Common Terminology Criteria for Adverse Events

133 Pages·2008·0.24 MB·English

by  Oracle Reports

Common Terminology Criteria for Adverse Events
Version 3.0
Index
Cancer Therapy Evaluation Program
NATIONAL INSTITUTES OF HEALTH
National Cancer Institute
http://ctep.cancer.gov/
10/22/2003
Public Health Service
Cancer Therapy Evaluation Program National Institutes of Health
National Cancer Institute
Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892
-- A --
abdomen
ENDOCRINE HEPATOBILIARY/PANCREAS
Adrenal insufficiency 17 Liver dysfunction/failure (clinical) 34
Pancreatitis 34
GASTROINTESTINAL
Colitis 19 PAIN
Distension/bloating, abdominal 20 Pain --Select 55
Enteritis (inflammation of the small bowel) 21
VASCULAR
Fistula, GI --Select 22
Portal vein flow 70
Typhlitis (cecal inflammation) 27
HEMORRHAGE/BLEEDING abducens
See: CN VI
Hemorrhage, GI --Select 31
HEPATOBILIARY/PANCREAS abnormal
Pancreatitis 34 BLOOD/BONE MARROW
INFECTION Myelodysplasia 4
Colitis, infectious (e.g., Clostridium difficile) 35 CONSTITUTIONAL SYMPTOMS
Infection (documented clinically or microbiologically) with 35 Odor (patient odor) 11
Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select
ENDOCRINE
Infection with normal ANC or Grade 1 or 2 neutrophils -- 35
Select Neuroendocrine: 17
Infection with unknown ANC --Select 36 ADH secretion abnormality (e.g., SIADH or low ADH)
Neuroendocrine: 17
MUSCULOSKELETAL/SOFT TISSUE
gonadotropin secretion abnormality
Soft tissue necrosis --Select 46 Neuroendocrine: 17
PAIN growth hormone secretion abnormality
Neuroendocrine: 17
Pain --Select 55
prolactin hormone secretion abnormality
SURGERY/INTRA-OPERATIVE INJURY
GASTROINTESTINAL
Intra-operative injury --Select 66
Fistula, GI --Select 22
abdominal pain GROWTH AND DEVELOPMENT
GASTROINTESTINAL Bone age (alteration in bone age) 29
Ascites (non-malignant) 19 INFECTION
Colitis 19
Viral hepatitis 36
Gastritis (including bile reflux gastritis) 22
MUSCULOSKELETAL/SOFT TISSUE
Heartburn/dyspepsia 22
Extremity-lower (gait/walking) 43
Typhlitis (cecal inflammation) 27
Ulcer, GI --Select 28 NEUROLOGY
abdomen - abnormal
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Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892
-- A --
accentuation
Pyramidal tract dysfunction (e.g., increased tone, 51 GROWTH AND DEVELOPMENT
hyperreflexia, positive Babinski, decreased fine motor Bone growth: 29
coordination) spine kyphosis/lordosis
OCULAR/VISUAL
access-related
Keratitis (corneal inflammation/corneal ulceration) 52
PULMONARY/UPPER RESPIRATORY
PULMONARY/UPPER RESPIRATORY
Pulmonary embolism 59
Fistula, pulmonary/upper respiratory --Select 57
VASCULAR
RENAL/GENITOURINARY
Thrombosis/embolism (vascular access-related) 70
Fistula, GU --Select 60
accessory nerve
SEXUAL/REPRODUCTIVE FUNCTION
See: CN XI
Breast function/lactation 64
Orgasmic dysfunction 65
achalasia
GASTROINTESTINAL
abrasion
Dysphagia (difficulty swallowing) 21
DERMATOLOGY/SKIN
Esophagitis 21
Rash: dermatitis associated with radiation --Select 15
acid
abscess
METABOLIC/LABORATORY
GASTROINTESTINAL
Uric acid, serum-high (hyperuricemia) 42
Colitis 19
Fistula, GI --Select 22 SYNDROMES
Proctitis 26 "Retinoic acid syndrome" 69
HEPATOBILIARY/PANCREAS
acidemia
Pancreatitis 34
See: acidosis
INFECTION
