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ID

19060

Beschrijving

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. 02-12-16 02-12-16 -
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2 december 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

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

    Final medical examination
    Beschrijving

    Final medical examination

    Alias
    UMLS CUI-1
    C0582103 (Medical Examination)
    SNOMED
    225886003
    Date
    Beschrijving

    Examination Date

    Datatype

    date

    Maateenheden
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C2826643 (Physical Examination Date)
    YYYY-MM-DD
    Physical Examination
    Beschrijving

    Physical Examination

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Adverse Event
    Beschrijving

    Adverse Event

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    DLT
    Beschrijving

    Dose-limiting toxicity

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1512043 (Dose-Limiting)
    UMLS CUI [1,2]
    C0013221 (Drug toxicity)
    SNOMED
    7895008
    Systolic Blood Pressure
    Beschrijving

    Systolic Blood Pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic Blood Pressure
    Beschrijving

    Diastolic Blood Pressure

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    Pulse
    Beschrijving

    Heart rate

    Datatype

    integer

    Maateenheden
    • Beats/Min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    Beats/Min
    Weight
    Beschrijving

    Body Weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Temperature
    Beschrijving

    Body temperature

    Datatype

    float

    Maateenheden
    • °C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    °C
    ECOG Status
    Beschrijving

    ECOG Status

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Haematology
    Beschrijving

    Haematology

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0474523 (Hematology finding)
    SNOMED
    250207003
    Urinanalysis
    Beschrijving

    Urinanalysis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    Tumor biopsies (optional)
    Beschrijving

    Tumor biopsy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0677862 (Biopsy sample)
    SNOMED
    258415003
    Collection of paraffin blocks/ slides
    Beschrijving

    Paraffin Embedded Tissue

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1519524 (Paraffin Embedded Tissue)
    CT/MRI tumor evaluation (RECIST)
    Beschrijving

    RECIST

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1709926 (Response Evaluation Criteria in Solid Tumors)
    ECG
    Beschrijving

    ECG

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0

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

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    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
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    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    ECOG Status
    integer
    C1520224 (UMLS CUI [1])
    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])
    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])
    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
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