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ID

15592

Beschreibung

ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00046514

Link

https://clinicaltrials.gov/show/NCT00046514

Stichworte

Versionen (1)
  1. 04.06.16 04.06.16 -
Hochgeladen am

4. Juni 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Breast Neoplasms NCT00046514

    Englisch

    Eligibility Breast Neoplasms NCT00046514

    1 Formulare  
    Criteria
    Beschreibung

    Criteria

    if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
    Beschreibung

    negative serum pregnancy test

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0430061
    eighteen years of age or older
    Beschreibung

    age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    karnofsky perfomance status of 70% or 0-2 swog performance status
    Beschreibung

    karnofsky perfomance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    no other malignancy, except non-melanoma skin cancer, cin, or in-situ cervical cancer
    Beschreibung

    no other malignancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0205394
    measurable disease
    Beschreibung

    measurable disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    suitable candidate for treatment with paclitaxel
    Beschreibung

    treatment with paclitaxel

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0144576
    UMLS CUI [1,2]
    C0332149
    previously treated with taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
    Beschreibung

    previously treated with taxol

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0144576
    if, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dl
    Beschreibung

    blood

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019046
    UMLS CUI [2]
    C0948762
    UMLS CUI [3]
    C0005821
    if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dl; creatinine levels less than or equal to 2 mg/dl; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
    Beschreibung

    blood measurements baseline

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0201899
    UMLS CUI [3]
    C0201836
    UMLS CUI [4]
    C0201850
    UMLS CUI [5]
    C0201976
    patient has an expected survival of at least 12 weeks
    Beschreibung

    expected survival

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    patient or his/her representative has signed an informed consent statement
    Beschreibung

    informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Breast Neoplasms NCT00046514

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    negative serum pregnancy test
    Item
    if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
    boolean
    C0430061 (UMLS CUI [1])
    age
    Item
    eighteen years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    karnofsky perfomance status
    Item
    karnofsky perfomance status of 70% or 0-2 swog performance status
    boolean
    C0206065 (UMLS CUI [1])
    no other malignancy
    Item
    no other malignancy, except non-melanoma skin cancer, cin, or in-situ cervical cancer
    boolean
    C0006826 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    measurable disease
    Item
    measurable disease
    boolean
    C1513041 (UMLS CUI [1])
    treatment with paclitaxel
    Item
    suitable candidate for treatment with paclitaxel
    boolean
    C0144576 (UMLS CUI [1,1])
    C0332149 (UMLS CUI [1,2])
    previously treated with taxol
    Item
    previously treated with taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
    boolean
    C0144576 (UMLS CUI [1])
    blood
    Item
    if, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dl
    boolean
    C0019046 (UMLS CUI [1])
    C0948762 (UMLS CUI [2])
    C0005821 (UMLS CUI [3])
    blood measurements baseline
    Item
    if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dl; creatinine levels less than or equal to 2 mg/dl; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
    boolean
    C1278039 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C0201850 (UMLS CUI [4])
    C0201976 (UMLS CUI [5])
    expected survival
    Item
    patient has an expected survival of at least 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    informed consent
    Item
    patient or his/her representative has signed an informed consent statement
    boolean
    C0021430 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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