0 Ratings

ID

44719

Description

see http://clinicaltrials.gov/ct2/show/record/NCT00617669 Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer

Link

http://clinicaltrials.gov/ct2/show/record/NCT00617669

Keywords

  1. 11/15/11 11/15/11 -
  2. 3/23/14 3/23/14 - Martin Dugas
  3. 8/10/14 8/10/14 - Martin Dugas
  4. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  5. 9/20/21 9/20/21 -
  6. 9/28/21 9/28/21 - Sarah Riepenhausen
Copyright Holder

AstraZeneca

Uploaded on

September 28, 2021

DOI

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License

Creative Commons BY 4.0

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    Eligibility DRKS00005404 NCT00617669 Prostate Cancer

    Eligibility NCT00617669

    1. StudyEvent: Eligibility
      1. Eligibility NCT00617669
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693 (Inclusion)
    18 Years and older
    Description

    Age

    Data type

    integer

    Measurement units
    • years
    Alias
    UMLS CUI-1
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    years
    male
    Description

    Gender Male

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0086582 (Males)
    SNOMED
    10052007
    Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)
    Description

    Prostate Cancer with bone metastasis

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0600139 (Prostate carcinoma)
    SNOMED
    254900004
    UMLS CUI-2
    C0153690 (Secondary malignant neoplasm of bone)
    SNOMED
    94222008
    Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
    Description

    PSA increase

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0138741 (Prostate-Specific Antigen)
    SNOMED
    102687007
    LOINC
    LP18193-0
    Currently receiving treatment with surgical or medical castration
    Description

    Castration

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0007347 (Male Castration)
    SNOMED
    386634006
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
    Description

    Previous chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    UMLS CUI-2
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    Suffering from heart failure or had a myocardial infarction within last 6 months
    Description

    Heart disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    UMLS CUI [1,2]
    C0155626 (Acute myocardial infarction)
    SNOMED
    57054005
    A history of epilepsy or seizures
    Description

    Epilepsy, seizures

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0014544 (Epilepsy)
    SNOMED
    84757009
    LOINC
    MTHU020586
    UMLS CUI-2
    C0036572 (Seizures)
    SNOMED
    91175000
    LOINC
    LA15899-0

    Similar models

    Eligibility NCT00617669

    1. StudyEvent: Eligibility
      1. Eligibility NCT00617669
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Age
    Item
    18 Years and older
    integer
    C0001779 (UMLS CUI-1)
    Gender Male
    Item
    male
    boolean
    C0086582 (UMLS CUI-1)
    Prostate Cancer with bone metastasis
    Item
    Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)
    boolean
    C0600139 (UMLS CUI-1)
    C0153690 (UMLS CUI-2)
    PSA increase
    Item
    Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
    boolean
    C0138741 (UMLS CUI-1)
    Castration
    Item
    Currently receiving treatment with surgical or medical castration
    boolean
    C0007347 (UMLS CUI-1)
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Previous chemotherapy
    Item
    Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
    boolean
    C0205156 (UMLS CUI-1)
    C0392920 (UMLS CUI-2)
    Heart disease
    Item
    Suffering from heart failure or had a myocardial infarction within last 6 months
    boolean
    C0018801 (UMLS CUI [1,1])
    C0155626 (UMLS CUI [1,2])
    Epilepsy, seizures
    Item
    A history of epilepsy or seizures
    boolean
    C0014544 (UMLS CUI-1)
    C0036572 (UMLS CUI-2)

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