ID

2600

Descrição

The collection of CDEs used in the Adverse Events/Serious Adverse Events module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4D0BC7DD-57DD-63BE-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4D0BC7DD-57DD-63BE-E044-0003BA3F9857

Palavras-chave

Transferido a

19 de setembro de 2012

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template - 2748814v1.0

model
Detalhes

No Instruction available.

1 Formulários

StudyEvent: NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template
1. No Instruction available.

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Mandatory Adverse Event Questions

Item Group

Mandatory Adverse Event Data Elements

CommonToxicityCriteriaAdverseEventTermType

Item

Adverse Event Name (v3.0) (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. )

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CL.1

Code List

Adverse Event Name (v3.0) (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. )

CL Item

Acidosis Nos (Acidosis (metabolic or respiratory))

C0001122 (NCI Metathesaurus)

CL Item

Capillary Leak Syndrome (Acute vascular leak syndrome)

C0343084 (NCI Metathesaurus)

CL Item

Adrenal Insufficiency (Adrenal insufficiency)

CL Item

Adult Respiratory Distress Syndrome (Adult respiratory distress syndrome (ARDS))

C3353 (NCI Thesaurus)
C0035222 (UMLS 2011AA)

CL Item

Blood Albumin Decreased (Albumin, serum-low (hypoalbuminemia))

CL039392 (NCI Metathesaurus)

CL Item

Alcohol Intolerance Syndrome (antabuse-like Syndrome) (Alcohol intolerance syndrome (antabuse-like syndrome))

CL Item

Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)

CL Item

Alkalosis Nos (Alkalosis (metabolic or respiratory))

C0002063 (NCI Metathesaurus)

CL Item

Hypersensitivity Nos (Allergic reaction/hypersensitivity (including drug fever))

CL Item

Rhinitis Allergic Nos (Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip))

C0002103 (NCI Metathesaurus)

CL Item

Allergy/immunology Other (Allergy/Immunology-Other (Specify))

CL Item

Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))

C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)

CL Item

Blood Amylase Increased (Amylase)

CL038581 (NCI Metathesaurus)

CL Item

Anorexia (Anorexia)

C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)

CL Item

Apnoea (Apnea)

CL Item

Arachnoiditis (Arachnoiditis/meningismus/radiculitis)

C37913 (NCI Thesaurus)
C0003708 (UMLS 2011AA)

CL Item

Arthritis Nos (Arthritis (non-septic))

CL Item

Ascites (Ascites (non-malignant))

C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)

CL Item

Aspiration (Aspiration)

C15631 (NCI Thesaurus)
C0349707 (UMLS 2011AA)

CL Item

Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))

C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)

CL Item

Ataxia Nec (Ataxia (incoordination))

CL Item

Atelectasis (Atelectasis)

C2888 (NCI Thesaurus)
C0004144 (UMLS 2011AA)

CL Item

Atrophy, Skin (Atrophy, skin)

CL Item

Atrophy, Subcutaneous Fat (Atrophy, subcutaneous fat)

CL Item

Auditory/ear Other (Auditory/Ear-Other (Specify))

CL Item

Autoimmune Disorder Nos (Autoimmune reaction)

CL Item

Blood Bicarbonate Decreased (Bicarbonate, serum-low)

CL038577 (NCI Metathesaurus)

CL Item

Blood Bilirubin Increased (Bilirubin (hyperbilirubinemia))

CL039714 (NCI Metathesaurus)

CL Item

Bladder Disorder Nos (Bladder spasms)

CL Item

Blood/bone Marrow Other (Blood/Bone Marrow-Other (Specify))

CL Item

Bone Age (alteration In Bone Age) (Bone age (alteration in bone age))

CL Item

Bone Growth: Femoral Head; Slipped Capital Femoral Epiphysis (Bone growth: femoral head; slipped capital femoral epiphysis)

CL Item

Bone Growth: Limb Length Discrepancy (Bone growth: limb length discrepancy)

CL Item

Bone Growth: Spine Kyphosis/lordosis (Bone growth: spine kyphosis/lordosis)

CL Item

Bone Marrow Depression Nos (Bone marrow cellularity)

CL Item

Bone: Spine-scoliosis (Bone: spine-scoliosis)

CL Item

Brachial Plexopathy (Brachial plexopathy)

C27194 (NCI Thesaurus)
C0700251 (UMLS 2011AA)

CL Item

Breast Function/lactation (Breast function/lactation)

CL Item

Breast Nipple/areolar Deformity (Breast nipple/areolar deformity)

CL Item

Breast Volume/hypoplasia (Breast volume/hypoplasia)

CL Item

Bronchospasm, Wheezing (Bronchospasm, wheezing)

CL Item

Ecchymosis (Bruising (in absence of grade 3 or 4 thrombocytopenia))

C26758 (NCI Thesaurus)
C0013491 (UMLS 2011AA)

CL Item

Burn (Burn)

C34441 (NCI Thesaurus)
C0006434 (UMLS 2011AA)

CL Item

Hypercalcaemia (Calcium, serum-high (hypercalcemia))

CL Item

Hypocalcaemia (Calcium, serum-low (hypocalcemia))

CL Item

Pulmonary Function Test Nos Decreased (Carbon monoxide diffusion capacity (DL(co)))

CL040958 (NCI Metathesaurus)

CL Item

Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify))

CL Item

Cardiac General Other (Cardiac General-Other (Specify))

CL Item

Myocardial Ischaemia (Cardiac ischemia/infarction)

C0151744 (NCI Metathesaurus)

CL Item

Cardiac Troponin I Increased (Cardiac troponin I (cTnI))

CL038402 (NCI Metathesaurus)

CL Item

Cardiac Troponin T Increased (Cardiac troponin T (cTnT))

CL038393 (NCI Metathesaurus)

CL Item

Cardiopulmonary Arrest, Cause Unknown (non-fatal) (Cardiopulmonary arrest, cause unknown (non-fatal))

CL Item

Cataract Nec (Cataract)

CL Item

Cd4 Lymphocytes Decreased (CD4 count)

CL038783 (NCI Metathesaurus)

CL Item

Cervical Spine-range Of Motion (Cervical spine-range of motion)

CL Item

Chelitis (Cheilitis)

CL Item

Cholecystitis (Cholecystitis)

C34465 (NCI Thesaurus)
C0008325 (UMLS 2011AA)

CL Item

Hypercholesteraemia (Cholesterol, serum-high (hypercholesteremia))

CL Item

Chyle Or Lymph Leakage (Chyle or lymph leakage)

CL Item

Chylothorax (Chylothorax)

C0008733 (NCI Metathesaurus)

CL Item

Cerebral Ischaemia (CNS cerebrovascular ischemia)

C0917798 (NCI Metathesaurus)

CL Item

Cns Necrosis/cystic Progression (CNS necrosis/cystic progression)

CL Item

Coagulation Disorder Nos (Coagulation-Other (Specify))

CL Item

Learning Disorder Nos (Cognitive disturbance)

C0023186 (NCI Metathesaurus)

CL Item

Colitis Nos (Colitis)

CL Item

Colitis, Infectious (e.g., Clostridium Difficile) (Colitis, infectious (e.g., Clostridium difficile))

CL Item

Ventricular Asystole (Conduction abnormality/Atrioventricular heart block - Asystole)

CL Item

Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality/Atrioventricular heart block - AV block-first degree)

CL Item

Conduction Abnormality/atrioventricular Heart Block - Av Block-second Degree Mobitz Type I (wenckebach) (Conduction abnormality/Atrioventricular heart block - AV block-Second degree Mobitz Type I (Wenckebach))

CL Item

Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality/Atrioventricular heart block - AV block-second degree Mobitz Type II)

CL Item

Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block))

CL Item

Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality/Atrioventricular heart block - Conduction abnormality NOS)

CL Item

Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality/Atrioventricular heart block - Sick sinus syndrome)

CL Item

Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality/Atrioventricular heart block - Stokes-Adams syndrome)

CL Item

Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality/Atrioventricular heart block - Wolff-Parkinson-White syndrome)

CL Item

Confusion (Confusion)

C37928 (NCI Thesaurus)
C0009676 (UMLS 2011AA)

CL Item

Constipation (Constipation)

C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)

CL Item

Constitutional Symptoms Other (Constitutional Symptoms-Other (Specify))

CL Item

Cough (Cough)

C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)

CL Item

Blood Creatine Phosphokinase Increased (CPK (creatine phosphokinase))

CL038686 (NCI Metathesaurus)

CL Item

Blood Creatinine Increased (Creatinine)

C0235431 (NCI Metathesaurus)

CL Item

Cushingoid (Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae))

C37938 (NCI Thesaurus)
C0878661 (UMLS 2011AA)

CL Item

Cystitis (Cystitis)

C26738 (NCI Thesaurus)
C0010692 (UMLS 2011AA)

CL Item

Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)

CL Item

Death Not Associated With Ctcae Term (Death not associated with CTCAE term - Death NOS)

CL Item

Death Not Associated With Ctcae Term (Death not associated with CTCAE term - Disease progression NOS)

CL Item

Death Not Associated With Ctcae Term (Death not associated with CTCAE term - Multi-organ failure)

CL Item

Death Not Associated With Ctcae Term (Death not associated with CTCAE term - Sudden death)

CL Item

Dehydration (Dehydration)

C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)

CL Item

Dental: Dentures Or Prosthesis (Dental: dentures or prosthesis)

CL Item

Dental: Periodontal Disease (Dental: periodontal disease)

CL Item

Dental: Teeth (Dental: teeth)

CL Item

Dental: Teeth Development (Dental: teeth development)

CL Item

Dermal Change Lymphedema, Phlebolymphedema (Dermal change lymphedema, phlebolymphedema)

CL Item

Dermatology/skin Other (Dermatology/Skin-Other (Specify))

CL Item

Diarrhoea Nos (Diarrhea)

CL Item

Disseminated Intravascular Coagulation (DIC (disseminated intravascular coagulation))

C2992 (NCI Thesaurus)
C0012739 (UMLS 2011AA)

CL Item

Distention/bloating, Abdominal (Distention/bloating, abdominal)

CL Item

Dizziness (exc Vertigo) (Dizziness)

CL Item

Dry Eye Nec (Dry eye syndrome)

CL Item

Dry Mouth (Dry mouth/salivary gland (xerostomia))

C26917 (NCI Thesaurus)
C0043352 (UMLS 2011AA)

