0 Ratings

ID

16942

Description

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study End of Study

Keywords

  1. 8/15/16 8/15/16 -
  2. 9/28/16 9/28/16 -
Uploaded on

August 15, 2016

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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    DM-ASP1941-1941-CL-0004 NCT01071850

    End of Study DM-ASP1941-1941-CL-0004 NCT01071850

    End of Treatment / Premature Discontinuation
    Description

    End of Treatment / Premature Discontinuation

    Alias
    UMLS CUI-1
    C0580352 (Treatment completed)
    SNOMED
    182992009
    UMLS CUI-3
    C0457454 (Discontinuation (procedure))
    Date of Last Treatment Evaluation Through Visit 9
    Description

    Date of Collection

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Did subject complete Study Drug Treatment?
    Description

    Complete Study Drug Treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013216 (Pharmacotherapy)
    SNOMED
    416608005
    End of Treatment Reason
    Description

    End of Treatment Reason

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0457454 (Discontinuation (procedure))
    If reason is "Withdrawal by Subject" please speficy follow-up allowance
    Description

    Withdrawal by subject

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0589120 (Follow-up status)
    SNOMED
    308273005
    LOINC
    LA9177-2
    Date of Withdrawal
    Description

    Date of Withdrawal

    Data type

    date

    Measurement units
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    dd/MMM/yyyy
    Did AE result in death?
    Description

    AE Result in death

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0011065 (Cessation of life)
    SNOMED
    419620001
    If protocol violation, specify
    Description

    Protocol Violation

    Data type

    text

    Alias
    UMLS CUI [1]
    C1709750 (Protocol Violation)
    If Other, specify
    Description

    Other

    Data type

    text

    Alias
    UMLS CUI [1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    End of Study
    Description

    End of Study

    Alias
    UMLS CUI-1
    C0444496 (End of protocol)
    SNOMED
    255253007
    Date of Last Evaluation
    Description

    Date of collection

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    End of Study Assessment
    Description

    End of Study Assessment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    Details of Withdrawal
    Description

    Details of Withdrawal

    Data type

    text

    Alias
    UMLS CUI [1]
    C2349954 (Withdraw (activity))
    If Other specify
    Description

    Other

    Data type

    text

    Alias
    UMLS CUI [1]
    C2349954 (Withdraw (activity))
    UMLS CUI [2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Mortality Report
    Description

    Mortality Report

    Alias
    UMLS CUI-1
    C0011065 (Cessation of life)
    SNOMED
    419620001
    Date of Death
    Description

    Date of Death

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011065 (Cessation of life)
    SNOMED
    419620001
    Cause of Death
    Description

    Cause of Death

    Data type

    text

    Alias
    UMLS CUI [1]
    C0007465 (Cause of Death)
    SNOMED
    16100001
    LOINC
    LA10595-9
    Relationship of Study Drug to Subject's Death?
    Description

    Relationship to Study Drug

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0304229 (Experimental drug)
    Was autopsy performed?
    Description

    Autopsy

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0004398 (Autopsy)
    SNOMED
    29240004
    LOINC
    LA20097-4
    Breaking the Blind
    Description

    Breaking the Blind

    Alias
    UMLS CUI-1
    C2347038 (Blinded Clinical Study)
    Was Blind Broken During the Study?
    Description

    Blind Broken

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347038 (Blinded Clinical Study)
    Date blind broken
    Description

    Date blind broken

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [2]
    C2347038 (Blinded Clinical Study)
    Time Blind Broken
    Description

    Time Blind Broken

    Data type

    time

    Alias
    UMLS CUI [1]
    C2347038 (Blinded Clinical Study)
    UMLS CUI [2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Person who requested blind to be broken
    Description

    Person Blind Broken

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347038 (Blinded Clinical Study)
    Person who broke the blind
    Description

    Person who broke the blind

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347038 (Blinded Clinical Study)
    Person contacted at Astellas
    Description

    Person contacted at Astellas

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347038 (Blinded Clinical Study)
    Reason for breaking the blind
    Description

    Reason for breaking the blind

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347038 (Blinded Clinical Study)
    UMLS CUI [2]
    C0566251 (Reason and justification)
    SNOMED
    288830005

