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ID

19060

Description

Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

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  1. 12/2/16 12/2/16 -
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December 2, 2016

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Creative Commons BY-NC-ND 3.0
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    WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24 DRKS00000657

    English

    WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24

    1 forms  
    Final medical examination
    Description

    Final medical examination

    Alias
    UMLS CUI-1
    C0582103
    Date
    Description

    Examination Date

    Data type

    date

    Measurement units
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C2826643
    YYYY-MM-DD
    Physical Examination
    Description

    Physical Examination

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Adverse Event
    Description

    Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    DLT
    Description

    Dose-limiting toxicity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512043
    UMLS CUI [1,2]
    C0013221
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0428883
    Pulse
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • Beats/Min
    Alias
    UMLS CUI [1]
    C0018810
    Beats/Min
    Weight
    Description

    Body Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Temperature
    Description

    Body temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    ECOG Status
    Description

    ECOG Status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1520224
    Haematology
    Description

    Haematology

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0474523
    Urinanalysis
    Description

    Urinanalysis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042014
    Tumor biopsies (optional)
    Description

    Tumor biopsy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0677862
    Collection of paraffin blocks/ slides
    Description

    Paraffin Embedded Tissue

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519524
    CT/MRI tumor evaluation (RECIST)
    Description

    RECIST

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1709926
    ECG
    Description

    ECG

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1623258
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    Similar models

    WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Final medical examination
    C0582103 (UMLS CUI-1)
    Examination Date
    Item
    Date
    date
    C2826643 (UMLS CUI [1])
    Item
    Physical Examination
    integer
    C0031809 (UMLS CUI [1])
    Physical Examination
    Code List
    Physical Examination
    CL Item
    not pathologic (0)
    CL Item
    pathologic (1)
    Adverse Event
    Item
    Adverse Event
    boolean
    C0877248 (UMLS CUI [1])
    Dose-limiting toxicity
    Item
    DLT
    boolean
    C1512043 (UMLS CUI [1,1])
    C0013221 (UMLS CUI [1,2])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Pulse
    integer
    C0018810 (UMLS CUI [1])
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    ECOG Status
    integer
    C1520224 (UMLS CUI [1])
    ECOG Status
    Code List
    ECOG Status
    CL Item
    Fully active (0)
    CL Item
    80-90% (1)
    CL Item
    60-70% (2)
    CL Item
    40-50% (3)
    CL Item
    10-30% (4)
    CL Item
    Dead (5)
    Item
    Haematology
    integer
    C0474523 (UMLS CUI [1])
    Haematology
    Code List
    Haematology
    CL Item
    normal (0)
    CL Item
    out of range NCS (1)
    CL Item
    out of range (2)
    Item
    Urinanalysis
    integer
    C0042014 (UMLS CUI [1])
    Urinanalysis
    Code List
    Urinanalysis
    CL Item
    normal (0)
    CL Item
    out of range NCS (1)
    CL Item
    out of range (2)
    Tumor biopsy
    Item
    Tumor biopsies (optional)
    boolean
    C0677862 (UMLS CUI [1])
    Paraffin Embedded Tissue
    Item
    Collection of paraffin blocks/ slides
    boolean
    C1519524 (UMLS CUI [1])
    RECIST
    Item
    CT/MRI tumor evaluation (RECIST)
    boolean
    C1709926 (UMLS CUI [1])
    Item
    ECG
    integer
    C1623258 (UMLS CUI [1])
    ECG
    Code List
    ECG
    CL Item
    normal (0)
    CL Item
    pathol. (1)
    Back to the top of the page 

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