0 Beoordelingen
ID

24754

Beschrijving

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

Trefwoorden

Versies (3)
  1. 16-08-17 16-08-17 -
  2. 16-08-17 16-08-17 -
  3. 16-08-17 16-08-17 -
Geüploaded op

16 augustus 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    daily record card documentation salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    Engels

    daily record card documentation salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 Formulieren  
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschrijving

    subject identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Description
    Beschrijving

    visit description

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0678257
    Day
    Beschrijving

    day of record

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0439228
    documentation of health status
    Beschrijving

    documentation of health status

    Alias
    UMLS CUI-1
    C0683314
    UMLS CUI-2
    C0920316
    Date
    Beschrijving

    date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008
    Morning Peak Flow Reading
    Beschrijving

    Highest of 3 readings

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0521299
    Did you take VENTOLIN in the 6 hours prior to your peak flow reading?
    Beschrijving

    taken ventolin before peak flow measurement

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0521299
    Number of night-time awakenings due to your COPD
    Beschrijving

    night time awakening due to COPD

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C4062814
    UMLS CUI [1,2]
    C0024117
    Number of occasions (not puffs) VENTOLIN was used in the previous 24 hours?
    Beschrijving

    number of occasions ventolin was used in last 24 hours

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C1442770
    How many days did you miss from work or usual activities in the previous 24 hours, due to worsening of your COPD symptoms?
    Beschrijving

    nuber of days missed work or unable to perform usual activities in last 24 hours due to COPD worsening

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0559457
    UMLS CUI [1,2]
    C3827729
    UMLS CUI [1,3]
    C1442770
    UMLS CUI [1,4]
    C0024117
    COPD Symptoms
    Beschrijving

    COPD Symptoms

    Alias
    UMLS CUI-1
    C0559457
    UMLS CUI-2
    C1457887
    Breathlessness
    Beschrijving

    none/not at all = 0 100 = worst symptoms experienced or as bad as it can be

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0013404
    Activity limitation
    Beschrijving

    none/not at all = 0 100 = worst symptoms experienced or as bad as it can be

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0026606
    UMLS CUI [1,2]
    C0449295
    Cough
    Beschrijving

    none/not at all = 0 100 = worst symptoms experienced or as bad as it can be

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0010200
    Sleep quality (trouble sleeping?)
    Beschrijving

    none/not at all = 0 100 = worst symptoms experienced or as bad as it can be

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0424563
    VAS Total
    Beschrijving

    VAS score

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3536884
    WORKSHEET
    Beschrijving

    WORKSHEET

    Alias
    UMLS CUI-1
    C2349155
    Start Date
    Beschrijving

    start date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0808070
    Medical Problem
    Beschrijving

    patient's problem

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1254481
    Treatment Taken
    Beschrijving

    treatment

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0087111
    Monitor’s signature
    Beschrijving

    signature

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1519316
    Date
    Beschrijving

    date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008
    Terug naar het begin van de pagina

    Similar models

    daily record card documentation salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item
    Visit Description
    text
    C0545082 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    visit description
    Code List
    Visit Description
    CL Item
    run-in period (RUN-IN PERIOD)
    CL Item
    treatment period visit 2 (TREATMENT PERIOD Visit 2)
    CL Item
    treatment period visit 3 (TREATMENT PERIOD Visit 3)
    CL Item
    treatment period visit 4 (TREATMENT PERIOD Visit 4)
    CL Item
    treatment period visit 5 (TREATMENT PERIOD Visit 5)
    CL Item
    treatment period visit 6 (TREATMENT PERIOD Visit 6)
    CL Item
    treatment period visit 7 (TREATMENT PERIOD Visit 7)
    Item
    Day
    integer
    C0439228 (UMLS CUI [1])
    day of record
    Code List
    Day
    CL Item
    Day 1 (1)
    CL Item
    Day 2 (2)
    CL Item
    Day 3 (3)
    CL Item
    Day 4 (4)
    CL Item
    Day 5 (5)
    CL Item
    Day 6 (6)
    CL Item
    Day 7 (7)
    CL Item
    Day 8 (8)
    CL Item
    Day 9 (9)
    CL Item
    Day 10 (10)
    CL Item
    Day 11 (11)
    CL Item
    Day 12 (12)
    CL Item
    Day 13 (13)
    CL Item
    Day 14 (14)
    CL Item
    Day 15 (15)
    CL Item
    Day 16 (16)
    CL Item
    Day 17 (17)
    CL Item
    Day 18 (18)
    CL Item
    Day 19 (19)
    CL Item
    Day 20 (20)
    CL Item
    Day 21 (21)
    CL Item
    Day 22 (22)
    CL Item
    Day 23 (23)
    CL Item
    Day 24 (24)
    CL Item
    Day 25 (25)
    CL Item
    Day 26 (26)
    CL Item
    Day 27 (27)
    CL Item
    Day 28 (28)
    CL Item
    Day 29 (29)
    CL Item
    Day 30 (30)
    CL Item
    Day 31 (31)
    Item Group
    documentation of health status
    C0683314 (UMLS CUI-1)
    C0920316 (UMLS CUI-2)
    date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    peak flow
    Item
    Morning Peak Flow Reading
    integer
    C0521299 (UMLS CUI [1])
    Item
    Did you take VENTOLIN in the 6 hours prior to your peak flow reading?
    text
    C0033744 (UMLS CUI [1,1])
    C0521299 (UMLS CUI [1,2])
    taken ventolin before peak flow measurement
    Code List
    Did you take VENTOLIN in the 6 hours prior to your peak flow reading?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    night time awakening due to COPD
    Item
    Number of night-time awakenings due to your COPD
    integer
    C4062814 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    number of occasions ventolin was used in last 24 hours
    Item
    Number of occasions (not puffs) VENTOLIN was used in the previous 24 hours?
    integer
    C0033744 (UMLS CUI [1,1])
    C1442770 (UMLS CUI [1,2])
    Item
    How many days did you miss from work or usual activities in the previous 24 hours, due to worsening of your COPD symptoms?
    text
    C0559457 (UMLS CUI [1,1])
    C3827729 (UMLS CUI [1,2])
    C1442770 (UMLS CUI [1,3])
    C0024117 (UMLS CUI [1,4])
    nuber of days missed work or unable to perform usual activities in last 24 hours due to COPD worsening
    Code List
    How many days did you miss from work or usual activities in the previous 24 hours, due to worsening of your COPD symptoms?
    CL Item
    0 (0)
    CL Item
    1/2 (1/2)
    CL Item
    1 (1)
    Item Group
    COPD Symptoms
    C0559457 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    dyspnoea
    Item
    Breathlessness
    integer
    C0013404 (UMLS CUI [1])
    physical activity limitation
    Item
    Activity limitation
    integer
    C0026606 (UMLS CUI [1,1])
    C0449295 (UMLS CUI [1,2])
    coughing
    Item
    Cough
    integer
    C0010200 (UMLS CUI [1])
    sleep quality
    Item
    Sleep quality (trouble sleeping?)
    integer
    C0424563 (UMLS CUI [1])
    VAS score
    Item
    VAS Total
    integer
    C3536884 (UMLS CUI [1])
    Item Group
    WORKSHEET
    C2349155 (UMLS CUI-1)
    start date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    patient's problem
    Item
    Medical Problem
    text
    C1254481 (UMLS CUI [1])
    treatment
    Item
    Treatment Taken
    text
    C0087111 (UMLS CUI [1])
    signature
    Item
    Monitor’s signature
    text
    C1519316 (UMLS CUI [1])
    date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Terug naar het begin van de pagina 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial