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ID

9596

Descrição

Southwest Oncology Group S0777 Induction and Maintenance Adverse Event Summary Form Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3345A7C2-9422-3C66-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3345A7C2-9422-3C66-E044-0003BA3F9857

Palavras-chave

  1. 18/12/2014 18/12/2014 - Martin Dugas
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 09/01/2015 09/01/2015 - Martin Dugas
Transferido a

9 de janeiro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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    Multiple Myeloma and Plasma Cell Neoplasm NCT00644228 Toxicity - Southwest Oncology Group S0777 Induction and Maintenance Adverse Event Summary Form - 2657103v1.0

    No Instruction available.

    1. StudyEvent: Southwest Oncology Group S0777 Induction and Maintenance Adverse Event Summary Form
      1. No Instruction available.
    Header
    Descrição

    Header

    SWOG Patient ID
    Descrição

    Trial subject ID SWOG

    Tipo de dados

    float

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2348585 (Clinical Trial Subject Unique Identifier)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS CUI-2
    C1519429 (SWOG)
    LOINC
    LA4458-1
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus Property-2
    C25699 (undefined)
    SWOG Study No.
    Descrição

    Protocol ID SWOG

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C3274381 (Clinical Trial Registry Identifier)
    NCI Thesaurus ObjectClass
    C25320 (undefined)
    UMLS CUI-2
    C1519429 (SWOG)
    LOINC
    LA4458-1
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus Property-2
    C25699 (undefined)
    Patient Initials (L, F M)
    Descrição

    Patient Initials

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2986440 (Person Initials)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25536 (undefined)
    Registration Step
    Descrição

    Registration Number

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C1514821 (Registration)
    NCI Thesaurus ObjectClass
    C25646 (undefined)
    UMLS CUI-2
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    NCI Thesaurus Property
    C16154 (undefined)
    NCI Thesaurus ValueDomain-2
    C16154 (undefined)
    Cycle completed
    Descrição

    TreatmentCycleCompleteName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS 2011AA ValueDomain
    C1547383 (Person Name)
    SNOMED
    734006007
    NCI Thesaurus Property
    C25250 (undefined)
    UMLS 2011AA Property
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    NCI Thesaurus ObjectClass
    C25472 (undefined)
    UMLS 2011AA ObjectClass
    C1511572 (event cycle)
    NCI Thesaurus ObjectClass-2
    C15368 (undefined)
    Institution/Affiliate
    Descrição

    Institution Name

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454 (undefined)
    UMLS CUI-1
    C1301943 (Institution name)
    SNOMED
    398321007
    NCI Thesaurus ObjectClass-2
    C21541 (undefined)
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    NCI Thesaurus ValueDomain-2
    C21541 (undefined)
    Physician
    Descrição

    Investigator Name

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2826892 (Investigator Name)
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus ObjectClass
    C17089 (undefined)
    NCI Thesaurus ObjectClass-2
    C25644 (undefined)
    Participating Group Name
    Descrição

    Participating Group

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2347449 (Participating Clinical Study Organization)
    NCI Thesaurus ObjectClass
    C25608 (undefined)
    NCI Thesaurus ObjectClass-2
    C17005 (undefined)
    NCI Thesaurus Property
    C25364 (undefined)
    Participating Group Study No.
    Descrição

    Study Number Participating Group

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C3274381 (Clinical Trial Registry Identifier)
    NCI Thesaurus ObjectClass
    C25320 (undefined)
    UMLS CUI-2
    C2347449 (Participating Clinical Study Organization)
    NCI Thesaurus Property
    C25608 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    Participating Group Patient ID
    Descrição

    Trial subject ID Participating Group

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2348585 (Clinical Trial Subject Unique Identifier)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS CUI-2
    C2347449 (Participating Clinical Study Organization)
    NCI Thesaurus Property
    C25608 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    Adverse Events
    Descrição

