Adverse Event/Serious Adverse Event ctcae v3 nci standard Template Form



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Adverse Event/Serious Adverse Event CTCAE v3 NCI Standard Template Form

2748814v2.0

As-of 8-22-2013

........................................................................................................................
Mandatory Adverse Event Questions

Must be included when this data is collected for reporting.


........................................................................................................................

1. Adverse Event Name (v3.0) caDSR CDE = 323 Ver.3.0


Instructions: Code used to identify the adverse event using a standard mechanism that facilitates analysis. CTEP's code list and associated Category/Term is currently a standard.


____Acidosis (metabolic or respiratory)
____Acute vascular leak syndrome
____Adrenal insufficiency
____Adult respiratory distress syndrome (ARDS)
____Albumin, serum-low (hypoalbuminemia)
____Alcohol intolerance syndrome (antabuse-like syndrome)
____Alkaline phosphatase
____Alkalosis (metabolic or respiratory)
____Allergic reaction/hypersensitivity (including drug fever)
____Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
____Allergy/Immunology-Other (Specify)
____ALT, SGPT (serum glutamic pyruvic transaminase)
____Amylase
____Anorexia
____Apnea
____Arachnoiditis/meningismus/radiculitis
____Arthritis (non-septic)
____Ascites (non-malignant)
____Aspiration
____AST, SGOT (serum glutamic oxaloacetic transaminase)
____Ataxia (incoordination)
____Atelectasis
____Atrophy, skin
____Atrophy, subcutaneous fat
____Auditory/Ear-Other (Specify)
____Autoimmune reaction
____Bicarbonate, serum-low
____Bilirubin (hyperbilirubinemia)
____Bladder spasms
____Blood/Bone Marrow-Other (Specify)
____Bone age (alteration in bone age)
____Bone growth: femoral head; slipped capital femoral epiphysis
____Bone growth: limb length discrepancy
____Bone growth: spine kyphosis/lordosis
____Bone marrow cellularity
____Bone: spine-scoliosis
____Brachial plexopathy
____Breast function/lactation
____Breast nipple/areolar deformity
____Breast volume/hypoplasia
____Bronchospasm, wheezing
____Bruising (in absence of grade 3 or 4 thrombocytopenia)
____Burn
____Calcium, serum-high (hypercalcemia)
____Calcium, serum-low (hypocalcemia)
____Carbon monoxide diffusion capacity (DL(co))
____Cardiac Arrhythmia-Other (Specify)
____Cardiac General-Other (Specify)
____Cardiac ischemia/infarction
____Cardiac troponin I (cTnI)
____Cardiac troponin T (cTnT)
____Cardiopulmonary arrest, cause unknown (non-fatal)
____Cataract
____CD4 count
____Cervical spine-range of motion
____Cheilitis
____Cholecystitis
____Cholesterol, serum-high (hypercholesteremia)
____Chyle or lymph leakage
____Chylothorax
____CNS cerebrovascular ischemia
____CNS necrosis/cystic progression
____Coagulation-Other (Specify)
____Cognitive disturbance
____Colitis
____Colitis, infectious (e.g., Clostridium difficile)
____Conduction abnormality/Atrioventricular heart block - Asystole
____Conduction abnormality/Atrioventricular heart block - AV block-first degree
____Conduction abnormality/Atrioventricular heart block - AV block-Second degree Mobitz Type I (Wenckebach)
____Conduction abnormality/Atrioventricular heart block - AV block-second degree Mobitz Type II
____Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block)
____Conduction abnormality/Atrioventricular heart block - Conduction abnormality NOS
____Conduction abnormality/Atrioventricular heart block - Sick sinus syndrome
____Conduction abnormality/Atrioventricular heart block - Stokes-Adams syndrome
____Conduction abnormality/Atrioventricular heart block - Wolff-Parkinson-White syndrome
____Confusion
____Constipation
____Constitutional Symptoms-Other (Specify)
____Cough
____CPK (creatine phosphokinase)
____Creatinine
____Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
____Cystitis
____Cytokine release syndrome/acute infusion reaction
____Death not associated with CTCAE term - Death NOS
____Death not associated with CTCAE term - Disease progression NOS
____Death not associated with CTCAE term - Multi-organ failure
____Death not associated with CTCAE term - Sudden death
____Dehydration
____Dental: dentures or prosthesis
____Dental: periodontal disease
____Dental: teeth
____Dental: teeth development
____Dermal change lymphedema, phlebolymphedema
____Dermatology/Skin-Other (Specify)
____Diarrhea
____DIC (disseminated intravascular coagulation)
____Distention/bloating, abdominal
____Dizziness
____Dry eye syndrome
____Dry mouth/salivary