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ID

28848

Description

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: Early Withdrawal

Keywords

Versions (2)
  1. 2/8/18 2/8/18 -
  2. 2/8/18 2/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 8, 2018

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License

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

    English

    Early Withdrawal

    1 forms  
    1. StudyEvent: ODM
      1. Early Withdrawal
    Adverse Events
    Description

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Center
    Description

    Center

    Data type

    text

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

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Initials
    Description

    Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Are there any new adverse events/ serious adverse events observed or reported by the subject or any changes to ongoing adverse events?
    Description

    I f 'Yes', record details on the Adverse Events panel.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C0013227
    Has there been any changes to the subject's concomitant medication or any new medications taken since the last visit?
    Description

    If 'Yes', record details on the Concomitant Medications panel.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2169461
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Blood Pressure - sitting, Systolic
    Description

    Blood Pressure - sitting, Systolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    mmHg
    Blood Pressure - sitting, Diastolic
    Description

    Blood Pressure - sitting, Diastolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    mmHg
    Heart Rate
    Description

    Heart Rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Waist circumference
    Description

    Waist circumference

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0455829
    cm
    Central Laboratory
    Description

    Central Laboratory

    Alias
    UMLS CUI-1
    C1880016
    UMLS CUI-2
    C0022885
    Were lab samples obtained?
    Description

    lab samples

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    UMLS CUI [2]
    C0200354
    Date Sample Taken
    Description

    Date Sample Taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Investigational Product Compliance
    Description

    Investigational Product Compliance

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C1321605
    What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
    Description

    Investigational Product Compliance

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1321605
    If compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
    Description

    Investigational Product Compliance Reason

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1321605
    UMLS CUI [1,3]
    C0392360
    If other reason, please specify
    Description

    Investigational Product Compliance Reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1321605
    UMLS CUI [1,3]
    C0392360
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    Similar models

    Early Withdrawal

    1 forms
    1. StudyEvent: ODM
      1. Early Withdrawal
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    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])
    adverse events
    Item
    Are there any new adverse events/ serious adverse events observed or reported by the subject or any changes to ongoing adverse events?
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    changes concomitant medication
    Item
    Has there been any changes to the subject's concomitant medication or any new medications taken since the last visit?
    boolean
    C2347852 (UMLS CUI [1,1])
    C2169461 (UMLS CUI [1,2])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Blood Pressure - sitting, Systolic
    Item
    Blood Pressure - sitting, Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Blood Pressure - sitting, Diastolic
    Item
    Blood Pressure - sitting, Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Waist circumference
    Item
    Waist circumference
    float
    C0455829 (UMLS CUI [1])
    Item Group
    Central Laboratory
    C1880016 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    lab samples
    Item
    Were lab samples obtained?
    boolean
    C0005834 (UMLS CUI [1])
    C0200354 (UMLS CUI [2])
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Item Group
    Investigational Product Compliance
    C0304229 (UMLS CUI-1)
    C1321605 (UMLS CUI-2)
    Item
    What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
    integer
    C0304229 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    Investigational Product Compliance
    Code List
    What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
    CL Item
    0% compliant (subject did not take any doses) (1)
    CL Item
    > 0% and < 80% compliant (subject missed a number of doses) (2)
    CL Item
    >=80% and <=120% (number of doses taken was within compliance range) (3)
    CL Item
    > 120% compliant (number of doses taken exceeds compliance limits) (4)
    Item
    If compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
    integer
    C0304229 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    inclusion criteria the subject failed
    Code List
    If compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
    CL Item
    Adverse event (ensure that details are recorded in the Adverse Events panel) (1)
    CL Item
    Dispensing error (2)
    CL Item
    Subject did not take medication according to protocol (3)
    CL Item
    Other (4)
    Investigational Product Compliance Reason
    Item
    If other reason, please specify
    text
    C0304229 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
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