ID

33005

Beskrivning

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the form for Electrocardiogram. It has to be filled in at screening, sessions 2, 3, 4, 5 and 6.

Nyckelord

Versioner (3)
  1. 2018-11-14 2018-11-14 -
  2. 2018-11-22 2018-11-22 -
  3. 2018-11-23 2018-11-23 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 november 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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    Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

    Engelsk

    Electrocardiogram

    1 Formulär  
    1. StudyEvent: ODM
      1. Electrocardiogram
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beskrivning

    Subject number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Session Number
    Beskrivning

    Session Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1883017
    UMLS CUI [1,2]
    C0750480
    12-Lead Electrocardiogram
    Beskrivning

    12-Lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456
    Row no.
    Beskrivning

    Note: For screening there are only three rows. For sessions there are all of the five rows.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0237753
    Date of ECG
    Beskrivning

    Date of ECG

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2826640
    Planned relative time
    Beskrivning

    Time relative to dosing. The 12hrs and pre dose relative time are only for session 2-6, Screening only for session 1. Please choose "unscheduled" in case of additional, unplanned ECGs.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0439564
    Actual time
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Ventricular rate
    Beskrivning

    Ventricular rate

    Datatyp

    integer

    Måttenheter
    • beats / min
    Alias
    UMLS CUI [1]
    C2189285
    beats / min
    PR interval
    Beskrivning

    PR interval

    Datatyp

    integer

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS duration
    Beskrivning

    QRS duration

    Datatyp

    integer

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    QT interval
    Beskrivning

    QT interval

    Datatyp

    integer

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0577807
    msec
    QTc interval
    Beskrivning

    QTc interval

    Datatyp

    integer

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0489625
    msec
    ECG normal
    Beskrivning

    ECG normal

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    ECG Abnormalities present
    Beskrivning

    ECG Abnormalities present

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0522055
    If abnormalities, is the abnormality clinically significant?
    Beskrivning

    If abnormalities are present which are clinically significant, complete additional ECG ABNORMALITIES FORM. Copy the session number from the top of this form and the date and time to the ECG ABNORMALITIES FORM.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    Tillbaka till toppen

    Similar models

    Electrocardiogram

    1 Formulär
    1. StudyEvent: ODM
      1. Electrocardiogram
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item
    Session Number
    integer
    C1883017 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Session Number
    Code List
    Session Number
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    Item Group
    12-Lead Electrocardiogram
    C0430456 (UMLS CUI-1)
    Item
    Row no.
    integer
    C0237753 (UMLS CUI [1])
    Row no.
    Code List
    Row no.
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    Date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Item
    Planned relative time
    text
    C0439564 (UMLS CUI [1])
    Planned relative time
    Code List
    Planned relative time
    CL Item
    Screening (S)
    CL Item
    Pre dose (P)
    CL Item
    12hrs (Hrs)
    CL Item
    Unscheduled (U)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Ventricular rate
    Item
    Ventricular rate
    integer
    C2189285 (UMLS CUI [1])
    PR interval
    Item
    PR interval
    integer
    C0429087 (UMLS CUI [1])
    QRS duration
    Item
    QRS duration
    integer
    C0429025 (UMLS CUI [1])
    QT interval
    Item
    QT interval
    integer
    C0577807 (UMLS CUI [1])
    QTc interval
    Item
    QTc interval
    integer
    C0489625 (UMLS CUI [1])
    ECG normal
    Item
    ECG normal
    boolean
    C0522054 (UMLS CUI [1])
    ECG Abnormalities present
    Item
    ECG Abnormalities present
    boolean
    C0522055 (UMLS CUI [1])
    Item
    If abnormalities, is the abnormality clinically significant?
    text
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    Abnormality clinically significant
    Code List
    If abnormalities, is the abnormality clinically significant?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Tillbaka till toppen 

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