    Adverse Events

    Reporting Period Start Date
    Descrição

    Reporting Period Start Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus Property
    C25616 (undefined)
    UMLS CUI-1
    C2361257 (Survey reporting period start date)
    LOINC
    MTHU028176
    NCI Thesaurus Property-2
    C25651 (undefined)
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    NCI Thesaurus ValueDomain-2
    C25431 (undefined)
    Date of Most Recent Adverse Event Assessment
    Descrição

    AdverseEventMostRecentAssessmentDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    NCI Thesaurus Property
    C20989 (undefined)
    UMLS 2011AA Property
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    NCI Thesaurus ObjectClass
    C41331 (undefined)
    UMLS 2011AA ObjectClass
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    NCI Thesaurus Property-2
    C25577 (undefined)
    UMLS 2011AA Property-2
    C1513491 (Most Recent)
    Were adverse events assessed during this time period?
    Descrição

    AdverseEventCurrentAssessmentInd

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180 (undefined)
    UMLS 2011AA ValueDomain
    C1522602 (Indicator)
    NCI Thesaurus Property
    C20989 (undefined)
    UMLS 2011AA Property
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    NCI Thesaurus Property-2
    C25471 (undefined)
    UMLS 2011AA Property-2
    C0521116 (Current (present time))
    SNOMED
    15240007
    NCI Thesaurus ObjectClass
    C41331 (undefined)
    UMLS 2011AA ObjectClass
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    CTC Adverse Event Term
    Descrição

    CTC Adverse Event Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS CUI-1
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-2
    C2826934 (Adverse Event Dictionary Derived Term)
    NCI Thesaurus Property
    C45559 (undefined)
    CTC AE Grade (3.0 1-5)
    Descrição

    CTC Adverse Event Grade

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-1
    C2985911 (Adverse Event Grade Code)
    NCI Thesaurus ValueDomain
    C18000 (undefined)
    NCI Thesaurus Property
    C25365 (undefined)
    CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
    Descrição

    CTC Adverse Event Attribution Category

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664 (undefined)
    UMLS CUI-1
    C1706735 (Adverse Event Attribution Category)
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    NCI Thesaurus Property
    C25358 (undefined)
    CTC Adverse Event Term Other (specify using CTCAE 3.0 terminology)
    Descrição

    CTC Adverse Event Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685 (undefined)
    UMLS CUI-1
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-2
    C2826934 (Adverse Event Dictionary Derived Term)
    NCI Thesaurus Property
    C45559 (undefined)
    Comments
    Descrição

    Comments

    Comments
    Descrição

    Research Comments

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704 (undefined)
    UMLS CUI-1
    C0947611 (Comment)
    LOINC
    LP72293-1
    NCI Thesaurus ObjectClass
    C15319 (undefined)
    NCI Thesaurus Property
    C25393 (undefined)

    Similar models

    No Instruction available.

