0 Evaluaciones
ID

28849

Descripción

Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: End of Study

Palabras clave

Versiones (1)
  1. 8/2/18 8/2/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

8 de febrero de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723

    Inglés

    End of Study

    1 formularios  
    1. StudyEvent: ODM
      1. End of Study
    Status Of Treatment Blind
    Descripción

    Status Of Treatment Blind

    Alias
    UMLS CUI-1
    C2347038
    UMLS CUI-2
    C0449438
    Center
    Descripción

    Center

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Subject ID
    Descripción

    Subject ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Initials
    Descripción

    Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440
    Visit Date
    Descripción

    Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Was the treatment blind broken during the study?
    Descripción

    Treatment Blind

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    If 'Yes' complete the following: Reason?
    Descripción

    Reason Treatment Blind broken

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    If Other, please specify
    Descripción

    Reason Treatment Blind broken

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Pregnancy Information
    Descripción

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant during the study?
    Descripción

    pregnant

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0032961
    Study Conclusion
    Descripción

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    Date of subject completion or withdrawal
    Descripción

    Date of subject completion or withdrawal

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2983670
    Was the subject withdrawn from the study?
    Descripción

    subject withdrawn

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Primary reason for withdrawal
    Descripción

    Primary reason for withdrawal

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    Primary reason for withdrawal. If Other, please specify
    Descripción

    Primary reason for withdrawal

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
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    Similar models

    End of Study

    1 formularios
    1. StudyEvent: ODM
      1. End of Study
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Status Of Treatment Blind
    C2347038 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Center
    Item
    Center
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Initials
    Item
    Initials
    text
    C2986440 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Treatment Blind
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Item
    If 'Yes' complete the following: Reason?
    integer
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason Treatment Blind broken
    Code List
    If 'Yes' complete the following: Reason?
    CL Item
    Medical emergency requiring identification of investigational product for further treatment (1)
    CL Item
    Other (2)
    Reason Treatment Blind broken
    Item
    If Other, please specify
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did the subject become pregnant during the study?
    integer
    C0032961 (UMLS CUI [1])
    pregnant
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not Applicable (not of childbearing potential or male) (3)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    subject withdrawn
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    Primary reason for withdrawal
    integer
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Primary reason for withdrawal
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse Event (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 (5)
    CL Item
    Insufficient therapeutic effect (6)
    CL Item
    Did not meet treatment eligibility criteria (7)
    CL Item
    Other (8)
    Primary reason for withdrawal
    Item
    Primary reason for withdrawal. If Other, please specify
    text
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
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