acidosis
Infection (documented clinically or microbiologically) with 35
Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select INFECTION
Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Febrile neutropenia (fever of unknown origin without 35
Select clinically or microbiologically documented infection)(ANC
Infection with unknown ANC --Select 36 <1.0 x 10e9/L, fever >=38.5 degrees C)
Infection (documented clinically or microbiologically) with 35
absorption Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select
HEPATOBILIARY/PANCREAS Infection with normal ANC or Grade 1 or 2 neutrophils -- 35
Select
Pancreas, exocrine enzyme deficiency 34
Infection with unknown ANC --Select 36
Opportunistic infection associated with >=Grade 2 36
abrasion - acidosis
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Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892
-- A --
acute vascular leak syndrome
Lymphopenia VASCULAR
METABOLIC/LABORATORY Acute vascular leak syndrome 70
Acidosis (metabolic or respiratory) 40
Adams-Stokes
Glucose, serum-high (hyperglycemia) 41
See: atrioventricular rhythm
RENAL/GENITOURINARY
ADD
Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62
tubular acidosis) NEUROLOGY
SYNDROMES ADD (Attention Deficit Disorder) 47
Cognitive disturbance 47
Fanconi's syndrome 68
Confusion 48
Renal tubular acidosis 68
adenoviral
acne/acneiform
INFECTION
DERMATOLOGY/SKIN
Infection (documented clinically or microbiologically) with 35
Rash: acne/acneiform 15
Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select
acrocyanosis Infection with normal ANC or Grade 1 or 2 neutrophils -- 35
Select
COAGULATION
Infection with unknown ANC --Select 36
DIC (disseminated intravascular coagulation) 10
Opportunistic infection associated with >=Grade 2 36
Lymphopenia
ACTH
Viral hepatitis 36
ENDOCRINE
Neuroendocrine: 17 ADH
ACTH deficiency ENDOCRINE
Neuroendocrine: 17
actinic keratosis
ADH secretion abnormality (e.g., SIADH or low ADH)
OCULAR/VISUAL
Keratitis (corneal inflammation/corneal ulceration) 52 ADHD
See: ADD
acuity
See: visual acuity adhesions
GASTROINTESTINAL
acute infusion reaction
Colitis 19
DERMATOLOGY/SKIN
Enteritis (inflammation of the small bowel) 21
Injection site reaction/extravasation changes 14 Fistula, GI --Select 22
SYNDROMES
adolescents
Cytokine release syndrome/acute infusion reaction 68
acne/acneiform - adolescents
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Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892
-- A --
AUDITORY/EAR NEUROLOGY
Hearing: patients with/without baseline audiogram and 2 Cognitive disturbance 47
enrolled in a monitoring program Confusion 48
Hearing: patients without baseline audiogram and not 2 Irritability (children <3 years of age) 48
enrolled in a monitoring program
Mood alteration --Select 49
Personality/behavioral 50
adrenal
Psychosis (hallucinations/delusions) 50
ENDOCRINE
Adrenal insufficiency 17 aguesia
Masculinization of female 17
GASTROINTESTINAL
METABOLIC/LABORATORY Taste alteration (dysgeusia) 27
Sodium, serum-low (hyponatremia) 42
airway
SURGERY/INTRA-OPERATIVE INJURY
ALLERGY/IMMUNOLOGY
Intra-operative injury --Select 66
Allergic rhinitis (including sneezing, nasal stuffiness, 1
postnasal drip)
adrenocortical dysfunction
ENDOCRINE INFECTION
