0 Avaliações
ID

24291

Descrição

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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Versões (1)
  1. 28/07/2017 28/07/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

28 de julho de 2017

DOI

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Licença

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

    Inglês

    Study Conclusion GSK Rosiglitazone Alzheimer's disease 100468

    1 Formulários  
    Patient Information
    Descrição

    Patient Information

    Alias
    UMLS CUI-1
    C1955348
    Subject Identifier
    Descrição

    Subject Identifier

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Pregnancy Information
    Descrição

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    Did the subject become pregnant during the study?
    Descrição

    If Yes, complete Pregnancy Notification form.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0032961
    Study Conclusion
    Descrição

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    Date of subject completion or withdrawal
    Descrição

    Completion, Withdrawal

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yy
    Alias
    UMLS CUI [1]
    C0805732
    UMLS CUI [2]
    C2349954
    dd-mmm-yy
    Was the subject withdrawn from the study?
    Descrição

    * If YES, specify the primary reason.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2349954
    If Yes, tick the primary reason for withdrawal:
    Descrição

    Primary Reason of Withdrawal

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C1549995
    If Yes, tick the primary reason for withdrawal: If Other, specify:
    Descrição

    Primary Reason of Withdrawal Specification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C1549995
    UMLS CUI [1,3]
    C2348235
    Investigator's Signature
    Descrição

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    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)
    Descrição

    Investigature's name

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of Report
    Descrição

    Date of Report

    Tipo de dados

    date

    Unidades de medida
    • dd-mmm-yy
    Alias
    UMLS CUI [1]
    C1302584
    dd-mmm-yy
    Voltar ao início da página

    Similar models

    Study Conclusion GSK Rosiglitazone Alzheimer's disease 100468

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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])
    Voltar ao início da página 

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