0 Evaluaciones
ID

31418

Descripción

Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

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Versiones (2)
  1. 21/8/18 21/8/18 -
  2. 21/8/18 21/8/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 de agosto de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384

    Inglés

    12-Lead ECG

    1 formularios  
    1. StudyEvent: ODM
      1. 12-Lead ECG
    Dosing date/ time
    Descripción

    Dosing date/ time

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI-2
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI-3
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI-4
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Dosing date/ time
    Descripción

    Pharmaceutical Preparations; Dosage; Date in time; Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,4]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Pre- Doses
    Descripción

    Pre- Doses

    Alias
    UMLS CUI-1
    C0439565 (Pre-dose)
    SNOMED
    255235001
    Pre- Dose number
    Descripción

    Pre-dose; Numbers

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0439565 (Pre-dose)
    SNOMED
    255235001
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Time of ECG
    Descripción

    Time; Electrocardiogram

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    Heart rate
    Descripción

    heart rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    PR Interval
    Descripción

    Electrocardiogram: P-R interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429087 (Electrocardiogram: P-R interval)
    SNOMED
    365411005
    msec
    QRS Duration
    Descripción

    QRS complex duration (observable entity)

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429025 (QRS complex duration (observable entity))
    SNOMED
    251208001
    LOINC
    LP31031-5
    msec
    Uncorrected QT Interval
    Descripción

    QT interval duration

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0577807 (QT interval duration)
    SNOMED
    301117000
    msec
    QTc Interval
    Descripción

    qtc interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0489625 (QTC interval)
    LOINC
    LP31071-1
    msec
    Method of QTc Calculation
    Descripción

    Electrocardiogram QT corrected interval; Evaluation Method

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0855331 (Electrocardiogram QT corrected interval)
    UMLS CUI [1,2]
    C2911685 (Evaluation Method)
    Result of the ECG
    Descripción

    EKG finding

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0438154 (Electrocardiogram finding)
    SNOMED
    271921002
    Post- Doses
    Descripción

    Post- Doses

    Alias
    UMLS CUI-1
    C0439568 (Post-dose)
    SNOMED
    255566006
    Hours Post- dose
    Descripción

    Post-dose; Hour

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0439568 (Post-dose)
    SNOMED
    255566006
    UMLS CUI [1,2]
    C0439227 (Hour)
    SNOMED
    258702006
    Time of ECG
    Descripción

    Time; Electrocardiogram

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    Heart rate
    Descripción

    heart rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    PR Interval
    Descripción

    Electrocardiogram: P-R interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429087 (Electrocardiogram: P-R interval)
    SNOMED
    365411005
    msec
    QRS Duration
    Descripción

    QRS complex duration (observable entity)

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429025 (QRS complex duration (observable entity))
    SNOMED
    251208001
    LOINC
    LP31031-5
    msec
    Uncorrected QT Interval
    Descripción

    QT interval duration

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0577807 (QT interval duration)
    SNOMED
    301117000
    msec
    QTc Interval
    Descripción

    qtc interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0489625 (QTC interval)
    LOINC
    LP31071-1
    msec
    Method of QTc Calculation
    Descripción

    Electrocardiogram QT corrected interval; Evaluation Method

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0855331 (Electrocardiogram QT corrected interval)
    UMLS CUI [1,2]
    C2911685 (Evaluation Method)
    Result of the ECG
    Descripción

    EKG finding

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0438154 (Electrocardiogram finding)
    SNOMED
    271921002
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    Similar models

    12-Lead ECG

    1 formularios
    1. StudyEvent: ODM
      1. 12-Lead ECG
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Dosing date/ time
    C0013227 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    C0011008 (UMLS CUI-3)
    C0040223 (UMLS CUI-4)
    Pharmaceutical Preparations; Dosage; Date in time; Time
    Item
    Dosing date/ time
    datetime
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item Group
    Pre- Doses
    C0439565 (UMLS CUI-1)
    Item
    Pre- Dose number
    integer
    C0439565 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    undefined item
    Code List
    Pre- Dose number
    CL Item
    Pre- Dose #1 (1)
    CL Item
    Pre- Dose #2 (2)
    CL Item
    Pre- Dose #3 (3)
    Time; Electrocardiogram
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Electrocardiogram: P-R interval
    Item
    PR Interval
    float
    C0429087 (UMLS CUI [1])
    QRS complex duration (observable entity)
    Item
    QRS Duration
    float
    C0429025 (UMLS CUI [1])
    QT interval duration
    Item
    Uncorrected QT Interval
    float
    C0577807 (UMLS CUI [1])
    qtc interval
    Item
    QTc Interval
    float
    C0489625 (UMLS CUI [1])
    Item
    Method of QTc Calculation
    integer
    C0855331 (UMLS CUI [1,1])
    C2911685 (UMLS CUI [1,2])
    Electrocardiogram QT corrected interval; Evaluation Method
    Code List
    Method of QTc Calculation
    CL Item
    Machine (1)
    CL Item
    Manual (2)
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    EKG finding
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant )Complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
    CL Item
    No result (not available) (4)
    Item Group
    Post- Doses
    C0439568 (UMLS CUI-1)
    Item
    Hours Post- dose
    integer
    C0439568 (UMLS CUI [1,1])
    C0439227 (UMLS CUI [1,2])
    undefined item
    Code List
    Hours Post- dose
    CL Item
    1.0 hour Post- dose (1)
    CL Item
    3.0 hours Post- dose (2)
    CL Item
    5.5 hours Post- dose (3)
    CL Item
    8.0 hours Post- dose (4)
    CL Item
    10.0 hours Post- dose (5)
    CL Item
    12.0 hours Post- dose (6)
    CL Item
    24.0 hours Post- dose (7)
    Time; Electrocardiogram
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Electrocardiogram: P-R interval
    Item
    PR Interval
    float
    C0429087 (UMLS CUI [1])
    QRS complex duration (observable entity)
    Item
    QRS Duration
    float
    C0429025 (UMLS CUI [1])
    QT interval duration
    Item
    Uncorrected QT Interval
    float
    C0577807 (UMLS CUI [1])
    qtc interval
    Item
    QTc Interval
    float
    C0489625 (UMLS CUI [1])
    Item
    Method of QTc Calculation
    integer
    C0855331 (UMLS CUI [1,1])
    C2911685 (UMLS CUI [1,2])
    Electrocardiogram QT corrected interval; Evaluation Method
    Code List
    Method of QTc Calculation
    CL Item
    Machine (1)
    CL Item
    Manual (2)
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    EKG finding
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant )Complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
    CL Item
    No result (not available) (4)
    Volver a la parte superior de la página 

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