0 Ratings
ID

254

Description

ODM derived from http://clinicaltrials.gov/show/NCT00321620

Link

http://clinicaltrials.gov/show/NCT00321620

Keywords

Versions (5)
  1. 3/20/12 3/20/12 -
  2. 3/20/12 3/20/12 -
  3. 4/14/14 4/14/14 - Julian Varghese
  4. 4/20/14 4/20/14 - Julian Varghese
  5. 9/20/21 9/20/21 -
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March 20, 2012

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Creative Commons BY-NC 3.0 Legacy
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    Double-blind Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Metastases in Men With Hormone-refractory Prostate Cancer

    German English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Age 18 Years and older
    Description

    age >=18 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Men >/= 18 years of age with histologically confirmed prostate cancer
    Description

    Men >/= 18 years of age with histologically confirmed prostate cancer

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0024554
    SNOMED CT 2011_0131
    248153007
    UMLS CUI 2011AA
    C0205462
    SNOMED CT 2011_0131
    67151002
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0600139
    SNOMED CT 2011_0131
    254900004
    MedDRA 14.1
    10036921
    Radiographic evidence of at least one bone metastasis
    Description

    Radiographic evidence of at least one bone metastasis

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0153690
    SNOMED CT 2011_0131
    94222008
    MedDRA 14.1
    10055101
    ICD-10-CM Version 2010
    C79.51
    ICD-9-CM Version 2011
    198.5
    UMLS CUI 2011AA
    C0444708
    SNOMED CT 2011_0131
    258106000
    UMLS CUI 2011AA
    C0332120
    SNOMED CT 2011_0131
    18669006
    Failure of at least one hormonal therapy as evidenced by a rising PSA
    Description

    Failure of at least one hormonal therapy as evidenced by a rising PSA

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0231174
    SNOMED CT 2011_0131
    76797004
    UMLS CUI 2011AA
    C0279025
    SNOMED CT 2011_0131
    169413002
    MedDRA 14.1
    10065646
    UMLS CUI 2011AA
    C0332120
    SNOMED CT 2011_0131
    18669006
    UMLS CUI 2011AA
    C0138741
    SNOMED CT 2011_0131
    102687007
    LOINC Version 232
    MTHU001466
    Serum testosterone level of <50 ng/dL
    Description

    Serum testosterone level of <50 ng/dL

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0857983
    MedDRA 14.1
    10040411
    UMLS CUI 2011AA
    C0428413
    SNOMED CT 2011_0131
    270973006
    MedDRA 14.1
    10040409
    ECOG performance status finding
    Description

    ECOG

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1828127
    SNOMED CT 2011_0131
    424122007
    Adequate organ function
    Description

    Adequate organ function

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205411
    SNOMED CT 2011_0131
    88323005
    UMLS CUI 2011AA
    C0678852
    Exclusion Criteria
    Description

    Exclusion Criteria

    Current or prior IV bisphosphonate administration
    Description

    Current or prior IV bisphosphonate administration

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0013125
    UMLS CUI 2011AA
    C0012544
    SNOMED CT 2011_0131
    372907000
    Current or prior oral bisphosphonates for bone mets
    Description

    Current or prior oral bisphosphonates for bone mets

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1527415
    SNOMED CT 2011_0131
    26643006
    HL7 V3 2006_05
    _OralRoute
    UMLS CUI 2011AA
    C0012544
    SNOMED CT 2011_0131
    372907000
    UMLS CUI 2011AA
    C0153690
    SNOMED CT 2011_0131
    94222008
    MedDRA 14.1
    10055101
    ICD-10-CM Version 2010
    C79.51
    ICD-9-CM Version 2011
    198.5
    life expectancy <6 months
    Description

    life expectancy of less than 6 months

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C2707931
    LOINC Version 232
    MTHU032184
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    age >=18 Years
    Item
    Age 18 Years and older
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Men >/= 18 years of age with histologically confirmed prostate cancer
    Item
    Men >/= 18 years of age with histologically confirmed prostate cancer
    boolean
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0024554 (UMLS CUI 2011AA)
    248153007 (SNOMED CT 2011_0131)
    C0205462 (UMLS CUI 2011AA)
    67151002 (SNOMED CT 2011_0131)
    C0750484 (UMLS CUI 2011AA)
    C0600139 (UMLS CUI 2011AA)
    254900004 (SNOMED CT 2011_0131)
    10036921 (MedDRA 14.1)
    Radiographic evidence of at least one bone metastasis
    Item
    Radiographic evidence of at least one bone metastasis
    boolean
    C0153690 (UMLS CUI 2011AA)
    94222008 (SNOMED CT 2011_0131)
    10055101 (MedDRA 14.1)
    C79.51 (ICD-10-CM Version 2010)
    198.5 (ICD-9-CM Version 2011)
    C0444708 (UMLS CUI 2011AA)
    258106000 (SNOMED CT 2011_0131)
    C0332120 (UMLS CUI 2011AA)
    18669006 (SNOMED CT 2011_0131)
    Failure of at least one hormonal therapy as evidenced by a rising PSA
    Item
    Failure of at least one hormonal therapy as evidenced by a rising PSA
    boolean
    C0231174 (UMLS CUI 2011AA)
    76797004 (SNOMED CT 2011_0131)
    C0279025 (UMLS CUI 2011AA)
    169413002 (SNOMED CT 2011_0131)
    10065646 (MedDRA 14.1)
    C0332120 (UMLS CUI 2011AA)
    18669006 (SNOMED CT 2011_0131)
    C0138741 (UMLS CUI 2011AA)
    102687007 (SNOMED CT 2011_0131)
    MTHU001466 (LOINC Version 232)
    Serum testosterone level of <50 ng/dL
    Item
    Serum testosterone level of <50 ng/dL
    boolean
    C0857983 (UMLS CUI 2011AA)
    10040411 (MedDRA 14.1)
    C0428413 (UMLS CUI 2011AA)
    270973006 (SNOMED CT 2011_0131)
    10040409 (MedDRA 14.1)
    ECOG
    Item
    ECOG performance status finding
    boolean
    C1828127 (UMLS CUI 2011AA)
    424122007 (SNOMED CT 2011_0131)
    Adequate organ function
    Item
    Adequate organ function
    boolean
    C0205411 (UMLS CUI 2011AA)
    88323005 (SNOMED CT 2011_0131)
    C0678852 (UMLS CUI 2011AA)
    Item Group
    Exclusion Criteria
    Current or prior IV bisphosphonate administration
    Item
    Current or prior IV bisphosphonate administration
    boolean
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0013125 (UMLS CUI 2011AA)
    C0012544 (UMLS CUI 2011AA)
    372907000 (SNOMED CT 2011_0131)
    Current or prior oral bisphosphonates for bone mets
    Item
    Current or prior oral bisphosphonates for bone mets
    boolean
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1527415 (UMLS CUI 2011AA)
    26643006 (SNOMED CT 2011_0131)
    _OralRoute (HL7 V3 2006_05)
    C0012544 (UMLS CUI 2011AA)
    372907000 (SNOMED CT 2011_0131)
    C0153690 (UMLS CUI 2011AA)
    94222008 (SNOMED CT 2011_0131)
    10055101 (MedDRA 14.1)
    C79.51 (ICD-10-CM Version 2010)
    198.5 (ICD-9-CM Version 2011)
    life expectancy of less than 6 months
    Item
    life expectancy <6 months
    boolean
    C2707931 (UMLS CUI 2011AA)
    MTHU032184 (LOINC Version 232)
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