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ID

38666

Description

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

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Versions (4)
  1. 11/5/18 11/5/18 -
  2. 11/5/18 11/5/18 -
  3. 12/4/18 12/4/18 -
  4. 10/30/19 10/30/19 - Sarah Riepenhausen
Copyright Holder

GSK group of companies

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October 30, 2019

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Creative Commons BY-NC 3.0
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    A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

    English

    Concomitant Medications Form

    1 forms  
    Concomitant Medication Details
    Description

    Concomitant Medication Details

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C1522508
    Sequence Number
    Description

    Sequence Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348184
    Drug Name
    Description

    Trade Name Preferred

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    Unit Dose
    Description

    Unit Dose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0869039
    Units
    Description

    Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795
    Medication Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1]
    C3476109
    Medication Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Reason for Medication
    Description

    Reason for Medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Generic dispensed?
    Description

    Generic dispensed?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3242750
    UMLS CUI [1,2]
    C0947323
    Prescription or OTC?
    Description

    Prescription or OTC?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0033080
    UMLS CUI [2]
    C0013231
    Medication Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    Medication Taken prior to study?
    Description

    Taken prior to study?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2603343
    UMLS CUI [1,3]
    C0332152
    Medication Ongoing?
    Description

    Ongoing?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    If NO, record the End Date
    Description

    If NO, record the End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Device Used to Administer Medication
    Description

    Device Used to Administer Medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C0699733
    UMLS CUI [2]
    C0013227
    Total Daily Dose
    Description

    Total Daily Dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0439810
    Was drug administered for an exacerbation?
    Description

    Was drug administered for an exacerbation?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0806914
    UMLS CUI [1,2]
    C0349790
    Was drug administered as a rescue medication?
    Description

    Was drug administered as a rescue medication?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0884980
    Cumulative Dose Used?
    Description

    Cumulative Dose Used?

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986497
    Was drug ever used?
    Description

    Was drug ever used?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0242510
    Drug usage Total duration
    Description

    Total duration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0242510
    UMLS CUI [1,2]
    C0449238
    Duration Unit
    Description

    Duration Unit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C1519795
    Medication Type
    Description

    Medication Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0332307
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    Similar models

    Concomitant Medications Form

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Concomitant Medication Details
    C2347852 (UMLS CUI-1)
    C1522508 (UMLS CUI-2)
    Sequence Number
    Item
    Sequence Number
    text
    C2348184 (UMLS CUI [1])
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    Unit Dose
    Item
    Unit Dose
    integer
    C0869039 (UMLS CUI [1])
    Units
    Item
    Units
    text
    C1519795 (UMLS CUI [1])
    Frequency
    Item
    Medication Frequency
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    Medication Route
    text
    C0013153 (UMLS CUI [1])
    Reason for Medication
    Item
    Reason for Medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Generic dispensed?
    Item
    Generic dispensed?
    boolean
    C3242750 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    Item
    Prescription or OTC?
    text
    C0013227 (UMLS CUI [1,1])
    C0033080 (UMLS CUI [1,2])
    C0013231 (UMLS CUI [2])
    Prescription of OTC?
    Code List
    Prescription or OTC?
    CL Item
    Prescription (1)
    CL Item
    OTC (2)
    Start Date
    Item
    Medication Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Taken prior to study?
    Item
    Medication Taken prior to study?
    boolean
    C0013227 (UMLS CUI [1,1])
    C2603343 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    Ongoing?
    Item
    Medication Ongoing?
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    If NO, record the End Date
    Item
    If NO, record the End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Device Used to Administer Medication
    Item
    Device Used to Administer Medication
    text
    C0699733 (UMLS CUI [1])
    C0013227 (UMLS CUI [2])
    Total Daily Dose
    Item
    Total Daily Dose
    text
    C2348070 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    Was drug administered for an exacerbation?
    Item
    Was drug administered for an exacerbation?
    boolean
    C0806914 (UMLS CUI [1,1])
    C0349790 (UMLS CUI [1,2])
    Was drug administered as a rescue medication?
    Item
    Was drug administered as a rescue medication?
    boolean
    C0013227 (UMLS CUI [1,1])
    C0884980 (UMLS CUI [1,2])
    Cumulative Dose Used?
    Item
    Cumulative Dose Used?
    text
    C2986497 (UMLS CUI [1])
    Was drug ever used?
    Item
    Was drug ever used?
    boolean
    C0242510 (UMLS CUI [1])
    Total duration
    Item
    Drug usage Total duration
    text
    C0242510 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Item
    Duration Unit
    text
    C0449238 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Duration Unit
    Code List
    Duration Unit
    CL Item
    Days (1)
    CL Item
    Months (2)
    CL Item
    Weeks (3)
    CL Item
    Years (4)
    Item
    Medication Type
    text
    C0013227 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Medication Type
    Code List
    Medication Type
    CL Item
    Non-Asthma (1)
    CL Item
    Asthma (2)
    Back to the top of the page 

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