heart | |||||
| Paroxysmal atrial tachycardia | Asymptomatic; intervention not indicated | Symptomatic; medical management indicated | IV medication indicated | 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 to 250 beats/min. The rhythm disturbance originates in the atria. | |||||
| 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 caused by inflammation | |||||
| Pericardial tamponade | — | — | — | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an increase in intrapericardial pressure resulting from the collection of blood or fluid in the pericardium | |||||
| Pericarditis | Asymptomatic; ECG or physical findings (eg, rub) consistent with pericarditis | Symptomatic pericarditis (eg, chest pain) | Pericarditis with physiologic consequences (eg, 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) | |||||
| 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 (eg, valve replacement, valvuloplasty) | Death |
| Definition: A disorder characterized by a defect in pulmonary valve function or structure | |||||
| Restrictive cardiomyopathy | — | — | Symptomatic heart failure or other cardiac symptoms, responsive to intervention | 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 | |||||
| Right ventricular dysfunction | Asymptomatic with laboratory (eg, BNP) or cardiac imaging abnormalities | Symptoms with mild to moderate activity or exertion | Severe symptoms, associated with hypoxemia, right heart failure; oxygen indicated | Life-threatening consequences; urgent intervention indicated (eg, 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. | |||||
| Sick sinus syndrome | Asymptomatic; intervention not indicated | Non-urgent intervention indicated | Severe, medically significant; medical 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 | |||||
| Sinus bradycardia | Asymptomatic; intervention not indicated | Symptomatic, medical intervention indicated | Severe, medically significant, medical intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by a dysrhythmia with a heart rate less than 60 beats/min that originates in the sinus node | |||||
| 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/min that originates in the sinus node | |||||
| Supraventricular tachycardia | Asymptomatic; intervention not indicated | Non-urgent medical intervention indicated | Medical intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats/min that originates above the ventricles | |||||
| 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 (eg, valve replacement, valvuloplasty) | Death |
| Definition: A disorder characterized by a defect in tricuspid valve function or structure | |||||
| Ventricular arrhythmia | Asymptomatic; intervention not indicated | Non-urgent medical intervention indicated | Medical intervention indicated | Life-threatening consequences; hemodynamic compromise; urgent intervention indicated | Death |
| Definition: A disorder characterized by a dysrhythmia that originates in the ventricles | |||||
| Ventricular fibrillation | — | — | — | Life-threatening consequences; hemodynamic compromise; urgent intervention indicated | Death |
| Definition: A disorder characterized by a dysrhythmia without discernible QRS complexes caused by rapid repetitive excitation of myocardial fibers without coordinated contraction of the ventricles | |||||
| Ventricular tachycardia | — | Non-urgent medical intervention indicated | Medical intervention indicated | Life-threatening consequences; hemodynamic compromise; urgent intervention indicated | Death |
| Definition: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats/min that originates distal to the bundle of His | |||||
| Wolff-Parkinson-White syndrome | Asymptomatic; intervention not indicated | Non-urgent medical intervention indicated | Symptomatic and incompletely controlled medically or controlled with procedure | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by the presence of an accessory conductive pathway between the atria and the ventricles that causes premature ventricular activation | |||||
| 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 ADLs | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
ADL, Activity of daily living; AV, atrioventricular; BNP, B-natriuretic peptide; ECG, electrocardiography; IV, intravenous.
| Congenital, Familial, and Genetic Disorders | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 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 ADLs | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
ADL, Activity of daily living.
| Ear and Labyrinth Disorders | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 5 | |
| Ear pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the ear | |||||
| External ear inflammation | External otitis with erythema or dry desquamation | External otitis with moist desquamation, edema, enhanced cerumen or discharge; tympanic membrane perforation; tympanostomy | External otitis with mastoiditis; stenosis, or osteomyelitis; necrosis of soft tissue or bone | Urgent operative intervention indicated | Death |
| Definition: A disorder characterized by inflammation, swelling, and redness to the outer ear and ear canal | |||||
| External ear pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the external ear region | |||||
| Hearing impaired | Adults enrolled on a monitoring program (on a 1-, 2-, 3-, 4-, 6- and 8-kHz audiogram): Threshold shift of 15–25 dB averaged at two contiguous test frequencies in at least one ear Adults not enrolled in 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 at 8 kHz in at least one ear | Adults enrolled in monitoring program (on a 1-, 2-, 3-, 4-, 6- and 8-kHz audiogram): Threshold shift of >25 dB averaged at two contiguous test frequencies in at least one ear. Adults not enrolled in monitoring program: hearing loss but hearing aid or intervention not indicated; limiting instrumental ADLs Pediatric (on a 1-, 2-, 3-, 4-, 6- and 8-kHz audiogram): threshold shift >20 dB at 4 kHz and above in at least one ear | Adults enrolled in monitoring program (on a 1-, 2-, 3-, 4-, 6- and 8-kHz audiogram): Threshold shift of >25 dB averaged at three contiguous test frequencies in at least one ear; therapeutic intervention indicated Adults not enrolled in monitoring program: hearing loss with hearing aid or intervention indicated; limiting self-care ADLs Pediatric (on a 11-, 2-, 3-, 4-, 6- and 8-kHz audiogram): hearing loss sufficient to indicate therapeutic intervention, including hearing aids; threshold shift >20 dB at 3 kHz and above in at least one ear; additional speech-language–related services indicated | 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 and additional speech-language–related services indicated | — |
| Definition: A disorder characterized by partial or complete loss of the ability to detect or understand sounds resulting from damage to ear structures | |||||
| 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 | |||||
| Tinnitus | Mild symptoms; intervention not indicated | Moderate symptoms; limiting instrumental ADLs | Severe symptoms; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by noise in the ears, such as ringing, buzzing, roaring, or clicking | |||||
| Vertigo | Mild symptoms | Moderate symptoms; limiting instrumental ADLs | Severe symptoms; limiting self-care ADLs | — | — |
| 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). | |||||
| Vestibular disorder | — | Symptomatic; limiting instrumental ADLs | Severe symptoms; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by dizziness, imbalance, nausea, and vision problems | |||||
| 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 ADLs | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
ADL, Activity of daily living; HL, hearing loss.