    1. StudyEvent: Southwest Oncology Group S0777 Induction and Maintenance Adverse Event Summary Form
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Header
    Trial subject ID SWOG
    Item
    SWOG Patient ID
    float
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-2)
    Protocol ID SWOG
    Item
    SWOG Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-2)
    Patient Initials
    Item
    Patient Initials (L, F M)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Registration Number
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    Item
    Cycle completed
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C25472 (NCI Thesaurus ObjectClass)
    C1511572 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus ObjectClass-2)
    Code List
    Cycle completed
    CL Item
    Induction (Induction)
    CL042203 (NCI Metathesaurus)
    CL Item
    Maintenance Therapy (Maintenance)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Investigator Name
    Item
    Physician
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    Participating Group
    Item
    Participating Group Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Group Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Item Group
    Adverse Events
    Reporting Period Start Date
    Item
    Reporting Period Start Date
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C2361257 (UMLS CUI-1)
    C25651 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    AdverseEventMostRecentAssessmentDate
    Item
    Date of Most Recent Adverse Event Assessment
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25577 (NCI Thesaurus Property-2)
    C1513491 (UMLS 2011AA Property-2)
    Item
    Were adverse events assessed during this time period?
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25471 (NCI Thesaurus Property-2)
    C0521116 (UMLS 2011AA Property-2)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    Code List
    Were adverse events assessed during this time period?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)
    CL Item
    Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    Code List
    CTC Adverse Event Term
    CL Item
    Vasculitis Nos (Vasculitis)
    CL Item
    Rhinitis Allergic Nos (Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip))
    C0002103 (NCI Metathesaurus)
    CL Item
    Tinnitus (Tinnitus)
    C50772 (NCI Thesaurus)
    C0040264 (UMLS 2011AA)
    CL Item
    Haemoglobin Decreased (Hemoglobin)
    C0162119 (NCI Metathesaurus)
    CL Item
    Sinus Bradycardia (Supraventricular and nodal arrhythmia - Sinus bradycardia)
    C26923 (NCI Thesaurus)
    C0085610 (UMLS 2011AA)
    CL Item
    Pericardial Effusion (Pericardial effusion (non-malignant))
    C3319 (NCI Thesaurus)
    C0031039 (UMLS 2011AA)
    CL Item
    Insomnia Nec (Insomnia)
    CL Item
    Dry Skin (Dry skin)
    C0151908 (NCI Metathesaurus)
    CL Item
    Flushing (Flushing)
    C26775 (NCI Thesaurus)
    C0016382 (UMLS 2011AA)
    CL Item
    Injection Site Reaction Nos (Injection site reaction/extravasation changes)
    CL Item
    Pruritus Nos (Pruritus/itching)
    CL Item
    Erythema Multiforme (Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis))
    C3024 (NCI Thesaurus)
    C0014742 (UMLS 2011AA)
    CL Item
    Hypothyroidism (Thyroid function, low (hypothyroidism))
    C26800 (NCI Thesaurus)
    C0020676 (UMLS 2011AA)
    CL Item
    Constipation (Constipation)
    C37930 (NCI Thesaurus)
    C0009806 (UMLS 2011AA)
    CL Item
    Dry Mouth (Dry mouth/salivary gland (xerostomia))
    C26917 (NCI Thesaurus)
    C0043352 (UMLS 2011AA)
    CL Item
    Oesophagitis Nos (Esophagitis)
    CL Item
    Ileus (Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation))
    C37979 (NCI Thesaurus)
    C1258215 (UMLS 2011AA)
    CL Item
    Taste Disturbance (Taste alteration (dysgeusia))
    CL Item
    Pancreatitis Nos (Pancreatitis)
    CL Item
    Edema: Head And Neck (Edema: head and neck)
    CL Item
    Oedema Nos (Edema: limb)
    CL Item
    Hypertension Nos (Hypertension)
    CL Item
    Hypotension Nos (Hypotension)
    CL Item
    Weight Decreased (Weight loss)
    CL Item
    Urticaria Nos (Urticaria (hives, welts, wheals))
    CL Item
    Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)
    CL Item
    Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))
    C26948 (NCI Thesaurus)
    C0151905 (UMLS 2011AA)
    CL Item
    Anorexia (Anorexia)