CL Item

Dry Skin (Dry skin)

C0151908 (NCI Metathesaurus)

CL Item

Dysphagia (Dysphagia (difficulty swallowing))

C2980 (NCI Thesaurus)
C0011168 (UMLS 2011AA)

CL Item

Dyspnoea Nos (Dyspnea (shortness of breath))

CL Item

Edema, Larynx (Edema, larynx)

CL Item

Edema: Head And Neck (Edema: head and neck)

CL Item

Oedema Nos (Edema: limb)

CL Item

Edema: Trunk/genital (Edema: trunk/genital)

CL Item

Edema: Viscera (Edema: viscera)

CL Item

Ejaculatory Dysfunction (Ejaculatory dysfunction)

CL Item

Encephalopathy (Encephalopathy)

C26920 (NCI Thesaurus)
C0085584 (UMLS 2011AA)

CL Item

Endocrine Other (Endocrine-Other (Specify))

CL Item

Enteritis (inflammation Of The Small Bowel) (Enteritis (inflammation of the small bowel))

CL Item

Impotence (Erectile dysfunction)

C3133 (NCI Thesaurus)
C0242350 (UMLS 2011AA)

CL Item

Oesophagitis Nos (Esophagitis)

CL Item

Exostosis (Exostosis)

C3029 (NCI Thesaurus)
C1442903 (UMLS 2011AA)

CL Item

Extrapyramidal Disorder Nec (Extrapyramidal/involuntary movement/restlessness)

CL Item

Extremity-lower (gait/walking) (Extremity-lower (gait/walking))

CL Item

Extremity-upper (function) (Extremity-upper (function))

CL Item

Eyelid Dysfunction (Eyelid dysfunction)

CL Item

Fatigue (Fatigue (asthenia, lethargy, malaise))

C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)

CL Item

Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)

CL Item

Feminization (Feminization of male)

C26773 (NCI Thesaurus)
C0015799 (UMLS 2011AA)

CL Item

Forced Expiratory Volume Decreased (FEV(1))

CL036765 (NCI Metathesaurus)

CL Item

Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))

CL Item

Blood Fibrinogen Decreased (Fibrinogen)

CL039651 (NCI Metathesaurus)

CL Item

Fibrosis-cosmesis (Fibrosis-cosmesis)

CL Item

Fibrosis-deep Connective Tissue (Fibrosis-deep connective tissue)

CL Item

Fistula, Gi (Fistula, GI - Abdomen NOS)

CL Item

Anal Fistula (Fistula, GI - Anus)

C0205929 (NCI Metathesaurus)

CL Item

Fistula, Gi (Fistula, GI - Biliary tree)

CL Item

Fistula, Gi (Fistula, GI - Colon/cecum/appendix)

CL Item

Intestinal Fistula (Fistula, GI - Duodenum)

C34732 (NCI Thesaurus)
C0021833 (UMLS 2011AA)

CL Item

Tracheo-oesophageal Fistula Nos (Fistula, GI - Esophagus)

CL Item

Fistula, Gi (Fistula, GI - Gallbladder)

CL Item

Fistula, Gi (Fistula, GI - Ileum)

CL Item

Fistula, Gi (Fistula, GI - Jejunum)

CL Item

Fistula, Gi (Fistula, GI - Oral cavity)

CL Item

Fistula, Gi (Fistula, GI - Pancreas)

CL Item

Fistula, Gi (Fistula, GI - Pharynx)

CL Item

Fistula, Gi (Fistula, GI - Rectum)

CL Item

Fistula, Gi (Fistula, GI - Salivary gland)

CL Item

Fistula, Gi (Fistula, GI - Small bowel NOS)

CL Item

Fistula, Gi (Fistula, GI - Stomach)

CL Item

Fistula, Gu (Fistula, GU - Bladder)

CL Item

Fistula, Gu (Fistula, GU - Genital tract-female)

CL Item

Fistula, Gu (Fistula, GU - Kidney)

CL Item

Fistula, Gu (Fistula, GU - Ureter)

CL Item

Fistula, Gu (Fistula, GU - Urethra)

CL Item

Fistula, Gu (Fistula, GU - Uterus)

CL Item

Urogenital Fistula (Fistula, GU - Vagina)

CL Item

Fistula, Pulmonary/upper Respiratory (Fistula, pulmonary/upper respiratory - Bronchus)

CL Item

Fistula, Pulmonary/upper Respiratory (Fistula, pulmonary/upper respiratory - Larynx)

CL Item

Fistula, Pulmonary/upper Respiratory (Fistula, pulmonary/upper respiratory - Lung)

CL Item

Fistula, Pulmonary/upper Respiratory (Fistula, pulmonary/upper respiratory - Oral cavity)

CL Item

Fistula, Pulmonary/upper Respiratory (Fistula, pulmonary/upper respiratory - Pharynx)

CL Item

Fistula, Pulmonary/upper Respiratory (Fistula, pulmonary/upper respiratory - Pleura)

CL Item

Fistula, Pulmonary/upper Respiratory (Fistula, pulmonary/upper respiratory - Trachea)

CL Item

Flatulence (Flatulence)

C37954 (NCI Thesaurus)
C0016204 (UMLS 2011AA)

CL Item

Flu-like Syndrome (Flu-like syndrome)

CL Item

Flushing (Flushing)

C26775 (NCI Thesaurus)
C0016382 (UMLS 2011AA)

CL Item

Fracture (Fracture)

C3046 (NCI Thesaurus)
C0016658 (UMLS 2011AA)

CL Item

Gastritis Nos (Gastritis (including bile reflux gastritis))

CL Item

Gastrointestinal Other (Gastrointestinal-Other (Specify))

CL Item

Gamma-glutamyltransferase Increased (GGT (gamma-glutamyl transpeptidase))

C26943 (NCI Thesaurus)
C0151662 (UMLS 2011AA)

CL Item

Glaucoma Nos (Glaucoma)

CL Item

Glomerular Filtration Rate (Glomerular filtration rate)

C0017654 (NCI Metathesaurus)

CL Item

Hyperglycaemia Nos (Glucose, serum-high (hyperglycemia))

CL Item

Hypoglycaemia Nos (Glucose, serum-low (hypoglycemia))

CL Item

Growth And Development Other (Growth and Development-Other (Specify))

CL Item

Growth Velocity (reduction In Growth Velocity) (Growth velocity (reduction in growth velocity))

CL Item

Gynaecomastia (Gynecomastia)

CL Item

Alopecia (Hair loss/Alopecia (scalp or body))

C2865 (NCI Thesaurus)

CL Item

Haptoglobin Decreased (Haptoglobin)

C0236062 (NCI Metathesaurus)

CL Item

Hearing: Patients With/without Baseline Audiogram And Enrolled In A Monitoring Program (Hearing: patients with/without baseline audiogram and enrolled in a monitoring program)

CL Item

Hearing: Patients Without Baseline Audiogram And Not Enrolled In A Monitoring Program (Hearing: patients without baseline audiogram and not enrolled in a monitoring program)

CL Item

Dyspepsia (Heartburn/dyspepsia)

C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)

CL Item

Hematoma (Hematoma)

C50579 (NCI Thesaurus)
C0018944 (UMLS 2011AA)

CL Item

Haemoglobin Decreased (Hemoglobin)

C0162119 (NCI Metathesaurus)

CL Item

Haemoglobinuria Present (Hemoglobinuria)

CL Item

Hemolysis Nos (Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis))

C0019054 (NCI Metathesaurus)

CL Item

Haemorrhagic Stroke (Hemorrhage, CNS)

CL036983 (NCI Metathesaurus)

CL Item

Melaena (Hemorrhage, GI - Abdomen NOS)

C0025222 (NCI Metathesaurus)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Anus)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Biliary tree)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Cecum/appendix)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Colon)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Duodenum)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Esophagus)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Ileum)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Jejunum)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Liver)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Lower GI NOS)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Oral cavity)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Pancreas)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Peritoneal cavity)

CL Item

Rectal Bleeding (Hemorrhage, GI - Rectum)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Stoma)

CL Item

Haematemesis (Hemorrhage, GI - Stomach)

C0018926 (NCI Metathesaurus)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Upper GI NOS)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Varices (esophageal))

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Varices (rectal))

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Bladder)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Fallopian tube)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Kidney)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Ovary)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Prostate)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Retroperitoneum)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Spermatic cord)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Stoma)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Testes)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Ureter)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Urethra)

CL Item

Haematuria Present (Hemorrhage, GU - Urinary NOS)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Uterus)

CL Item

Vaginal Haemorrhage (Hemorrhage, GU - Vagina)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Vas deferens)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Bronchus)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Larynx)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Lung)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Mediastinum)

CL Item

Epistaxis (Hemorrhage, pulmonary/upper respiratory - Nose)

C26766 (NCI Thesaurus)
C0014591 (UMLS 2011AA)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Pharynx)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Pleura)

CL Item

Haemoptysis (Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Stoma)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Trachea)

CL Item

Post-operative Haemorrhage (Hemorrhage/bleeding associated with surgery, intra-operative or post-operative)

CL Item

Hemorrhage/bleeding Other (Hemorrhage/Bleeding-Other (Specify))

CL Item

Hemorrhoids (Hemorrhoids)

CL Item

Hepatobiliary/pancreas Other (Hepatobiliary/Pancreas-Other (Specify))

CL Item

Hiccups (Hiccoughs (hiccups, singultus))

C0019521 (NCI Metathesaurus)

CL Item

Menopausal Symptoms (Hot flashes/flushes)

CL Item

Hydrocephalus (Hydrocephalus)

C3111 (NCI Thesaurus)
C0020255 (UMLS 2011AA)

CL Item

Skin Discolouration (Hyperpigmentation)

CL Item

Hypertension Nos (Hypertension)

CL Item

Hypopigmentation (Hypopigmentation)

CL Item

Hypotension Nos (Hypotension)

CL Item

Hypothermia (Hypothermia)

C0020672 (NCI Metathesaurus)

CL Item

Hypoxia (Hypoxia)

C3890 (NCI Thesaurus)
C0242184 (UMLS 2011AA)

CL Item

Ileus (Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation))

C37979 (NCI Thesaurus)
C1258215 (UMLS 2011AA)

CL Item

Incontinence, Anal (Incontinence, anal)

CL Item

Urinary Incontinence (Incontinence, urinary)

C3429 (NCI Thesaurus)
C0021167 (UMLS 2011AA)