| Endocrine Disorders | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 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 that occurs when the adrenal cortex does not produce enough of the hormone cortisol and in some cases, the hormone aldosterone. It may be caused by a disorder of the adrenal cortex as in Addison disease or primary adrenal insufficiency. | |||||
| 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 disease or syndrome: buffalo hump obesity, striations, adiposity, hypertension, diabetes, and osteoporosis, usually caused by exogenous corticosteroids | |||||
| Delayed puberty | — | No breast development by age 13 yr for females; testes volume of <3 cc or no Tanner stage 2 development by age 14.5 yr for males | No breast development by age 14 yr for females; no increase in testes volume or no Tanner stage 2 by age 16 yr for males; hormone replacement indicated | — | — |
| Definition: A disorder characterized by unusually late sexual maturity. | |||||
| Growth accelerated | — | ≥ +2 SD above mid parental height or target height | — | — | — |
| Definition: A disorder characterized by greater growth than expected for age | |||||
| 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). | |||||
| Hyperthyroidism | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; thyroid suppression therapy indicated; limiting instrumental ADLs | Severe symptoms; limiting self-care ADLs; 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. | |||||
| 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 | |||||
| Hypothyroidism | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; thyroid replacement indicated; limiting instrumental ADLs | Severe symptoms; limiting self-care ADLs; 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 | |||||
| Precocious puberty | Physical signs of puberty with no biochemical markers for females <8 yr and males <9 yr | Physical signs and biochemical markers of puberty for females <8 yr and males <9 yr | — | — | — |
| Definition: A disorder characterized by unusually early development of secondary sexual features; the onset of sexual maturation begins usually before age 8 yr for girls and before age 9 yr for boys | |||||
| 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 | |||||
| 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 ADLs | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
ADL, Activity of daily living; SD, standard deviation.
| Eye Disorders | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 5 | |
| Blurred vision | Intervention not indicated | Symptomatic; limiting instrumental ADLs | Limiting self-care ADLs | — | — |
| Definition: A disorder characterized by visual perception of unclear or fuzzy images | |||||
| Cataract | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; moderate decrease in visual acuity (20/40 or better) | Symptomatic with marked decrease in visual acuity (worse than 20/40 but better than 20/200); operative intervention indicated (eg, cataract surgery) | Blindness (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. | |||||
| Conjunctivitis | Asymptomatic or mild symptoms; intervention not indicated | Symptomatic; topical intervention indicated (eg, antibiotics); limiting instrumental ADLs | Limiting self-care ADLs | — | — |
| Definition: A disorder characterized by inflammation, swelling, and redness to the conjunctiva of the eye | |||||
| Corneal ulcer | — | Symptomatic; medical intervention indicated (eg, topical agents); limiting instrumental ADLs | Limiting self-care ADLs; declining vision (worse than 20/40 but better than 20/200) | Perforation or blindness (20/200 or worse) 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. | |||||
| Dry eye | Asymptomatic; clinical or diagnostic observations only; mild symptoms relieved by lubricants | Symptomatic; multiple agents indicated; limiting instrumental ADLs | Decrease in visual acuity (<20/40); limiting self-care ADLs | — | — |
| Definition: A disorder characterized by dryness of the cornea and conjunctiva | |||||
| Extraocular muscle paresis | Asymptomatic; clinical or diagnostic observations only | Symptomatic; limiting instrumental ADLs | Limiting self-care ADLs; disabling | — | — |
| Definition: A disorder characterized by incomplete paralysis of an extraocular muscle | |||||
| Eye pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the eye | |||||
| Eyelid function disorder | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; nonoperative intervention indicated; limiting instrumental ADLs | Limiting self-care ADLs; operative intervention indicated | — | — |
| Definition: A disorder characterized by impaired eyelid function | |||||
| Flashing lights | Symptomatic but not limiting ADLs | Limiting instrumental ADLs | Limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sudden or brief burst of light | |||||
| Floaters | Symptomatic but not limiting ADLs | Limiting instrumental ADLs | Limiting self-care ADLs | — | — |
| Definition: A disorder characterized by an individual seeing spots before his or her eyes. The spots are shadows of opaque cell fragments in the vitreous humor or lens. | |||||
| Glaucoma | EIOP with single topical agent for intervention; no visual field deficit | EIOP causing early visual field deficits; multiple topical or oral agents indicated; limiting instrumental ADLs | EIOP causing marked visual field deficits (eg, involving both superior and inferior visual fields); operative intervention indicated; limiting self-care ADLs | Blindness (20/200 or worse) in the affected eye | — |
| Definition: A disorder characterized by an increase in pressure in the eyeball due to obstruction of the aqueous humor outflow | |||||
| Keratitis | — | Symptomatic; medical intervention indicated (eg, topical agents); limiting instrumental ADLs | Decline in vision (worse than 20/40 but better than 20/200); limiting self-care ADLs | Perforation or blindness (20/200 or worse) in the affected eye | — |
| Definition: A disorder characterized by inflammation to the cornea of the eye | |||||
| Night blindness | Symptomatic but not limiting ADLs | Limiting instrumental ADLs | Limiting self-care ADLs | Blindness (20/200 or worse) in the affected eye | — |
| Definition: A disorder characterized by an inability to see clearly in dim light | |||||
| Optic nerve disorder | Asymptomatic; clinical or diagnostic observations only | Limiting vision of the affected eye (20/40 or better) | Limiting vision in the affected eye (worse than 20/40 but better than 20/200) | Blindness (20/200 or worse) in the affected eye | — |
| Definition: A disorder characterized by involvement of the optic nerve (second cranial nerve) | |||||
| Papilledema | Asymptomatic; no visual field defects | Symptomatic decline in vision; visual field defect present sparing the central 20 degrees | Marked visual field defect (worse than 20/40 but better than 20/200) | Blindness (20/200 or worse) in the affected eye | — |
| Definition: A disorder characterized by swelling around the optic disc | |||||
| Photophobia | Symptomatic but not limiting ADLs | Limiting instrumental ADLs | Limiting self-care ADLs | — | — |
| Definition: A disorder characterized by fear and avoidance of light | |||||
| Retinal detachment | Asymptomatic | Exudative and visual acuity 20/40 or better | Rhegmatogenous or exudative detachment; operative intervention indicated; decline in vision (worse than 20/40 but better than 20/200) | Blindness (20/200 or worse) in the affected eye | — |
| Definition: A disorder characterized by the separation of the inner retina layers from the underlying pigment epithelium | |||||
| Retinal tear | — | Laser therapy or pneumopexy indicated | Vitreoretinal surgical repair indicated | Blindness (20/200 or worse) in the affected eye | — |
| 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. | |||||
| Retinal vascular disorder | — | Topical medication indicated | Intravitreal medication; operative intervention indicated | — | — |
| Definition: A disorder characterized by pathologic retinal blood vessels that adversely affects vision | |||||
