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ID

17492

Beschrijving

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)

Trefwoorden

  1. 18-09-16 18-09-16 -
  2. 25-09-16 25-09-16 -
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18 september 2016

DOI

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Licentie

Creative Commons BY-NC-ND 3.0

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    GSK Concomitant Medication NCT00428090

    GSK Concomitant Medication NCT00428090

    Patient Information
    Beschrijving

    Patient Information

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

    Patient Study ID

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Concomitant Medication
    Beschrijving

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Where any concomitant medications taken by the subject during the study?
    Beschrijving

    Concomitant Medications

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Drug Name (Trade Name preferred) (e.g. Aspirin) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    Beschrijving

    Drug Name

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Total Daily Dose (e.g. 400) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    Beschrijving

    Total Daily Dose

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348070 (Daily Dose)
    Units (e.g. mg) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    Beschrijving

    Units

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Route (e.g. PO) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    Beschrijving

    Route

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Reason for Medication (e.g. Headache) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    Beschrijving

    Reason for Medication

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Start Date (Day Month Year) (e.g. 31 MAY 02) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    Beschrijving

    Start date

    Datatype

    date

    Maateenheden
    • dd/MMM/yy
    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    dd/MMM/yy
    Stop Date (Day Month Year) (e.g. 31 MAY 02) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    Beschrijving

    Stop Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Ongoing Medication (Yes - No) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    Beschrijving

    Ongoing Medication

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)

    Similar models

    GSK Concomitant Medication NCT00428090

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Patient Information
    C1955348 (UMLS CUI-1)
    Patient Study ID
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant Medications
    Item
    Where any concomitant medications taken by the subject during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Drug Name
    Item
    Drug Name (Trade Name preferred) (e.g. Aspirin) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    text
    C0013227 (UMLS CUI [1])
    Total Daily Dose
    Item
    Total Daily Dose (e.g. 400) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    text
    C2348070 (UMLS CUI [1])
    Units
    Item
    Units (e.g. mg) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    text
    C1519795 (UMLS CUI [1])
    Route
    Item
    Route (e.g. PO) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    text
    C0013153 (UMLS CUI [1])
    Reason for Medication
    Item
    Reason for Medication (e.g. Headache) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Start date
    Item
    Start Date (Day Month Year) (e.g. 31 MAY 02) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    date
    C0013227 (UMLS CUI [1])
    Stop Date
    Item
    Stop Date (Day Month Year) (e.g. 31 MAY 02) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    date
    C0806020 (UMLS CUI [1])
    Ongoing Medication
    Item
    Ongoing Medication (Yes - No) If "YES", record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
    boolean
    C2826666 (UMLS CUI [1])

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