0 Bedömningar
ID

15592

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00046514

Nyckelord

Versioner (1)
  1. 2016-06-04 2016-06-04 -
Uppladdad den

4 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Breast Neoplasms NCT00046514

    Engelsk

    Eligibility Breast Neoplasms NCT00046514

    1 Formulär  
    Criteria
    Beskrivning

    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
    Beskrivning

    negative serum pregnancy test

    Datatyp

    boolean

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

    age

    Datatyp

    boolean

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

    karnofsky perfomance status

    Datatyp

    boolean

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

    no other malignancy

    Datatyp

    boolean

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

    measurable disease

    Datatyp

    boolean

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

    treatment with paclitaxel

    Datatyp

    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
    Beskrivning

    previously treated with taxol

    Datatyp

    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
    Beskrivning

    blood

    Datatyp

    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)
    Beskrivning

    blood measurements baseline

    Datatyp

    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
    Beskrivning

    expected survival

    Datatyp

    boolean

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

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Tillbaka till toppen

    Similar models

    Eligibility Breast Neoplasms NCT00046514

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Tillbaka till toppen 

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