gland (xerostomia)
____Dry skin
____Dysphagia (difficulty swallowing)
____Dyspnea (shortness of breath)
____Edema, larynx
____Edema: head and neck
____Edema: limb
____Edema: trunk/genital
____Edema: viscera
____Ejaculatory dysfunction
____Encephalopathy
____Endocrine-Other (Specify)
____Enteritis (inflammation of the small bowel)
____Erectile dysfunction
____Esophagitis
____Exostosis
____Extrapyramidal/involuntary movement/restlessness
____Extremity-lower (gait/walking)
____Extremity-upper (function)
____Eyelid dysfunction
____Fatigue (asthenia, lethargy, malaise)
____Febrile neutropenia
____Feminization of male
____FEV(1)
____Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)
____Fibrinogen
____Fibrosis-cosmesis
____Fibrosis-deep connective tissue
____Fistula, GI - Abdomen NOS
____Fistula, GI - Anus
____Fistula, GI - Biliary tree
____Fistula, GI - Colon/cecum/appendix
____Fistula, GI - Duodenum
____Fistula, GI - Esophagus
____Fistula, GI - Gallbladder
____Fistula, GI - Ileum
____Fistula, GI - Jejunum
____Fistula, GI - Oral cavity
____Fistula, GI - Pancreas
____Fistula, GI - Pharynx
____Fistula, GI - Rectum
____Fistula, GI - Salivary gland
____Fistula, GI - Small bowel NOS
____Fistula, GI - Stomach
____Fistula, GU - Bladder
____Fistula, GU - Genital tract-female
____Fistula, GU - Kidney
____Fistula, GU - Ureter
____Fistula, GU - Urethra
____Fistula, GU - Uterus
____Fistula, GU - Vagina
____Fistula, pulmonary/upper respiratory - Bronchus
____Fistula, pulmonary/upper respiratory - Larynx
____Fistula, pulmonary/upper respiratory - Lung
____Fistula, pulmonary/upper respiratory - Oral cavity
____Fistula, pulmonary/upper respiratory - Pharynx
____Fistula, pulmonary/upper respiratory - Pleura
____Fistula, pulmonary/upper respiratory - Trachea
____Flatulence
____Flu-like syndrome
____Flushing
____Fracture
____Gastritis (including bile reflux gastritis)
____Gastrointestinal-Other (Specify)
____GGT (gamma-glutamyl transpeptidase)
____Glaucoma
____Glomerular filtration rate
____Glucose, serum-high (hyperglycemia)
____Glucose, serum-low (hypoglycemia)
____Growth and Development-Other (Specify)
____Growth velocity (reduction in growth velocity)
____Gynecomastia
____Hair loss/Alopecia (scalp or body)
____Haptoglobin
____Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
____Hearing: patients without baseline audiogram and not enrolled in a monitoring program
____Heartburn/dyspepsia
____Hematoma
____Hemoglobin
____Hemoglobinuria
____Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis)
____Hemorrhage, CNS
____Hemorrhage, GI - Abdomen NOS
____Hemorrhage, GI - Anus
____Hemorrhage, GI - Biliary tree
____Hemorrhage, GI - Cecum/appendix
____Hemorrhage, GI - Colon
____Hemorrhage, GI - Duodenum
____Hemorrhage, GI - Esophagus
____Hemorrhage, GI - Ileum
____Hemorrhage, GI - Jejunum
____Hemorrhage, GI - Liver
____Hemorrhage, GI - Lower GI NOS
____Hemorrhage, GI - Oral cavity
____Hemorrhage, GI - Pancreas
____Hemorrhage, GI - Peritoneal cavity
____Hemorrhage, GI - Rectum
____Hemorrhage, GI - Stoma
____Hemorrhage, GI - Stomach
____Hemorrhage, GI - Upper GI NOS
____Hemorrhage, GI - Varices (esophageal)
____Hemorrhage, GI - Varices (rectal)
____Hemorrhage, GU - Bladder
____Hemorrhage, GU - Fallopian tube
____Hemorrhage, GU - Kidney
____Hemorrhage, GU - Ovary
____Hemorrhage, GU - Prostate
____Hemorrhage, GU - Retroperitoneum
____Hemorrhage, GU - Spermatic cord
____Hemorrhage, GU - Stoma
____Hemorrhage, GU - Testes
____Hemorrhage, GU - Ureter
____Hemorrhage, GU - Urethra
____Hemorrhage, GU - Urinary NOS
____Hemorrhage, GU - Uterus
____Hemorrhage, GU - Vagina
____Hemorrhage, GU - Vas deferens
____Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
____Hemorrhage, pulmonary/upper respiratory - Bronchus
____Hemorrhage, pulmonary/upper respiratory - Larynx
____Hemorrhage, pulmonary/upper respiratory - Lung
____Hemorrhage, pulmonary/upper respiratory - Mediastinum
____Hemorrhage, pulmonary/upper respiratory - Nose
____Hemorrhage, pulmonary/upper respiratory - Pharynx
____Hemorrhage, pulmonary/upper respiratory - Pleura
____Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS
____Hemorrhage, pulmonary/upper respiratory - Stoma
____Hemorrhage, pulmonary/upper respiratory - Trachea
____Hemorrhage/bleeding associated with surgery, intra-operative or post-operative
____Hemorrhage/Bleeding-Other (Specify)
____Hemorrhoids
____Hepatobiliary/Pancreas-Other (Specify)
____Hiccoughs (hiccups, singultus)
____Hot flashes/flushes
____Hydrocephalus
____Hyperpigmentation
____Hypertension
____Hypopigmentation
____Hypotension
____Hypothermia
____Hypoxia
____Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
____Incontinence, anal
____Incontinence, urinary
____Induration/fibrosis (skin and subcutaneous tissue)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Abdomen NOS
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Anal/perianal