CL Item

Induration/fibrosis (skin And Subcutaneous Tissue) (Induration/fibrosis (skin and subcutaneous tissue))

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Abdomen NOS)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Cecum)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Colon)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Ileum)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Joint)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lens)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Liver)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Nose)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Penis)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Sinus)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Vein)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Vulva)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Wound)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Anal/perianal)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Artery)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Biliary tree)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Blood)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Bone (osteomyelitis))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Brain (encephalitis, infectious))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Brain + Spinal cord (encephalomyelitis))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Cecum)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Cervix)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Colon)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Conjunctiva)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Cornea)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Dental-tooth)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Duodenum)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Esophagus)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - External ear (otitis externa))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Eye NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Fallopian tube)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body (e.g., graft, implant, prosthesis, stent))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Gallbladder (cholecystitis))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Heart (endocarditis))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Ileum)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Jejunum)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Joint)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Larynx)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lens)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lip/perioral)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Liver)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lymphatic)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Mediastinum NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Meninges (meningitis))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Middle ear (otitis media))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Mucosa)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Muscle (infection myositis))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Neck NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-cranial)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-peripheral)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Nose)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Pancreas)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Paranasal)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Pelvis NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Penis)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Peristomal)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Peritoneal cavity)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Pharynx)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Pleura (empyema))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Prostate)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Rectum)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Salivary gland)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Scrotum)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Small bowel NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Spinal cord (myelitis))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Spleen)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Stomach)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Trachea)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Ungual (nails))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Upper aerodigestive NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Ureter)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Urethra)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Uterus)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Vein)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Vulva)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Wound)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Abdomen NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Anal/perianal)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Appendix)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Artery)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Biliary tree)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Bladder (urinary))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Blood)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Bone (osteomyelitis))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Brain (encephalitis, infectious))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Brain + Spinal cord (encephalomyelitis))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Bronchus)

CL Item

Implant Infection (Infection with unknown ANC - Catheter-related)

CL039939 (NCI Metathesaurus)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Cecum)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Cervix)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Colon)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Conjunctiva)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Cornea)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Dental-tooth)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Duodenum)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Esophagus)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - External ear (otitis externa))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Eye NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Fallopian tube)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Foreign body (e.g., graft, implant, prosthesis, stent))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Gallbladder (cholecystitis))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Heart (endocarditis))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Ileum)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Jejunum)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Joint)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Kidney)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Larynx)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Lens)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Lip/perioral)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Liver)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Lung (pneumonia))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Lymphatic)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Mediastinum NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Meninges (meningitis))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Middle ear (otitis media))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Mucosa)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Muscle (infection myositis))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Neck NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Nerve-cranial)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Nerve-peripheral)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Nose)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Oral cavity-gums (gingivitis))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Pancreas)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Paranasal)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Pelvis NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Penis)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Peristomal)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Peritoneal cavity)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Pharynx)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Pleura (empyema))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Prostate)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Rectum)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Salivary gland)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Scrotum)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Sinus)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Skin (cellulitis))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Small bowel NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Soft tissue NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Spinal cord (myelitis))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Spleen)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Stomach)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Trachea)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Ungual (nails))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Upper aerodigestive NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Upper airway NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Ureter)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Urethra)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Urinary tract NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Uterus)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Vagina)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Vein)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Vulva)

CL Item

Culture Wound Positive (Infection with unknown ANC - Wound)

C0476436 (NCI Metathesaurus)

CL Item

Infection Nos (Infection-Other (Specify))

CL Item

Infertility/sterility (Infertility/sterility)

CL Item

Injection Site Reaction Nos (Injection site reaction/extravasation changes)

CL Item

Prothrombin Time Prolonged (INR (International Normalized Ratio of prothrombin time))

CL Item

Insomnia Nec (Insomnia)

CL Item

Intra-operative Injury (Intra-operative injury - Abdomen NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Adrenal gland)

CL Item

Intra-operative Injury (Intra-operative injury - Anal sphincter)

CL Item

Intra-operative Injury (Intra-operative injury - Anus)

CL Item

Intra-operative Injury (Intra-operative injury - Appendix)

CL Item

Intra-operative Injury (Intra-operative injury - Artery NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Artery-aorta)

CL Item

Intra-operative Injury (Intra-operative injury - Artery-carotid)

CL Item

Intra-operative Injury (Intra-operative injury - Artery-cerebral)

CL Item

Intra-operative Injury (Intra-operative injury - Artery-extremity (lower))

CL Item

Intra-operative Injury (Intra-operative injury - Artery-extremity (upper))

CL Item

Intra-operative Injury (Intra-operative injury - Artery-hepatic)

CL Item

Intra-operative Injury (Intra-operative injury - Artery-major visceral artery)

CL Item

Intra-operative Injury (Intra-operative injury - Artery-pulmonary)

CL Item

Intra-operative Injury (Intra-operative injury - Biliary tree NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Biliary tree-common bile duct)

CL Item

Intra-operative Injury (Intra-operative injury - Biliary tree-common hepatic duct)

CL Item

Intra-operative Injury (Intra-operative injury - Biliary tree-left hepatic duct)

CL Item

Intra-operative Injury (Intra-operative injury - Biliary tree-right hepatic duct)

CL Item

Bladder Perforation Postoperative (Intra-operative injury - Bladder)

CL036716 (NCI Metathesaurus)

CL Item

Intra-operative Injury (Intra-operative injury - Bone)

CL Item

Intra-operative Injury (Intra-operative injury - Brachial plexus)

CL Item

Intra-operative Injury (Intra-operative injury - Brain)

CL Item

Intra-operative Injury (Intra-operative injury - Breast)

CL Item

Intra-operative Injury (Intra-operative injury - Bronchus)

CL Item

Intra-operative Injury (Intra-operative injury - Cartilage)

CL Item

Intra-operative Injury (Intra-operative injury - Cecum)

CL Item

Intra-operative Injury (Intra-operative injury - Cervix)

CL Item

Intra-operative Injury (Intra-operative injury - CN I (olfactory))

CL Item

Intra-operative Injury (Intra-operative injury - CN II (optic))

CL Item

Intra-operative Injury (Intra-operative injury - CN III (oculomotor))

CL Item

Intra-operative Injury (Intra-operative injury - CN IV (trochlear))

CL Item

Intra-operative Injury (Intra-operative injury - CN IX (glossopharyngeal) motor pharynx)

CL Item

Intra-operative Injury (Intra-operative injury - CN IX (glossopharyngeal) sensory ear-pharynx-tongue)

CL Item

Intra-operative Injury (Intra-operative injury - CN V (trigeminal) motor)

CL Item

Intra-operative Injury (Intra-operative injury - CN V (trigeminal) sensory)

CL Item

Intra-operative Injury (Intra-operative injury - CN VI (abducens))

CL Item

Intra-operative Injury (Intra-operative injury - CN VII (facial) motor-face)

CL Item

Intra-operative Injury (Intra-operative injury - CN VII (facial) sensory-taste)

CL Item

Intra-operative Injury (Intra-operative injury - CN VIII (vestibulocochlear))

CL Item

Intra-operative Injury (Intra-operative injury - CN X (vagus))

CL Item

Intra-operative Injury (Intra-operative injury - CN XI (spinal accessory))

CL Item

Intra-operative Injury (Intra-operative injury - CN XII (hypoglossal))

CL Item

Intra-operative Injury (Intra-operative injury - Colon)

CL Item

Intra-operative Injury (Intra-operative injury - Conjunctiva)

CL Item

Intra-operative Injury (Intra-operative injury - Cornea)

CL Item

Intra-operative Injury (Intra-operative injury - Cranial nerve or branch NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Duodenum)

CL Item

Intra-operative Injury (Intra-operative injury - Esophagus)

CL Item

Intra-operative Injury (Intra-operative injury - Extremity-lower)

CL Item

Intra-operative Injury (Intra-operative injury - Extremity-upper)

CL Item

Intra-operative Injury (Intra-operative injury - Eye NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Face NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Fallopian tube)

CL Item

Intra-operative Injury (Intra-operative injury - Gallbladder)

CL Item

Intra-operative Injury (Intra-operative injury - Gingiva)

CL Item

Intra-operative Injury (Intra-operative injury - Heart)

CL Item

Intra-operative Injury (Intra-operative injury - Ileum)

CL Item

Intra-operative Injury (Intra-operative injury - Inner ear)

CL Item

Intra-operative Injury (Intra-operative injury - Jejunum)

CL Item

Intra-operative Injury (Intra-operative injury - Joint)

CL Item

Intra-operative Injury (Intra-operative injury - Kidney)

CL Item

Intra-operative Injury (Intra-operative injury - Larynx)

CL Item

Intra-operative Injury (Intra-operative injury - Lens)

CL Item

Intra-operative Injury (Intra-operative injury - Ligament)

CL Item

Intra-operative Injury (Intra-operative injury - Lingual)

CL Item

Intra-operative Injury (Intra-operative injury - Lip/perioral area)

CL Item

Intra-operative Injury (Intra-operative injury - Liver)

CL Item

Intra-operative Injury (Intra-operative injury - Lung)

CL Item

Intra-operative Injury (Intra-operative injury - Lung thoracic)

CL Item

Intra-operative Injury (Intra-operative injury - Mediastinum)

CL Item

Intra-operative Injury (Intra-operative injury - Meninges)

CL Item

Intra-operative Injury (Intra-operative injury - Middle ear)

CL Item

Intra-operative Injury (Intra-operative injury - Muscle)

CL Item

Intra-operative Injury (Intra-operative injury - Nails)

CL Item

Intra-operative Injury (Intra-operative injury - Nasal cavity)

CL Item

Intra-operative Injury (Intra-operative injury - Nasopharynx)

CL Item

Intra-operative Injury (Intra-operative injury - Neck NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Nose)

CL Item

Intra-operative Injury (Intra-operative injury - Oral)

CL Item

Intra-operative Injury (Intra-operative injury - Oral cavity NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Outer ear NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Outer ear-pinna)

CL Item

Intra-operative Injury (Intra-operative injury - Ovary)

CL Item

Intra-operative Injury (Intra-operative injury - Pancreas)

CL Item

Intra-operative Injury (Intra-operative injury - Pancreatic duct)

CL Item

Intra-operative Injury (Intra-operative injury - Parathyroid)

CL Item

Intra-operative Injury (Intra-operative injury - Parotid gland)

CL Item

Intra-operative Injury (Intra-operative injury - Pelvis NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Penis)