Masculinization of female 17 Infection (documented clinically or microbiologically) with 35
Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select
Neuroendocrine: 17
Infection with normal ANC or Grade 1 or 2 neutrophils -- 35
ACTH deficiency
Select
aerodigestive Infection with unknown ANC --Select 36
GASTROINTESTINAL PULMONARY/UPPER RESPIRATORY
Mucositis/stomatitis (functional/symptomatic) --Select 24 Atelectasis 56
INFECTION Bronchospasm, wheezing 56
Edema, larynx 57
Infection (documented clinically or microbiologically) with 35
Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Fistula, pulmonary/upper respiratory --Select 57
Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Obstruction/stenosis of airway --Select 58
Select Prolonged intubation after pulmonary resection (>24 hrs 59
Infection with unknown ANC --Select 36 after surgery)
SURGERY/INTRA-OPERATIVE INJURY SURGERY/INTRA-OPERATIVE INJURY
Intra-operative injury --Select 66 Intra-operative injury --Select 66
AGC albumin
See: ANC INFECTION
Viral hepatitis 36
agitation
adrenal - albumin
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Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892
-- A --
METABOLIC/LABORATORY Alkalosis (metabolic or respiratory) 40
Albumin, serum-low (hypoalbuminemia) 40
alkalosis
Calcium, serum-low (hypocalcemia) 40
See: alkaline
albuminuria
allergic
METABOLIC/LABORATORY
ALLERGY/IMMUNOLOGY
Proteinuria 42
Allergic reaction/hypersensitivity (including drug fever) 1
alcohol Allergic rhinitis (including sneezing, nasal stuffiness, 1
postnasal drip)
METABOLIC/LABORATORY
Autoimmune reaction 1
GGT (gamma-Glutamyl transpeptidase) 41
Serum sickness 1
SYNDROMES Vasculitis 1
Alcohol intolerance syndrome (antabuse-like syndrome) 68
PULMONARY/UPPER RESPIRATORY
Bronchospasm, wheezing 56
aldosterone
Edema, larynx 57
ENDOCRINE
Obstruction/stenosis of airway --Select 58
Adrenal insufficiency 17
SYNDROMES
alimentary tract Cytokine release syndrome/acute infusion reaction 68
GASTROINTESTINAL
alopecia
Dry mouth/salivary gland (xerostomia) 21
See: hair
Malabsorption 23
Mucositis/stomatitis (functional/symptomatic) --Select 24 DERMATOLOGY/SKIN
Necrosis, GI --Select 25 Hair loss/alopecia (scalp or body)
LYMPHATICS
ALT
Edema: 38
INFECTION
viscera
Opportunistic infection associated with >=Grade 2 36
MUSCULOSKELETAL/SOFT TISSUE
Lymphopenia
Trismus (difficulty, restriction or pain when opening mouth) 46 Viral hepatitis 36
PULMONARY/UPPER RESPIRATORY METABOLIC/LABORATORY
Aspiration 56 ALT, SGPT (serum glutamic pyruvic transaminase) 40
alkaline alveolitis
METABOLIC/LABORATORY PULMONARY/UPPER RESPIRATORY
Alkaline phosphatase 40 Pneumonitis/pulmonary infiltrates 58
albuminuria - amblyopia
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Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892
-- A --
amblyopia
OCULAR/VISUAL Wound complication, non-infectious 16
Vision-blurred vision 54 GASTROINTESTINAL
Dental: 20
ambulation
teeth
MUSCULOSKELETAL/SOFT TISSUE
LYMPHATICS
Arthritis (non-septic) 43
Edema: 38
Extremity-lower (gait/walking) 43
limb
Joint-function 44
MUSCULOSKELETAL/SOFT TISSUE
Muscle weakness, generalized or specific area (not due to 45
neuropathy) --Select Fibrosis-deep connective tissue 44
Fracture 44
amenorrhea
