0 Ratings

ID

17583

Description

NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

Keywords

  1. 9/11/16 9/11/16 -
  2. 9/25/16 9/25/16 -
Uploaded on

September 25, 2016

DOI

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License

Creative Commons BY-NC-ND 3.0

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    REFLECT-1 Study End/ Follow Up NCT00428090

    REFLECT-1 Study End/ Follow Up NCT00428090

    Patient Information
    Description

    Patient Information

    Alias
    UMLS CUI-1
    C1955348
    Subject Identifier
    Description

    Patient Study ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Description

    Centre ID

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Visit Date
    Description

    Visit Date

    Data type

    date

    Measurement units
    • dd/MMM/yy
    Alias
    UMLS CUI [1]
    C1320303
    dd/MMM/yy
    Central Laboratory (Non Fasting Samples)
    Description

    Central Laboratory (Non Fasting Samples)

    Alias
    UMLS CUI-1
    C1880016
    UMLS CUI-2
    C1442085
    Blood samples to be taken for laboratory assessment only where follow-up of abnormal value(s) indicated.
    Description

    Central Laboratory Instructions

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1880016
    UMLS CUI [1,2]
    C1442085
    Investigator Instructions
    Description

    Investigator Instructions

    Alias
    UMLS CUI-1
    C1442085
    Telephone the IVRS system to register the visit.
    Description

    Investigator Instructions

    Data type

    text

    Alias
    UMLS CUI [1]
    C1442085
    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
    Systolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
    Description

    Systolic Blood Pressure

    Data type

    float

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
    Description

    Diastolic Blood Pressure

    Data type

    float

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Patient Position: Sitting. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
    Description

    Patient Position

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0449850
    Heart rate. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
    Description

    Heart Rate

    Data type

    float

    Measurement units
    • Beats/Min
    Alias
    UMLS CUI [1]
    C0018810
    Beats/Min
    Central Laboratory (Non Fasting Samples)
    Description

    Central Laboratory (Non Fasting Samples)

    Alias
    UMLS CUI-1
    C1880016
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Measurement units
    • dd/MMM/yy
    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0200345
    dd/MMM/yy
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Record any changes to the subject´s concomitant medications or any new medications taken since the last visit in the apporpriate Concomitant Medications sections.
    Description

    Concomitant medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    Adverse Event
    Description

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
    Description

    Adverse Event

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.
    Description

    Physical Examination

    Data type

    text

    Alias
    UMLS CUI [1]
    C0031809
    Pedal Oedema
    Description

    Pedal Oedema

    Alias
    UMLS CUI-1
    C0574002
    Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick one:
    Description

    Pedal Oedema: Depth

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0574002
    UMLS CUI [1,2]
    C0205125
    Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
    Description

    Pedal Oedema: Site

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0574002
    UMLS CUI [1,2]
    C1515974

    Similar models

    REFLECT-1 Study End/ Follow Up NCT00428090

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Patient Information
    C1955348 (UMLS CUI-1)
    Patient Study ID
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Centre ID
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Central Laboratory (Non Fasting Samples)
    C1880016 (UMLS CUI-1)
    C1442085 (UMLS CUI-2)
    Central Laboratory Instructions
    Item
    Blood samples to be taken for laboratory assessment only where follow-up of abnormal value(s) indicated.
    text
    C1880016 (UMLS CUI [1,1])
    C1442085 (UMLS CUI [1,2])
    Item Group
    Investigator Instructions
    C1442085 (UMLS CUI-1)
    Investigator Instructions
    Item
    Telephone the IVRS system to register the visit.
    text
    C1442085 (UMLS CUI [1])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
    float
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
    float
    C0428883 (UMLS CUI [1])
    Patient Position
    Item
    Patient Position: Sitting. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
    boolean
    C0449850 (UMLS CUI [1])
    Heart Rate
    Item
    Heart rate. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
    float
    C0018810 (UMLS CUI [1])
    Item Group
    Central Laboratory (Non Fasting Samples)
    C1880016 (UMLS CUI-1)
    Date sample taken
    Item
    Date sample taken
    date
    C0011008 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant medication
    Item
    Record any changes to the subject´s concomitant medications or any new medications taken since the last visit in the apporpriate Concomitant Medications sections.
    text
    C2347852 (UMLS CUI [1])
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    Adverse Event
    Item
    Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
    text
    C0877248 (UMLS CUI [1])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Physical Examination
    Item
    Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.
    text
    C0031809 (UMLS CUI [1])
    Item Group
    Pedal Oedema
    C0574002 (UMLS CUI-1)
    Item
    Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick one:
    text
    C0574002 (UMLS CUI [1,1])
    C0205125 (UMLS CUI [1,2])
    Code List
    Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick one:
    CL Item
    < 1 mm (< 1 mm)
    CL Item
    1 - 2 mm (1 - 2 mm)
    CL Item
    3 - 5 mm (3 - 5 mm)
    CL Item
    6 - 10 mm (6 - 10 mm)
    CL Item
    > 10 mm (> 10 mm)
    Item
    Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
    text
    C0574002 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Code List
    Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
    CL Item
    Left Ankle (Left Ankle)
    CL Item
    Right Ankle (Right Ankle)

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