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29566

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 2.

Link

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

Stichworte

Versionen (1)
  1. 6/4/18 6/4/18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

6 de abril de 2018

DOI

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Lizenz

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 2

    1 Formulare  
    Conduction
    Beschreibung

    Conduction

    Alias
    UMLS CUI-1
    C0264886 (Conduction disorder of the heart)
    SNOMED
    44808001
    First degree AV block (PR interval > 200 msec)
    Beschreibung

    C 1 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0085614 (First degree atrioventricular block)
    SNOMED
    270492004
    LOINC
    LA17086-2
    Short PR interval
    Beschreibung

    C 20 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0520878 (Shortened PR interval)
    SNOMED
    49578007
    Second degree AV block (Mobitz type 1)
    Beschreibung

    C 2 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0264907 (Mobitz type I incomplete atrioventricular block)
    SNOMED
    54016002
    Second degree AV block (Mobitz type 2)
    Beschreibung

    C 3 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0155700 (Mobitz type II atrioventricular block)
    SNOMED
    28189009
    2:1 AV block
    Beschreibung

    C 16 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2346542 (2:1 Atrioventricular Block by ECG Finding)
    Third degree AV block
    Beschreibung

    C 4 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0151517 (Complete atrioventricular block)
    SNOMED
    27885002
    LOINC
    LA17089-6
    Left axis deviation (QRS axis more negative than -30°)
    Beschreibung

    C 5 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232297 (Left axis deviation)
    SNOMED
    39732003
    Right axis deviation (QRS axis more positive than +110°)
    Beschreibung

    C 6 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232296 (Right axis deviation)
    SNOMED
    47665007
    Incomplete right bundle branch block
    Beschreibung

    C 7 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0262525 (Incomplete right bundle branch block)
    SNOMED
    251124007
    Incomplete left bundle branch block
    Beschreibung

    C 13 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0281878 (Incomplete left bundle branch block)
    SNOMED
    251120003
    Right bundle branch block
    Beschreibung

    C 8 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0085615 (Right bundle branch block)
    SNOMED
    59118001
    Left anterior hemiblock (synonymous to left anterior fascicular block)
    Beschreibung

    C 14 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0264912 (Left anterior fascicular block)
    SNOMED
    37760005
    Left posterior hemiblock (synonymous to left posterior fascicular block)
    Beschreibung

    C 15 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0264913 (Left posterior fascicular block)
    SNOMED
    62026008
    Left bundle branch block
    Beschreibung

    C 9 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023211 (Left Bundle-Branch Block)
    SNOMED
    63467002
    Bifascicular block
    Beschreibung

    C 17 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0264914 (Bifascicular block)
    SNOMED
    74021003
    Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
    Beschreibung

    C 10 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3697597 (Non-specific intraventricular conduction delay)
    SNOMED
    698252002
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
    Beschreibung

    C 11 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0264897 (Accessory Atrioventricular Bundle (disorder))
    SNOMED
    16797001
    UMLS CUI [2]
    C0043202 (Wolff-Parkinson-White Syndrome)
    SNOMED
    74390002
    UMLS CUI [3]
    C0024054 (Lown-Ganong-Levine Syndrome)
    SNOMED
    55475008
    Prolonged QT interval
    Beschreibung

    C 19 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0151878 (Prolonged QT interval)
    SNOMED
    111975006
    QT/QTc prolongation ≥ 500 msec
    Beschreibung

    C 12 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0151878 (Prolonged QT interval)
    SNOMED
    111975006
    UMLS CUI [1,2]
    C1560305 (Prolonged QTc interval)
    AV dissociation
    Beschreibung

    C 18 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004331 (Auriculo-Ventricular Dissociation)
    SNOMED
    50799005
    Other Conduction
    Beschreibung

    C 99 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0340494 (Other conduction disorders)
    Other Conduction: Comment
    Beschreibung

    C 99 Report, if clinically significant.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0340494 (Other conduction disorders)
    UMLS CUI [1,2]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Myocardial infarction
    Beschreibung

    Myocardial infarction

    Alias
    UMLS CUI-1
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    Myocardial infarction, old
    Beschreibung

    D 1 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0155668 (Old myocardial infarction)
    SNOMED
    1755008
    Myocardial infarction, anterior
    Beschreibung

