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ID

15496

Beschreibung

Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01423695

Link

https://clinicaltrials.gov/show/NCT01423695

Stichworte

  1. 01.06.16 01.06.16 -
Hochgeladen am

1. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Metastatic Breast Cancer NCT01423695

    Eligibility Metastatic Breast Cancer NCT01423695

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    histologically confirmed metastatic breast cancer overexpressing her2
    Beschreibung

    metastatic breast cancer

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1960398 (HER2-positive carcinoma of breast)
    SNOMED
    427685000
    UMLS CUI [1,2]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    pretreatment with anthracycline in either the adjuvant or palliative setting.
    Beschreibung

    anthracycline

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0003234 (Anthracycline Antibiotics)
    SNOMED
    108787006
    her2 positivity was defined as 2+ or 3+ overexpression using the dako herceptest, confirmed by fluorescence in-situ hybridization (fish) if 2+.
    Beschreibung

    her2 positivity

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C4031572 (biopsy of breast showed her2 positive carcinoma)
    informed consent
    Beschreibung

    informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    more than 1 chemotherapy for advanced disease
    Beschreibung

    chemotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    taxane or trastuzumab pretreatment
    Beschreibung

    taxane or trastuzumab

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0215136 (taxane)
    UMLS CUI [2]
    C0728747 (trastuzumab)
    SNOMED
    327397006
    brain metastases
    Beschreibung

    brain metastases

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
    eastern cooperative oncology group (ecog) performance status >1
    Beschreibung

    performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    pregnancy or lactation, childbearing potential without reliable contraception
    Beschreibung

    pregnancy or lactation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    clinically significant cardiac disease,
    Beschreibung

    cardiac disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018799 (Heart Diseases)
    SNOMED
    56265001
    neutrophils <1500/µl, platelets <75,000/µl
    Beschreibung

    neutrophils platelets

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0948762 (Absolute neutrophil count)
    UMLS CUI [2]
    C0005821 (Blood Platelets)
    SNOMED
    16378004
    LOINC
    LP70360-0
    total bilirubin and creatinine >1.5 × the upper limit of normal
    Beschreibung

    total bilirubin and creatinine

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201913 (Bilirubin, total measurement)
    SNOMED
    359986008
    UMLS CUI [2]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003

    Ähnliche Modelle

    Eligibility Metastatic Breast Cancer NCT01423695

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    metastatic breast cancer
    Item
    histologically confirmed metastatic breast cancer overexpressing her2
    boolean
    C1960398 (UMLS CUI [1,1])
    C0027627 (UMLS CUI [1,2])
    anthracycline
    Item
    pretreatment with anthracycline in either the adjuvant or palliative setting.
    boolean
    C0003234 (UMLS CUI [1])
    her2 positivity
    Item
    her2 positivity was defined as 2+ or 3+ overexpression using the dako herceptest, confirmed by fluorescence in-situ hybridization (fish) if 2+.
    boolean
    C4031572 (UMLS CUI [1])
    informed consent
    Item
    informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    chemotherapy
    Item
    more than 1 chemotherapy for advanced disease
    boolean
    C0392920 (UMLS CUI [1])
    taxane or trastuzumab
    Item
    taxane or trastuzumab pretreatment
    boolean
    C0215136 (UMLS CUI [1])
    C0728747 (UMLS CUI [2])
    brain metastases
    Item
    brain metastases
    boolean
    C0220650 (UMLS CUI [1])
    performance status
    Item
    eastern cooperative oncology group (ecog) performance status >1
    boolean
    C1520224 (UMLS CUI [1])
    pregnancy or lactation
    Item
    pregnancy or lactation, childbearing potential without reliable contraception
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    cardiac disease
    Item
    clinically significant cardiac disease,
    boolean
    C0018799 (UMLS CUI [1])
    neutrophils platelets
    Item
    neutrophils <1500/µl, platelets <75,000/µl
    boolean
    C0948762 (UMLS CUI [1])
    C0005821 (UMLS CUI [2])
    total bilirubin and creatinine
    Item
    total bilirubin and creatinine >1.5 × the upper limit of normal
    boolean
    C0201913 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])

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