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


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


____Acoustic nerve disorder NOS

____Activated partial thromboplastin time prolonged

____Acute coronary syndrome

____Acute kidney injury

____Adrenal insufficiency

____Adult respiratory distress syndrome



____Alanine aminotransferase increased

____Alcohol intolerance

____Alkaline phosphatase increased


____Allergic reaction

____Allergic rhinitis



____Anal fistula

____Anal hemorrhage

____Anal mucositis

____Anal necrosis

____Anal pain

____Anal stenosis

____Anal ulcer



____Ankle fracture

____Anorectal infection




____Aortic injury

____Aortic valve disease




____Appendicitis perforated


____Arterial injury

____Arteritis infective




____Aspartate aminotransferase increased





____Atrial fibrillation

____Atrial flutter

____Atrioventricular block complete

____Atrioventricular block first degree

____Autoimmune disorder

____Avascular necrosis


____Back pain

____Bile duct stenosis

____Biliary anastomotic leak

____Biliary fistula

____Biliary tract infection

____Bladder anastomotic leak

____Bladder infection

____Bladder perforation

____Bladder spasm


____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



____Bullous dermatitis


____Buttock pain

____Capillary leak syndrome

____Carbon monoxide diffusing capacity decreased

____Cardiac arrest

____Cardiac disorders - Other, Specify

____Cardiac troponin I increased

____Cardiac troponin T increased


____Catheter related infection

____CD4 lymphocytes decreased

____Cecal hemorrhage

____Cecal infection

____Central nervous system necrosis

____Cerebrospinal fluid leakage

____Cervicitis infection


____Chest pain - cardiac

____Chest wall pain



____Cholesterol high

____Chronic kidney disease


____Cognitive disturbance


____Colonic fistula

____Colonic hemorrhage

____Colonic obstruction

____Colonic perforation

____Colonic stenosis

____Colonic ulcer

____Concentration impairment

____Conduction disorder


____Congenital, familial and genetic disorders - Other, Specify


____Conjunctivitis infective


____Constrictive pericarditis

____Corneal infection

____Corneal ulcer


____CPK increased

____Cranial nerve infection

____Creatinine increased


____Cystitis noninfective

____Cytokine release syndrome

____Death neonatal

____Death NOS


____Delayed orgasm

____Delayed puberty



____Dental caries

____Depressed level of consciousness


____Dermatitis radiation

____Device related infection


____Disseminated intravascular coagulation


____Dry eye

____Dry mouth

____Dry skin

____Duodenal fistula

____Duodenal hemorrhage

____Duodenal infection

____Duodenal obstruction

____Duodenal perforation

____Duodenal stenosis

____Duodenal ulcer










____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


____Endocarditis infective

____Endocrine disorders - Other, Specify



____Enterocolitis infectious

____Enterovesical fistula


____Erectile dysfunction

____Erythema multiforme


____Esophageal anastomotic leak

____Esophageal fistula

____Esophageal hemorrhage

____Esophageal infection

____Esophageal necrosis

____Esophageal obstruction

____Esophageal pain

____Esophageal perforation

____Esophageal stenosis

____Esophageal ulcer

____Esophageal varices hemorrhage




____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


____Fallopian tube anastomotic leak

____Fallopian tube obstruction

____Fallopian tube perforation

____Fallopian tube stenosis

____Fat atrophy


____Febrile neutropenia

____Fecal incontinence

____Female genital tract fistula

____Feminization acquired

____Fetal death

____Fetal growth retardation


____Fibrinogen decreased

____Fibrosis deep connective tissue

____Flank pain

____Flashing lights



____Flu like symptoms


____Forced expiratory volume decreased


____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


____Gastroesophageal reflux disease

____Gastrointestinal anastomotic leak

____Gastrointestinal disorders - Other, Specify

____Gastrointestinal fistula

____Gastrointestinal pain

____Gastrointestinal stoma necrosis


____General disorders and administration site conditions - Other,

Specify ** Value Length = 89

____Generalized muscle weakness

____Genital edema

____GGT increased

____Gingival pain


____Glossopharyngeal nerve disorder

____Glucose intolerance

____Growth accelerated

____Growth hormone abnormal

____Growth suppression

____Gum infection



____Haptoglobin decreased

____Head soft tissue necrosis


____Hearing impaired

____Heart failure




____Hemoglobin increased



____Hemolytic uremic syndrome

____Hemorrhoidal hemorrhage


____Hepatic failure

____Hepatic hemorrhage

____Hepatic infection

____Hepatic necrosis

____Hepatic pain

____Hepatitis viral

____Hepatobiliary disorders - Other, Specify


____Hip fracture



____Hot flashes

















____Hypoglossal nerve disorder












____Ileal fistula

____Ileal hemorrhage

____Ileal obstruction

____Ileal perforation

____Ileal stenosis

____Ileal ulcer


____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,


____INR increased


____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


____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


____Kidney anastomotic leak

____Kidney infection


____Lactation disorder

____Large intestinal anastomotic leak

____Laryngeal edema

____Laryngeal fistula

____Laryngeal hemorrhage

____Laryngeal inflammation

____Laryngeal mucositis

____Laryngeal obstruction

____Laryngeal stenosis


____Laryngopharyngeal dysesthesia


____Left ventricular systolic dysfunction


____Leukemia secondary to oncology chemotherapy



____Libido decreased

____Libido increased

____Lip infection

____Lip pain

____Lipase increased


____Localized edema


____Lower gastrointestinal hemorrhage

____Lung infection

____Lymph gland infection

____Lymph leakage

____Lymph node pain



____Lymphocyte count decreased

____Lymphocyte count increased




____Mediastinal hemorrhage

____Mediastinal infection

____Memory impairment





____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,


____Musculoskeletal deformity



____Myelodysplastic syndrome

____Myocardial infarction



____Nail discoloration

____Nail infection

____Nail loss

____Nail ridging

____Nasal congestion


____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


____Neutrophil count decreased

____Night blindness

____Nipple deformity

____Non-cardiac chest pain



____Obstruction gastric

____Oculomotor nerve disorder

____Olfactory nerve disorder


____Optic nerve disorder

____Oral cavity fistula

____Oral dysesthesia

____Oral hemorrhage

____Oral pain

____Osteonecrosis of jaw


____Otitis externa

____Otitis media

____Ovarian hemorrhage

____Ovarian infection

____Ovarian rupture

____Ovulation pain


____Pain in extremity

____Pain of skin

____Palmar-plantar erythrodysesthesia syndrome


____Pancreas infection

____Pancreatic anastomotic leak

____Pancreatic duct stenosis

____Pancreatic enzymes decreased

____Pancreatic fistula

____Pancreatic hemorrhage

____Pancreatic necrosis



____Papulopustular rash



____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


____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


____Pharyngolaryngeal pain


____Phlebitis infective



____Platelet count decreased

____Pleural effusion

____Pleural hemorrhage

____Pleural infection

____Pleuritic pain



____Portal hypertension

____Portal vein thrombosis

____Postnasal drip

____Postoperative hemorrhage

____Postoperative thoracic procedure complication

____Precocious puberty

____Pregnancy, puerperium and perinatal conditions - Other,


____Premature delivery

____Premature menopause



____Productive cough

____Prolapse of intestinal stoma

____Prolapse of urostomy

____Prostate infection

____Prostatic hemorrhage

____Prostatic obstruction

____Prostatic pain



____Psychiatric disorders - Other, Specify


____Pulmonary edema

____Pulmonary fibrosis

____Pulmonary fistula

____Pulmonary hypertension

____Pulmonary valve disease


____Pyramidal tract syndrome

____Radiation recall reaction (dermatologic)


____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,



____Restrictive cardiomyopathy

____Retinal detachment

____Retinal tear

____Retinal vascular disorder

____Retinoic acid syndrome


____Retroperitoneal hemorrhage

____Reversible posterior leukoencephalopathy syndrome

____Rhinitis infective

____Right ventricular dysfunction

____Salivary duct inflammation

____Salivary gland fistula

____Salivary gland infection

____Scalp pain

____Scleral disorder


____Scrotal infection

____Scrotal pain




____Serum amylase increased

____Serum sickness

____Sick sinus syndrome

____Sinus bradycardia

____Sinus disorder

____Sinus pain

____Sinus tachycardia


____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


____Social circumstances - Other, Specify

____Soft tissue infection

____Soft tissue necrosis lower limb

____Soft tissue necrosis upper limb


____Sore throat


____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



____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



____Testicular disorder

____Testicular hemorrhage

____Testicular pain

____Thromboembolic event

____Thrombotic thrombocytopenic purpura


____Tooth development disorder

____Tooth discoloration

____Tooth infection


____Toxic epidermal necrolysis

____Tracheal fistula

____Tracheal hemorrhage

____Tracheal mucositis

____Tracheal obstruction

____Tracheal stenosis


____Tracheostomy site bleeding

____Transient ischemic attacks

____Treatment related secondary malignancy


____Tricuspid valve disease

____Trigeminal nerve disorder


____Tumor lysis syndrome

____Tumor pain


____Unequal limb length

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