Adverse Event/Serious Adverse Event ctcae v4 nci standard Template Form



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Adverse Event/Serious Adverse Event CTCAE v4 NCI Standard Template Form

326567v2.0

As-of 8-22-2013
........................................................................................................................

Mandatory Adverse Event Questions

Must be included when this data is collected for reporting.

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


1. Adverse Event Term (v4.0) caDSR CDE = 3125302 Ver.1.1


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.

____Abdominal distension

____Abdominal infection

____Abdominal pain

____Abdominal soft tissue necrosis

____Abducens nerve disorder

____Accessory nerve disorder

____Acidosis

____Acoustic nerve disorder NOS

____Activated partial thromboplastin time prolonged

____Acute coronary syndrome

____Acute kidney injury

____Adrenal insufficiency

____Adult respiratory distress syndrome

____Agitation

____Akathisia

____Alanine aminotransferase increased

____Alcohol intolerance

____Alkaline phosphatase increased

____Alkalosis

____Allergic reaction

____Allergic rhinitis

____Alopecia

____Amnesia

____Anal fistula

____Anal hemorrhage

____Anal mucositis

____Anal necrosis

____Anal pain

____Anal stenosis

____Anal ulcer

____Anaphylaxis

____Anemia

____Ankle fracture

____Anorectal infection

____Anorexia

____Anorgasmia

____Anxiety

____Aortic injury

____Aortic valve disease

____Aphonia

____Apnea

____Appendicitis

____Appendicitis perforated

____Arachnoiditis

____Arterial injury

____Arteritis infective

____Arthralgia

____Arthritis

____Ascites

____Aspartate aminotransferase increased

____Aspiration

____Asystole

____Ataxia

____Atelectasis

____Atrial fibrillation

____Atrial flutter

____Atrioventricular block complete

____Atrioventricular block first degree

____Autoimmune disorder

____Avascular necrosis

____Azoospermia

____Back pain

____Bile duct stenosis

____Biliary anastomotic leak

____Biliary fistula

____Biliary tract infection

____Bladder anastomotic leak

____Bladder infection

____Bladder perforation

____Bladder spasm

____Bloating

____Blood and lymphatic system disorders - Other, Specify

____Blood antidiuretic hormone abnormal

____Blood bilirubin increased

____Blood corticotrophin decreased

____Blood gonadotrophin abnormal

____Blood prolactin abnormal

____Blurred vision

____Body odor

____Bone infection

____Bone marrow hypocellular

____Bone pain

____Brachial plexopathy

____Breast atrophy

____Breast infection

____Breast pain

____Bronchial fistula

____Bronchial infection

____Bronchial obstruction

____Bronchial stricture

____Bronchopleural fistula

____Bronchopulmonary hemorrhage

____Bronchospasm

____Bruising

____Bullous dermatitis

____Burn

____Buttock pain

____Capillary leak syndrome

____Carbon monoxide diffusing capacity decreased

____Cardiac arrest

____Cardiac disorders - Other, Specify

____Cardiac troponin I increased

____Cardiac troponin T increased

____Cataract

____Catheter related infection

____CD4 lymphocytes decreased

____Cecal hemorrhage

____Cecal infection

____Central nervous system necrosis

____Cerebrospinal fluid leakage

____Cervicitis infection

____Cheilitis

____Chest pain - cardiac

____Chest wall pain

____Chills

____Cholecystitis

____Cholesterol high

____Chronic kidney disease

____Chylothorax

____Cognitive disturbance

____Colitis

____Colonic fistula

____Colonic hemorrhage

____Colonic obstruction

____Colonic perforation

____Colonic stenosis

____Colonic ulcer

____Concentration impairment

____Conduction disorder

____Confusion

____Congenital, familial and genetic