0 Ratings
ID

33414

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 (2)
  1. 11/7/18 11/7/18 -
  2. 12/7/18 12/7/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 7, 2018

DOI

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License

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

    English

    Patient's Diary Card 1: Screening/Run-In Visit 1

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Daily Assessments
    Description

    Daily Assessments

    Alias
    UMLS CUI-1
    C0220825
    UMLS CUI-2
    C0332173
    Assessment Date
    Description

    Date

    Data type

    text

    Alias
    UMLS CUI [1]
    C2985720
    Asthma symptoms score over the past 24 hours
    Description

    0 = No symptoms during the day or previous night 1 = Symptoms for one short period during the day or previous night 2 = Symptoms for two or more short periods during the day or previous night 3 = Symptoms for most of the day or previous night which did not affect my normal activities 4 = Symptoms for most of the day or previous night which did affect my normal activities 5 = Symptoms so severe that I could not go to work or perform normal activities Circle only one number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C1457887
    Number of puffs albuterol/salbutamol taken in the past 24 hours
    Description

    if nono, enter zero (0)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1533107
    UMLS CUI [1,2]
    C0001927
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    Similar models

    Patient's Diary Card 1: Screening/Run-In Visit 1

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Daily Assessments
    C0220825 (UMLS CUI-1)
    C0332173 (UMLS CUI-2)
    Item
    Assessment Date
    text
    C2985720 (UMLS CUI [1])
    Date
    Code List
    Assessment Date
    CL Item
    Date 1 (1)
    CL Item
    Date 2 (2)
    CL Item
    Date 3 (3)
    CL Item
    Date 4 (4)
    CL Item
    Date 5 (5)
    CL Item
    Date 6 (6)
    CL Item
    Date 7 (7)
    CL Item
    Date 8 (8)
    CL Item
    Date 9 (9)
    CL Item
    Date 10 (10)
    CL Item
    Date 11 (11)
    CL Item
    Date 12 (12)
    CL Item
    Date 13 (13)
    CL Item
    Date 14 (14)
    CL Item
    Date 15 (15)
    CL Item
    Date 16 (16)
    CL Item
    Date 17 (17)
    CL Item
    Date 18 (18)
    CL Item
    Date 19 (19)
    CL Item
    Date 20 (20)
    CL Item
    Date 21 (21)
    CL Item
    Date 22 (22)
    Item
    Asthma symptoms score over the past 24 hours
    text
    C0004096 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    Asthma symptoms score over the past 24 hours
    Code List
    Asthma symptoms score over the past 24 hours
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    Number of puffs albuterol/salbutamol taken in the past 24 hours
    Item
    Number of puffs albuterol/salbutamol taken in the past 24 hours
    integer
    C1533107 (UMLS CUI [1,1])
    C0001927 (UMLS CUI [1,2])
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