| Retinopathy | Asymptomatic; clinical or diagnostic observations only | Symptomatic with moderate decrease in visual acuity (20/40 or better); limiting instrumental ADLs | Symptomatic with marked decrease in visual acuity (worse than 20/40); disabling; limiting self-care ADLs | Blindness (20/200 or worse) in the affected eye | — |
| Definition: A disorder involving the retina | |||||
| Scleral disorder | Asymptomatic; clinical or diagnostic observations only | Symptomatic, limiting instrumental ADLs; moderate decrease in visual acuity (20/40 or better) | Symptomatic, limiting self-care ADLs; marked decrease in visual acuity (worse than 20/40) | Blindness (20/200 or worse) in the affected eye | — |
| Definition: A disorder characterized by involvement of the sclera of the eye | |||||
| Uveitis | Asymptomatic; clinical or diagnostic observations only | Anterior uveitis; medical intervention indicated | Posterior or pan-uveitis | Blindness (20/200 or worse) in the affected eye | — |
| Definition: A disorder characterized by inflammation to the uvea of the eye | |||||
| Vitreous hemorrhage | Asymptomatic or mild symptoms; clinical or diagnostic observations only | Symptomatic; limiting instrumental ADLs | Limiting self-care ADLs; vitrectomy indicated | Blindness (20/200 or worse) in the affected eye | — |
| Definition: A disorder characterized by blood extravasation into the vitreous humor | |||||
| Watering eyes | Intervention not indicated | Intervention indicated | Operative intervention indicated | — | — |
| Definition: A disorder of excessive tearing in the eyes; it can be caused by overproduction of tears or impaired drainage of the tear duct | |||||
| Eye 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 ADLs | Severe or medically significant but not immediately sight-threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Sight-threatening consequences; urgent intervention indicated; blindness (20/200 or worse) in the affected eye | — |
ADL, Activity of daily living; EIOP, elevated intraocular pressure.
| Gastrointestinal Disorders | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 5 | |
| Abdominal distention | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; limiting instrumental ADLs | Severe discomfort; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by swelling of the abdomen | |||||
| Abdominal pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the abdominal region | |||||
| Anal fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; tube feeding, TPN, or hospitalization indicated; elective operative 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 | |||||
| Anal hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the anal region | |||||
| Anal mucositis | Asymptomatic or mild symptoms; intervention not indicated | Symptomatic; medical intervention indicated; limiting instrumental ADLs | Severe symptoms; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by inflammation of the mucous membrane of the anus | |||||
| Anal necrosis | — | — | TPN or hospitalization indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a necrotic process occurring in the anal region | |||||
| Anal pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the anal region | |||||
| Anal stenosis | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Symptomatic and severely altered GI function; nonemergent 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 | |||||
| Anal ulcer | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; TPN indicated; elective operative or endoscopic intervention indicated; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a circumscribed, inflammatory, and necrotic erosive lesion on the mucosal surface of the anal canal | |||||
| 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 | |||||
| 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 | |||||
| Cecal hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the cecum | |||||
| Cheilitis | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Moderate symptoms; limiting instrumental ADLs | Severe symptoms; limiting self-care ADLs; intervention indicated | — | — |
| Definition: A disorder characterized by inflammation of the lip | |||||
| Colitis | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Abdominal pain; mucus or blood in stool | Severe abdominal pain; change in bowel habits; medical intervention indicated; peritoneal signs | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by inflammation of the colon | |||||
| Colonic fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; bowel rest, TPN or hospitalization indicated; elective operative 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 | |||||
| Colonic hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the colon | |||||
| Colonic obstruction | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Hospitalization indicated; elective operative intervention indicated; disabling | 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 | |||||
| Colonic perforation | — | Symptomatic; medical intervention indicated | Severe symptoms; elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by a rupture in the colonic wall | |||||
| 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 | |||||
| Colonic ulcer | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; TPN indicated; elective operative or endoscopic intervention indicated; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a circumscribed, inflammatory and necrotic erosive lesion on the mucosal surface of the colon | |||||
| 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 ADLs | Obstipation with manual evacuation indicated; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by irregular and infrequent or difficult evacuation of the bowels | |||||
| 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 or porous | |||||
| Diarrhea | Increase of <4 stools per day over baseline; mild increase in ostomy output compared with baseline | Increase of 4–6 stools per day over baseline; moderate increase in ostomy output compared with baseline | Increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared with baseline; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by frequent and watery bowel movements | |||||
| Dry mouth | Symptomatic (eg, dry or thick saliva) without significant dietary alteration; unstimulated saliva flow >0.2 mL/min | Moderate symptoms; oral intake alterations (eg, copious water, other lubricants, diet limited to purees or soft, moist foods); unstimulated saliva 0.1–0.2 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 | |||||
| Duodenal fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; tube feeding, TPN or hospitalization indicated; elective operative 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 | |||||
| Duodenal hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the duodenum | |||||
| Duodenal obstruction | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Hospitalization or elective operative intervention indicated; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by blockage of the normal flow of stomach contents through the duodenum | |||||
| Duodenal perforation | — | Symptomatic; medical intervention indicated | Severe symptoms; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a rupture in the duodenal wall | |||||
| Duodenal stenosis | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; tube feeding; 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 | |||||
| Duodenal ulcer | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Moderate symptoms; medical intervention indicated; limiting instrumental ADLs | Severely altered GI function; TPN indicated; elective operative or endoscopic intervention indicated; limiting self-care ADLs; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a circumscribed, inflammatory, and necrotic erosive lesion on the mucosal surface of the duodenal wall | |||||
| Dyspepsia | Mild symptoms; intervention not indicated | Moderate symptoms; medical intervention indicated | Severe symptoms; surgical 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. | |||||
| Dysphagia | Symptomatic, able to eat regular diet | Symptomatic and altered eating or swallowing | Severely altered eating or swallowing; tube feeding, TPN, or hospitalization indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by difficulty in swallowing | |||||
| 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 | |||||
