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ID

17916

Descrizione

The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00065325

collegamento

https://clinicaltrials.gov/show/NCT00065325

Keywords

  1. 09/10/16 09/10/16 -
Caricato su

9 ottobre 2016

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Locally Advanced Breast Cancer NCT00065325

    Eligibility Locally Advanced Breast Cancer NCT00065325

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    biopsy confirmation of breast cancer
    Descrizione

    Breast Carcinoma | Biopsy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0678222
    UMLS CUI [2]
    C0005558
    breast cancer has continued to grow after having received treatment with an aromatase inhibitor
    Descrizione

    Therapeutic procedure Breast Carcinoma | Aromatase Inhibitor | Disease Progression

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0678222
    UMLS CUI [2]
    C0593802
    UMLS CUI [3]
    C0242656
    postmenopausal women defined as a women who has stopped having menstrual periods
    Descrizione

    Postmenopausal state | Periods have stopped

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0232970
    UMLS CUI [2]
    C0425957
    evidence of hormone sensitivity
    Descrizione

    hormone sensitivity Evidence of

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0920555
    UMLS CUI [1,2]
    C0332120
    written informed consent to participate in the trial
    Descrizione

    Informed Consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    previous treatment with faslodex (fulvestrant) or aromasin (exemestane)
    Descrizione

    Faslodex | fulvestrant | Aromasin | exemestane

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0701491
    UMLS CUI [2]
    C0935916
    UMLS CUI [3]
    C0876723
    UMLS CUI [4]
    C0851344
    any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
    Descrizione

    Hormone Therapy Other medical condition Changing | Non-Steroidal Aromatase Inhibitor

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0279025
    UMLS CUI [1,2]
    C3843040
    UMLS CUI [1,3]
    C0392747
    UMLS CUI [2]
    C1518386
    treatment with an investigational or non-approved drug within one month
    Descrizione

    Investigational New Drugs | Illicit Drugs

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    UMLS CUI [2]
    C0086190
    an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
    Descrizione

    Disease Serious Preventing participation | Disease Serious Preventing Protocol Compliance | Condition Preventing participation | Condition Preventing Protocol Compliance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [1,3]
    C1292733
    UMLS CUI [1,4]
    C0679823
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0205404
    UMLS CUI [2,3]
    C1292733
    UMLS CUI [2,4]
    C0525058
    UMLS CUI [3,1]
    C0348080
    UMLS CUI [3,2]
    C1292733
    UMLS CUI [3,3]
    C0679823
    UMLS CUI [4,1]
    C0348080
    UMLS CUI [4,2]
    C1292733
    UMLS CUI [4,3]
    C0525058
    a history of allergies to any active or inactive ingredients of faslodex or exemestane (i.e. castor oil or mannitol)
    Descrizione

    Hypersensitivity Faslodex Ingredient | Hypersensitivity exemestane Ingredient | Hypersensitivity Castor Oil | Hypersensitivity Mannitol

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0701491
    UMLS CUI [1,3]
    C1550600
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0851344
    UMLS CUI [2,3]
    C1550600
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0007343
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C0024730

    Similar models

    Eligibility Locally Advanced Breast Cancer NCT00065325

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Breast Carcinoma | Biopsy
    Item
    biopsy confirmation of breast cancer
    boolean
    C0678222 (UMLS CUI [1])
    C0005558 (UMLS CUI [2])
    Therapeutic procedure Breast Carcinoma | Aromatase Inhibitor | Disease Progression
    Item
    breast cancer has continued to grow after having received treatment with an aromatase inhibitor
    boolean
    C0087111 (UMLS CUI [1,1])
    C0678222 (UMLS CUI [1,2])
    C0593802 (UMLS CUI [2])
    C0242656 (UMLS CUI [3])
    Postmenopausal state | Periods have stopped
    Item
    postmenopausal women defined as a women who has stopped having menstrual periods
    boolean
    C0232970 (UMLS CUI [1])
    C0425957 (UMLS CUI [2])
    hormone sensitivity Evidence of
    Item
    evidence of hormone sensitivity
    boolean
    C0920555 (UMLS CUI [1,1])
    C0332120 (UMLS CUI [1,2])
    Informed Consent
    Item
    written informed consent to participate in the trial
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Faslodex | fulvestrant | Aromasin | exemestane
    Item
    previous treatment with faslodex (fulvestrant) or aromasin (exemestane)
    boolean
    C0701491 (UMLS CUI [1])
    C0935916 (UMLS CUI [2])
    C0876723 (UMLS CUI [3])
    C0851344 (UMLS CUI [4])
    Hormone Therapy Other medical condition Changing | Non-Steroidal Aromatase Inhibitor
    Item
    any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
    boolean
    C0279025 (UMLS CUI [1,1])
    C3843040 (UMLS CUI [1,2])
    C0392747 (UMLS CUI [1,3])
    C1518386 (UMLS CUI [2])
    Investigational New Drugs | Illicit Drugs
    Item
    treatment with an investigational or non-approved drug within one month
    boolean
    C0013230 (UMLS CUI [1])
    C0086190 (UMLS CUI [2])
    Disease Serious Preventing participation | Disease Serious Preventing Protocol Compliance | Condition Preventing participation | Condition Preventing Protocol Compliance
    Item
    an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C1292733 (UMLS CUI [1,3])
    C0679823 (UMLS CUI [1,4])
    C0012634 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    C1292733 (UMLS CUI [2,3])
    C0525058 (UMLS CUI [2,4])
    C0348080 (UMLS CUI [3,1])
    C1292733 (UMLS CUI [3,2])
    C0679823 (UMLS CUI [3,3])
    C0348080 (UMLS CUI [4,1])
    C1292733 (UMLS CUI [4,2])
    C0525058 (UMLS CUI [4,3])
    Hypersensitivity Faslodex Ingredient | Hypersensitivity exemestane Ingredient | Hypersensitivity Castor Oil | Hypersensitivity Mannitol
    Item
    a history of allergies to any active or inactive ingredients of faslodex or exemestane (i.e. castor oil or mannitol)
    boolean
    C0020517 (UMLS CUI [1,1])
    C0701491 (UMLS CUI [1,2])
    C1550600 (UMLS CUI [1,3])
    C0020517 (UMLS CUI [2,1])
    C0851344 (UMLS CUI [2,2])
    C1550600 (UMLS CUI [2,3])
    C0020517 (UMLS CUI [3,1])
    C0007343 (UMLS CUI [3,2])
    C0020517 (UMLS CUI [4,1])
    C0024730 (UMLS CUI [4,2])

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