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ID

6181

Description

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00952588

Link

http://clinicaltrials.gov/ct2/show/record/NCT00952588

Keywords

Versions (4)
  1. 11/14/11 11/14/11 -
  2. 12/6/13 12/6/13 - Martin Dugas
  3. 4/11/14 4/11/14 - Julian Varghese
  4. 12/16/14 12/16/14 - Martin Dugas
Uploaded on

December 16, 2014

DOI

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License

Creative Commons BY 4.0
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    Eligibility AZD1152 and LDAC in AML

    English

    Eligibility AZD1152 and LDAC in AML

    1 forms  
    Inclusion criteria
    Description

    Inclusion criteria

    Alias
    UMLS CUI-1
    C1512693
    Provision of written informed consent
    Description

    consent

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0021430
    Newly diagnosed male or female patients aged 60 and over
    Description

    Newly diagnosed patients aged 60 and over

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0001779
    De Novo or Secondary AML
    Description

    De Novo or Secondary AML

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0023467
    Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following: Age >=75 years; Adverse cytogenetics, e.g., as defined by the MRC Prognostic Groupings; WHO performance status >2; Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia
    Description

    Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following: Age >=75 years; Adverse cytogenetics, e.g., as defined by the MRC Prognostic Groupings; WHO performance status >2; Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia

    Data type

    boolean

    Alias
    UMLS CUI-1
    C3242266
    UMLS CUI-2
    C0600558
    Exclusion criteria
    Description

    Exclusion criteria

    Alias
    UMLS CUI-1
    C0680251
    Participation in another clinical study in which an investigational product was received within 14 days before the first dose in this study, or at any time if the patient has not recovered from side-effects associated with that investigational product
    Description

    Participation in another clinical study in which an investigational product was received within 14 days before the first dose in this study, or at any time if the patient has not recovered from side-effects associated with that investigational product

    Data type

    boolean

    Alias
    UMLS CUI-1
    C2348568
    Administration of LDAC is clinically contraindicated
    Description

    Administration of LDAC is clinically contraindicated

    Data type

    boolean

    Alias
    UMLS CUI-1
    C1301624
    UMLS CUI-2
    C0010711
    Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)
    Description

    Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0023487
    Patients with blast crisis of chronic myeloid leukaemia
    Description

    Patients with blast crisis of chronic myeloid leukaemia

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0023473
    UMLS CUI-2
    C0005699
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    Similar models

    Eligibility AZD1152 and LDAC in AML

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion criteria
    C1512693 (UMLS CUI-1)
    consent
    Item
    Provision of written informed consent
    boolean
    C0021430 (UMLS CUI-1)
    Age
    Item
    Newly diagnosed male or female patients aged 60 and over
    boolean
    C0001779 (UMLS CUI-1)
    AML
    Item
    De Novo or Secondary AML
    boolean
    C0023467 (UMLS CUI-1)
    Patient not eligible for Induction therapy
    Item
    Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following: Age >=75 years; Adverse cytogenetics, e.g., as defined by the MRC Prognostic Groupings; WHO performance status >2; Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia
    boolean
    C3242266 (UMLS CUI-1)
    C0600558 (UMLS CUI-2)
    Item Group
    Exclusion criteria
    C0680251 (UMLS CUI-1)
    other trial
    Item
    Participation in another clinical study in which an investigational product was received within 14 days before the first dose in this study, or at any time if the patient has not recovered from side-effects associated with that investigational product
    boolean
    C2348568 (UMLS CUI-1)
    Contraindication LDAC
    Item
    Administration of LDAC is clinically contraindicated
    boolean
    C1301624 (UMLS CUI-1)
    C0010711 (UMLS CUI-2)
    AML M3 APL
    Item
    Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)
    boolean
    C0023487 (UMLS CUI-1)
    CML blast crisis
    Item
    Patients with blast crisis of chronic myeloid leukaemia
    boolean
    C0023473 (UMLS CUI-1)
    C0005699 (UMLS CUI-2)
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