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ID

18885

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. 11/23/16 11/23/16 -
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November 23, 2016

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Creative Commons BY-NC-ND 3.0
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    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 Week 4 (V5) 2009-011417-24 DRKS00000657

    English

    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 Week 4 (V5) 2009-011417-24

    1 forms  
    Vital signs
    Description

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Start of cycle
    Description

    Start of cycle

    Data type

    date

    Measurement units
    • YYYY-MM-DD
    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1302181
    YYYY-MM-DD
    Weight
    Description

    Weight

    Data type

    float

    Alias
    UMLS CUI [1]
    C0005910
    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

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    pulse
    Description

    Heart rate

    Data type

    integer

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

    Body temperature

    Data type

    float

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

    ECG

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1623258
    Physical examination
    Description

    Physical examination

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Adverse events
    Description

    Adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    DLT
    Description

    Dose-limiting toxicity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1512043
    UMLS CUI [1,2]
    C0013221
    Concomitant medications
    Description

    Concomitant medications

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    ECOG Status
    Description

    ECOG Status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1520224
    Hematology
    Description

    Hematological Assessment

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0279810
    UMLS CUI [1,2]
    C0220825
    Urinanalysis
    Description

    Urinanalysis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042014
    Biochemistry
    Description

    Biochemistry assessment

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005477
    UMLS CUI [1,2]
    C0220825
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    Similar models

    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 Week 4 (V5) 2009-011417-24

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Start of cycle
    Item
    Start of cycle
    date
    C0808070 (UMLS CUI [1,1])
    C1302181 (UMLS CUI [1,2])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    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 temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    ECG
    integer
    C1623258 (UMLS CUI [1])
    ECG
    Code List
    ECG
    CL Item
    normal (0)
    CL Item
    out of range NCS (1)
    CL Item
    out of range (2)
    Item
    Physical examination
    integer
    C0031809 (UMLS CUI [1])
    Physical examination
    Code List
    Physical examination
    CL Item
    normal (0)
    CL Item
    out of range NCS (1)
    CL Item
    out of range (2)
    Adverse event
    Item
    Adverse events
    boolean
    C0877248 (UMLS CUI [1])
    Dose-limiting toxicity
    Item
    DLT
    text
    C1512043 (UMLS CUI [1,1])
    C0013221 (UMLS CUI [1,2])
    Concomitant medications
    Item
    Concomitant medications
    boolean
    C2347852 (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
    Hematology
    integer
    C0279810 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    Hematological Assessment
    Code List
    Hematology
    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)
    Item
    Biochemistry
    integer
    C0005477 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    Biochemistry assessment
    Code List
    Biochemistry
    CL Item
    normal (0)
    CL Item
    out of range NCS (1)
    CL Item
    out of range (2)
    Back to the top of the page 

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