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ID

14451

Descrizione

A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia; ODM derived from: https://clinicaltrials.gov/show/NCT00220311

collegamento

https://clinicaltrials.gov/show/NCT00220311

Keywords

  1. 15/04/16 15/04/16 -
Caricato su

15 aprile 2016

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Leukemia, Lymphocytic, Chronic, B-Cell NCT00220311

    Eligibility Leukemia, Lymphocytic, Chronic, B-Cell NCT00220311

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients with histologically or cytologically confirmed cll
    Descrizione

    CLL

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023434 (Chronic Lymphocytic Leukemia)
    SNOMED
    51092000
    LOINC
    LP34550-1
    patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal
    Descrizione

    Hemoglobin and platelet count

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0518015 (Hemoglobin measurement)
    UMLS CUI [2]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    patients who have not received cancer chemotherapy or radiotherapy
    Descrizione

    No chemotherapy or radiotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [1,2]
    C0332155 (Did not receive therapy or drug for)
    SNOMED
    25265005
    UMLS CUI [2,1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [2,2]
    C0332155 (Did not receive therapy or drug for)
    SNOMED
    25265005
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients with apparent infections (including viral infections)
    Descrizione

    Infections

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    patients with serious complications (heart, liver, or kidney disease, etc.)
    Descrizione

    Complications

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009566 (Complication)
    SNOMED
    116223007
    patients with a serious bleeding tendency (e.g., dic)
    Descrizione

    Bleeding tendency

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0005779 (Blood Coagulation Disorders)
    SNOMED
    64779008
    patients with serious cns symptoms
    Descrizione

    CNS symptoms

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0422879 (CNS symptom)
    SNOMED
    246557006
    patients with fever >= 38°c (excluding tumor fever)
    Descrizione

    Fever (excluding tumor fever)

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0015967 (Fever)
    SNOMED
    50177009
    LOINC
    MTHU013518
    UMLS CUI [2,1]
    C0332196 (Exclude)
    SNOMED
    77765009
    UMLS CUI [2,2]
    C0948348 (Tumour associated fever)
    patients with interstitial pneumonia or pulmonary fibrosis
    Descrizione

    Interstitial pneumonia or pulmonary fibrosis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0206061 (Pneumonia, Interstitial)
    SNOMED
    64667001
    UMLS CUI [2]
    C0034069 (Pulmonary Fibrosis)
    SNOMED
    51615001
    patients with active multiple cancers
    Descrizione

    Multiple cancers

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0346429 (Multiple malignancy)
    SNOMED
    363500001
    patients receiving other investigational products within 6 months before registration in this study
    Descrizione

    Experimental drug

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0304229 (Experimental drug)
    patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives)
    Descrizione

    Allergy to trial product

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C3854006 (clinical trial drug)
    women who are pregnant, of childbearing potential, or lactating
    Descrizione

    Gynaecological status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C3831118 (Childbearing Potential)
    UMLS CUI [3]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0

    Similar models

    Eligibility Leukemia, Lymphocytic, Chronic, B-Cell NCT00220311

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    CLL
    Item
    patients with histologically or cytologically confirmed cll
    boolean
    C0023434 (UMLS CUI [1])
    Hemoglobin and platelet count
    Item
    patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal
    boolean
    C0518015 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    No chemotherapy or radiotherapy
    Item
    patients who have not received cancer chemotherapy or radiotherapy
    boolean
    C0392920 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2,1])
    C0332155 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Infections
    Item
    patients with apparent infections (including viral infections)
    boolean
    C0009450 (UMLS CUI [1])
    Complications
    Item
    patients with serious complications (heart, liver, or kidney disease, etc.)
    boolean
    C0009566 (UMLS CUI [1])
    Bleeding tendency
    Item
    patients with a serious bleeding tendency (e.g., dic)
    boolean
    C0005779 (UMLS CUI [1])
    CNS symptoms
    Item
    patients with serious cns symptoms
    boolean
    C0422879 (UMLS CUI [1])
    Fever (excluding tumor fever)
    Item
    patients with fever >= 38°c (excluding tumor fever)
    boolean
    C0015967 (UMLS CUI [1])
    C0332196 (UMLS CUI [2,1])
    C0948348 (UMLS CUI [2,2])
    Interstitial pneumonia or pulmonary fibrosis
    Item
    patients with interstitial pneumonia or pulmonary fibrosis
    boolean
    C0206061 (UMLS CUI [1])
    C0034069 (UMLS CUI [2])
    Multiple cancers
    Item
    patients with active multiple cancers
    boolean
    C0346429 (UMLS CUI [1])
    Experimental drug
    Item
    patients receiving other investigational products within 6 months before registration in this study
    boolean
    C0304229 (UMLS CUI [1])
    Allergy to trial product
    Item
    patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives)
    boolean
    C0020517 (UMLS CUI [1,1])
    C3854006 (UMLS CUI [1,2])
    Gynaecological status
    Item
    women who are pregnant, of childbearing potential, or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C3831118 (UMLS CUI [2])
    C0006147 (UMLS CUI [3])

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