disorders - Other, Specify

____Conjunctivitis

____Conjunctivitis infective

____Constipation

____Constrictive pericarditis

____Corneal infection

____Corneal ulcer

____Cough

____CPK increased

____Cranial nerve infection

____Creatinine increased

____Cushingoid

____Cystitis noninfective

____Cytokine release syndrome

____Death neonatal

____Death NOS

____Dehydration

____Delayed orgasm

____Delayed puberty

____Delirium

____Delusions

____Dental caries

____Depressed level of consciousness

____Depression

____Dermatitis radiation

____Device related infection

____Diarrhea

____Disseminated intravascular coagulation

____Dizziness

____Dry eye

____Dry mouth

____Dry skin

____Duodenal fistula

____Duodenal hemorrhage

____Duodenal infection

____Duodenal obstruction

____Duodenal perforation

____Duodenal stenosis

____Duodenal ulcer

____Dysarthria

____Dysesthesia

____Dysgeusia

____Dysmenorrhea

____Dyspareunia

____Dyspepsia

____Dysphagia

____Dysphasia

____Dyspnea

____Ear and labyrinth disorders - Other, Specify

____Ear pain

____Edema cerebral

____Edema face

____Edema limbs

____Edema trunk

____Ejaculation disorder

____Ejection fraction decreased

____Electrocardiogram QT corrected interval prolonged

____Encephalitis infection

____Encephalomyelitis infection

____Encephalopathy

____Endocarditis infective

____Endocrine disorders - Other, Specify

____Endophthalmitis

____Enterocolitis

____Enterocolitis infectious

____Enterovesical fistula

____Epistaxis

____Erectile dysfunction

____Erythema multiforme

____Erythroderma

____Esophageal anastomotic leak

____Esophageal fistula

____Esophageal hemorrhage

____Esophageal infection

____Esophageal necrosis

____Esophageal obstruction

____Esophageal pain

____Esophageal perforation

____Esophageal stenosis

____Esophageal ulcer

____Esophageal varices hemorrhage

____Esophagitis

____Euphoria

____Exostosis

____External ear inflammation

____External ear pain

____Extraocular muscle paresis

____Extrapyramidal disorder

____Eye disorders - Other, Specify

____Eye infection

____Eye pain

____Eyelid function disorder

____Facial muscle weakness

____Facial nerve disorder

____Facial pain

____Fall

____Fallopian tube anastomotic leak

____Fallopian tube obstruction

____Fallopian tube perforation

____Fallopian tube stenosis

____Fat atrophy

____Fatigue

____Febrile neutropenia

____Fecal incontinence

____Female genital tract fistula

____Feminization acquired

____Fetal death

____Fetal growth retardation

____Fever

____Fibrinogen decreased

____Fibrosis deep connective tissue

____Flank pain

____Flashing lights

____Flatulence

____Floaters

____Flu like symptoms

____Flushing

____Forced expiratory volume decreased

____Fracture

____Gait disturbance

____Gallbladder fistula

____Gallbladder infection

____Gallbladder necrosis

____Gallbladder obstruction

____Gallbladder pain

____Gallbladder perforation

____Gastric anastomotic leak

____Gastric fistula

____Gastric hemorrhage

____Gastric necrosis

____Gastric perforation

____Gastric stenosis

____Gastric ulcer

____Gastritis

____Gastroesophageal reflux disease

____Gastrointestinal anastomotic leak

____Gastrointestinal disorders - Other, Specify

____Gastrointestinal fistula

____Gastrointestinal pain

____Gastrointestinal stoma necrosis

____Gastroparesis

____General disorders and administration site conditions - Other,

Specify ** Value Length = 89

____Generalized muscle weakness

____Genital edema

____GGT increased

____Gingival pain

____Glaucoma

____Glossopharyngeal nerve disorder

____Glucose intolerance

____Growth accelerated

____Growth hormone abnormal

____Growth suppression

____Gum infection

____Gynecomastia

____Hallucinations

____Haptoglobin decreased

____Head soft tissue necrosis

____Headache

____Hearing impaired

____Heart failure

____Hematoma

____Hematosalpinx

____Hematuria

____Hemoglobin increased

____Hemoglobinuria

____Hemolysis

____Hemolytic uremic syndrome

____Hemorrhoidal hemorrhage

____Hemorrhoids

____Hepatic failure

____Hepatic hemorrhage

____Hepatic infection

____Hepatic necrosis

____Hepatic pain

____Hepatitis viral

____Hepatobiliary disorders - Other, Specify

____Hiccups

____Hip fracture

____Hirsutism

____Hoarseness

____Hot flashes

____Hydrocephalus

____Hypercalcemia

____Hyperglycemia

____Hyperhidrosis

____Hyperkalemia

____Hypermagnesemia

____Hypernatremia

____Hyperparathyroidism

____Hypersomnia

____Hypertension

____Hyperthyroidism

____Hypertrichosis

____Hypertriglyceridemia

____Hyperuricemia

____Hypoalbuminemia

____Hypocalcemia

____Hypoglossal nerve disorder

____Hypoglycemia

____Hypohidrosis

____Hypokalemia

____Hypomagnesemia

____Hyponatremia

____Hypoparathyroidism

____Hypophosphatemia

____Hypotension

____Hypothermia

____Hypothyroidism

____Hypoxia

____Ileal fistula

____Ileal hemorrhage

____Ileal obstruction

____Ileal perforation

____Ileal stenosis

____Ileal ulcer

____Ileus

____Immune system disorders - Other, Specify

____Infections and infestations - Other, Specify

____Infective myositis

____Infusion related reaction

____Infusion site extravasation

____Injection site reaction

____Injury to carotid artery

____Injury to inferior vena cava

____Injury to jugular vein

____Injury to superior vena cava

____Injury, poisoning and procedural complications - Other,

Specify

____INR increased

____Insomnia

____Intestinal stoma leak

____Intestinal stoma obstruction

____Intestinal stoma site bleeding

____Intra-abdominal hemorrhage

____Intracranial hemorrhage

____Intraoperative arterial injury

____Intraoperative breast injury

____Intraoperative cardiac injury

____Intraoperative ear injury

____Intraoperative endocrine injury

____Intraoperative gastrointestinal injury

____Intraoperative head and neck injury

____Intraoperative hemorrhage

____Intraoperative hepatobiliary injury

____Intraoperative musculoskeletal injury

____Intraoperative neurological injury

____Intraoperative ocular injury

____Intraoperative renal injury

____Intraoperative reproductive tract injury

____Intraoperative respiratory injury

____Intraoperative skin injury

____Intraoperative splenic injury

____Intraoperative urinary injury

____Intraoperative venous injury

____Investigations - Other, Specify

____Iron overload

____Irregular menstruation

____Irritability

____Ischemia cerebrovascular

____IVth nerve disorder

____Jejunal fistula

____Jejunal hemorrhage

____Jejunal obstruction

____Jejunal perforation

____Jejunal stenosis

____Jejunal ulcer

____Joint effusion

____Joint infection

____Joint range of motion decreased

____Joint range of motion decreased cervical spine

____Joint range of motion decreased lumbar spine

____Keratitis

____Kidney anastomotic leak

____Kidney infection

____Kyphosis

____Lactation disorder

____Large intestinal anastomotic leak

____Laryngeal edema

____Laryngeal fistula

____Laryngeal hemorrhage

____Laryngeal inflammation

____Laryngeal mucositis

____Laryngeal obstruction

____Laryngeal stenosis

____Laryngitis

____Laryngopharyngeal dysesthesia

____Laryngospasm

____Left ventricular systolic dysfunction

____Lethargy

____Leukemia secondary to oncology chemotherapy

____Leukocytosis

____Leukoencephalopathy

____Libido decreased

____Libido increased

____Lip infection

____Lip pain

____Lipase increased

____Lipohypertrophy

____Localized edema

____Lordosis

____Lower