CL Item

Intra-operative Injury (Intra-operative injury - Peripheral motor NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Peripheral sensory NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Peritoneal cavity)

CL Item

Intra-operative Injury (Intra-operative injury - Pharynx)

CL Item

Intra-operative Injury (Intra-operative injury - Pituitary)

CL Item

Intra-operative Injury (Intra-operative injury - Pleura)

CL Item

Intra-operative Injury (Intra-operative injury - Prostate)

CL Item

Intra-operative Injury (Intra-operative injury - Rectum)

CL Item

Intra-operative Injury (Intra-operative injury - Recurrent laryngeal)

CL Item

Intra-operative Injury (Intra-operative injury - Retina)

CL Item

Intra-operative Injury (Intra-operative injury - Sacral plexus)

CL Item

Intra-operative Injury (Intra-operative injury - Salivary duct)

CL Item

Intra-operative Injury (Intra-operative injury - Salivary gland)

CL Item

Intra-operative Injury (Intra-operative injury - Sciatic)

CL Item

Intra-operative Injury (Intra-operative injury - Scrotum)

CL Item

Intra-operative Injury (Intra-operative injury - Sinus)

CL Item

Intra-operative Injury (Intra-operative injury - Skin)

CL Item

Intra-operative Injury (Intra-operative injury - Small bowel NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Soft tissue NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Spinal cord)

CL Item

Intra-operative Injury (Intra-operative injury - Spleen)

CL Item

Intra-operative Injury (Intra-operative injury - Stoma (GI))

CL Item

Intra-operative Injury (Intra-operative injury - Stomach)

CL Item

Intra-operative Injury (Intra-operative injury - Teeth)

CL Item

Intra-operative Injury (Intra-operative injury - Tendon)

CL Item

Intra-operative Injury (Intra-operative injury - Testis)

CL Item

Intra-operative Injury (Intra-operative injury - Thoracic duct)

CL Item

Intra-operative Injury (Intra-operative injury - Thoracodorsal)

CL Item

Intra-operative Injury (Intra-operative injury - Thyroid)

CL Item

Intra-operative Injury (Intra-operative injury - Tongue)

CL Item

Intra-operative Injury (Intra-operative injury - Trachea)

CL Item

Intra-operative Injury (Intra-operative injury - Upper aerodigestive NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Upper airway NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Ureter)

CL Item

Intra-operative Injury (Intra-operative injury - Urethra)

CL Item

Intra-operative Injury (Intra-operative injury - Urinary conduit)

CL Item

Intra-operative Injury (Intra-operative injury - Urinary tract NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Uterus)

CL Item

Intra-operative Injury (Intra-operative injury - Vagina)

CL Item

Intra-operative Injury - Vein (Intra-operative injury - Vein NOS)

CL Item

Intra-operative Injury (Intra-operative injury - Vein-extremity (lower))

CL Item

Intra-operative Injury (Intra-operative injury - Vein-extremity (upper))

CL Item

Intra-operative Injury (Intra-operative injury - Vein-hepatic)

CL Item

Intra-operative Injury (Intra-operative injury - Vein-inferior vena cava)

CL Item

Intra-operative Injury (Intra-operative injury - Vein-jugular)

CL Item

Intra-operative Injury (Intra-operative injury - Vein-major visceral vein)

CL Item

Intra-operative Injury (Intra-operative injury - Vein-portal vein)

CL Item

Intra-operative Injury (Intra-operative injury - Vein-pulmonary)

CL Item

Intra-operative Injury (Intra-operative injury - Vein-superior vena cava)

CL Item

Intra-operative Injury (Intra-operative injury - Vulva)

CL Item

Intra-operative Injury Other (Intra-operative Injury-Other (Specify))

CL Item

Iron Overload (Iron overload)

CL Item

Menstruation Irregular (Irregular menses (change from baseline))

CL Item

Irritability (Irritability (children <3 years of age))

C0022107 (NCI Metathesaurus)

CL Item

Joint-effusion (Joint-effusion)

CL Item

Joint-effusion (Joint-function)

CL Item

Keratitis Nec (Keratitis (corneal inflammation/corneal ulceration))

CL Item

Laryngeal Nerve Dysfunction (Laryngeal nerve dysfunction)

CL Item

Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Biliary tree)

CL Item

Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Esophagus)

CL Item

Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Large bowel)

CL Item

Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Leak NOS)

CL Item

Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Pancreas)

CL Item

Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Pharynx)

CL Item

Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Rectum)

CL Item

Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Small bowel)

CL Item

Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Stoma)

CL Item

Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Stomach)

CL Item

Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Bladder)

CL Item

Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Fallopian tube)

CL Item

Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Kidney)

CL Item

Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Spermatic cord)

CL Item

Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Stoma)

CL Item

Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Ureter)

CL Item

Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Urethra)

CL Item

Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Uterus)

CL Item

Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Vagina)

CL Item

Leak (including Anastomotic), Gu (Leak (including anastomotic), GU - Vas deferens)

CL Item

Leak, Cerebrospinal Fluid (csf) (Leak, cerebrospinal fluid (CSF))

CL Item

Left Ventricular Diastolic Dysfunction (Left ventricular diastolic dysfunction)

CL Item

Left Ventricular Failure (Left ventricular systolic dysfunction)

C0023212 (NCI Metathesaurus)

CL Item

Leucopenia Nos (Leukocytes (total WBC))

CL Item

Encephalopathy Nos (Leukoencephalopathy (radiolographic findings))

CL Item

Libido Decreased (Libido)

C0011124 (NCI Metathesaurus)

CL Item

Lipase Increased (Lipase)

C0549475 (NCI Metathesaurus)

CL Item

Hepatic Failure (Liver dysfunction/failure (clinical))

C26922 (NCI Thesaurus)
C0085605 (UMLS 2011AA)

CL Item

Local Complication - Device/prosthesis-related (Local complication - device/prosthesis-related)

CL Item

Lumbar Spine-range Of Motion (Lumbar spine-range of motion)

CL Item

Lymphatics Other (Lymphatics-Other (Specify))

CL Item

Lymphedema-related Fibrosis (Lymphedema-related fibrosis)

CL Item

Lymphocele (Lymphocele)

C0024248 (NCI Metathesaurus)

CL Item

Lymphopenia (Lymphopenia)

C26823 (NCI Thesaurus)
C0024312 (UMLS 2011AA)

CL Item

Hypermagnesaemia (Magnesium, serum-high (hypermagnesemia))

C0151714 (NCI Metathesaurus)

CL Item

Blood Magnesium Decreased (Magnesium, serum-low (hypomagnesemia))

CL039365 (NCI Metathesaurus)

CL Item

Malabsorption (Malabsorption)

CL Item

Virilism (Masculinization of female)

C26914 (NCI Thesaurus)

CL Item

Amnesia Nec (Memory impairment)

CL Item

Mental Status (Mental status)

C0278060 (NCI Metathesaurus)

CL Item

Metabolic/laboratory Other (Metabolic/Laboratory-Other (Specify))

CL Item

Mood Alteration - Agitation (Mood alteration - agitation)

CL Item

Anxiety Nec (Mood alteration - anxiety)

CL Item

Depression Nec (Mood alteration - depression)

CL Item

Euphoric Mood (Mood alteration - euphoria)

C27011 (NCI Thesaurus)
C0235146 (UMLS 2011AA)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Anus)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Esophagus)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Large bowel)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Larynx)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Oral cavity)

CL Item

Stomatitis (Mucositis/stomatitis (clinical exam) - Pharynx)

C26887 (NCI Thesaurus)
C0038362 (UMLS 2011AA)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Rectum)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Small bowel)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Stomach)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Trachea)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Anus)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Esophagus)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Large bowel)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Larynx)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Pharynx)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Rectum)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Small bowel)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Stomach)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Trachea)

CL Item

Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular)

CL Item

Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower)

CL Item

Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-upper)

CL Item

Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Facial)

CL Item

Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided)

CL Item

Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Ocular)

CL Item

Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Pelvic)

CL Item

Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Right-sided)

CL Item

Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Trunk)

CL Item

Muscle Weakness Nos (Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized)

C0151786 (NCI Metathesaurus)

CL Item

Muscular/skeletal Hypoplasia (Muscular/skeletal hypoplasia)

CL Item

Musculoskeletal/soft Tissue Other (Musculoskeletal/Soft Tissue-Other (Specify))

CL Item

Myelitis (Myelitis)

C26832 (NCI Thesaurus)
C0026975 (UMLS 2011AA)

CL Item

Myelodysplasia (Myelodysplasia)

CL Item

Myocarditis Nos (Myocarditis)

CL Item

Myositis (Myositis (inflammation/damage of muscle))

C27578 (NCI Thesaurus)
C0027121 (UMLS 2011AA)

CL Item

Nail Abnormality Nos (Nail changes)

CL038732 (NCI Metathesaurus)

CL Item

Nasal Cavity/paranasal Sinus Reactions (Nasal cavity/paranasal sinus reactions)

CL Item

Nausea (Nausea)

C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)

CL Item

Necrosis, Gi (Necrosis, GI - Anus)

CL Item

Necrosis, Gi (Necrosis, GI - Colon/cecum/appendix)

CL Item

Necrosis, Gi (Necrosis, GI - Duodenum)

CL Item

Necrosis, Gi (Necrosis, GI - Esophagus)

CL Item

Necrosis, Gi (Necrosis, GI - Gallbladder)

CL Item

Necrosis, Gi (Necrosis, GI - Hepatic)

CL Item

Necrosis, Gi (Necrosis, GI - Ileum)

CL Item

Necrosis, Gi (Necrosis, GI - Jejunum)

CL Item

Necrosis, Gi (Necrosis, GI - Oral)

CL Item

Necrosis, Gi (Necrosis, GI - Pancreas)

CL Item

Necrosis, Gi (Necrosis, GI - Peritoneal cavity)

CL Item

Necrosis, Gi (Necrosis, GI - Pharynx)

CL Item

Necrosis, Gi (Necrosis, GI - Rectum)

CL Item

Necrosis, Gi (Necrosis, GI - Small bowel NOS)

CL Item

Necrosis, Gi (Necrosis, GI - Stoma)

CL Item

Necrosis, Gi (Necrosis, GI - Stomach)

CL Item

Neuroendocrine: Acth Deficiency (Neuroendocrine: ACTH deficiency)

CL Item

Inappropriate Adh Secretion (Neuroendocrine: ADH secretion abnormality (e.g., SIADH or low ADH))

CL Item

Neuroendocrine: Gonadotropin Secretion Abnormality (Neuroendocrine: gonadotropin secretion abnormality)

CL Item

Neuroendocrine: Growth Hormone Secretion Abnormality (Neuroendocrine: growth hormone secretion abnormality)

CL Item

Neuroendocrine: Prolactin Hormone Secretion Abnormality (Neuroendocrine: prolactin hormone secretion abnormality)

CL Item

Neurology Other (Neurology-Other (Specify))

CL Item

Parosmia (Neuropathy: cranial - CN I Smell)

C0085626 (NCI Metathesaurus)

CL Item

Cranial Nerve Injury Nos (Neuropathy: cranial - CN II Vision)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - CN III Pupil, upper eyelid, extra ocular movements)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - CN IV Downward, inward movement of eye)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - CN IX Motor-pharynx; Sensory-ear, pharynx, tongue)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - CN VI Lateral deviation of eye)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - CN VII Motor-face; Sensory-taste)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - CN VIII Hearing and balance)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - CN X Motor-palate; pharynx, larynx)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - CN XI Motor-sternomastoid and trapezius)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - CN XII Motor-tongue)

CL Item

Peripheral Motor Neuropathy (Neuropathy: motor)

C3500 (NCI Thesaurus)
C0018995 (UMLS 2011AA)

CL Item

Peripheral Sensory Neuropathy (Neuropathy: sensory)

C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)

CL Item

Neutropenia (Neutrophils/granulocytes (ANC/AGC))

C3277 (NCI Thesaurus)

CL Item

Blindness Night (Night blindness (nyctalopia))

CL Item

Nystagmus Nos (Nystagmus)

CL Item

Obesity (Obesity)

C3283 (NCI Thesaurus)
C0028754 (UMLS 2011AA)

CL Item

Obstruction, Gi (Obstruction, GI - Cecum)

CL Item

Obstruction, Gi (Obstruction, GI - Colon)

CL Item

Obstruction, Gi (Obstruction, GI - Duodenum)

CL Item

Obstruction, Gi (Obstruction, GI - Esophagus)

CL Item

Obstruction, Gi (Obstruction, GI - Gallbladder)

CL Item

Obstruction, Gi (Obstruction, GI - Ileum)

CL Item

Obstruction, Gi (Obstruction, GI - Jejunum)

CL Item

Obstruction, Gi (Obstruction, GI - Rectum)

CL Item

Obstruction, Gi (Obstruction, GI - Small bowel NOS)

CL Item

Obstruction, Gi (Obstruction, GI - Stoma)

CL Item

Obstruction, Gi (Obstruction, GI - Stomach)

CL Item

Obstruction, Gu (Obstruction, GU - Bladder)

CL Item

Obstruction, Gu (Obstruction, GU - Fallopian tube)

CL Item

Obstruction, Gu (Obstruction, GU - Prostate)

CL Item

Obstruction, Gu (Obstruction, GU - Spermatic cord)

CL Item

Obstruction, Gu (Obstruction, GU - Stoma)

CL Item

Obstruction, Gu (Obstruction, GU - Testes)

CL Item

Ureteric Obstruction (Obstruction, GU - Ureter)

C0041956 (NCI Metathesaurus)

CL Item

Obstruction, Gu (Obstruction, GU - Urethra)

CL Item

Obstruction, Gu (Obstruction, GU - Uterus)

CL Item

Obstruction, Gu (Obstruction, GU - Vagina)

CL Item

Obstruction, Gu (Obstruction, GU - Vas deferens)

CL Item

Obstruction/stenosis Of Airway (Obstruction/stenosis of airway - Bronchus)

CL Item

Obstruction/stenosis Of Airway (Obstruction/stenosis of airway - Larynx)

CL Item

Obstruction/stenosis Of Airway (Obstruction/stenosis of airway - Pharynx)

CL Item

Obstruction/stenosis Of Airway (Obstruction/stenosis of airway - Trachea)

CL Item

Conjunctivitis Nec (Ocular surface disease)

CL Item

Ocular/visual Other (Ocular/Visual-Other (Specify))

CL Item

Odor (patient Odor) (Odor (patient odor))

CL Item

Diplopia (Ophthalmoplegia/diplopia (double vision))

C37941 (NCI Thesaurus)
C0012569 (UMLS 2011AA)

CL Item

Opportunistic Infection Associated With >=grade 2 Lymphopenia (Opportunistic infection associated with >=Grade 2 lymphopenia)

CL Item

Optic Disc Edema (Optic disc edema)

CL Item

Orgasmic Dysfunction (Orgasmic dysfunction)

CL Item

Osteonecrosis (Osteonecrosis (avascular necrosis))

CL Item

Osteoporosis (Osteoporosis)

C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)

CL Item

Otitis Externa (exc Boil Of Meatus) Nos (Otitis, external ear (non-infectious))

CL Item

Otitis Media Serous Nos (Otitis, middle ear (non-infectious))

C0271453 (NCI Metathesaurus)

CL Item

Abdominal Pain Nos (Pain - Abdomen NOS)

CL Item

Pain (Pain - Anus)

C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)

CL Item

Pain (Pain - Back)

CL Item

Pain (Pain - Bladder)

CL Item

Bone Pain (Pain - Bone)

C38644 (NCI Thesaurus)
C0151825 (UMLS 2011AA)

CL Item

Pain (Pain - Breast)

CL Item

Pain (Pain - Buttock)

CL Item

Pain (Pain - Cardiac/heart)

CL Item

Pain (Pain - Chest wall)

CL Item

Chest Pain (Pain - Chest/thorax NOS)

C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)

CL Item

Pain (Pain - Dental/teeth/peridontal)

CL Item

Pain (Pain - Esophagus)

CL Item

Earache (Pain - External ear)

C37944 (NCI Thesaurus)
C0013456 (UMLS 2011AA)

CL Item

Pain (Pain - Extremity-limb)

CL Item

Pain (Pain - Eye)

CL Item

Pain (Pain - Face)

CL Item

Pain (Pain - Gallbladder)

CL Item

Headache Nos (Pain - Head/headache)

CL Item

Pain (Pain - Intestine)

CL Item

Arthralgia (Pain - Joint)

C0003862 (NCI Metathesaurus)

CL Item

Pain (Pain - Kidney)

CL Item

Pain (Pain - Larynx)

CL Item

Pain (Pain - Lip)

CL Item

Hepatic Pain (Pain - Liver)

C0522067 (NCI Metathesaurus)

CL Item

Pain (Pain - Lymph node)

CL Item

Pain (Pain - Middle ear)

CL Item

Myalgia (Pain - Muscle)

C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)

CL Item

Pain (Pain - Neck)

CL Item

Neuralgia Nos (Pain - Neuralgia/peripheral nerve)

C0027796 (NCI Metathesaurus)

CL Item

Pain (Pain - Oral cavity)

CL Item

Pain (Pain - Oral-gums)

CL Item

Pain (Pain - Ovulatory)

CL Item

Pain (Pain - Pain NOS)

CL Item

Pelvic Pain Nos (Pain - Pelvis)

C0030794 (NCI Metathesaurus)

CL Item

Pain (Pain - Penis)

CL Item

Pain (Pain - Pericardium)

CL Item

Pain (Pain - Perineum)

CL Item

Pain (Pain - Peritoneum)

CL Item

Pain (Pain - Phantom (pain associated with missing limb))

CL Item

Pleuritic Pain (Pain - Pleura)

C0008033 (NCI Metathesaurus)

CL Item

Pain (Pain - Prostate)

CL Item

Proctalgia (Pain - Rectum)

C0034886 (NCI Metathesaurus)

CL Item

Pain (Pain - Scalp)

CL Item

Pain (Pain - Scrotum)

CL Item

Pain (Pain - Sinus)

CL Item

Pain (Pain - Skin)

CL Item

Pain (Pain - Stomach)

CL Item

Pain (Pain - Testicle)

CL Item

Pain (Pain - Throat/pharynx/larynx)

CL Item

Tumour Pain (Pain - Tumor pain)

CL Item

Dysuria (Pain - Urethra)

C2999 (NCI Thesaurus)
C0013428 (UMLS 2011AA)

CL Item

Dysmenorrhoea (Pain - Uterus)

CL Item

Pain (Pain - Vagina)

CL Item

Pain Other (Pain-Other (Specify))

CL Item

Palpitations (Palpitations)

C0030252 (NCI Metathesaurus)

CL Item

Pancreas, Exocrine Enzyme Deficiency (Pancreas, exocrine enzyme deficiency)

CL Item

Pancreatic Endocrine: Glucose Intolerance (Pancreatic endocrine: glucose intolerance)

CL Item

Pancreatitis Nos (Pancreatitis)

CL Item

Parathyroid Function, Low (hypoparathyroidism) (Parathyroid function, low (hypoparathyroidism))

CL Item

Perforation, Gi (Perforation, GI - Appendix)

CL Item

Perforation, Gi (Perforation, GI - Biliary tree)

CL Item

Perforation, Gi (Perforation, GI - Cecum)

CL Item

Perforation, Gi (Perforation, GI - Colon)

CL Item

Perforation, Gi (Perforation, GI - Duodenum)

CL Item

Perforation, Gi (Perforation, GI - Esophagus)

CL Item

Perforation, Gi (Perforation, GI - Gallbladder)

CL Item

Perforation, Gi (Perforation, GI - Ileum)

CL Item

Perforation, Gi (Perforation, GI - Jejunum)

CL Item

Perforation, Gi (Perforation, GI - Rectum)

CL Item

Perforation, Gi (Perforation, GI - Small bowel NOS)

CL Item

Perforation, Gi (Perforation, GI - Stomach)

CL Item

Perforation, Gu (Perforation, GU - Bladder)

CL Item

Perforation, Gu (Perforation, GU - Fallopian tube)

CL Item

Perforation, Gu (Perforation, GU - Kidney)

CL Item

Perforation, Gu (Perforation, GU - Ovary)

CL Item

Perforation, Gu (Perforation, GU - Prostate)

CL Item

Perforation, Gu (Perforation, GU - Spermatic cord)

CL Item

Perforation, Gu (Perforation, GU - Stoma)

CL Item

Perforation, Gu (Perforation, GU - Testes)

CL Item

Perforation, Gu (Perforation, GU - Ureter)

CL Item

Perforation, Gu (Perforation, GU - Urethra)

