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24291

Description

Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Study Conclusion

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  1. 7/28/17 7/28/17 -
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GlaxoSmithKline

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July 28, 2017

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Creative Commons BY-NC-ND 3.0
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    Study Conclusion GSK Rosiglitazone Alzheimer's disease 100468

    English

    Study Conclusion GSK Rosiglitazone Alzheimer's disease 100468

    1 forms  
    Patient Information
    Description

    Patient Information

    Alias
    UMLS CUI-1
    C1955348 (Patient Information)
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Pregnancy Information
    Description

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    Did the subject become pregnant during the study?
    Description

    If Yes, complete Pregnancy Notification form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    Date of subject completion or withdrawal
    Description

    Completion, Withdrawal

    Data type

    date

    Measurement units
    • dd-mmm-yy
    Alias
    UMLS CUI [1]
    C0805732 (Completion Status)
    UMLS CUI [2]
    C2349954 (Withdraw (activity))
    dd-mmm-yy
    Was the subject withdrawn from the study?
    Description

    * If YES, specify the primary reason.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2349954 (Withdraw (activity))
    If Yes, tick the primary reason for withdrawal:
    Description

    Primary Reason of Withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C1549995 (Primary Reason)
    If Yes, tick the primary reason for withdrawal: If Other, specify:
    Description

    Primary Reason of Withdrawal Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C1549995 (Primary Reason)
    UMLS CUI [1,3]
    C2348235 (Specification)
    Investigator's Signature
    Description

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576 (Investigator Signature)
    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's name (print)
    Description

    Investigature's name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date of Report
    Description

    Date of Report

    Data type

    date

    Measurement units
    • dd-mmm-yy
    Alias
    UMLS CUI [1]
    C1302584 (Date of report)
    SNOMED
    399651003
    dd-mmm-yy
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    Similar models

    Study Conclusion GSK Rosiglitazone Alzheimer's disease 100468

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Patient Information
    C1955348 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1])
    Pregnancy
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not Applicable (not of childbearing potential or male) (X)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    Completion, Withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C0805732 (UMLS CUI [1])
    C2349954 (UMLS CUI [2])
    Item
    Was the subject withdrawn from the study?
    text
    C2349954 (UMLS CUI [1])
    Withdrawn
    Code List
    Was the subject withdrawn from the study?
    CL Item
    Yes* (Y)
    CL Item
    No (N)
    Item
    If Yes, tick the primary reason for withdrawal:
    text
    C2349954 (UMLS CUI [1,1])
    C1549995 (UMLS CUI [1,2])
    Primary Reason of Withdrawal
    Code List
    If Yes, tick the primary reason for withdrawal:
    CL Item
    Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropirate) (1)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from the study (4)
    CL Item
    Sponsor terminated study (6)
    CL Item
    Non-compliance (17)
    CL Item
    Other (Z)
    Primary Reason of Withdrawal Specification
    Item
    If Yes, tick the primary reason for withdrawal: If Other, specify:
    text
    C2349954 (UMLS CUI [1,1])
    C1549995 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigature's name
    Item
    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's name (print)
    text
    C2346576 (UMLS CUI [1])
    Date of Report
    Item
    Date of Report
    date
    C1302584 (UMLS CUI [1])
    Back to the top of the page 

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