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19061

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. 02/12/2016 02/12/2016 -
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2 décembre 2016

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Creative Commons BY-NC-ND 3.0
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    WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24 DRKS00000657

    Anglais

    WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24

    1 Formulaires  
    End of study report
    Description

    End of study report

    Alias
    UMLS CUI-1
    C2732579
    Date of end of study
    Description

    Study End Date

    Type de données

    date

    Unités de mesure
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C2983670
    YYYY-MM-DD
    Who ended the study?
    Description

    End of study: Physician

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2826892
    UMLS CUI [1,2]
    C2732579
    Premature end of study
    Description

    Premature end of study

    Alias
    UMLS CUI-1
    C1279919
    UMLS CUI-2
    C2732579
    Premature end of study
    Description

    Premature end of study

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1279919
    UMLS CUI [1,2]
    C2732579
    If Yes: reasons for discontinuation of the study (multiple reasons are possible)
    Description

    Reason for discontinuation

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C0457454
    Other:
    Description

    Reason for discontination: Specification

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C2348235
    Other remarks or events
    Description

    Remarks or events

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0947611
    UMLS CUI [2]
    C0441471
    Investigator's name
    Description

    Investigator's name

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2826892
    Investigator's stamp
    Description

    Investigator's stamp

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3825804
    Date
    Description

    Date

    Alias
    UMLS CUI-1
    C0011008
    Date
    Description

    Date

    Type de données

    date

    Unités de mesure
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C0011008
    YYYY-MM-DD
    Investigator's signature
    Description

    Investigator's signature

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2346576
    Retour au début de la page

    Similar models

    WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    End of study report
    C2732579 (UMLS CUI-1)
    Study End Date
    Item
    Date of end of study
    date
    C2983670 (UMLS CUI [1])
    Item
    Who ended the study?
    integer
    C2826892 (UMLS CUI [1,1])
    C2732579 (UMLS CUI [1,2])
    End of study: Physician
    Code List
    Who ended the study?
    CL Item
    patient (1)
    CL Item
    doctor (2)
    Item Group
    Premature end of study
    C1279919 (UMLS CUI-1)
    C2732579 (UMLS CUI-2)
    Premature end of study
    Item
    Premature end of study
    boolean
    C1279919 (UMLS CUI [1,1])
    C2732579 (UMLS CUI [1,2])
    Item
    If Yes: reasons for discontinuation of the study (multiple reasons are possible)
    integer
    C0566251 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    Reason for discontinuation
    Code List
    If Yes: reasons for discontinuation of the study (multiple reasons are possible)
    CL Item
    lost to follow up (1)
    CL Item
    Patient died (2)
    CL Item
    Withdrawal of consent (3)
    CL Item
    non-compliance of the patient (4)
    CL Item
    forbidden concomitant therapy (5)
    CL Item
    disease progression (6)
    CL Item
    adverse events (7)
    CL Item
    other (8)
    Reason for discontination: Specification
    Item
    Other:
    text
    C0566251 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Remarks or events
    Item
    Other remarks or events
    text
    C0947611 (UMLS CUI [1])
    C0441471 (UMLS CUI [2])
    Investigator's name
    Item
    Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Investigator's stamp
    Item
    Investigator's stamp
    boolean
    C3825804 (UMLS CUI [1])
    Item Group
    Date
    C0011008 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Investigator's signature
    Item
    Investigator's signature
    boolean
    C2346576 (UMLS CUI [1])
    Retour au début de la page 

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