| Enterovesical fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; noninvasive intervention indicated | Severe, medically significant; medical intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an abnormal communication between the urinary bladder and the intestine | |||||
| Esophageal fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; tube feeding, TPN or hospitalization indicated; elective operative 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 | |||||
| Esophageal hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the esophagus | |||||
| Esophageal necrosis | — | — | Inability to aliment adequately by GI tract; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a necrotic process occurring in the esophageal wall | |||||
| Esophageal obstruction | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; limiting instrumental ADLs | Hospitalization indicated; elective operative intervention indicated; limiting self-care ADLs; disabling | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by blockage of the normal flow of the contents in the esophagus | |||||
| Esophageal pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the esophageal region | |||||
| Esophageal perforation | — | Symptomatic; medical intervention indicated | Severe symptoms; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a rupture in the wall of the esophagus | |||||
| Esophageal stenosis | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; tube feeding; 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 | |||||
| Esophageal ulcer | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; limiting instrumental ADLs | Severely altered GI function; TPN indicated; elective operative or endoscopic intervention indicated; limiting self-care ADLs; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a circumscribed, inflammatory, and necrotic erosive lesion on the mucosal surface of the esophageal wall | |||||
| Esophageal varices hemorrhage | — | Self-limited; intervention not indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from esophageal varices | |||||
| Esophagitis | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered eating or swallowing; oral supplements indicated | Severely altered eating or 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 | |||||
| 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 | |||||
| Flatulence | Mild symptoms; intervention not indicated | Moderate; persistent; psychosocial sequelae | — | — | — |
| Definition: A disorder characterized by a state of excessive gas in the alimentary canal | |||||
| Gastric fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; bowel rest; tube feeding, TPN or hospitalization indicated; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by an abnormal communication between the stomach and another organ or anatomic site | |||||
| Gastric hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the gastric wall | |||||
| Gastric necrosis | — | — | Inability to aliment adequately by GI tract; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a necrotic process occurring in the gastric wall | |||||
| Gastric perforation | — | Symptomatic; medical intervention indicated | Severe symptoms; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a rupture in the stomach wall | |||||
| Gastric stenosis | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; tube feeding; 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 | |||||
| Gastric ulcer | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; medical intervention indicated; limiting instrumental ADLs | Severely altered GI function; TPN indicated; elective operative or endoscopic intervention indicated; limiting self-care ADLs; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a circumscribed, inflammatory, and necrotic erosive lesion on the mucosal surface of the stomach | |||||
| 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 | |||||
| Gastroesophageal reflux disease | Mild symptoms; intervention not indicated | Moderate symptoms; medical intervention indicated | Severe symptoms; surgical intervention indicated | — | — |
| Definition: A disorder characterized by reflux of the gastric or duodenal contents into the distal esophagus. It is chronic in nature and usually caused by incompetence of the lower esophageal sphincter. It may result in injury to the esophageal mucosal. Symptoms include heartburn and acid indigestion. | |||||
| GI fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; tube feeding, TPN, or hospitalization indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by an abnormal communication between any part of the GI system and another organ or anatomic site | |||||
| Gastrointestinal pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the GI region | |||||
| 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; refractory to medical intervention; unable to maintain nutrition orally | — | — |
| 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 | |||||
| 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 | |||||
| Hemorrhoidal hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the hemorrhoids | |||||
| Hemorrhoids | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; banding or medical intervention indicated | Severe symptoms; radiologic, endoscopic or elective operative intervention indicated | — | — |
| Definition: A disorder characterized by the presence of dilated veins in the rectum and surrounding area | |||||
| Ileal fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; TPN or hospitalization indicated; elective operative 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 | |||||
| Ileal hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the ileal wall | |||||
| Ileal obstruction | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; limiting instrumental ADLs | Hospitalization indicated; elective operative intervention indicated; limiting self-care ADLs; disabling | 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 | |||||
| Ileal perforation | — | Symptomatic; medical intervention indicated | Severe symptoms; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a rupture in the ileal wall | |||||
| 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 | |||||
| Ileal ulcer | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; TPN indicated; elective operative or endoscopic intervention indicated; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a circumscribed, inflammatory and necrotic erosive lesion on the mucosal surface of the ileum | |||||
| Ileus | — | Symptomatic; altered GI function; bowel rest indicated | Severely altered GI function; TPN indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by failure of the ileum to transport intestinal contents. | |||||
| Intraabdominal hemorrhage | — | Medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding in the abdominal cavity | |||||
| Jejunal fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; TPN or hospitalization indicated; elective operative 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 | |||||
| Jejunal hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the jejunal wall | |||||
| Jejunal obstruction | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; limiting instrumental ADLs | Hospitalization indicated; elective operative intervention indicated; limiting self-care ADLs; disabling | 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 | |||||
| Jejunal perforation | — | Symptomatic; medical intervention indicated | Severe symptoms; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a rupture in the jejunal wall | |||||
| 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 | |||||
| Jejunal ulcer | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; TPN indicated; elective operative or endoscopic intervention indicated; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a circumscribed, inflammatory, and necrotic erosive lesion on the mucosal surface of the jejunum | |||||
| Lip pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort of the lip. | |||||
| Lower GI hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the lower GI tract (small intestine, large intestine, and anus) | |||||
