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29565

Beschreibung

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains ECG Abnormalities Form Part 1.

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Stichworte

Versionen (1)
  1. 06.04.18 06.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

6. April 2018

DOI

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Creative Commons BY-NC 3.0
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    GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

    Englisch

    ECG Abnormalities Form Part 1

    1 Formulare  
    Date and Time of ECG
    Beschreibung

    Date and Time of ECG

    Alias
    UMLS CUI-1
    C2826846
    Date of ECG
    Beschreibung

    Date of ECG

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826640
    Time of ECG
    Beschreibung

    Time of ECG

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Rhythm
    Beschreibung

    Rhythm

    Alias
    UMLS CUI-1
    C0232187
    Sinus bradycardia
    Beschreibung

    A 1 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0085610
    Sinus bradycardia frequency
    Beschreibung

    Sinus bradycardia frequency

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0085610
    UMLS CUI [1,2]
    C0439603
    Sinus pause
    Beschreibung

    Record, if clinically significant. A 3

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1955864
    Sinus tachycardia (heart rate >100 beats/min)
    Beschreibung

    A 2 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0039239
    Ectopic supraventricular beats
    Beschreibung

    A 4 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0033036
    Ectopic supraventricular rhythm
    Beschreibung

    A 20 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348376
    Wandering Atrial Pacemaker
    Beschreibung

    A 17 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1321523
    Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
    Beschreibung

    A 26 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0221158
    Supraventricular tachycardia (heart rate >100 beats/min)
    Beschreibung

    A 6 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0039240
    Atrial flutter
    Beschreibung

    A 7 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004239
    Atrial fibrillation
    Beschreibung

    A 8 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004238
    Junctional rhythm (heart rate ≤100 beats/min)
    Beschreibung

    A 5 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232208
    UMLS CUI [1,2]
    C0018810
    Junctional rhythm
    Beschreibung

    A 25 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232208
    Junctional tachycardia (heart rate > 100 beats/min)
    Beschreibung

    A 24 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0039235
    Ectopic ventricular beats
    Beschreibung

    A 9 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0151636
    Ventricular couplets
    Beschreibung

    A 12 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0429001
    Bigeminy
    Beschreibung

    A 13 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0262662
    Trigeminy
    Beschreibung

    A 28 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0428999
    Electrical alternans
    Beschreibung

    A 14 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1142551
    R on T phenomenon
    Beschreibung

    A 29 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0877658
    Ventricular fibrillation
    Beschreibung

    A 18 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0042510
    Idioventricular rhythm (heart rate < 100 beats/min)
    Beschreibung

    A 19 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0700363
    UMLS CUI [1,2]
    C0018810
    Sustained ventricular tachycardia
    Beschreibung

    A 10 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0750197
    Non-sustained ventricular tachycardia
    Beschreibung

    A 11 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0750194
    Wide QRS Tachycardia (diagnosis unknown)
    Beschreibung

    A 32 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0344429
    Ventricular Tachycardia
    Beschreibung

    A 27 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0042514
    Monomorphic ventricular tachycardia
    Beschreibung

    A 30 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0344431
    Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
    Beschreibung

    A 15 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0040479
    Polymorphic (sustained and non-sustained) ventricular tachycardia
    Beschreibung

    A 31 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0344432
    Artificial pacemaker
    Beschreibung

    A 16 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0030163
    Other abnormal rhythm
    Beschreibung

    A 99 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1533266
    UMLS CUI [1,2]
    C0205394
    Other abnormal rhythm: comment
    Beschreibung

    Other abnormal rhythm

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1533266
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    P-wave and QRS morphology
    Beschreibung

    P-wave and QRS morphology

    Alias
    UMLS CUI-1
    C2216025
    UMLS CUI-2
    C0429098
    Left atrial abnormality (P mitrale)
    Beschreibung

    B 1 Report, if clinically significant.

    Datentyp

    boolean

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

    B 2 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0344696
    UMLS CUI [1,2]
    C0232308
    Right ventricular hypertrophy
    Beschreibung

    B 3 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0162770
    Intraatrial conduction delay
    Beschreibung

    A 5 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2346510
    Increased voltage consistent with left ventricular hypertrophy
    Beschreibung

    D 14 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1112650
    UMLS CUI [2]
    C0149721
    Other morphology
    Beschreibung

    B 99 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2216025
    UMLS CUI [1,2]
    C0429098
    UMLS CUI [1,3]
    C0205394
    Other morphology: Comment
    Beschreibung

    Other morphology

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2216025
    UMLS CUI [1,2]
    C0429098
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C0947611
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    ECG Abnormalities Form Part 1

