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ID

32971

Beschrijving

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 ECG-abnormalities. It has to be filled in if ECG-abnormalities occur during study.

Trefwoorden

Versies (3)
  1. 14-11-18 14-11-18 -
  2. 22-11-18 22-11-18 -
  3. 23-11-18 23-11-18 - Sarah Riepenhausen
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GlaxoSmithKline

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22 november 2018

DOI

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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

    Engels

    Electrocardiogram Abnormalities Form

    1 Formulieren  
    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beschrijving

    Subject number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Session Number
    Beschrijving

    Session Number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1883017
    UMLS CUI [1,2]
    C0750480
    Electrocardiogram
    Beschrijving

    Electrocardiogram

    Alias
    UMLS CUI-1
    C1623258
    Date of ECG
    Beschrijving

    Day Month Year

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2826640
    Time of ECG
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Ventricular rate/heart rate
    Beschrijving

    Ventricular rate

    Datatype

    integer

    Maateenheden
    • bpm
    Alias
    UMLS CUI [1]
    C2189285
    bpm
    ECG
    Beschrijving

    ECG result

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0456984
    Were any of the abnormalities clinically significant?
    Beschrijving

    If YES, tick all that apply

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0456984
    Rhythm
    Beschrijving

    Rhythm

    Alias
    UMLS CUI-1
    C0232201
    Sinus bradycardia
    Beschrijving

    Sinus bradycardia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0085610
    Sinus tachycardia
    Beschrijving

    Sinus tachycardia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0039239
    Sinus pause
    Beschrijving

    Sinus pause

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1955864
    Ectopic supraventricular beats
    Beschrijving

    Ectopic supraventricular beats

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0033036
    Junctional rhythm (<= 100/min)
    Beschrijving

    Junctional rhythm

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0232208
    Supraventricular tachycardia (>100/min)
    Beschrijving

    Supraventricular tachycardia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0039240
    Atrial flutter
    Beschrijving

    Atrial flutter

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0004239
    Atrial Fibrillation
    Beschrijving

    Atrial Fibrillation

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0004238
    Ectopic ventricular beats
    Beschrijving

    Ectopic ventricular beats

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0151636
    Ventricular rhythm
    Beschrijving

    comment below

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0232216
    If Ventricular rhythm, Comment
    Beschrijving

    Comment Ventricular rhythm

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C3845569
    Pacemaker
    Beschrijving

    Pacemaker

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0030163
    P-Wave Morphology
    Beschrijving

    P-Wave Morphology

    Alias
    UMLS CUI-1
    C2216025
    Left atrial abnormality (P mitrale)
    Beschrijving

    Left atrial abnormality (P mitrale)

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0344711
    UMLS CUI [1,2]
    C0232310
    Right atrial abnormality (P pulmonale)
    Beschrijving

    Right atrial abnormality (P pulmonale)

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0344696
    UMLS CUI [1,2]
    C0232308
    Conduction
    Beschrijving

    Conduction

    Alias
    UMLS CUI-1
    C0232217
    First degree AV block (PR interval> 0.20 sec)
    Beschrijving

    First degree AV block

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0085614
    Second degree AV block (Mobitz type 1)
    Beschrijving

    Second degree AV block (Mobitz type 1)

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0264907
    Second degree AV block (Mobitz type 2)
    Beschrijving

    Second degree AV block (Mobitz type 2)

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0155700
    Third degree AV block
    Beschrijving

    Third degree AV block

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0151517
    Left axis deviation
    Beschrijving

    definied as: QRS axis more negative than - 30 degrees

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0232297
    Right axis deviation
    Beschrijving

    defined as: QRS axis more positive than + 110 degrees

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0232296
    Incomplete right bundle branch block
    Beschrijving

    Incomplete right bundle branch block

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0262525
    Right bundle branch block
    Beschrijving

    Right bundle branch block

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0085615
    Left bundle branch block
    Beschrijving

    Left bundle branch block

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023211
    Nonspecific intraventricular conduction delay
    Beschrijving

    defined as: QRS greater than 0,12sec

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1882112
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
    Beschrijving

    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0264897
    UMLS CUI [2]
    C0043202
    UMLS CUI [3]
    C0024054
    QT/QTc prolongation
    Beschrijving

    QT/QTc prolongation

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0855333
    Depolarization/Repolarization (QRS-T)
    Beschrijving

    Depolarization/Repolarization (QRS-T)

    Alias
    UMLS CUI-1
    C1331539
    UMLS CUI-2
    C3279217
    Myocardial infarction, old
    Beschrijving

    Myocardial infarction, old

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0155668
    Myocardial infarction, other
    Beschrijving

    comment below

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C0205394
    If Myocardial infarction, other, Comment
    Beschrijving

    Comment Myocardial infarction, other

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C3845569
    Non-specific ST-T changes
    Beschrijving

    Non-specific ST-T changes

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1112720
    Low QRS voltage
    Beschrijving

    Low QRS voltage

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2349945
    Other
    Beschrijving

    Other

    Alias
    UMLS CUI-1
    C0205394
    Other, specify in comments
    Beschrijving

    Other

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0205394
    If other abnormalities, Comment
    Beschrijving

    Comment other abnormalities

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C3845569
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    Similar models