| 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. | |||||
| Mucositis oral | Asymptomatic or mild symptoms; intervention not indicated | Moderate pain; not interfering with oral intake; modified diet indicated | Severe pain; interfering with oral intake | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by inflammation of the oral mucosal | |||||
| 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 or the urge to vomit | |||||
| Obstruction gastric | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; limiting instrumental ADLs | Hospitalization indicated; elective operative intervention indicated; limiting self-care ADLs; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by blockage of the normal flow of the contents in the stomach | |||||
| Oral cavity fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; TPN or hospitalization indicated; elective operative 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 | |||||
| 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 | |||||
| Oral hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the mouth | |||||
| Oral pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the mouth, tongue, or lips | |||||
| 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 | |||||
| Pancreatic fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; tube feeding, TPN, or hospitalization indicated; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by an abnormal communication between the pancreas and another organ or anatomic site | |||||
| Pancreatic hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the pancreas | |||||
| Pancreatic necrosis | — | — | Tube feeding or TPN indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a necrotic process occurring in the pancreas | |||||
| Pancreatitis | — | Enzyme elevation or radiologic findings only | Severe pain; vomiting; medical intervention indicated (eg, analgesia, nutritional support) | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by inflammation of the pancreas | |||||
| 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 | |||||
| Peritoneal necrosis | — | — | Tube feeding or TPN indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a necrotic process occurring in the peritoneum | |||||
| Proctitis | Rectal discomfort, intervention not indicated | Symptoms (eg, rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADLs | Severe symptoms; fecal urgency or stool incontinence; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by inflammation of the rectum | |||||
| Rectal fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function | Severely altered GI function; TPN or hospitalization indicated; elective operative 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 | |||||
| Rectal hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the rectal wall and discharged from the anus | |||||
| Rectal mucositis | Asymptomatic or mild symptoms; intervention not indicated | Symptomatic; medical intervention indicated; limiting instrumental ADLs | Severe symptoms; limiting self-care ADLs | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by inflammation of the mucous membrane of the rectum | |||||
| Rectal necrosis | — | — | Tube feeding or TPN indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a necrotic process occurring in the rectal wall | |||||
| Rectal obstruction | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; limiting instrumental ADLs | Hospitalization indicated; elective operative intervention indicated; limiting self-care ADLs; disabling | 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 | |||||
| Rectal pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the rectal region | |||||
| Rectal perforation | — | Symptomatic; medical intervention indicated | Severe symptoms; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a rupture in the rectal wall | |||||
| 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 | |||||
| Rectal ulcer | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function (eg, altered dietary habits, vomiting, diarrhea) | Severely altered GI function; TPN indicated; elective operative or endoscopic intervention indicated; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a circumscribed, inflammatory, and necrotic erosive lesion on the mucosal surface of the rectum | |||||
| Retroperitoneal hemorrhage | — | Self-limited; intervention indicated | Transfusion, medical, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the retroperitoneal area | |||||
| Salivary duct inflammation | Slightly thickened saliva; slightly altered taste (eg, metallic) | Thick, ropy, sticky saliva; markedly altered taste; alteration in diet indicated; secretion-induced symptoms; limiting instrumental ADLs | Acute salivary gland necrosis; severe secretion-induced symptoms (eg, thick saliva/oral secretions or gagging); tube feeding or TPN indicated; limiting self-care ADLs; disabling | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by inflammation of the salivary duct | |||||
| Salivary gland fistula | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; tube feeding indicated | Severely altered GI function; hospitalization indicated; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by an abnormal communication between a salivary gland and another organ or anatomic site | |||||
| Small intestinal mucositis | Asymptomatic or mild symptoms; intervention not indicated | Symptomatic; medical intervention indicated; limiting instrumental ADLs | Severe pain; interfering with oral intake; tube feeding, TPN, or hospitalization indicated; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by inflammation of the mucous membrane of the small intestine | |||||
| Small intestinal obstruction | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; limiting instrumental ADLs | Hospitalization indicated; elective operative intervention indicated; limiting self-care ADLs; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by blockage of the normal flow of the intestinal contents | |||||
| Small intestinal perforation | — | Symptomatic; medical intervention indicated | Severe symptoms; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a rupture in the small intestine wall | |||||
| 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 | |||||
| Small intestine ulcer | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; limiting instrumental ADLs | Severely altered GI function; TPN indicated; elective operative or endoscopic intervention indicated; limiting self-care ADLs; disabling | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a circumscribed, inflammatory, and necrotic erosive lesion on the mucosal surface of the small intestine | |||||
| Stomach pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the stomach | |||||
| Tooth development disorder | Asymptomatic; hypoplasia of tooth or enamel | Impairment correctable with oral surgery | Maldevelopment with impairment not surgically correctable; disabling | — | — |
| Definition: A disorder characterized by a pathologic process of the teeth occurring during tooth development | |||||
| Tooth discoloration | Surface stains | — | — | — | — |
| Definition: A disorder characterized by a change in tooth hue or tint | |||||
| Toothache | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the tooth | |||||
| Typhlitis | — | — | Symptomatic (eg, abdominal pain, fever, change in bowel habits with ileus); peritoneal signs | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by inflammation of the cecum | |||||
| Upper gastrointestinal hemorrhage | Mild; intervention not indicated | Moderate symptoms; medical intervention or minor cauterization indicated | Transfusion, radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the upper GI tract (oral cavity, pharynx, esophagus, and stomach) | |||||
| Vomiting | 1–2 episodes (separated by 5 min) in 24 h | 3–5 episodes (separated by 5 min) in 24 h | ≥6 episodes (separated by 5 min) in 24 h; tube feeding, TPN, or hospitalization indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth | |||||
| GI 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 ADLs | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
ADL, Activity of daily living; GI, gastrointestinal; TPN, total parenteral nutrition.