    C2875 (NCI Thesaurus)
    C0003123 (UMLS 2011AA)
    CL Item
    Dehydration (Dehydration)
    C26740 (NCI Thesaurus)
    C0011175 (UMLS 2011AA)
    CL Item
    Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))
    C26947 (NCI Thesaurus)
    C0151904 (UMLS 2011AA)
    CL Item
    Blood Creatinine Increased (Creatinine)
    C0235431 (NCI Metathesaurus)
    CL Item
    Hypercalcaemia (Calcium, serum-high (hypercalcemia))
    CL Item
    Hypocalcaemia (Calcium, serum-low (hypocalcemia))
    CL Item
    Hyperglycaemia Nos (Glucose, serum-high (hyperglycemia))
    CL Item
    Hypoglycaemia Nos (Glucose, serum-low (hypoglycemia))
    CL Item
    Lipase Increased (Lipase)
    C0549475 (NCI Metathesaurus)
    CL Item
    Gamma-glutamyltransferase Increased (GGT (gamma-glutamyl transpeptidase))
    C26943 (NCI Thesaurus)
    C0151662 (UMLS 2011AA)
    CL Item
    Blood Magnesium Decreased (Magnesium, serum-low (hypomagnesemia))
    CL039365 (NCI Metathesaurus)
    CL Item
    Hypophosphataemia (Phosphate, serum-low (hypophosphatemia))
    C0085682 (NCI Metathesaurus)
    CL Item
    Diarrhoea Nos (Diarrhea)
    CL Item
    Fatigue (Fatigue (asthenia, lethargy, malaise))
    C3036 (NCI Thesaurus)
    C0015672 (UMLS 2011AA)
    CL Item
    Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
    CL Item
    Flatulence (Flatulence)
    C37954 (NCI Thesaurus)
    C0016204 (UMLS 2011AA)
    CL Item
    Dyspepsia (Heartburn/dyspepsia)
    C26756 (NCI Thesaurus)
    C0013395 (UMLS 2011AA)
    CL Item
    Haemorrhagic Stroke (Hemorrhage, CNS)
    CL036983 (NCI Metathesaurus)
    CL Item
    Leucopenia Nos (Leukocytes (total WBC))
    CL Item
    Nausea (Nausea)
    C3258 (NCI Thesaurus)
    C0027497 (UMLS 2011AA)
    CL Item
    Neutropenia (Neutrophils/granulocytes (ANC/AGC))
    C3277 (NCI Thesaurus)
    CL Item
    Cerebral Ischaemia (CNS cerebrovascular ischemia)
    C0917798 (NCI Metathesaurus)
    CL Item
    Platelet Count Decreased (Platelets)
    C0392386 (NCI Metathesaurus)
    CL Item
    Dermatitis Exfoliative Nos (Rash/desquamation)
    CL Item
    Rigors (Rigors/chills)
    C0424790 (NCI Metathesaurus)
    CL Item
    Vomiting Nos (Vomiting)
    CL Item
    Cough (Cough)
    C37935 (NCI Thesaurus)
    C0010200 (UMLS 2011AA)
    CL Item
    Dyspnoea Nos (Dyspnea (shortness of breath))
    CL Item
    Extremity-lower (gait/walking) (Extremity-lower (gait/walking))
    CL Item
    Muscle Weakness Nos (Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized)
    C0151786 (NCI Metathesaurus)
    CL Item
    Osteonecrosis (Osteonecrosis (avascular necrosis))
    CL Item
    Osteoporosis (Osteoporosis)
    C3298 (NCI Thesaurus)
    C0029456 (UMLS 2011AA)
    CL Item
    Confusion (Confusion)
    C37928 (NCI Thesaurus)
    C0009676 (UMLS 2011AA)
    CL Item
    Dizziness (exc Vertigo) (Dizziness)
    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
    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
    Delusion Nos (Psychosis (hallucinations/delusions))
    CL Item
    Convulsions Nos (Seizure)
    CL Item
    Depressed Level Of Consciousness (Somnolence/depressed level of consciousness)
    C0549249 (NCI Metathesaurus)
    CL Item
    Syncope (Syncope (fainting))
    C35053 (NCI Thesaurus)
    C0039070 (UMLS 2011AA)
    CL Item
    Tremor Nec (Tremor)
    CL Item
    Dry Eye Nec (Dry eye syndrome)
    CL Item
    Diplopia (Ophthalmoplegia/diplopia (double vision))
    C37941 (NCI Thesaurus)
    C0012569 (UMLS 2011AA)
    CL Item
    Vision Blurred (Vision-blurred vision)
    CL Item
    Nasal Cavity/paranasal Sinus Reactions (Nasal cavity/paranasal sinus reactions)
    CL Item
    Pleural Effusion (Pleural effusion (non-malignant))
    C3331 (NCI Thesaurus)
    C0021071 (UMLS 2011AA)
    CL Item
    Sexual/reproductive Function Other (Sexual/Reproductive Function-Other (Specify))
    CL Item
    Peripheral Ischaemia Nos (Peripheral arterial ischemia)
    CL Item
    Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access-related))
    CTC Adverse Event Grade
    Item
    CTC AE Grade (3.0 1-5)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    Code List
    CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
    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)
    CTC Adverse Event Term
    Item
    CTC Adverse Event Term Other (specify using CTCAE 3.0 terminology)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)

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