VASCULAR
ENDOCRINE
Peripheral arterial ischemia 70
Neuroendocrine: 17
prolactin hormone secretion abnormality
amylase
SEXUAL/REPRODUCTIVE FUNCTION HEPATOBILIARY/PANCREAS
Irregular menses (change from baseline) 64 Liver dysfunction/failure (clinical) 34
Pancreatitis 34
aminotransferase
See: AST, ALT METABOLIC/LABORATORY
METABOLIC/LABORATORY Amylase 40
ALT, SGPT (serum glutamic pyruvic transaminase)
anal
AST, SGOT(serum glutamic oxaloacetic transaminase)
See: anus
AML/MDS GASTROINTESTINAL
SECONDARY MALIGNANCY Fistula, GI --Select
Incontinence, anal
Secondary Malignancy - possibly related to cancer treatment 63
(Specify, __) Stricture/stenosis (including anastomotic), GI --Select
Ulcer, GI --Select
amnesia
HEMORRHAGE/BLEEDING
NEUROLOGY
Hemorrhage, GI --Select
Memory impairment 49
INFECTION
amputation Infection (documented clinically or microbiologically) with
ALLERGY/IMMUNOLOGY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select
Infection with normal ANC or Grade 1 or 2 neutrophils --
Vasculitis 1
Select
DERMATOLOGY/SKIN Infection with unknown ANC --Select
amblyopia - anal
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Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892
-- A --
See: anus BLOOD/BONE MARROW
PAIN Neutrophils/granulocytes (ANC/AGC) 4
Pain --Select
CONSTITUTIONAL SYMPTOMS
SURGERY/INTRA-OPERATIVE INJURY Fever (in the absence of neutropenia, where neutropenia is 11
Intra-operative injury --Select defined as ANC <1.0 x 10e9/L)
INFECTION
anal/perianal
Febrile neutropenia (fever of unknown origin without 35
See: anus
clinically or microbiologically documented infection)(ANC
INFECTION <1.0 x 10e9/L, fever >=38.5 degrees C)
Infection (documented clinically or microbiologically) with Infection (documented clinically or microbiologically) with 35
Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select
Infection with normal ANC or Grade 1 or 2 neutrophils -- Infection with normal ANC or Grade 1 or 2 neutrophils -- 35
Select Select
Infection with unknown ANC --Select Infection with unknown ANC --Select 36
Opportunistic infection associated with >=Grade 2 36
anaphylaxis Lymphopenia
ALLERGY/IMMUNOLOGY Viral hepatitis 36
Allergic reaction/hypersensitivity (including drug fever) 1
anejaculation
SYNDROMES
SEXUAL/REPRODUCTIVE FUNCTION
Cytokine release syndrome/acute infusion reaction 68
Ejaculatory dysfunction 64
anastomosis
anemia
GASTROINTESTINAL
ALLERGY/IMMUNOLOGY
Dysphagia (difficulty swallowing) 21
Autoimmune reaction 1
Leak (including anastomotic), GI --Select 23
BLOOD/BONE MARROW
Prolapse of stoma, GI 26
Hemoglobin 4
Stricture/stenosis (including anastomotic), GI --Select 27
Hemolysis (e.g., immune hemolytic anemia, drug-related 4
HEPATOBILIARY/PANCREAS
hemolysis)
Biliary tree damage 34
COAGULATION
Stricture (biliary tree, hepatic or pancreatic) 34
Thrombotic microangiopathy (e.g., thrombotic 10
RENAL/GENITOURINARY thrombocytopenic purpura [TTP] or hemolytic uremic
Leak (including anastomotic), GU --Select 60 syndrome [HUS])
Prolapse of stoma, GU 61 HEMORRHAGE/BLEEDING
Stricture/stenosis (including anastomotic), GU --Select 62 Hemorrhage, CNS 30
Hemorrhage, GI --Select 31
ANC
anal/perianal - anemia
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Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892