CL Item

Perforation, Gu (Perforation, GU - Uterus)

CL Item

Perforation, Gu (Perforation, GU - Vagina)

CL Item

Perforation, Gu (Perforation, GU - Vas deferens)

CL Item

Pericardial Effusion (Pericardial effusion (non-malignant))

C3319 (NCI Thesaurus)
C0031039 (UMLS 2011AA)

CL Item

Pericarditis (Pericarditis)

C34915 (NCI Thesaurus)
C0031046 (UMLS 2011AA)

CL Item

Peripheral Ischaemia Nos (Peripheral arterial ischemia)

CL Item

Personality Change (Personality/behavioral)

CL036101 (NCI Metathesaurus)

CL Item

Petechiae (Petechiae/purpura (hemorrhage/bleeding into skin or mucosa))

CL Item

Phlebitis Superficial (Phlebitis (including superficial thrombosis))

C0750876 (NCI Metathesaurus)

CL Item

Phlebolymphatic Cording (Phlebolymphatic cording)

CL Item

Hypophosphataemia (Phosphate, serum-low (hypophosphatemia))

C0085682 (NCI Metathesaurus)

CL Item

Photosensitivity Reaction Nos (Photosensitivity)

CL Item

Phrenic Nerve Dysfunction (Phrenic nerve dysfunction)

CL Item

Platelet Count Decreased (Platelets)

C0392386 (NCI Metathesaurus)

CL Item

Pleural Effusion (Pleural effusion (non-malignant))

C3331 (NCI Thesaurus)
C0021071 (UMLS 2011AA)

CL Item

Pneumonitis Nos (Pneumonitis/pulmonary infiltrates)

CL Item

Pneumothorax Nos (Pneumothorax)

C0032326 (NCI Metathesaurus)

CL Item

Portal Hypertension (Portal vein flow)

C3119 (NCI Thesaurus)
C0020541 (UMLS 2011AA)

CL Item

Hyperkalaemia (Potassium, serum-high (hyperkalemia))

C0020461 (NCI Metathesaurus)

CL Item

Hypokalaemia (Potassium, serum-low (hypokalemia))

C0020621 (NCI Metathesaurus)

CL Item

Proctitis Nos (Proctitis)

C0033246 (NCI Metathesaurus)

CL Item

Prolapse Of Stoma, Gi (Prolapse of stoma, GI)

CL Item

Prolapse Of Stoma, Gu (Prolapse of stoma, GU)

CL Item

Prolonged Chest Tube Drainage Or Air Leak After Pulmonary Resection (Prolonged chest tube drainage or air leak after pulmonary resection)

CL Item

Prolonged Intubation After Pulmonary Resection (>24 Hrs After Surgery) (Prolonged intubation after pulmonary resection (>24 hrs after surgery))

CL Item

Electrocardiogram Qt Prolonged (Prolonged QTc interval)

C0151878 (NCI Metathesaurus)

CL Item

Proptosis/enophthalmos (Proptosis/enophthalmos)

CL Item

Proteinuria Present (Proteinuria)

CL Item

Pruritus Nos (Pruritus/itching)

CL Item

Delusion Nos (Psychosis (hallucinations/delusions))

CL Item

Activated Partial Thromboplastin Time Prolonged (PTT (Partial thromboplastin time))

CL038857 (NCI Metathesaurus)

CL Item

Puberty (delayed) (Puberty (delayed))

CL Item

Puberty (precocious) (Puberty (precocious))

CL Item

Pulmonary Fibrosis (Pulmonary fibrosis (radiographic changes))

C26869 (NCI Thesaurus)
C0034069 (UMLS 2011AA)

CL Item

Pulmonary Hypertension (Pulmonary hypertension)

C3120 (NCI Thesaurus)
C0020542 (UMLS 2011AA)

CL Item

Pulmonary/upper Respiratory Other (Pulmonary/Upper Respiratory-Other (Specify))

CL Item

Upper Motor Neurone Lesion (Pyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positive Babinski, decreased fine motor coordination))

CL Item

Dermatitis Exfoliative Nos (Rash/desquamation)

CL Item

Rash: Acne/acneiform (Rash: acne/acneiform)

CL Item

Radiation Recall Syndrome (Rash: dermatitis associated with radiation - Chemoradiation)

CL036754 (NCI Metathesaurus)

CL Item

Dermatitis Radiation Nos (Rash: dermatitis associated with radiation - Radiation)

CL Item

Erythema Multiforme (Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis))

C3024 (NCI Thesaurus)
C0014742 (UMLS 2011AA)

CL Item

Localised Exfoliation (Rash: hand-foot skin reaction)

CL Item

Renal Failure Nos (Renal failure)

CL Item

Renal/genitourinary Other (Renal/Genitourinary-Other (Specify))

CL Item

Restrictive Cardiomyopathy (Restrictive cardiomyopathy)

C0007196 (NCI Metathesaurus)

CL Item

Retinal Detachment (Retinal detachment)

C26874 (NCI Thesaurus)
C0035305 (UMLS 2011AA)

CL Item

Retinoic Acid Syndrome (Retinoic acid syndrome)

CL044783 (NCI Metathesaurus)

CL Item

Retinopathy (Retinopathy)

CL Item

Right Ventricular Dysfunction (cor Pulmonale) (Right ventricular dysfunction (cor pulmonale))

CL Item

Rigors (Rigors/chills)

C0424790 (NCI Metathesaurus)

CL Item

Salivary Gland Disorder Nos (Salivary gland changes/saliva)

CL Item

Scleral Necrosis/melt (Scleral necrosis/melt)

CL Item

Secondary Malignancy Possibly Related To Cancer Treatment (Secondary Malignancy-possibly related to cancer treatment (Specify))

CL Item

Convulsions Nos (Seizure)

CL Item

Seroma (Seroma)

C0262627 (NCI Metathesaurus)

CL Item

Serum Sickness (Serum sickness)

C0036830 (NCI Metathesaurus)

CL Item

Sexual/reproductive Function Other (Sexual/Reproductive Function-Other (Specify))

CL Item

Short Stature (Short stature)

C0349588 (NCI Metathesaurus)

CL Item

Skin Breakdown/decubitus Ulcer (Skin breakdown/decubitus ulcer)

CL Item

Hypernatraemia (Sodium, serum-high (hypernatremia))

C0020488 (NCI Metathesaurus)

CL Item

Hyponatraemia (Sodium, serum-low (hyponatremia))

CL Item

Soft Tissue Necrosis (Soft tissue necrosis - Abdomen)

CL Item

Soft Tissue Necrosis (Soft tissue necrosis - Extremity-lower)

CL Item

Soft Tissue Necrosis (Soft tissue necrosis - Extremity-upper)

CL Item

Soft Tissue Necrosis (Soft tissue necrosis - Head)

CL Item

Soft Tissue Necrosis (Soft tissue necrosis - Neck)

CL Item

Soft Tissue Necrosis (Soft tissue necrosis - Pelvic)

CL Item

Soft Tissue Necrosis (Soft tissue necrosis - Thorax)

CL Item

Depressed Level Of Consciousness (Somnolence/depressed level of consciousness)

C0549249 (NCI Metathesaurus)

CL Item

Speech Disorder Nec (Speech impairment (e.g., dysphasia or aphasia))

CL Item

Splenic Function (Splenic function)

CL Item

Striae (Striae)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Anus)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Biliary tree)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Cecum)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Colon)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Duodenum)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Esophagus)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Ileum)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Jejunum)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Pancreas/pancreatic duct)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Pharynx)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Rectum)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Small bowel NOS)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Stoma)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture/stenosis (including anastomotic), GI - Stomach)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Bladder)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Fallopian tube)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Prostate)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Spermatic cord)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Stoma)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Testes)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Ureter)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Urethra)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Uterus)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Vagina)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture/stenosis (including anastomotic), GU - Vas deferens)

CL Item

Supraventricular And Nodal Arrhythmia (Supraventricular and nodal arrhythmia - Atrial fibrillation)

CL Item

Supraventricular And Nodal Arrhythmia (Supraventricular and nodal arrhythmia - Atrial flutter)

CL Item

Supraventricular And Nodal Arrhythmia (Supraventricular and nodal arrhythmia - Atrial tachycardia/paroxysmal atrial tachycardia)

CL Item

Supraventricular And Nodal Arrhythmia (Supraventricular and nodal arrhythmia - Nodal/junctional)

CL Item

Supraventricular And Nodal Arrhythmia (Supraventricular and nodal arrhythmia - Sinus arrhythmia)

CL Item

Sinus Bradycardia (Supraventricular and nodal arrhythmia - Sinus bradycardia)

C26923 (NCI Thesaurus)
C0085610 (UMLS 2011AA)

CL Item

Sinus Tachycardia (Supraventricular and nodal arrhythmia - Sinus tachycardia)

C26889 (NCI Thesaurus)
C0039239 (UMLS 2011AA)

CL Item

Supraventricular Arrhythmia Nos (Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS)

CL Item

Supraventricular And Nodal Arrhythmia - Supraventricular Extrasystoles (premature Atrial Contractions; Premature Nodal/junctional Contractions) (Supraventricular and nodal arrhythmia - Supraventricular extrasystoles (premature atrial contractions; premature nodal/junctional contractions))

CL Item

Supraventricular And Nodal Arrhythmia (Supraventricular and nodal arrhythmia - Supraventricular tachycardia)

CL Item

Sweating Increased (Sweating (diaphoresis))

C0700590 (NCI Metathesaurus)

CL Item

Syncope (Syncope (fainting))

C35053 (NCI Thesaurus)
C0039070 (UMLS 2011AA)

CL Item

Syndromes Other (Syndromes-Other (Specify))

CL Item

Taste Disturbance (Taste alteration (dysgeusia))

CL Item

Telangiectasia (Telangiectasia)

C28194 (NCI Thesaurus)
C0039446 (UMLS 2011AA)

CL Item

Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access-related))

CL Item

Thrombosis Nos (Thrombosis/thrombus/embolism)

CL Item

Thrombotic Microangiopathy (e.g., Thrombotic Thrombocytopenic Purpura[ttp] Or Hemolytic Uremic Syndrome[hus]) (Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura or hemolytic uremic syndrome))

CL Item

Thyroid Function, High (hyperthyroidism, Thyrotoxicosis) (Thyroid function, high (hyperthyroidism, thyrotoxicosis))