    D 2 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0340293 (Anterior myocardial infarction)
    Myocardial infarction, lateral
    Beschreibung

    D 3 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0340312 (Lateral myocardial infarction)
    Myocardial infarction, posterior
    Beschreibung

    D 4 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0340319 (Posterior myocardial infarction)
    Myocardial infarction, inferior
    Beschreibung

    D 5 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0340305 (Inferior Wall Myocardial Infarction)
    Myocardial infarction, septal
    Beschreibung

    D 6 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0746727 (Septal myocardial infarction)
    Myocardial infarction, Non-Q wave
    Beschreibung

    D 20 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0542269 (Non-Q wave myocardial infarction)
    SNOMED
    314207007
    Other myocardial infarction
    Beschreibung

    D 98 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Other myocardial infarction: Comment
    Beschreibung

    Other myocardial infarction

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,3]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Depolarisation/Repolarisation, QRS-T
    Beschreibung

    Depolarisation/Repolarisation, QRS-T

    Alias
    UMLS CUI-1
    C0948857 (Electrocardiogram repolarisation abnormality)
    UMLS CUI-2
    C1331539 (Ventricular Depolarization [PE])
    UMLS CUI-3
    C0520880 (QRS interval, function)
    SNOMED
    39632005
    UMLS CUI-4
    C0438167 (EKG: T wave abnormal)
    SNOMED
    164934002
    Non-specific ST-T changes
    Beschreibung

    D 7 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1112720 (ECG Nonspecific ST-T change)
    J point elevation
    Beschreibung

    D 19 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2346597 (J Point Elevation)
    ST elevation
    Beschreibung

    D 8 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0520886 (ST segment elevation (finding))
    SNOMED
    164931005
    ST elevation-pericarditis
    Beschreibung

    D 21 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348119 (ST Elevation Pericarditis by ECG Finding)
    ST depression
    Beschreibung

    D 9 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0520887 (ST segment depression (finding))
    SNOMED
    429622005
    U waves abnormal
    Beschreibung

    D 10 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0438169 (EKG: U wave abnormal)
    SNOMED
    164937009
    T wave inversion
    Beschreibung

    D 11 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0520888 (Inverted T wave)
    SNOMED
    59931005
    T wave peaked
    Beschreibung

    D 12 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0239242 (T Wave Peaked by ECG Finding)
    T waves flat
    Beschreibung

    D 15 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2215959 (electrocardiogram: flat T waves)
    T waves biphasic
    Beschreibung

    D 16 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348639 (T Waves Biphasic by ECG Finding)
    Notched T-waves
    Beschreibung

    D 18 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2347367 (T Wave Notched by ECG Finding)
    Low QRS voltage
    Beschreibung

    D 13 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2349945 (electrocardiogram: low voltage QRS complete)
    SNOMED
    251146004
    T-wave flattening/inversion
    Beschreibung

    D 17 Record, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0520888 (Inverted T wave)
    SNOMED
    59931005
    UMLS CUI [1,2]
    C0429059 (Flattened T wave (finding))
    SNOMED
    66812002
    Other depolarisation/repolarisation
    Beschreibung

    D 99 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0948857 (Electrocardiogram repolarisation abnormality)
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Other depolarisation/repolarisation: Comment
    Beschreibung

    Other depolarisation/repolarisation

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0948857 (Electrocardiogram repolarisation abnormality)
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,3]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Other abnormalities
    Beschreibung

    Other abnormalities

    Alias
    UMLS CUI-1
    C0522055 (Electrocardiogram abnormal (finding))
    SNOMED
    102594003
    LOINC
    LA24621-7
    UMLS CUI-2
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Other abnormalities
    Beschreibung

    E 99 Report, if clinically significant.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0522055 (Electrocardiogram abnormal (finding))
    SNOMED
    102594003
    LOINC
    LA24621-7
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Other abnormalities: Comment
    Beschreibung

    Other abnormalities

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0522055 (Electrocardiogram abnormal (finding))
    SNOMED
    102594003
    LOINC
    LA24621-7
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,3]
    C0947611 (Comment)
    LOINC
    LP72293-1
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    Ähnliche Modelle

    ECG Abnormalities Form Part 2

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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