gastrointestinal hemorrhage

____Lung infection

____Lymph gland infection

____Lymph leakage

____Lymph node pain

____Lymphedema

____Lymphocele

____Lymphocyte count decreased

____Lymphocyte count increased

____Malabsorption

____Malaise

____Mania

____Mediastinal hemorrhage

____Mediastinal infection

____Memory impairment

____Meningismus

____Meningitis

____Menopause

____Menorrhagia

____Metabolism and nutrition disorders - Other, Specify

____Middle ear inflammation

____Mitral valve disease

____Mobitz (type) II atrioventricular block

____Mobitz type I

____Movements involuntary

____Mucosal infection

____Mucositis oral

____Multi-organ failure

____Muscle weakness left-sided

____Muscle weakness lower limb

____Muscle weakness right-sided

____Muscle weakness trunk

____Muscle weakness upper limb

____Musculoskeletal and connective tissue disorders - Other,

Specify


____Musculoskeletal deformity

____Myalgia

____Myelitis

____Myelodysplastic syndrome

____Myocardial infarction

____Myocarditis

____Myositis

____Nail discoloration

____Nail infection

____Nail loss

____Nail ridging

____Nasal congestion

____Nausea

____Neck edema

____Neck pain

____Neck soft tissue necrosis

____Neoplasms benign, malignant and unspecified (incl cysts and polyps) -

Other, Specify ** Value Length = 104

____Nervous system disorders - Other, Specify

____Neuralgia

____Neutrophil count decreased

____Night blindness

____Nipple deformity

____Non-cardiac chest pain

____Nystagmus

____Obesity

____Obstruction gastric

____Oculomotor nerve disorder

____Olfactory nerve disorder

____Oligospermia

____Optic nerve disorder

____Oral cavity fistula

____Oral dysesthesia

____Oral hemorrhage

____Oral pain

____Osteonecrosis of jaw

____Osteoporosis

____Otitis externa

____Otitis media

____Ovarian hemorrhage

____Ovarian infection

____Ovarian rupture

____Ovulation pain

____Pain

____Pain in extremity

____Pain of skin

____Palmar-plantar erythrodysesthesia syndrome

____Palpitations

____Pancreas infection

____Pancreatic anastomotic leak

____Pancreatic duct stenosis

____Pancreatic enzymes decreased

____Pancreatic fistula

____Pancreatic hemorrhage

____Pancreatic necrosis

____Pancreatitis

____Papilledema

____Papulopustular rash

____Paresthesia

____Paronychia

____Paroxysmal atrial tachycardia

____Pelvic floor muscle weakness

____Pelvic infection

____Pelvic pain

____Pelvic soft tissue necrosis

____Penile infection

____Penile pain

____Perforation bile duct

____Pericardial effusion

____Pericardial tamponade

____Pericarditis

____Perineal pain

____Periodontal disease

____Periorbital edema

____Periorbital infection

____Peripheral ischemia

____Peripheral motor neuropathy

____Peripheral nerve infection

____Peripheral sensory neuropathy

____Peritoneal infection

____Peritoneal necrosis

____Personality change

____Phantom pain

____Pharyngeal anastomotic leak

____Pharyngeal fistula

____Pharyngeal hemorrhage

____Pharyngeal mucositis

____Pharyngeal necrosis

____Pharyngeal stenosis

____Pharyngitis

____Pharyngolaryngeal pain

____Phlebitis

____Phlebitis infective

____Photophobia

____Photosensitivity

____Platelet count decreased

____Pleural effusion

____Pleural hemorrhage

____Pleural infection

____Pleuritic pain

____Pneumonitis

____Pneumothorax

____Portal hypertension

____Portal vein thrombosis

____Postnasal drip

____Postoperative hemorrhage

____Postoperative thoracic procedure complication

____Precocious puberty

____Pregnancy, puerperium and perinatal conditions - Other,

Specify