| General Disorders and Administration Site Conditions | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 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 | |||||
| Death neonatal | — | — | — | — | Death |
| Definition: A disorder characterized by cessation of life occurring during the first 28 days of life. | |||||
| Death NOS | — | — | — | — | Death |
| Definition: A cessation of life that cannot be attributed to a CTCAE term associated with grade 5 | |||||
| Edema face | Localized facial edema | Moderate localized facial edema; limiting instrumental ADLs | Severe swelling; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by swelling due to excessive fluid accumulation in facial tissues | |||||
| Edema limbs | 5%–10% interlimb discrepancy in volume or circumference at point of greatest visible difference; swelling or obscuration of anatomic architecture on close inspection | >10%–30% interlimb 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 ADLs | >30% interlimb discrepancy in volume; gross deviation from normal anatomic contour; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by swelling caused by excessive fluid accumulation in the upper or lower extremities | |||||
| 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 ADLs | Gross deviation from normal anatomic contour; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by swelling resulting from excessive fluid accumulation in the trunk area | |||||
| Facial pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the face | |||||
| Fatigue | Fatigue relieved by rest | Fatigue not relieved by rest; limiting instrumental ADLs | Fatigue not relieved by rest, limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities | |||||
| Fever | 38.0°–39.0°C (100.4°–102.2°F) | >39.0°–40.0°C (102.3°–104.0°F) | >40.0°C (>104.0°F) for ≤24 h | >40.0°C (>104.0°F) for >24 h | Death |
| Definition: A disorder characterized by elevation of the body’s temperature above the upper limit of normal | |||||
| Flulike symptoms | Mild flulike symptoms present | Moderate symptoms; limiting instrumental ADLs | Severe symptoms; limiting self-care ADLs | — | — |
| 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. | |||||
| Gait disturbance | Mild change in gait (eg, wide based, limping, or hobbling) | Moderate change in gait (eg, wide based, limping, or hobbling); assistive device indicated; limiting instrumental ADLs | Disabling; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by walking difficulties | |||||
| Hypothermia | — | 35°–>32°C; 95°–>89.6°F | 32°–>28°C; 89.6°–>82.4°F | ≤28°C; 82.4°F; life-threatening consequences (eg, 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 35°C (95°F) or below. | |||||
| Infusion-related reaction | Mild transient reaction; infusion interruption not indicated; intervention not indicated | Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDs, narcotics, IV fluids); prophylactic medications indicated for ≤24 h | Prolonged (eg, not rapidly responsive to symptomatic medication 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 pharmacologic or biologic substances | |||||
| Infusion site extravasation | — | Erythema with associated symptoms (eg, 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 a pharmacologic or a biologic substance from the infusion site into the surrounding tissue. Signs and symptoms include induration, erythema, swelling, burning sensation, and marked discomfort at the infusion site. | |||||
| Injection site reaction | Tenderness with or without associated symptoms (eg, 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 | |||||
| Irritability | Mild; easily consolable | Moderate; limiting instrumental ADLs; increased attention indicated | Severe abnormal or excessive response; limiting self-care ADLs; inconsolable | — | — |
| Definition: A disorder characterized by an abnormal responsiveness to stimuli or physiologic arousal; may be in response to pain, fright, a drug, an emotional situation, or a medical condition | |||||
| Localized edema | Localized to dependent areas; no disability or functional impairment | Moderate localized edema and intervention indicated; limiting instrumental ADLs | Severe localized edema and intervention indicated; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by swelling caused by excessive fluid accumulation at a specific anatomic site | |||||
| Malaise | Uneasiness or lack of well-being | Uneasiness or lack of well-being; limiting instrumental ADLs | — | — | — |
| Definition: A disorder characterized by a feeling of general discomfort or uneasiness, an out-of-sorts feeling | |||||
| Multiorgan failure | — | — | Shock with azotemia and acid–base disturbances; significant coagulation abnormalities | Life-threatening consequences (eg, 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 | |||||
| Neck edema | Asymptomatic localized neck edema | Moderate neck edema; slight obliteration of anatomic landmarks; limiting instrumental ADLs | Generalized neck edema (eg, difficulty in turning neck); limiting self-care ADLs | — | — |
| Definition: A disorder characterized by swelling caused by an accumulation of excessive fluid in the neck | |||||
| Noncardiac chest pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by discomfort in the chest unrelated to a heart disorder | |||||
| Pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by the sensation of marked discomfort, distress, or agony | |||||
| Sudden death NOS | — | — | — | — | Death |
| Definition: An unexpected cessation of life that cannot be attributed to a CTCAE term associated with grade 5 | |||||
| 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 ADLs | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
ADL, Activity of daily living; IV, intravenous; NOS, not otherwise specified; NSAID, nonsteroidal antiinflammatory drug.