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Date and Time of ECG
    C2826846 (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])
    Item Group
    Rhythm
    C0232187 (UMLS CUI-1)
    Sinus bradycardia
    Item
    Sinus bradycardia
    boolean
    C0085610 (UMLS CUI [1])
    Item
    Sinus bradycardia frequency
    text
    C0085610 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Sinus bradycardia frequency
    Code List
    Sinus bradycardia frequency
    CL Item
    heart rate 40-50 beats/min (A21)
    CL Item
    heart rate 30-39 beats/min (A22)
    CL Item
    heart rate <30 beats/min (A23)
    Sinus pause
    Item
    Sinus pause
    boolean
    C1955864 (UMLS CUI [1])
    Sinus tachycardia
    Item
    Sinus tachycardia (heart rate >100 beats/min)
    boolean
    C0039239 (UMLS CUI [1])
    Ectopic supraventricular beats
    Item
    Ectopic supraventricular beats
    boolean
    C0033036 (UMLS CUI [1])
    Ectopic supraventricular rhythm
    Item
    Ectopic supraventricular rhythm
    boolean
    C2348376 (UMLS CUI [1])
    Wandering Atrial Pacemaker
    Item
    Wandering Atrial Pacemaker
    boolean
    C1321523 (UMLS CUI [1])
    Multifocal atrial tachycardia
    Item
    Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
    boolean
    C0221158 (UMLS CUI [1])
    Supraventricular tachycardia
    Item
    Supraventricular tachycardia (heart rate >100 beats/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])
    Junctional rhythm (heart rate ≤100 beats/min)
    Item
    Junctional rhythm (heart rate ≤100 beats/min)
    boolean
    C0232208 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    Junctional rhythm
    Item
    Junctional rhythm
    boolean
    C0232208 (UMLS CUI [1])
    Junctional tachycardia (heart rate > 100 beats/min)
    Item
    Junctional tachycardia (heart rate > 100 beats/min)
    boolean
    C0039235 (UMLS CUI [1])
    Ectopic ventricular beats
    Item
    Ectopic ventricular beats
    boolean
    C0151636 (UMLS CUI [1])
    Ventricular couplets
    Item
    Ventricular couplets
    boolean
    C0429001 (UMLS CUI [1])
    Bigeminy
    Item
    Bigeminy
    boolean
    C0262662 (UMLS CUI [1])
    Trigeminy
    Item
    Trigeminy
    boolean
    C0428999 (UMLS CUI [1])
    Electrical alternans
    Item
    Electrical alternans
    boolean
    C1142551 (UMLS CUI [1])
    R on T phenomenon
    Item
    R on T phenomenon
    boolean
    C0877658 (UMLS CUI [1])
    Ventricular fibrillation
    Item
    Ventricular fibrillation
    boolean
    C0042510 (UMLS CUI [1])
    Idioventricular rhythm (heart rate < 100 beats/min)
    Item
    Idioventricular rhythm (heart rate < 100 beats/min)
    boolean
    C0700363 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    Sustained ventricular tachycardia
    Item
    Sustained ventricular tachycardia
    boolean
    C0750197 (UMLS CUI [1])
    Non-sustained ventricular tachycardia
    Item
    Non-sustained ventricular tachycardia
    boolean
    C0750194 (UMLS CUI [1])
    Wide QRS Tachycardia (diagnosis unknown)
    Item
    Wide QRS Tachycardia (diagnosis unknown)
    boolean
    C0344429 (UMLS CUI [1])
    Ventricular Tachycardia
    Item
    Ventricular Tachycardia
    boolean
    C0042514 (UMLS CUI [1])
    Monomorphic ventricular tachycardia
    Item
    Monomorphic ventricular tachycardia
    boolean
    C0344431 (UMLS CUI [1])
    Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
    Item
    Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
    boolean
    C0040479 (UMLS CUI [1])
    Polymorphic (sustained and non-sustained) ventricular tachycardia
    Item
    Polymorphic (sustained and non-sustained) ventricular tachycardia
    boolean
    C0344432 (UMLS CUI [1])
    Artificial pacemaker
    Item
    Artificial pacemaker
    boolean
    C0030163 (UMLS CUI [1])
    Other abnormal rhythm
    Item
    Other abnormal rhythm
    boolean
    C1533266 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other abnormal rhythm
    Item
    Other abnormal rhythm: comment
    text
    C1533266 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item Group
    P-wave and QRS morphology
    C2216025 (UMLS CUI-1)
    C0429098 (UMLS CUI-2)
    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])
    Right ventricular hypertrophy
    Item
    Right ventricular hypertrophy
    boolean
    C0162770 (UMLS CUI [1])
    Intraatrial conduction delay
    Item
    Intraatrial conduction delay
    boolean
    C2346510 (UMLS CUI [1])
    Increased voltage, left ventricular hypertrophy
    Item
    Increased voltage consistent with left ventricular hypertrophy
    boolean
    C1112650 (UMLS CUI [1])
    C0149721 (UMLS CUI [2])
    Other morphology
    Item
    Other morphology
    boolean
    C2216025 (UMLS CUI [1,1])
    C0429098 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Other morphology
    Item
    Other morphology: Comment
    text
    C2216025 (UMLS CUI [1,1])
    C0429098 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    Zum Seitenanfang zurückkehren 

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