-- A --
Hemorrhage, GU --Select 32 Weight loss 12
Hemorrhage, pulmonary/upper respiratory --Select 32
ENDOCRINE
Hemorrhage/bleeding associated with surgery, intra- 30
Adrenal insufficiency 17
operative or postoperative
Petechiae/purpura (hemorrhage/bleeding into skin or 32 GASTROINTESTINAL
mucosa) Anorexia 19
Nausea 24
angiitis
ALLERGY/IMMUNOLOGY anosmia
Vasculitis 1 NEUROLOGY
VASCULAR Neuropathy: cranial --Select 50
Vessel injury-artery --Select 70
antabuse
Vessel injury-vein --Select 71
SYNDROMES
angina Alcohol intolerance syndrome (antabuse-like syndrome) 68
CARDIAC GENERAL
anti-androgens
Cardiac ischemia/infarction 7
SYNDROMES
Cardiac troponin I (cTnI) 7
Cardiac troponin T (cTnT) 7 Alcohol intolerance syndrome (antabuse-like syndrome) 68
Hypotension 8
anti-estrogens/androgens
PAIN
SYNDROMES
Pain --Select 55
Tumor flare 69
angioedema
anti-osteoporotic
ALLERGY/IMMUNOLOGY See: osteoporosis
Allergic reaction/hypersensitivity (including drug fever) 1
anticoagulation
ankylosed/fused COAGULATION
MUSCULOSKELETAL/SOFT TISSUE Fibrinogen 10
Cervical spine-range of motion 43 INR (International Normalized Ratio of prothrombin time) 10
Lumbar spine-range of motion 44 PTT (Partial Thromboplastin Time) 10
VASCULAR
Ano-rectal
See: anus Phlebitis (including superficial thrombosis) 70
Thrombosis/embolism (vascular access-related) 70
anorexia Thrombosis/thrombus/embolism 70
CONSTITUTIONAL SYMPTOMS
angiitis - antiglobulin
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Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892
-- A --
antiglobulin anxiety
BLOOD/BONE MARROW NEUROLOGY
Hemolysis (e.g., immune hemolytic anemia, drug-related 4 Confusion 48
hemolysis) Irritability (children <3 years of age) 48
Memory impairment 49
antitussive
Mood alteration --Select 49
PULMONARY/UPPER RESPIRATORY
Personality/behavioral 50
Cough 56
Psychosis (hallucinations/delusions) 50
anuria
aorta
RENAL/GENITOURINARY
SURGERY/INTRA-OPERATIVE INJURY
Renal failure 61
Intra-operative injury --Select 66
Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62
VASCULAR
tubular acidosis)
Vessel injury-artery --Select 70
anus
GASTROINTESTINAL aphasia
Fistula, GI --Select 22 NEUROLOGY
Incontinence, anal 23 Aphasia, receptive and/or expressive 47
Mucositis/stomatitis (clinical exam) --Select 24 Dysphasia, receptive and/or expressive 48
Mucositis/stomatitis (functional/symptomatic) --Select 24 Speech impairment (e.g., dysphasia or aphasia) 51
Necrosis, GI --Select 25
aphonic
Stricture/stenosis (including anastomotic), GI --Select 27
PULMONARY/UPPER RESPIRATORY
Ulcer, GI --Select 28
Voice changes/dysarthria (e.g., hoarseness, loss or 59
HEMORRHAGE/BLEEDING
alteration in voice, laryngitis)
Hemorrhage, GI --Select 31
aplasia
INFECTION
BLOOD/BONE MARROW
Infection (documented clinically or microbiologically) with 35
Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Bone marrow cellularity 4
Infection with normal ANC or Grade 1 or 2 neutrophils -- 35
Select apnea
Infection with unknown ANC --Select 36 NEUROLOGY
PAIN Apnea 47
Pain --Select 55 PULMONARY/UPPER RESPIRATORY
SURGERY/INTRA-OPERATIVE INJURY Hypoxia 57
Intra-operative injury --Select 66
appendix
antiglobulin - appendix
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