CL Item

Hypothyroidism (Thyroid function, low (hypothyroidism))

C26800 (NCI Thesaurus)
C0020676 (UMLS 2011AA)

CL Item

Tinnitus (Tinnitus)

C50772 (NCI Thesaurus)
C0040264 (UMLS 2011AA)

CL Item

Tremor Nec (Tremor)

CL Item

Hypertriglyceridaemia (Triglyceride, serum-high (hypertriglyceridemia))

C0020557 (NCI Metathesaurus)

CL Item

Trismus (difficulty, Restriction Or Pain When Opening Mouth) (Trismus (difficulty, restriction or pain when opening mouth))

CL Item

Tumour Flare (Tumor flare)

CL039490 (NCI Metathesaurus)

CL Item

Tumour Lysis Syndrome (Tumor lysis syndrome)

CL Item

Caecitis (Typhlitis (cecal inflammation))

C0267537 (NCI Metathesaurus)

CL Item

Ulcer, Gi (Ulcer, GI - Anus)

CL Item

Ulcer, Gi (Ulcer, GI - Cecum)

CL Item

Ulcer, Gi (Ulcer, GI - Colon)

CL Item

Duodenal Ulcer (Ulcer, GI - Duodenum)

C26755 (NCI Thesaurus)
C0013295 (UMLS 2011AA)

CL Item

Ulcer, Gi (Ulcer, GI - Esophagus)

CL Item

Ulcer, Gi (Ulcer, GI - Ileum)

CL Item

Ulcer, Gi (Ulcer, GI - Jejunum)

CL Item

Ulcer, Gi (Ulcer, GI - Rectum)

CL Item

Ulcer, Gi (Ulcer, GI - Small bowel NOS)

CL Item

Ulcer, Gi (Ulcer, GI - Stoma)

CL Item

Gastric Ulcer (Ulcer, GI - Stomach)

C3388 (NCI Thesaurus)
C0038358 (UMLS 2011AA)

CL Item

Ulceration (Ulceration)

C25757 (NCI Thesaurus)
C0041582 (UMLS 2011AA)

CL Item

Hyperuricaemia (Uric acid, serum-high (hyperuricemia))

C0740394 (NCI Metathesaurus)

CL Item

Fanconi Syndrome (Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis))

C0015624 (NCI Metathesaurus)

CL Item

Urinary Frequency (Urinary frequency/urgency)

C26906 (NCI Thesaurus)
C0677481 (UMLS 2011AA)

CL Item

Urinary Retention (Urinary retention (including neurogenic bladder))

C0080274 (NCI Metathesaurus)

CL Item

Urine Discolouration (Urine color change)

CL Item

Urticaria Nos (Urticaria (hives, welts, wheals))

CL Item

Uveitis (Uveitis)

C26909 (NCI Thesaurus)
C0042164 (UMLS 2011AA)

CL Item

Vaginal Discharge (non-infectious) (Vaginal discharge (non-infectious))

CL Item

Vulvovaginal Dryness (Vaginal dryness)

CL036720 (NCI Metathesaurus)

CL Item

Vaginal Mucositis (Vaginal mucositis)

CL Item

Vaginal Stenosis/length (Vaginal stenosis/length)

CL Item

Vaginitis (Vaginitis (not due to infection))

C26911 (NCI Thesaurus)
C0042267 (UMLS 2011AA)

CL Item

Valvular Heart Disease (Valvular heart disease)

CL Item

Vascular Other (Vascular-Other (Specify))

CL Item

Vasculitis Nos (Vasculitis)

CL Item

Vasovagal Attack (Vasovagal episode)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia - Bigeminy)

C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia - Idioventricular rhythm)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia - PVCs)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia - Torsade de pointes)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia - Trigeminy)

CL Item

Ventricular Arrhythmia Nos (Ventricular arrhythmia - Ventricular arrhythmia NOS)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia - Ventricular fibrillation)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia - Ventricular flutter)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia - Ventricular tachycardia)

CL Item

Vessel Injury-artery (Vessel injury-artery - Aorta)

CL Item

Vessel Injury-artery (Vessel injury-artery - Carotid)

CL Item

Vessel Injury-artery (Vessel injury-artery - Extremity-lower)

CL Item

Vessel Injury-artery (Vessel injury-artery - Extremity-upper)

CL Item

Vessel Injury-artery (Vessel injury-artery - Other NOS)

CL Item

Vessel Injury-artery (Vessel injury-artery - Visceral)

CL Item

Vessel Injury-vein (Vessel injury-vein - Extremity-lower)

CL Item

Vessel Injury-vein (Vessel injury-vein - Extremity-upper)

CL Item

Vessel Injury-vein (Vessel injury-vein - IVC)

CL Item

Vessel Injury-vein (Vessel injury-vein - Jugular)

CL Item

Vessel Injury-vein (Vessel injury-vein - Other NOS)

CL Item

Vessel Injury-vein (Vessel injury-vein - SVC)

CL Item

Vessel Injury-vein (Vessel injury-vein - Viscera)

CL Item

Viral Hepatitis (Viral hepatitis)

C35124 (NCI Thesaurus)
C0042721 (UMLS 2011AA)

CL Item

Visceral Arterial Ischaemia (Visceral arterial ischemia (non-myocardial))

CL039426 (NCI Metathesaurus)

CL Item

Vision Blurred (Vision-blurred vision)

CL Item

Photopsia (Vision-flashing lights/floaters)

C0085635 (NCI Metathesaurus)

CL Item

Photophobia (Vision-photophobia)

C28210 (NCI Thesaurus)
C0085636 (UMLS 2011AA)

CL Item

Vital Capacity (Vital capacity)

C0042834 (NCI Metathesaurus)

CL Item

Vitreous Hemorrhage (Vitreous hemorrhage)

CL Item

Dysphonia (Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis))

C0935979 (NCI Metathesaurus)

CL Item

Vomiting Nos (Vomiting)

CL Item

Lacrimation Increased (Watery eye (epiphora, tearing))

C0262476 (NCI Metathesaurus)

CL Item

Weight Increased (Weight gain)

C0043094 (NCI Metathesaurus)

CL Item

Weight Decreased (Weight loss)

CL Item

Culture Wound Negative (Wound complication, non-infectious)

CL040841 (NCI Metathesaurus)

AdverseEventVerbatimTermText

Item

Describe 'Other' Adverse Event (Verbatim AE Description used to 'reinforce' selected AE Type - Code.)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CommonToxicityCriteriaAdverseEventReportingGrade

Item

Adverse Event Grade (A coded value to identify the severity of the AE.)

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.2

Code List

Adverse Event Grade (A coded value to identify the severity of the AE.)

CL Item

Mild Adverse Event (1)

C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

CL Item

Life-threatening Or Disabling Adverse Event (4)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

Conditional Adverse Event Questions

Item Group

Conditional Adverse Event Data Elements

AdverseEventOnsetDate

Item

AE Start Date (Date on which the AE was first evident.)

text

C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)

CL.3

Code List

AE Start Date (Date on which the AE was first evident.)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientToxicityHospitalizationIndicator

Item

Was patient hospitalized for toxicity? (Normally required only if AE is deemed 'serious'.)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27990 (NCI Thesaurus Property)
C0600688 (UMLS 2011AA Property)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)

CL.4

Code List

Was patient hospitalized for toxicity? (Normally required only if AE is deemed 'serious'.)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

TreatmentCycleNumber

Item

Cycle # (A repeating period of activity involving treatment and rest. Several cycles can make up a course.)

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)

Optional Adverse Event Questions

Item Group

Optional Adverse Event Data Elements

AdverseEventCancerTreatmentRelatedType

Item

To what is the AE attributed? (List of other therapies surgery, radiation, etc, disease, concomitant meds, other. Select MOST likely.)

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25648 (NCI Thesaurus ValueDomain)
C0439849 (UMLS 2011AA ValueDomain)

CL.5

Code List

To what is the AE attributed? (List of other therapies surgery, radiation, etc, disease, concomitant meds, other. Select MOST likely.)

CL Item

Biological Therapy (Biological Therapy)

C15187 (NCI Thesaurus)
C0005527 (UMLS 2011AA)

CL Item

Chemotherapy (Chemotherapy)

C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)

CL Item

Combined Modality (Combined modality)

CL Item

Concomitant Agent (Concomitant medication)

C70902 (NCI Thesaurus)
C2347852 (UMLS 2011AA)

CL Item

Medical_device (Device)

C16830 (NCI Thesaurus)
C0025080 (UMLS 2011AA)

CL Item

Disease (Disease)

CL Item

Endocrine Therapy (Endocrine Therapy)

C15445 (NCI Thesaurus)
C0279025 (UMLS 2011AA)

CL Item

Immunotherapy (Immunotherapy)

C15262 (NCI Thesaurus)
C0021083 (UMLS 2011AA)

CL Item

Investigational Agent (Investigational agent)

C1708 (NCI Thesaurus)
C0450442 (UMLS 2011AA)
C28041 (NCI Thesaurus)
C1517586 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Radiation Therapy (Radiation therapy)

C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

AdverseEventSuspectedOtherAttributionTextName

Item

Other Attribution, Specify (If 'other' selected in data element above, must provide a - description of the presumed cause.)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)

AdverseEventResolvedAlphaDVGDate

Item

AE Stop Date (Date on which the AE resolved.)

text

C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C75906 (NCI Thesaurus ObjectClass)
C2699488 (UMLS 2011AA ObjectClass)

CL.6

Code List

AE Stop Date (Date on which the AE resolved.)

