0 Evaluaciones

ID

18899

Descripción

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).

Palabras clave

  1. 23/11/16 23/11/16 -
Subido en

23 de noviembre de 2016

DOI

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Licencia

Creative Commons BY-NC-ND 3.0

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    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 2 Week 7 (V8) 2009-011417-24 DRKS00000657

    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 2 Week 7 (V8) 2009-011417-24

    Vital signs
    Descripción

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Start of Week 7
    Descripción

    Start of week

    Tipo de datos

    date

    Unidades de medida
    • YYYY-MM-DD
    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1302181
    UMLS CUI [1,3]
    C0439230
    YYYY-MM-DD
    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005910
    Systolic blood pressure
    Descripción

    Systolic blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic blood pressure
    Descripción

    Diastolic blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    pulse
    Descripción

    Heart rate

    Tipo de datos

    integer

    Unidades de medida
    • Beats/Min
    Alias
    UMLS CUI [1]
    C0018810
    Beats/Min
    Temperature
    Descripción

    Body temperature

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    ECG
    Descripción

    ECG

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1623258
    Physical examination
    Descripción

    Physical examination

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Adverse events
    Descripción

    Adverse event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    DLT
    Descripción

    Dose-limiting toxicity

    Tipo de datos

    boolean

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

    Concomitant medications

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    ECOG Status
    Descripción

    ECOG Status

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1520224
    Hematology
    Descripción

    Hematological Assessment

    Tipo de datos

    integer

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

    Urinanalysis

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0042014
    Biochemistry
    Descripción

    Biochemistry assessment

    Tipo de datos

    integer

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

    Similar models

    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 2 Week 7 (V8) 2009-011417-24

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Start of week
    Item
    Start of Week 7
    date
    C0808070 (UMLS CUI [1,1])
    C1302181 (UMLS CUI [1,2])
    C0439230 (UMLS CUI [1,3])
    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])
    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])
    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
    boolean
    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])
    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])
    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])
    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])
    Code List
    Biochemistry
    CL Item
    normal (0)
    CL Item
    out of range NCS (1)
    CL Item
    out of range (2)

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