    Electrocardiogram Abnormalities Form

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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
    Session 1 (1)
    CL Item
    Session 2 (2)
    CL Item
    Session 3 (3)
    CL Item
    Session 4 (4)
    CL Item
    Session 5 (5)
    CL Item
    Session 6 (6)
    Item Group
    Electrocardiogram
    C1623258 (UMLS CUI-1)
    Date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Ventricular rate
    Item
    Ventricular rate/heart rate
    integer
    C2189285 (UMLS CUI [1])
    Item
    ECG
    text
    C1623258 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    ECG result
    Code List
    ECG
    CL Item
    Normal (N)
    CL Item
    Abnormalities present (A)
    Item
    Were any of the abnormalities clinically significant?
    text
    C1623258 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    ECG Result
    Code List
    Were any of the abnormalities clinically significant?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Rhythm
    C0232201 (UMLS CUI-1)
    Sinus bradycardia
    Item
    Sinus bradycardia
    boolean
    C0085610 (UMLS CUI [1])
    Sinus tachycardia
    Item
    Sinus tachycardia
    boolean
    C0039239 (UMLS CUI [1])
    Sinus pause
    Item
    Sinus pause
    boolean
    C1955864 (UMLS CUI [1])
    Ectopic supraventricular beats
    Item
    Ectopic supraventricular beats
    boolean
    C0033036 (UMLS CUI [1])
    Junctional rhythm
    Item
    Junctional rhythm (<= 100/min)
    boolean
    C0232208 (UMLS CUI [1])
    Supraventricular tachycardia
    Item
    Supraventricular tachycardia (>100/min)
    boolean
    C0039240 (UMLS CUI [1])
    Atrial flutter
    Item
    Atrial flutter
    boolean
    C0004239 (UMLS CUI [1])
    Atrial Fibrillation
    Item
    Atrial Fibrillation
    boolean
    C0004238 (UMLS CUI [1])
    Ectopic ventricular beats
    Item
    Ectopic ventricular beats
    boolean
    C0151636 (UMLS CUI [1])
    Ventricular rhythm
    Item
    Ventricular rhythm
    boolean
    C0232216 (UMLS CUI [1])
    Comment Ventricular rhythm
    Item
    If Ventricular rhythm, Comment
    text
    C0522055 (UMLS CUI [1,1])
    C3845569 (UMLS CUI [1,2])
    Pacemaker
    Item
    Pacemaker
    boolean
    C0030163 (UMLS CUI [1])
    Item Group
    P-Wave Morphology
    C2216025 (UMLS CUI-1)
    Left atrial abnormality (P mitrale)
    Item
    Left atrial abnormality (P mitrale)
    boolean
    C0344711 (UMLS CUI [1,1])
    C0232310 (UMLS CUI [1,2])
    Right atrial abnormality (P pulmonale)
    Item
    Right atrial abnormality (P pulmonale)
    boolean
    C0344696 (UMLS CUI [1,1])
    C0232308 (UMLS CUI [1,2])
    Item Group
    Conduction
    C0232217 (UMLS CUI-1)
    First degree AV block
    Item
    First degree AV block (PR interval> 0.20 sec)
    boolean
    C0085614 (UMLS CUI [1])
    Second degree AV block (Mobitz type 1)
    Item
    Second degree AV block (Mobitz type 1)
    boolean
    C0264907 (UMLS CUI [1])
    Second degree AV block (Mobitz type 2)
    Item
    Second degree AV block (Mobitz type 2)
    boolean
    C0155700 (UMLS CUI [1])
    Third degree AV block
    Item
    Third degree AV block
    boolean
    C0151517 (UMLS CUI [1])
    Left axis deviation
    Item
    Left axis deviation
    boolean
    C0232297 (UMLS CUI [1])
    Right axis deviation
    Item
    Right axis deviation
    boolean
    C0232296 (UMLS CUI [1])
    Incomplete right bundle branch block
    Item
    Incomplete right bundle branch block
    boolean
    C0262525 (UMLS CUI [1])
    Right bundle branch block
    Item
    Right bundle branch block
    boolean
    C0085615 (UMLS CUI [1])
    Left bundle branch block
    Item
    Left bundle branch block
    boolean
    C0023211 (UMLS CUI [1])
    Nonspecific intraventricular conduction delay
    Item
    Nonspecific intraventricular conduction delay
    boolean
    C1882112 (UMLS CUI [1])
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
    Item
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
    boolean
    C0264897 (UMLS CUI [1])
    C0043202 (UMLS CUI [2])
    C0024054 (UMLS CUI [3])
    QT/QTc prolongation
    Item
    QT/QTc prolongation
    boolean
    C0855333 (UMLS CUI [1])
    Item Group
    Depolarization/Repolarization (QRS-T)
    C1331539 (UMLS CUI-1)
    C3279217 (UMLS CUI-2)
    Myocardial infarction, old
    Item
    Myocardial infarction, old
    boolean
    C0155668 (UMLS CUI [1])
    Myocardial infarction, other
    Item
    Myocardial infarction, other
    boolean
    C0027051 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Comment Myocardial infarction, other
    Item
    If Myocardial infarction, other, Comment
    text
    C0522055 (UMLS CUI [1,1])
    C3845569 (UMLS CUI [1,2])
    Non-specific ST-T changes
    Item
    Non-specific ST-T changes
    boolean
    C1112720 (UMLS CUI [1])
    Low QRS voltage
    Item
    Low QRS voltage
    boolean
    C2349945 (UMLS CUI [1])
    Item Group
    Other
    C0205394 (UMLS CUI-1)
    Other
    Item
    Other, specify in comments
    boolean
    C0205394 (UMLS CUI [1])
    Comment other abnormalities
    Item
    If other abnormalities, Comment
    text
    C0522055 (UMLS CUI [1,1])
    C3845569 (UMLS CUI [1,2])
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