CL Item

Unknown Date (Unknown)

CL Item

Event/occurrence Is Ongoing (Ongoing)

MedDRASystemOrganClassTermName

Item

MedDRA System Organ Class (SOC)

text

C71888 (NCI Thesaurus ObjectClass)
C2347091 (UMLS 2011AA ObjectClass)
C43820 (NCI Thesaurus Property)
C1140263 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C71888 (NCI Thesaurus ValueDomain)
C2347091 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

CL.7

Code List

MedDRA System Organ Class (SOC)

CL Item

Hematopoietic And Lymphoid System Disorder (Blood and lymphatic system disorders)

C35814 (NCI Thesaurus)
C0851353 (UMLS 2011AA)

CL Item

Cardiac Disorders (Cardiac disorders)

C3079 (NCI Thesaurus)
C0018799 (UMLS 2011AA)

CL Item

Congenital, Familial And Genetic Disorder Class (Congenital, familial and genetic disorders)

C49399 (NCI Thesaurus)
C0851352 (UMLS 2011AA)

CL Item

Ear And Labyrinth Disorder Class (Ear and labyrinth disorders)

C49400 (NCI Thesaurus)
C0851354 (UMLS 2011AA)

CL Item

Endocrine Disorder (Endocrine disorders)

C3009 (NCI Thesaurus)
C0014130 (UMLS 2011AA)

CL Item

Eye Disorder (Eye disorders)

C26767 (NCI Thesaurus)
C0015397 (UMLS 2011AA)

CL Item

Gastrointestinal Disorder (Gastrointestinal disorders)

C2990 (NCI Thesaurus)
C0012242 (UMLS 2011AA)

CL Item

General Disorders And Administration Site Conditions Class (General disorders and administration site conditions)

C49401 (NCI Thesaurus)
C0851362 (UMLS 2011AA)

CL Item

Liver And Biliary Tract Disorder (Hepatobiliary disorders)

C3959 (NCI Thesaurus)
C0267792 (UMLS 2011AA)

CL Item

Immune System Disorder (Immune system disorders)

C3507 (NCI Thesaurus)
C0021053 (UMLS 2011AA)

CL Item

Infection And Infestation (Infections and infestations)

C26726 (NCI Thesaurus)
C0009450 (UMLS 2011AA)

CL Item

Injury, Poisoning And Procedural Complication Class (Injury, poisoning and procedural complications)

C49402 (NCI Thesaurus)
C0947733 (UMLS 2011AA)

CL Item

Investigation (Investigations)

C41198 (NCI Thesaurus)
C1261322 (UMLS 2011AA)

CL Item

Metabolism And Nutrition Disorder Class (Metabolism and nutrition disorders)

C49403 (NCI Thesaurus)
C0851358 (UMLS 2011AA)

CL Item

Connective And Soft Tissue Disorder (Musculoskeletal and connective tissue disorders)

C27574 (NCI Thesaurus)
C1333150 (UMLS 2011AA)

CL Item

Neoplasm (Neoplasms benign, malignant and unspecified (incl cysts and polyps))

C3262 (NCI Thesaurus)
C0027651 (UMLS 2011AA)

CL Item

Nervous System Disorder (Nervous system disorders)

C26835 (NCI Thesaurus)
C0027765 (UMLS 2011AA)

CL Item

Pregnancy, Puerperium And Perinatal Condition Class (Pregnancy, puerperium and perinatal conditions)

C49404 (NCI Thesaurus)
C0851363 (UMLS 2011AA)

CL Item

Psychiatric Disorder (Psychiatric disorders)

C2893 (NCI Thesaurus)
C0004936 (UMLS 2011AA)

CL Item

Urinary Tract Disorder (Renal and urinary disorders)

C3430 (NCI Thesaurus)
C0042075 (UMLS 2011AA)

CL Item

Reproductive System And Breast Disorder Class (Reproductive system and breast disorders)

C49405 (NCI Thesaurus)
C0851366 (UMLS 2011AA)

CL Item

Respiratory And Thoracic Disorder (Respiratory, thoracic and mediastinal disorders)

C27669 (NCI Thesaurus)
C0851355 (UMLS 2011AA)

CL Item

Skin Disorder (Skin and subcutaneous tissue disorders)

C3371 (NCI Thesaurus)
C0037274 (UMLS 2011AA)

CL Item

Social Circumstances (Social circumstances)

C20188 (NCI Thesaurus)
C0851364 (UMLS 2011AA)

CL Item

Intervention Or Procedure (Surgical and medical procedures)

C25218 (NCI Thesaurus)
C1948041 (UMLS 2011AA)

CL Item

Vascular Disorder (Vascular disorders)

C35117 (NCI Thesaurus)
C0042373 (UMLS 2011AA)

MedDRAAdverseEventCode

Item

MedDRA AE Code (CTCAE v3.0) (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.)

double

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C43820 (NCI Thesaurus ObjectClass)
C1140263 (UMLS 2011AA ObjectClass)
C25162 (NCI Thesaurus Property)
C0805701 (UMLS 2011AA Property)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C43820 (NCI Thesaurus ValueDomain)
C1140263 (UMLS 2011AA ValueDomain)

CTCAdverseEventAttributionScale

Item

AE Attribution (This question is not asked for baseline assessments. Question should be asked mandatory for all studies that involve drug therapy.)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)

CL.8

Code List

AE Attribution (This question is not asked for baseline assessments. Question should be asked mandatory for all studies that involve drug therapy.)

CL Item

Definite (Definite)

CL209464 (NCI Metathesaurus)

CL Item

Possible (Possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (Probable)

C0332148 (NCI Metathesaurus)

CL Item

Unlikely (Unlikely)

CL Item

Unrelated (Unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

AdverseEventFinalAssessmentDate

Item

Reporting Period End Date (End of the assessment period.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25508 (NCI Thesaurus Property)
C0205088 (UMLS 2011AA Property)

AdverseEventMostRecentAssessmentInd-3

Item

Were adverse events assessed during most recent period (Indicator to clarify whether any AEs were identified during the - reporting period. This is confirmation that the remainder of the form was intentionally left blank.)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)

CL.9

Code List

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

AdverseEventExpectedIndicator

Item

Expected? (Yes/No)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25501 (NCI Thesaurus Property)
C1517001 (UMLS 2011AA Property)

CL.10

Code List

Expected? (Yes/No)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

SeriousAdverseEventIndicator

Item

Serious? (If a 'yes' response is entered, complete the SAE section for - this AE.)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL124429 (NCI Metathesaurus Property)

CL.11

Code List

Serious? (If a 'yes' response is entered, complete the SAE section for - this AE.)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

AdverseEventOnsetTime

Item

Event Onset Time (Enter the time of day when AE was first evident. Used when Date of Onset is insufficient.)

time

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)

ProtocolCourseNumberCount

Item

Course (May be used during protocol therapy period to automatically - set the evaluation start/end dates to the period of the course of treatment e.g. user supplies course# and evaluation period derived.)

double

C25337 (NCI Thesaurus Property)
C0237753 (UMLS 2011AA Property)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus ObjectClass)
C0750729 (UMLS 2011AA ObjectClass)

AdverseEventBeginAssessmentDate

Item

AE Evaluation Period Start Date (Date of the beginning start of the assessment period.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)

AdverseEventPre-ExistingIndicator

Item

Pre-existing AE? (Should be derivable if you capture AEs for specified periods; not needed if you track an AE until it resolves including worseningrather than for a defined assessment period.)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C73621 (NCI Thesaurus Property)
C2347662 (UMLS 2011AA Property)

CL.12

Code List

Pre-existing AE? (Should be derivable if you capture AEs for specified periods; not needed if you track an AE until it resolves including worseningrather than for a defined assessment period.)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

AdverseEventResolutionTime

Item

AE Resolved Time (Enter the time of day when AE was resolved.)

time

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C25655 (NCI Thesaurus Property)
C1514893 (UMLS 2011AA Property)

AdverseEventOngoingEventIndicator

Item

AE Ongoing? (Flag to indicate whether AE has resolved or not. This ensures that leaving 'Stop Date' blank was not done inadvertently.)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL259742 (NCI Metathesaurus Property)

CL.13

Code List

AE Ongoing? (Flag to indicate whether AE has resolved or not. This ensures that leaving 'Stop Date' blank was not done inadvertently.)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

AdverseEventOutcomeType

Item

Participant Status/Outcome

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C49489 (NCI Thesaurus ValueDomain)
C1705586 (UMLS 2011AA ValueDomain)

CL.14

Code List

Participant Status/Outcome

CL Item

Death (Fatal)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Not Recovered Or Not Resolved (Not Recovered/Not Resolved)

C49494 (NCI Thesaurus)
C1709277 (UMLS 2011AA)

CL Item

Recovered Or Resolved (Recovered/Resolved)

C49498 (NCI Thesaurus)
C1709863 (UMLS 2011AA)

CL Item

Recovered Or Resolved With Sequelae (Recovered/Resolved with Sequelae)

C49495 (NCI Thesaurus)
C1709862 (UMLS 2011AA)

CL Item

Recovering Or Resolving (Recovering/Resolving)

C49496 (NCI Thesaurus)
C1709864 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

AdverseEventConditionPattern

Item

Adverse Event Condition Pattern (This should be derivable from a review of AEs over time.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)

CL.15

Code List

Adverse Event Condition Pattern (This should be derivable from a review of AEs over time.)

CL Item

Single Episode (1)

CL Item

Intermittent (2)

CL Item

Continuous (3)

C53279 (NCI Thesaurus)
C0549178 (UMLS 2011AA)

AdverseEventReappearanceIndicator

Item

Did event reappear after study agent was reintroduced? (Enter response from choice list.)

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C0034897 (NCI Metathesaurus Property)
C0021212 (NCI Metathesaurus ValueDomain)

CL.16

Code List

Did event reappear after study agent was reintroduced? (Enter response from choice list.)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (N/A)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

ResearchCommentsText

Item

Comments (A general comment that should not be specific to a single AE.)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

Optional Serious Adverse Event Questions

Item Group

Optional Serious Adverse Event Questions

SeriousAdverseEventDescriptionReasonText

Item

Why serious? (Select the appropriate response.)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL124429 (NCI Metathesaurus Property)

CL.17

Code List

Why serious? (Select the appropriate response.)

CL Item

Results In Death (1)

CL Item

Is Life-threatening (2)

CL Item

Requires Inpatient Hospitalization Or Prolongation Of Existing Hospitalization (3)

CL Item

Results In Persistent Or Significant Disability/incapacity (4)

CL Item

Is A Congenital Anomaly/birth Defect (5)

CL Item

In The Medical Judgment Of The Treating Physician And/or Investigator, It May Jeopardize The Participant Or Require Intervention To Prevent One Of These Outcomes (6)

CL Item

Other, Specify (7)

CL Item

Meets Criteria Per Protocol But Does Not Meet Other Criterion (above) (8)

DoseLimitingToxicityInd

Item

Dose-Limiting Toxicity? (Select the appropriate response.)

text

CL110648 (NCI Metathesaurus ObjectClass)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C27990 (NCI Thesaurus Property)
C0600688 (UMLS 2011AA Property)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.18

Code List

Dose-Limiting Toxicity? (Select the appropriate response.)

CL Item

No (N)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Y)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

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NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template - 2748814v1.0

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