ID

29566

Description

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 2.

Link

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

Keywords

Versions (1)
  1. 4/6/18 4/6/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 6, 2018

DOI

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License

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

    English

    ECG Abnormalities Form Part 2

    1 forms  
    Conduction
    Description

    Conduction

    Alias
    UMLS CUI-1
    C0264886
    First degree AV block (PR interval > 200 msec)
    Description

    C 1 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085614
    Short PR interval
    Description

    C 20 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0520878
    Second degree AV block (Mobitz type 1)
    Description

    C 2 Report, if clinically significant.

    Data type

    boolean

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

    C 3 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0155700
    2:1 AV block
    Description

    C 16 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2346542
    Third degree AV block
    Description

    C 4 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0151517
    Left axis deviation (QRS axis more negative than -30°)
    Description

    C 5 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232297
    Right axis deviation (QRS axis more positive than +110°)
    Description

    C 6 Report, if clinically significant.

    Data type

    boolean

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

    C 7 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0262525
    Incomplete left bundle branch block
    Description

    C 13 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0281878
    Right bundle branch block
    Description

    C 8 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085615
    Left anterior hemiblock (synonymous to left anterior fascicular block)
    Description

    C 14 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0264912
    Left posterior hemiblock (synonymous to left posterior fascicular block)
    Description

    C 15 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0264913
    Left bundle branch block
    Description

    C 9 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023211
    Bifascicular block
    Description

    C 17 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0264914
    Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
    Description

    C 10 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3697597
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
    Description

    C 11 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0264897
    UMLS CUI [2]
    C0043202
    UMLS CUI [3]
    C0024054
    Prolonged QT interval
    Description

    C 19 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0151878
    QT/QTc prolongation ≥ 500 msec
    Description

    C 12 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0151878
    UMLS CUI [1,2]
    C1560305
    AV dissociation
    Description

    C 18 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004331
    Other Conduction
    Description

    C 99 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0340494
    Other Conduction: Comment
    Description

    C 99 Report, if clinically significant.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0340494
    UMLS CUI [1,2]
    C0947611
    Myocardial infarction
    Description

    Myocardial infarction

    Alias
    UMLS CUI-1
    C0027051
    Myocardial infarction, old
    Description

    D 1 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0155668
    Myocardial infarction, anterior
    Description

    D 2 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0340293
    Myocardial infarction, lateral
    Description

    D 3 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0340312
    Myocardial infarction, posterior
    Description

    D 4 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0340319
    Myocardial infarction, inferior
    Description

    D 5 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0340305
    Myocardial infarction, septal
    Description

    D 6 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0746727
    Myocardial infarction, Non-Q wave
    Description

    D 20 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0542269
    Other myocardial infarction
    Description

    D 98 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C0205394
    Other myocardial infarction: Comment
    Description

    Other myocardial infarction

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Depolarisation/Repolarisation, QRS-T
    Description

    Depolarisation/Repolarisation, QRS-T

    Alias
    UMLS CUI-1
    C0948857
    UMLS CUI-2
    C1331539
    UMLS CUI-3
    C0520880
    UMLS CUI-4
    C0438167
    Non-specific ST-T changes
    Description

    D 7 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1112720
    J point elevation
    Description

    D 19 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2346597
    ST elevation
    Description

    D 8 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0520886
    ST elevation-pericarditis
    Description

    D 21 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348119
    ST depression
    Description

    D 9 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0520887
    U waves abnormal
    Description

    D 10 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0438169
    T wave inversion
    Description

    D 11 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0520888
    T wave peaked
    Description

    D 12 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0239242
    T waves flat
    Description

    D 15 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2215959
    T waves biphasic
    Description

    D 16 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348639
    Notched T-waves
    Description

    D 18 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347367
    Low QRS voltage
    Description

    D 13 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2349945
    T-wave flattening/inversion
    Description

    D 17 Record, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0520888
    UMLS CUI [1,2]
    C0429059
    Other depolarisation/repolarisation
    Description

    D 99 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0948857
    UMLS CUI [1,2]
    C0205394
    Other depolarisation/repolarisation: Comment
    Description

    Other depolarisation/repolarisation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0948857
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Other abnormalities
    Description

    Other abnormalities

    Alias
    UMLS CUI-1
    C0522055
    UMLS CUI-2
    C0205394
    Other abnormalities
    Description

    E 99 Report, if clinically significant.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    Other abnormalities: Comment
    Description

    Other abnormalities

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
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    Similar models