____Premature delivery

____Premature menopause

____Presyncope

____Proctitis

____Productive cough

____Prolapse of intestinal stoma

____Prolapse of urostomy

____Prostate infection

____Prostatic hemorrhage

____Prostatic obstruction

____Prostatic pain

____Proteinuria

____Pruritus

____Psychiatric disorders - Other, Specify

____Psychosis

____Pulmonary edema

____Pulmonary fibrosis

____Pulmonary fistula

____Pulmonary hypertension

____Pulmonary valve disease

____Purpura

____Pyramidal tract syndrome

____Radiation recall reaction (dermatologic)

____Radiculitis

____Rash acneiform

____Rash maculo-papular

____Rash pustular

____Rectal anastomotic leak

____Rectal fistula

____Rectal hemorrhage

____Rectal mucositis

____Rectal necrosis

____Rectal obstruction

____Rectal pain

____Rectal perforation

____Rectal stenosis

____Rectal ulcer

____Recurrent laryngeal nerve palsy

____Renal and urinary disorders - Other, Specify

____Renal calculi

____Renal colic

____Renal hemorrhage

____Reproductive system and breast disorders - Other, Specify

____Respiratory failure

____Respiratory, thoracic and mediastinal disorders - Other,

Specify


____Restlessness

____Restrictive cardiomyopathy

____Retinal detachment

____Retinal tear

____Retinal vascular disorder

____Retinoic acid syndrome

____Retinopathy

____Retroperitoneal hemorrhage

____Reversible posterior leukoencephalopathy syndrome

____Rhinitis infective

____Right ventricular dysfunction

____Salivary duct inflammation

____Salivary gland fistula

____Salivary gland infection

____Scalp pain

____Scleral disorder

____Scoliosis

____Scrotal infection

____Scrotal pain

____Seizure

____Sepsis

____Seroma

____Serum amylase increased

____Serum sickness

____Sick sinus syndrome

____Sinus bradycardia

____Sinus disorder

____Sinus pain

____Sinus tachycardia

____Sinusitis

____Skin and subcutaneous tissue disorders - Other, Specify

____Skin atrophy

____Skin hyperpigmentation

____Skin hypopigmentation

____Skin induration

____Skin infection

____Skin ulceration

____Sleep apnea

____Small intestinal anastomotic leak

____Small intestinal mucositis

____Small intestinal obstruction

____Small intestinal perforation

____Small intestinal stenosis

____Small intestine infection

____Small intestine ulcer

____Sneezing

____Social circumstances - Other, Specify

____Soft tissue infection

____Soft tissue necrosis lower limb

____Soft tissue necrosis upper limb

____Somnolence

____Sore throat

____Spasticity

____Spermatic cord anastomotic leak

____Spermatic cord hemorrhage

____Spermatic cord obstruction

____Spinal fracture

____Spleen disorder

____Splenic infection

____Stenosis of gastrointestinal stoma

____Stevens-Johnson syndrome

____Stoma site infection

____Stomach pain

____Stomal ulcer

____Stridor

____Stroke

____Sudden death NOS

____Suicidal ideation

____Suicide attempt

____Superficial soft tissue fibrosis

____Superficial thrombophlebitis

____Superior vena cava syndrome

____Supraventricular tachycardia

____Surgical and medical procedures - Other, Specify

____Syncope

____Telangiectasia

____Testicular disorder

____Testicular hemorrhage

____Testicular pain

____Thromboembolic event

____Thrombotic thrombocytopenic purpura

____Tinnitus

____Tooth development disorder

____Tooth discoloration

____Tooth infection

____Toothache

____Toxic epidermal necrolysis

____Tracheal fistula

____Tracheal hemorrhage

____Tracheal mucositis

____Tracheal obstruction

____Tracheal stenosis

____Tracheitis

____Tracheostomy site bleeding

____Transient ischemic attacks

____Treatment related secondary malignancy

____Tremor

____Tricuspid valve disease

____Trigeminal nerve disorder

____Trismus

____Tumor lysis syndrome

____Tumor pain

____Typhlitis

____Unequal limb length




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