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Appendix
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Artery
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Biliary tree
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Bladder (urinary)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Bone (osteomyelitis)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Brain (encephalitis, infectious)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Brain + Spinal cord (encephalomyelitis)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Bronchus
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Catheter-related
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Cecum
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Cervix
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Colon
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Conjunctiva
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Cornea
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Dental-tooth
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Duodenum
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Esophagus
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - External ear (otitis externa)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Eye NOS
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Fallopian tube
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Foreign body (e.g., graft, implant, prosthesis, stent)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Gallbladder (cholecystitis)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Heart (endocarditis)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Ileum
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Jejunum
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Joint
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Kidney
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Larynx
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lens
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lip/perioral
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Liver
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumonia)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lymphatic
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Mediastinum NOS
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Meninges (meningitis)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Middle ear (otitis media)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Mucosa
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Muscle (infection myositis)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Neck NOS
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Nerve-cranial
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Nerve-peripheral
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Nose
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Oral cavity-gums (gingivitis)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pancreas
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Paranasal
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pelvis NOS
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Penis
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Peristomal
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Peritoneal cavity
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pharynx
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pleura (empyema)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Prostate
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Rectum
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Salivary gland
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Scrotum
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Sinus
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Skin (cellulitis)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Small bowel NOS
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Soft tissue NOS
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Spinal cord (myelitis)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Spleen
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Stomach
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Trachea
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Ungual (nails)
