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29859

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

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April 24, 2018

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Creative Commons BY-NC 3.0
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    GSK Study ID 104864-201 Adverse Experiences (non-serious)

    English

    Adverse Experiences (non-Serious)

    1 forms  
    Identification Numbers
    Description

    Identification Numbers

    Alias
    UMLS CUI-1
    C1300638
    Center Number
    Description

    Center Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    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
    Adverse Experiences (non-Serious)
    Description

    Adverse Experiences (non-Serious)

    Alias
    UMLS CUI-1
    C1518404
    If no adverse experiences occurred during the study, please sign form below and mark this box
    Description

    No Advers Experiences

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1298908
    Serious adverse experience
    Description

    If you consider this to be a serious adverse experience (SAE), please do not enter on this page but enter in the SAE section in the back of this binder (See tab for definitions of an SAE).

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519255
    Adverse Experiences (non-Serious)
    Description

    Adverse Experiences (non-Serious)

    Alias
    UMLS CUI-1
    C1518404
    Adverse Experience
    Description

    Record any adverse experiences (using standard medical terminology ) observed or elicited by the following direct question to patient: "Do you feel different in any way since starting the treatment or since the last visit ?" Provide the diagnosis not symptoms where possible. Enter one adverse experience per column

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
    Onset Data and Time
    Description

    Onset Data and Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    End Date and Time (if ongoing please leave blank)
    Description

    End Date and Time (if ongoing please leave blank)

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2981425
    Outcome- If patient died, STOP: go to SAE section and follow instructions given here
    Description

    Outcome

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705586
    Experience Course
    Description

    Experience Course

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    Common Toxicity Grade: 1-4
    Description

    Common Toxicity Grade

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826262
    Action Taken with Respect to Investigational Drug
    Description

    Action Taken with Respect to Investigational Drug

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826626
    Relationship to Investigational Drug
    Description

    Relationship to Investigational Drug

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439849
    UMLS CUI [1,2]
    C3854006
    If ´Yes´ record details in the Concomitant Medication section
    Description

    Corrective Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    Was patient withdrawn due to this specific AE?
    Description

    Withdrawn due to this specific AE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1518404
    Investigators Signature
    Description

    Investigators Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigators Signature Date
    Description

    Investigators Signature Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0807937
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    Similar models

    Adverse Experiences (non-Serious)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Identification Numbers
    C1300638 (UMLS CUI-1)
    Center Number
    Item
    Center Number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Adverse Experiences (non-Serious)
    C1518404 (UMLS CUI-1)
    No Advers Experiences
    Item
    If no adverse experiences occurred during the study, please sign form below and mark this box
    boolean
    C0877248 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    Serious adverse experience
    Item
    Serious adverse experience
    text
    C1519255 (UMLS CUI [1])
    Item Group
    Adverse Experiences (non-Serious)
    C1518404 (UMLS CUI-1)
    Adverse Experience
    Item
    Adverse Experience
    text
    C0877248 (UMLS CUI [1])
    Onset Data and Time
    Item
    Onset Data and Time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    End Date and Time (if ongoing please leave blank)
    Item
    End Date and Time (if ongoing please leave blank)
    datetime
    C2981425 (UMLS CUI [1])
    Item
    Outcome- If patient died, STOP: go to SAE section and follow instructions given here
    text
    C1705586 (UMLS CUI [1])
    Outcome
    Code List
    Outcome- If patient died, STOP: go to SAE section and follow instructions given here
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    CL Item
    Died (3)
    Item
    Experience Course
    text
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Experience Course
    Code List
    Experience Course
    CL Item
    Intermittent (number of episodes:..............) (1)
    CL Item
    Constant (2)
    Common Toxicity Grade
    Item
    Common Toxicity Grade: 1-4
    text
    C2826262 (UMLS CUI [1])
    Item
    Action Taken with Respect to Investigational Drug
    text
    C2826626 (UMLS CUI [1])
    Action Taken with Respect to Investigational Drug
    Code List
    Action Taken with Respect to Investigational Drug
    CL Item
    None (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose increased (3)
    CL Item
    Drug stopped (4)
    CL Item
    Drug interrupted/restarted (5)
    CL Item
    Dose delayed (6)
    CL Item
    Dose delayed and decreased (7)
    Item
    Relationship to Investigational Drug
    text
    C0439849 (UMLS CUI [1,1])
    C3854006 (UMLS CUI [1,2])
    Relationship to Investigational Drug
    Code List
    Relationship to Investigational Drug
    CL Item
    Not related (4)
    CL Item
    Unlikely (3)
    CL Item
    Suspected (reasonable possibility) (2)
    CL Item
    Probable (1)
    Corrective Therapy
    Item
    If ´Yes´ record details in the Concomitant Medication section
    boolean
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Withdrawn due to this specific AE
    Item
    Was patient withdrawn due to this specific AE?
    boolean
    C0422727 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Investigators Signature
    Item
    Investigators Signature
    text
    C2346576 (UMLS CUI [1])
    Investigators Signature Date
    Item
    Investigators Signature Date
    date
    C0807937 (UMLS CUI [1])
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