    Similar models

    End of Study DM-ASP1941-1941-CL-0004 NCT01071850

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    End of Treatment / Premature Discontinuation
    C0580352 (UMLS CUI-1)
    C0457454 (UMLS CUI-3)
    Date of Collection
    Item
    Date of Last Treatment Evaluation Through Visit 9
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Complete Study Drug Treatment
    Item
    Did subject complete Study Drug Treatment?
    boolean
    C0013216 (UMLS CUI [1])
    Item
    End of Treatment Reason
    integer
    C0457454 (UMLS CUI [1])
    Code List
    End of Treatment Reason
    CL Item
    Not fulfill inclusion or exclusion criteria (1)
    CL Item
    adverse event (2)
    CL Item
    lack of efficacy (3)
    CL Item
    withdrawal by subject (4)
    CL Item
    subject lost to follow up (5)
    CL Item
    protocol violation (6)
    CL Item
    randomized/registered but never received/dispensed study drug (7)
    CL Item
    other (8)
    Item
    If reason is "Withdrawal by Subject" please speficy follow-up allowance
    integer
    C0589120 (UMLS CUI [1])
    Code List
    If reason is "Withdrawal by Subject" please speficy follow-up allowance
    CL Item
    allows follow-up after withdrawal (1)
    CL Item
    does not allow follow-up after withdrawal (2)
    Date of Withdrawal
    Item
    Date of Withdrawal
    date
    C2349954 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Did AE result in death?
    integer
    C0011065 (UMLS CUI [1])
    Code List
    Did AE result in death?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Unknown (3)
    Protocol Violation
    Item
    If protocol violation, specify
    text
    C1709750 (UMLS CUI [1])
    Other
    Item
    If Other, specify
    text
    C0205394 (UMLS CUI [1])
    Item Group
    End of Study
    C0444496 (UMLS CUI-1)
    Date of collection
    Item
    Date of Last Evaluation
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    End of Study Assessment
    integer
    C0220825 (UMLS CUI [1])
    Code List
    End of Study Assessment
    CL Item
    Completed (1)
    CL Item
    Death (2)
    CL Item
    Lost to Follow-up (3)
    CL Item
    Withdrawal by Subject (4)
    CL Item
    Not Applicable (5)
    CL Item
    Other (6)
    Details of Withdrawal
    Item
    Details of Withdrawal
    text
    C2349954 (UMLS CUI [1])
    Other
    Item
    If Other specify
    text
    C2349954 (UMLS CUI [1])
    C0205394 (UMLS CUI [2])
    Item Group
    Mortality Report
    C0011065 (UMLS CUI-1)
    Date of Death
    Item
    Date of Death
    date
    C0011065 (UMLS CUI [1])
    Cause of Death
    Item
    Cause of Death
    text
    C0007465 (UMLS CUI [1])
    Item
    Relationship of Study Drug to Subject's Death?
    integer
    C0877248 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Code List
    Relationship of Study Drug to Subject's Death?
    CL Item
    Not related (1)
    CL Item
    Possible (2)
    CL Item
    Probable (3)
    Item
    Was autopsy performed?
    integer
    C0004398 (UMLS CUI [1])
    Code List
    Was autopsy performed?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Unknown (3)
    Item Group
    Breaking the Blind
    C2347038 (UMLS CUI-1)
    Blind Broken
    Item
    Was Blind Broken During the Study?
    boolean
    C2347038 (UMLS CUI [1])
    Date blind broken
    Item
    Date blind broken
    date
    C0011008 (UMLS CUI [1])
    C2347038 (UMLS CUI [2])
    Time Blind Broken
    Item
    Time Blind Broken
    time
    C2347038 (UMLS CUI [1])
    C0040223 (UMLS CUI [2])
    Person Blind Broken
    Item
    Person who requested blind to be broken
    text
    C2347038 (UMLS CUI [1])
    Person who broke the blind
    Item
    Person who broke the blind
    text
    C2347038 (UMLS CUI [1])
    Person contacted at Astellas
    Item
    Person contacted at Astellas
    text
    C2347038 (UMLS CUI [1])
    Reason for breaking the blind
    Item
    Reason for breaking the blind
    text
    C2347038 (UMLS CUI [1])
    C0566251 (UMLS CUI [2])

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