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ID

29857

Description

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

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https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

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Versions (1)
  1. 4/24/18 4/24/18 - Halim Ugurlu
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GSK

Uploaded on

April 24, 2018

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Creative Commons BY-NC 3.0
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    GSK Study ID 104864-201 Pre-Next Course

    English

    Pre-Next Course

    1 forms  
    1. StudyEvent: ODM
      1. Pre-Next Course
    Identification Numbers
    Description

    Identification Numbers

    Alias
    UMLS CUI-1
    C1300638
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Serious Adverse Experiences
    Description

    Serious Adverse Experiences

    Alias
    UMLS CUI-1
    C1519255
    Has the patient had any serious adverse experiences during this course?
    Description

    If there have been any serious adverse experiences since the last visit, please record details in the Serious Adverse Experience section.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    12-Lead Electrocardiogram
    Description

    12-Lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456
    Date Performed
    Description

    Date Performed

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0011008
    Result of 12-Lead ECG
    Description

    Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0430456
    Is this not done?
    Description

    Perform only if clinically indicated, or if this is the patient's last course.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1623258
    Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)
    Description

    Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)

    Alias
    UMLS CUI-1
    C0013516
    UMLS CUI-3
    C0521317
    Was an Ejection Fraction obtained?
    Description

    Ejection Fraction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232174
    If Yes for the obtained Ejection Fraction
    Description

    If Yes for the obtained Ejection Fraction

    Alias
    UMLS CUI-1
    C2700378
    Date Performed
    Description

    Date Performed

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013516
    UMLS CUI [2]
    C0521317
    LV Ejection Fraction (2-dimensional mode) (%)
    Description

    LV Ejection Fraction (2-dimensional mode) (%)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0428772
    Which procedure was performed?
    Description

    Which procedure was performed?

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013516
    UMLS CUI [2]
    C0521317
    Result of Echocardiography/MUGA
    Description

    Result of Echocardiography/MUGA

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0013516
    UMLS CUI [2]
    C0521317
    Chest X-Ray
    Description

    Chest X-Ray

    Alias
    UMLS CUI-1
    C0039985
    Date Performed
    Description

    Date Performed

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0039985
    Result of Chest X-Ray
    Description

    Result of Chest X-Ray

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0039985
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    Similar models

    Pre-Next Course

    1 forms
    1. StudyEvent: ODM
      1. Pre-Next Course
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Identification Numbers
    C1300638 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Serious Adverse Experiences
    C1519255 (UMLS CUI-1)
    Serious adverse experiences
    Item
    Has the patient had any serious adverse experiences during this course?
    boolean
    C1519255 (UMLS CUI [1])
    Item Group
    12-Lead Electrocardiogram
    C0430456 (UMLS CUI-1)
    Date Performed
    Item
    Date Performed
    date
    C0013798 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Result of 12-Lead ECG
    text
    C1274040 (UMLS CUI [1,1])
    C0430456 (UMLS CUI [1,2])
    Result
    Code List
    Result of 12-Lead ECG
    CL Item
    Normal/no clinically significant abnormality (1)
    CL Item
    Clinically significant abnormality (If 'Yes' please record details on the Significant Medical/ Surgical History and Physical Examination page.) (2)
    Perform Status
    Item
    Is this not done?
    boolean
    C1623258 (UMLS CUI [1])
    Item Group
    Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)
    C0013516 (UMLS CUI-1)
    C0521317 (UMLS CUI-3)
    Ejection Fraction
    Item
    Was an Ejection Fraction obtained?
    boolean
    C0232174 (UMLS CUI [1])
    Item Group
    If Yes for the obtained Ejection Fraction
    C2700378 (UMLS CUI-1)
    Date Performed
    Item
    Date Performed
    date
    C0011008 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    C0521317 (UMLS CUI [2])
    LV Ejection Fraction (2-dimensional mode) (%)
    Item
    LV Ejection Fraction (2-dimensional mode) (%)
    float
    C0428772 (UMLS CUI [1])
    Item
    Which procedure was performed?
    text
    C0013516 (UMLS CUI [1])
    C0521317 (UMLS CUI [2])
    Which procedure was performed?
    Code List
    Which procedure was performed?
    CL Item
    Echocardiogram (1)
    CL Item
    MUGA (2)
    Item
    Result of Echocardiography/MUGA
    text
    C1274040 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    C0521317 (UMLS CUI [2])
    Result of Echocardiography/MUGA
    Code List
    Result of Echocardiography/MUGA
    CL Item
    No significant worsening since screening (1)
    CL Item
    Worsening since screening (Please record in the Adverse Experience section) (2)
    Item Group
    Chest X-Ray
    C0039985 (UMLS CUI-1)
    Date Performed
    Item
    Date Performed
    date
    C0011008 (UMLS CUI [1,1])
    C0039985 (UMLS CUI [1,2])
    Item
    Result of Chest X-Ray
    text
    C1274040 (UMLS CUI [1,1])
    C0039985 (UMLS CUI [1,2])
    Result of Chest X-Ray
    Code List
    Result of Chest X-Ray
    CL Item
    No significant worsening since screenin (1)
    CL Item
    Worsening since screening (Please record in the Adverse Experience section) (2)
    Back to the top of the page 

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