    ECG Abnormalities Form Part 2

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Conduction
    C0264886 (UMLS CUI-1)
    First degree AV block
    Item
    First degree AV block (PR interval > 200 msec)
    boolean
    C0085614 (UMLS CUI [1])
    Short PR interval
    Item
    Short PR interval
    boolean
    C0520878 (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])
    2:1 AV block
    Item
    2:1 AV block
    boolean
    C2346542 (UMLS CUI [1])
    Third degree AV block
    Item
    Third degree AV block
    boolean
    C0151517 (UMLS CUI [1])
    Left axis deviation (QRS axis more negative than -30°)
    Item
    Left axis deviation (QRS axis more negative than -30°)
    boolean
    C0232297 (UMLS CUI [1])
    Right axis deviation (QRS axis more positive than +110°)
    Item
    Right axis deviation (QRS axis more positive than +110°)
    boolean
    C0232296 (UMLS CUI [1])
    Incomplete right bundle branch block
    Item
    Incomplete right bundle branch block
    boolean
    C0262525 (UMLS CUI [1])
    Incomplete left bundle branch block
    Item
    Incomplete left bundle branch block
    boolean
    C0281878 (UMLS CUI [1])
    Right bundle branch block
    Item
    Right bundle branch block
    boolean
    C0085615 (UMLS CUI [1])
    Left anterior hemiblock
    Item
    Left anterior hemiblock (synonymous to left anterior fascicular block)
    boolean
    C0264912 (UMLS CUI [1])
    Left posterior hemiblock
    Item
    Left posterior hemiblock (synonymous to left posterior fascicular block)
    boolean
    C0264913 (UMLS CUI [1])
    Left bundle branch block
    Item
    Left bundle branch block
    boolean
    C0023211 (UMLS CUI [1])
    Bifascicular block
    Item
    Bifascicular block
    boolean
    C0264914 (UMLS CUI [1])
    Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
    Item
    Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
    boolean
    C3697597 (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])
    Prolonged QT interval
    Item
    Prolonged QT interval
    boolean
    C0151878 (UMLS CUI [1])
    QT/QTc prolongation ≥ 500 msec
    Item
    QT/QTc prolongation ≥ 500 msec
    boolean
    C0151878 (UMLS CUI [1,1])
    C1560305 (UMLS CUI [1,2])
    AV dissociation
    Item
    AV dissociation
    boolean
    C0004331 (UMLS CUI [1])
    Other Conduction
    Item
    Other Conduction
    boolean
    C0340494 (UMLS CUI [1])
    Other Conduction
    Item
    Other Conduction: Comment
    text
    C0340494 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Myocardial infarction
    C0027051 (UMLS CUI-1)
    Myocardial infarction, old
    Item
    Myocardial infarction, old
    boolean
    C0155668 (UMLS CUI [1])
    Myocardial infarction, anterior
    Item
    Myocardial infarction, anterior
    boolean
    C0340293 (UMLS CUI [1])
    Myocardial infarction, lateral
    Item
    Myocardial infarction, lateral
    boolean
    C0340312 (UMLS CUI [1])
    Myocardial infarction, posterior
    Item
    Myocardial infarction, posterior
    boolean
    C0340319 (UMLS CUI [1])
    Myocardial infarction, inferior
    Item
    Myocardial infarction, inferior
    boolean
    C0340305 (UMLS CUI [1])
    Myocardial infarction, septal
    Item
    Myocardial infarction, septal
    boolean
    C0746727 (UMLS CUI [1])
    Myocardial infarction, Non-Q wave
    Item
    Myocardial infarction, Non-Q wave
    boolean
    C0542269 (UMLS CUI [1])
    Other myocardial infarction
    Item
    Other myocardial infarction
    boolean
    C0027051 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other myocardial infarction
    Item
    Other myocardial infarction: Comment
    text
    C0027051 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item Group
    Depolarisation/Repolarisation, QRS-T
    C0948857 (UMLS CUI-1)
    C1331539 (UMLS CUI-2)
    C0520880 (UMLS CUI-3)
    C0438167 (UMLS CUI-4)
    Non-specific ST-T changes
    Item
    Non-specific ST-T changes
    boolean
    C1112720 (UMLS CUI [1])
    J point elevation
    Item
    J point elevation
    boolean
    C2346597 (UMLS CUI [1])
    ST elevation
    Item
    ST elevation
    boolean
    C0520886 (UMLS CUI [1])
    ST elevation-pericarditis
    Item
    ST elevation-pericarditis
    boolean
    C2348119 (UMLS CUI [1])
    ST depression
    Item
    ST depression
    boolean
    C0520887 (UMLS CUI [1])
    U waves abnormal
    Item
    U waves abnormal
    boolean
    C0438169 (UMLS CUI [1])
    T wave inversion
    Item
    T wave inversion
    boolean
    C0520888 (UMLS CUI [1])
    T wave peaked
    Item
    T wave peaked
    boolean
    C0239242 (UMLS CUI [1])
    T waves flat
    Item
    T waves flat
    boolean
    C2215959 (UMLS CUI [1])
    T waves biphasic
    Item
    T waves biphasic
    boolean
    C2348639 (UMLS CUI [1])
    Notched T-waves
    Item
    Notched T-waves
    boolean
    C2347367 (UMLS CUI [1])
    Low QRS voltage
    Item
    Low QRS voltage
    boolean
    C2349945 (UMLS CUI [1])
    T-wave flattening/inversion
    Item
    T-wave flattening/inversion
    boolean
    C0520888 (UMLS CUI [1,1])
    C0429059 (UMLS CUI [1,2])
    Other depolarisation/repolarisation
    Item
    Other depolarisation/repolarisation
    boolean
    C0948857 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other depolarisation/repolarisation
    Item
    Other depolarisation/repolarisation: Comment
    text
    C0948857 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item Group
    Other abnormalities
    C0522055 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Other abnormalities
    Item
    Other abnormalities
    boolean
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other abnormalities
    Item
    Other abnormalities: Comment
    text
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
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