0 Evaluaciones
ID

19061

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).

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Versiones (1)
  1. 2/12/16 2/12/16 -
Subido en

2 de diciembre de 2016

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Licencia

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

    Inglés

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

    1 formularios  
    End of study report
    Descripción

    End of study report

    Alias
    UMLS CUI-1
    C2732579 (Completion of clinical trial)
    SNOMED
    443729008
    Date of end of study
    Descripción

    Study End Date

    Tipo de datos

    date

    Unidades de medida
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    YYYY-MM-DD
    Who ended the study?
    Descripción

    End of study: Physician

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C2826892 (Investigator Name)
    UMLS CUI [1,2]
    C2732579 (Completion of clinical trial)
    SNOMED
    443729008
    Premature end of study
    Descripción

    Premature end of study

    Alias
    UMLS CUI-1
    C1279919 (Early)
    SNOMED
    264499004
    LOINC
    LA12111-3
    UMLS CUI-2
    C2732579 (Completion of clinical trial)
    SNOMED
    443729008
    Premature end of study
    Descripción

    Premature end of study

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1279919 (Early)
    SNOMED
    264499004
    LOINC
    LA12111-3
    UMLS CUI [1,2]
    C2732579 (Completion of clinical trial)
    SNOMED
    443729008
    If Yes: reasons for discontinuation of the study (multiple reasons are possible)
    Descripción

    Reason for discontinuation

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,2]
    C0457454 (Discontinuation (procedure))
    Other:
    Descripción

    Reason for discontination: Specification

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,2]
    C0457454 (Discontinuation (procedure))
    UMLS CUI [1,3]
    C2348235 (Specification)
    Other remarks or events
    Descripción

    Remarks or events

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [2]
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    Investigator's name
    Descripción

    Investigator's name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    Investigator's stamp
    Descripción

    Investigator's stamp

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3825804 (Stamp collecting)
    Date
    Descripción

    Date

    Alias
    UMLS CUI-1
    C0011008 (Date in time)
    SNOMED
    410671006
    Date
    Descripción

    Date

    Tipo de datos

    date

    Unidades de medida
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    YYYY-MM-DD
    Investigator's signature
    Descripción

    Investigator's signature

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
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    Similar models

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

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
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