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18883

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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    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V4) Haematology 2009-011417-24 DRKS00000657

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    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V4) Haematology 2009-011417-24

    1 Formulaires  
    Laboratory results hematology
    Description

    Laboratory results hematology

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0018943
    Please mark if evaluation was not done
    Description

    Evaluation

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0220825
    Date sample taken
    Description

    Date sample taken

    Type de données

    date

    Unités de mesure
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C1302413
    YYYY-MM-DD
    Name of laboratory
    Description

    Name of laboratory

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3258037
    WBC
    Description

    White Blood Count

    Type de données

    float

    Unités de mesure
    • 10^9/ L
    Alias
    UMLS CUI [1]
    C0023508
    10^9/ L
    RBC
    Description

    Red Blood Count

    Type de données

    float

    Unités de mesure
    • 10^12/ L
    Alias
    UMLS CUI [1]
    C1287262
    10^12/ L
    Hb
    Description

    Haemoglobin

    Type de données

    float

    Unités de mesure
    • g/dL
    Alias
    UMLS CUI [1]
    C0518015
    g/dL
    Haematocrit
    Description

    Haematocrit

    Type de données

    float

    Unités de mesure
    • L/L
    Alias
    UMLS CUI [1]
    C0018935
    L/L
    Platelets
    Description

    Platelets

    Type de données

    float

    Unités de mesure
    • 10^9/ L
    Alias
    UMLS CUI [1]
    C0005821
    10^9/ L
    Differential Count
    Description

    Differential Count

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0009555
    Neutrophils: Unit
    Description

    Neutrophils count unit

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0948762
    UMLS CUI [1,2]
    C1519795
    Neutrophils
    Description

    Neutrophils

    Type de données

    float

    Alias
    UMLS CUI [1]
    C0948762
    Lymphocytes: Unit
    Description

    Lymphocytes count unit

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0200635
    UMLS CUI [1,2]
    C1519795
    Lymphocytes
    Description

    Lymphocytes count

    Type de données

    float

    Alias
    UMLS CUI [1]
    C0200635
    Eosinophils: Unit
    Description

    Eosinophils count unit

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0200638
    UMLS CUI [1,2]
    C1519795
    Eosinophils
    Description

    Eosinophils count

    Type de données

    float

    Alias
    UMLS CUI [1]
    C0200638
    Basophils: Unit
    Description

    Basophils count unit

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0200641
    UMLS CUI [1,2]
    C1519795
    Basophils
    Description

    Basophils count

    Type de données

    float

    Alias
    UMLS CUI [1]
    C0200641
    Monocytes: Unit
    Description

    Monocytes count unit

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0200637
    UMLS CUI [1,2]
    C1519795
    Monocytes
    Description

    Monocytes count

    Type de données

    float

    Alias
    UMLS CUI [1]
    C0200637
    Relevant findings within the laboratory
    Description

    Relevant findings within the laboratory

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0587081
    Pharmacokinetics (PK) - Cycle 1 Day 15
    Description

    Pharmacokinetics (PK) - Cycle 1 Day 15

    Alias
    UMLS CUI-1
    C0031327
    Time of administration (LBH)
    Description

    Time of administration (LBH)

    Type de données

    time

    Unités de mesure
    • HH:NN
    Alias
    UMLS CUI [1,1]
    C1317775
    UMLS CUI [1,2]
    C1566164
    HH:NN
    Time of administration (Imatinib)
    Description

    Time of administration (Imatinib)

    Type de données

    time

    Unités de mesure
    • HH:NN
    Alias
    UMLS CUI [1,1]
    C1317775
    UMLS CUI [1,2]
    C0935989
    HH:NN
    Date
    Description

    Date of administration

    Type de données

    date

    Unités de mesure
    • YYYY-MM-DD
    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    YYYY-MM-DD
    PK sample taken (0h prior to therapy, 4h after therapy, 24h after therapy)
    Description

    Pharmacokinetics sample taken

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0031327
    Time PK sample taken (0h prior to therapy, 4h after therapy, 24h after therapy)
    Description

    Time Pharmacokinetics sample taken

    Type de données

    time

    Unités de mesure
    • HH:NN
    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0031327
    UMLS CUI [2]
    C0040223
    HH:NN
    End Date
    Description