| Hepatobiliary Disorders | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 5 | |
| Bile duct stenosis | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; IV fluids indicated <24 h | Severely altered GI function; radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by a narrowing of the lumen of the bile duct | |||||
| Biliary fistula | — | Symptomatic and intervention not indicated | Severely altered GI function; TPN indicated; endoscopic intervention indicated; elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by an abnormal communication between the bile ducts and another organ or anatomic site | |||||
| Cholecystitis | — | Symptomatic; medical intervention indicated | Severe symptoms; radiologic, endoscopic, or elective operative 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. | |||||
| Gallbladder fistula | Asymptomatic clinical or diagnostic observations only; intervention not indicated | Symptomatic and intervention not indicated | Symptomatic or severely altered GI function; TPN indicated; radiologic, endoscopic, or elective operative intervention indicated | Life-threatening consequences; urgent operative intervention indicated | Death |
| Definition: A disorder characterized by an abnormal communication between the gallbladder and another organ or anatomic site | |||||
| Gallbladder necrosis | — | — | — | Life-threatening consequences; urgent radiologic or operative intervention indicated | Death |
| Definition: A disorder characterized by a necrotic process occurring in the gallbladder | |||||
| Gallbladder obstruction | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; altered GI function; IV fluids indicated <24 h | 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 | |||||
| Gallbladder pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the gallbladder region | |||||
| Gallbladder perforation | — | — | — | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by a rupture in the gallbladder wall | |||||
| Hepatic failure | — | — | Asterixis; mild encephalopathy; limiting self-care ADLs | Moderate to severe encephalopathy; coma; life-threatening consequences | 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, and alkaline phosphatase. | |||||
| Hepatic hemorrhage | Mild; intervention not indicated | Symptomatic; medical intervention indicated | Transfusion indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by bleeding from the liver | |||||
| Hepatic necrosis | — | — | — | Life-threatening consequences; urgent radiologic or operative intervention indicated | Death |
| Definition: A disorder characterized by a necrotic process occurring in the hepatic parenchyma | |||||
| Hepatic pain | Mild pain | Moderate pain; limiting instrumental ADLs | Severe pain; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by a sensation of marked discomfort in the liver region | |||||
| Perforation of bile duct | — | — | Radiologic, endoscopic or elective operative 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 | |||||
| Portal hypertension | — | Decreased portal vein flow | Reversal or retrograde portal vein flow; associated with varices or ascites | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an increase in blood pressure in the portal venous system | |||||
| 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 | |||||
| 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 ADLs | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
ADL, Activity of daily living; GI, gastrointestinal; IV, intravenous; TPN, total parenteral nutrition.
| Immune System Disorders | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 5 | |
| Allergic reaction | Transient flushing or rash, drug fever <38°C (<100.4°F); intervention not indicated | Intervention or infusion interruption indicated; responds promptly to symptomatic treatment (eg, antihistamines, NSAIDs, narcotics); prophylactic medications indicated for ≤24 h | Prolonged (eg, not rapidly responsive to symptomatic medication or brief interruption of infusion); recurrence of symptoms after initial improvement; hospitalization indicated for clinical sequelae (eg, renal impairment, pulmonary infiltrates) | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an adverse local or general response from exposure to an allergen | |||||
| Anaphylaxis | — | — | Symptomatic bronchospasm, with or without urticaria; parenteral intervention indicated; allergy-related edema or 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. | |||||
| Autoimmune disorder | Asymptomatic; serologic or other evidence of autoimmune reaction, with normal organ function; intervention not indicated | Evidence of autoimmune reaction involving a nonessential organ or function (eg, hypothyroidism) | Autoimmune reactions involving major organ (eg, colitis, anemia, myocarditis, kidney) | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder resulting from 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 | |||||
| Cytokine release syndrome | Mild reaction; infusion interruption not indicated; intervention not indicated | Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDs, narcotics, IV fluids); prophylactic medications indicated for ≤24 h | Prolonged (eg, not rapidly responsive to symptomatic medication or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae (eg, renal impairment, pulmonary infiltrates) | Life-threatening consequences; pressor or ventilatory support indicated | Death |
| Definition: A disorder characterized by nausea, headache, tachycardia, hypotension, rash, and shortness of breath; it is caused by the release of cytokines from the cells | |||||
| 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 6 to 21 days after the administration of the foreign antigen. Symptoms include fever, arthralgias, myalgias, skin eruptions, lymphadenopathy, marked chest discomfort, and dyspnea. | |||||
| 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 ADLs | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
ADL, Activity of daily living; NSAID, nonsteroidal antiinflammatory drug.
