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ID

14835

Beschrijving

Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT01423032

Link

https://clinicaltrials.gov/show/NCT01423032

Trefwoorden

  1. 01-05-16 01-05-16 -
Geüploaded op

1 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Chronic Lymphocytic Leukemia NCT01423032

    Eligibility Chronic Lymphocytic Leukemia NCT01423032

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    histologically or immunologically confirmed chronic b-cell leukemia
    Beschrijving

    ID.1

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023434 (Chronic Lymphocytic Leukemia)
    SNOMED
    51092000
    LOINC
    LP34550-1
    UMLS CUI [1,2]
    C0019638 (Histology)
    refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen
    Beschrijving

    ID.2

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0278791 (Chronic lymphocytic leukaemia refractory)
    UMLS CUI [2]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    disease stage ii-iv according to rai or b/c according to binet staging system, respectively
    Beschrijving

    ID.3

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1511118 (Binet Staging System)
    UMLS CUI [2]
    C1514715 (Rai Staging System)
    eastern cooperative oncology group (ecog) performance status of 3 or better
    Beschrijving

    ID.4

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    negative pregnancy test/ adequate method of contraception
    Beschrijving

    ID.5

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    t-cll, pll (prolymphocytic leukemia)
    Beschrijving

    ID.6

    Datatype

    boolean

    presence of richter's transformation
    Beschrijving

    ID.7

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0349631 (Richter's syndrome)
    SNOMED
    277550009
    first-line treatment containing either fludarabine or bendamustine
    Beschrijving

    ID.8

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0059985 (fludarabine)
    SNOMED
    108763009
    UMLS CUI [2]
    C0525079 (bendamustine)
    SNOMED
    428012008
    acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin > 5mg/dl), renal system (creatinine > 2 mg/dl), or metabolic disorders
    Beschrijving

    ID.9

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0275518 (Acute infectious disease)
    SNOMED
    63171007
    UMLS CUI [2]
    C0025517 (Metabolic Diseases)
    SNOMED
    30390004
    UMLS CUI [3]
    C0678852 (body system or organ function)
    secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)
    Beschrijving

    ID.10

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3266877 (Secondary Malignant Neoplasm)

    Similar models

    Eligibility Chronic Lymphocytic Leukemia NCT01423032

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    ID.1
    Item
    histologically or immunologically confirmed chronic b-cell leukemia
    boolean
    C0023434 (UMLS CUI [1,1])
    C0019638 (UMLS CUI [1,2])
    ID.2
    Item
    refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen
    boolean
    C0278791 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    ID.3
    Item
    disease stage ii-iv according to rai or b/c according to binet staging system, respectively
    boolean
    C1511118 (UMLS CUI [1])
    C1514715 (UMLS CUI [2])
    ID.4
    Item
    eastern cooperative oncology group (ecog) performance status of 3 or better
    boolean
    C1520224 (UMLS CUI [1])
    ID.5
    Item
    negative pregnancy test/ adequate method of contraception
    boolean
    C0032961 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    ID.6
    Item
    t-cll, pll (prolymphocytic leukemia)
    boolean
    ID.7
    Item
    presence of richter's transformation
    boolean
    C0349631 (UMLS CUI [1])
    ID.8
    Item
    first-line treatment containing either fludarabine or bendamustine
    boolean
    C0059985 (UMLS CUI [1])
    C0525079 (UMLS CUI [2])
    ID.9
    Item
    acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin > 5mg/dl), renal system (creatinine > 2 mg/dl), or metabolic disorders
    boolean
    C0275518 (UMLS CUI [1])
    C0025517 (UMLS CUI [2])
    C0678852 (UMLS CUI [3])
    ID.10
    Item
    secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)
    boolean
    C3266877 (UMLS CUI [1])

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