    End Date

    Type de données

    text

    Unités de mesure
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C0806020
    YYYY-MM-DD
    If PK sample was not taken please comment
    Description

    Comment

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0947611
    Retour au début de la page

    Similar models

    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V4) Haematology 2009-011417-24

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Laboratory results hematology
    C1254595 (UMLS CUI-1)
    C0018943 (UMLS CUI-2)
    Evaluation
    Item
    Please mark if evaluation was not done
    boolean
    C0220825 (UMLS CUI [1])
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Name of laboratory
    Item
    Name of laboratory
    text
    C3258037 (UMLS CUI [1])
    White Blood Count
    Item
    WBC
    float
    C0023508 (UMLS CUI [1])
    Red Blood Count
    Item
    RBC
    float
    C1287262 (UMLS CUI [1])
    Haemoglobin
    Item
    Hb
    float
    C0518015 (UMLS CUI [1])
    Haematocrit
    Item
    Haematocrit
    float
    C0018935 (UMLS CUI [1])
    Platelets
    Item
    Platelets
    float
    C0005821 (UMLS CUI [1])
    Differential Count
    Item
    Differential Count
    text
    C0009555 (UMLS CUI [1])
    Item
    Neutrophils: Unit
    integer
    C0948762 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Neutrophils count unit
    Code List
    Neutrophils: Unit
    CL Item
    % (1)
    CL Item
    10^9/L (2)
    Neutrophils
    Item
    Neutrophils
    float
    C0948762 (UMLS CUI [1])
    Item
    Lymphocytes: Unit
    integer
    C0200635 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Lymphocytes count unit
    Code List
    Lymphocytes: Unit
    CL Item
    % (1)
    CL Item
    10^9/L (2)
    Lymphocytes count
    Item
    Lymphocytes
    float
    C0200635 (UMLS CUI [1])
    Item
    Eosinophils: Unit
    integer
    C0200638 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Eosinophils count unit
    Code List
    Eosinophils: Unit
    CL Item
    % (1)
    CL Item
    10^9/L (2)
    Eosinophils count
    Item
    Eosinophils
    float
    C0200638 (UMLS CUI [1])
    Item
    Basophils: Unit
    integer
    C0200641 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Basophils count unit
    Code List
    Basophils: Unit
    CL Item
    % (1)
    CL Item
    10^9/L (2)
    Basophils count
    Item
    Basophils
    float
    C0200641 (UMLS CUI [1])
    Item
    Monocytes: Unit
    integer
    C0200637 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Monocytes count unit
    Code List
    Monocytes: Unit
    CL Item
    % (1)
    CL Item
    10^9/L (2)
    Monocytes count
    Item
    Monocytes
    float
    C0200637 (UMLS CUI [1])
    Relevant findings within the laboratory
    Item
    Relevant findings within the laboratory
    boolean
    C0587081 (UMLS CUI [1])
    Item Group
    Pharmacokinetics (PK) - Cycle 1 Day 15
    C0031327 (UMLS CUI-1)
    Time of administration (LBH)
    Item
    Time of administration (LBH)
    time
    C1317775 (UMLS CUI [1,1])
    C1566164 (UMLS CUI [1,2])
    Time of administration (Imatinib)
    Item
    Time of administration (Imatinib)
    time
    C1317775 (UMLS CUI [1,1])
    C0935989 (UMLS CUI [1,2])
    Date of administration
    Item
    Date
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Pharmacokinetics sample taken
    Item
    PK sample taken (0h prior to therapy, 4h after therapy, 24h after therapy)
    boolean
    C1277698 (UMLS CUI [1,1])
    C0031327 (UMLS CUI [1,2])
    Time Pharmacokinetics sample taken
    Item
    Time PK sample taken (0h prior to therapy, 4h after therapy, 24h after therapy)
    time
    C1277698 (UMLS CUI [1,1])
    C0031327 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [2])
    End Date
    Item
    End Date
    text
    C0806020 (UMLS CUI [1])
    Comment
    Item
    If PK sample was not taken please comment
    text
    C0947611 (UMLS CUI [1])
    Retour au début de la page 

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