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Upper aerodigestive NOS
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Upper airway NOS
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Ureter
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Urethra
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Urinary tract NOS
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Uterus
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Vagina
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Vein
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Vulva
____Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Wound
____Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS
____Infection with normal ANC or Grade 1 or 2 neutrophils - Anal/perianal
____Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix
____Infection with normal ANC or Grade 1 or 2 neutrophils - Artery
____Infection with normal ANC or Grade 1 or 2 neutrophils - Biliary tree
____Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
____Infection with normal ANC or Grade 1 or 2 neutrophils - Bone (osteomyelitis)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Brain (encephalitis, infectious)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Brain + Spinal cord (encephalomyelitis)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus
____Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
____Infection with normal ANC or Grade 1 or 2 neutrophils - Cecum
____Infection with normal ANC or Grade 1 or 2 neutrophils - Cervix
____Infection with normal ANC or Grade 1 or 2 neutrophils - Colon
____Infection with normal ANC or Grade 1 or 2 neutrophils - Conjunctiva
____Infection with normal ANC or Grade 1 or 2 neutrophils - Cornea
____Infection with normal ANC or Grade 1 or 2 neutrophils - Dental-tooth
____Infection with normal ANC or Grade 1 or 2 neutrophils - Duodenum
____Infection with normal ANC or Grade 1 or 2 neutrophils - Esophagus
____Infection with normal ANC or Grade 1 or 2 neutrophils - External ear (otitis externa)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Eye NOS
____Infection with normal ANC or Grade 1 or 2 neutrophils - Fallopian tube
____Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body (e.g., graft, implant, prosthesis, stent)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Gallbladder (cholecystitis)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Heart (endocarditis)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Ileum
____Infection with normal ANC or Grade 1 or 2 neutrophils - Jejunum
____Infection with normal ANC or Grade 1 or 2 neutrophils - Joint
____Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney
____Infection with normal ANC or Grade 1 or 2 neutrophils - Larynx
____Infection with normal ANC or Grade 1 or 2 neutrophils - Lens
____Infection with normal ANC or Grade 1 or 2 neutrophils - Lip/perioral
____Infection with normal ANC or Grade 1 or 2 neutrophils - Liver
____Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Lymphatic
____Infection with normal ANC or Grade 1 or 2 neutrophils - Mediastinum NOS
____Infection with normal ANC or Grade 1 or 2 neutrophils - Meninges (meningitis)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Middle ear (otitis media)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Mucosa
____Infection with normal ANC or Grade 1 or 2 neutrophils - Muscle (infection myositis)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Neck NOS
____Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-cranial
____Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-peripheral
____Infection with normal ANC or Grade 1 or 2 neutrophils - Nose
____Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Pancreas
____Infection with normal ANC or Grade 1 or 2 neutrophils - Paranasal
____Infection with normal ANC or Grade 1 or 2 neutrophils - Pelvis NOS
____Infection with normal ANC or Grade 1 or 2 neutrophils - Penis
____Infection with normal ANC or Grade 1 or 2 neutrophils - Peristomal
____Infection with normal ANC or Grade 1 or 2 neutrophils - Peritoneal cavity
____Infection with normal ANC or Grade 1 or 2 neutrophils - Pharynx
____Infection with normal ANC or Grade 1 or 2 neutrophils - Pleura (empyema)
____Infection with normal ANC or Grade 1 or 2 neutrophils - Prostate
____Infection with normal ANC or Grade 1 or 2 neutrophils - Rectum
____Infection with normal ANC or Grade 1 or 2 neutrophils - Salivary gland
____Infection with normal ANC or Grade 1 or 2 neutrophils - Scrotum
____Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus



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