| Infections and Infestations | |||||
| Adverse Event | Grade | ||||
| 1 | 2 | 3 | 4 | 5 | |
| Abdominal infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the abdominal cavity | |||||
| Anorectal infection | Localized; local intervention indicated | Oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the anal area and the rectum | |||||
| Appendicitis | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or 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 | |||||
| Appendicitis perforated | — | Symptomatic; medical intervention indicated | Severe symptoms; elective 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. | |||||
| Arteritis infective | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving an artery | |||||
| Biliary tract infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the biliary tract | |||||
| Bladder infection | — | Oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the bladder | |||||
| Bone infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the bones | |||||
| Breast infection | — | Local infection with moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | Severe infection; axillary adenitis; IV antibacterial, antifungal, or antiviral intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the breast | |||||
| Bronchial infection | — | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the bronchi | |||||
| Catheter-related infection | — | Localized; local intervention indicated; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process that arises secondary to catheter use | |||||
| Cecal infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the cecum | |||||
| Cervicitis infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the uterine cervix | |||||
| Conjunctivitis infective | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the conjunctiva. Clinical manifestations include pink or red color in the eyes. | |||||
| Corneal infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the cornea | |||||
| Cranial nerve infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving a cranial nerve | |||||
| Device-related infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the use of a medical device | |||||
| Duodenal infection | — | Moderate symptoms; medical intervention indicated (eg, oral antibiotics) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the duodenum | |||||
| 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 | |||||
| Encephalomyelitis infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the brain and spinal cord tissues | |||||
| Endocarditis infective | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the endocardial layer of the heart | |||||
| Endophthalmitis | — | Local intervention indicated | Systemic intervention or hospitalization indicated | Blindness (20/200 or worse) | — |
| Enterocolitis infectious | — | Passage of >3 unformed stools per 24 h or duration of illness >48 h; moderate abdominal pain | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative 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 | |||||
| Esophageal infection | — | Local intervention indicated (eg, oral antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the esophagus | |||||
| Eye infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated; enucleation | Death |
| Definition: A disorder characterized by an infectious process involving the eye | |||||
| Gallbladder infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the gallbladder | |||||
| Gum infection | Local therapy indicated (swish and swallow) | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the gums | |||||
| Hepatic infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the liver | |||||
| Hepatitis, viral | Asymptomatic; treatment not indicated | — | Symptomatic liver dysfunction; fibrosis by biopsy; compensated cirrhosis; reactivation of chronic hepatitis | Decompensated liver function (eg, ascites, coagulopathy, encephalopathy, coma) | Death |
| Definition: A disorder characterized by a viral pathologic process involving the liver parenchyma | |||||
| Infective myositis | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the skeletal muscles | |||||
| Joint infection | — | Localized; local intervention indicated; oral intervention indicated (eg, antibiotic, antifungal, antiviral); needle aspiration indicated (single or multiple) | Arthroscopic intervention indicated (eg, drainage) or arthrotomy (eg, open surgical drainage) | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving a joint | |||||
| Kidney infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the kidney | |||||
| Laryngitis | — | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an inflammatory process involving the larynx | |||||
| Lip infection | Localized, local intervention indicated | Oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | — | — |
| Definition: A disorder characterized by an infectious process involving the lips | |||||
| Lung infection | — | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the lungs | |||||
| Lymph gland infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the lymph nodes | |||||
| Mediastinal infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the mediastinum | |||||
| Meningitis | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative 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, spinal cord, or both | |||||
| Mucosal infection | Localized, local intervention indicated | Oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving a mucosal surface | |||||
| Nail infection | Localized, local intervention indicated | Oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | — | — |
| Definition: A disorder characterized by an infectious process involving the nail | |||||
| Otitis externa | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative 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. | |||||
| Otitis media | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the middle ear | |||||
| Ovarian infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the ovary | |||||
| Pancreas infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the pancreas | |||||
| Papulopustular rash | Papules or pustules covering <10% BSA, which may or may not be associated with symptoms of pruritus or tenderness | Papules 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 ADLs | Papules or pustules covering >30% BSA, which may or may not be associated with symptoms of pruritus or tenderness; limiting self-care ADLs; associated with local superinfection with oral antibiotics indicated | 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; 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. | |||||
| Paronychia | Nail fold edema or erythema; disruption of the cuticle | Localized intervention indicated; oral intervention indicated (eg, antibiotic, antifungal, antiviral); nail fold edema or erythema with pain; associated with discharge or nail plate separation; limiting instrumental ADLs | Surgical intervention or IV antibiotics indicated; limiting self-care ADLs | — | — |
| Definition: A disorder characterized by an infectious process involving the soft tissues around the nail | |||||
| Pelvic infection | — | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the pelvic cavity | |||||
| Penile infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the penis | |||||
| Periorbital infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the orbit of the eye | |||||
| Peripheral nerve infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the peripheral nerves | |||||
| Peritoneal infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the peritoneum | |||||
| Pharyngitis | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by inflammation of the throat | |||||
| Phlebitis infective | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative 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. | |||||
| Pleural infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the pleura | |||||
| Prostate infection | — | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the prostate gland | |||||
| Rash pustular | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | — | — |
| Definition: A disorder characterized by a circumscribed and elevated skin lesion filled with pus | |||||
| Rhinitis infective | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | — | — | — |
| Definition: A disorder characterized by an infectious process involving the nasal mucosal | |||||
| Salivary gland infection | — | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the salivary gland | |||||
| Scrotal infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the scrotum | |||||
| Sepsis | — | — | — | 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 | |||||
| Sinusitis | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative 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 | |||||
| Skin infection | Localized, local intervention indicated | Oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the skin | |||||
| Small intestine infection | — | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the small intestine | |||||
| Soft tissue infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving soft tissues | |||||
| Splenic infection | — | — | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the spleen | |||||
| Stoma site infection | Localized, local intervention indicated | Oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative 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) | |||||
| Tooth infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving a tooth | |||||
| Tracheitis | — | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the trachea | |||||
| Upper respiratory infection | — | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative 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) | |||||
| Urethral infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic, endoscopic, or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the urethra | |||||
| Urinary tract infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative 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 | |||||
| Uterine infection | — | Moderate symptoms; oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative 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 | |||||
| Vaginal infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the vagina. | |||||
| Vulval infection | Localized, local intervention indicated | Oral intervention indicated (eg, antibiotic, antifungal, antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the vulva | |||||
| Wound infection | — | Localized; local intervention indicated (eg, topical antibiotic, antifungal, or antiviral) | IV antibiotic, antifungal, or antiviral intervention indicated; radiologic or operative intervention indicated | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an infectious process involving the wound | |||||
| 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 ADLs | Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs | Life-threatening consequences; urgent intervention indicated | Death |
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