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31420

Description

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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Versions (2)
  1. 8/21/18 8/21/18 -
  2. 8/21/18 8/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 21, 2018

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License

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

    English

    Vital Signs and ECG - Predose and Post- dose

    1 forms  
    ECG Dosing date/ time
    Description

    ECG Dosing date/ time

    Alias
    UMLS CUI-1
    C1623258
    UMLS CUI-2
    C0013227
    UMLS CUI-3
    C0178602
    UMLS CUI-4
    C0011008
    UMLS CUI-5
    C0040223
    Dosing date/ time
    Description

    Pharmaceutical Preparations; Dosage; Date in time; Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Pre- Dose ECG
    Description

    Pre- Dose ECG

    Alias
    UMLS CUI-1
    C1623258
    UMLS CUI-2
    C0439565
    Pre- Dose number
    Description

    Pre-dose; Numbers

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439565
    UMLS CUI [1,2]
    C0237753
    Time of ECG
    Description

    Time; Electrocardiogram

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Heart rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Description

    Electrocardiogram: P-R interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS Duration
    Description

    QRS complex duration (observable entity)

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    QT interval duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0577807
    msec
    QTc Interval
    Description

    qtc interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0489625
    msec
    Method of QTc Calculation
    Description

    Electrocardiogram QT corrected interval; Evaluation Method

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C2911685
    Result of the ECG
    Description

    EKG finding

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Post- Dose ECG
    Description

    Post- Dose ECG

    Alias
    UMLS CUI-1
    C1623258
    UMLS CUI-2
    C0439568
    Hours Post- dose
    Description

    Post-dose; Hour

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439568
    UMLS CUI [1,2]
    C0439227
    Time of ECG
    Description

    Time; Electrocardiogram

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Heart rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Description

    Electrocardiogram: P-R interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS Duration
    Description

    QRS complex duration (observable entity)

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    QT interval duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0577807
    msec
    QTc Interval
    Description

    qtc interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0489625
    msec
    Method of QTc Calculation
    Description

    Electrocardiogram QT corrected interval; Evaluation Method

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C2911685
    Result of the ECG
    Description

    EKG finding

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Vital Signs Dosing date and time
    Description

    Vital Signs Dosing date and time

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0013227
    UMLS CUI-3
    C0178602
    UMLS CUI-4
    C0011008
    UMLS CUI-5
    C0040223
    Vital Signs Dosing date and time
    Description

    Vital signs | Pharmaceutical Preparations; Dosage; Date in time; Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C0011008
    UMLS CUI [2,4]
    C0040223
    Pre- dose Vital Signs
    Description

    Pre- dose Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439565
    Actual time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Blood pressure (systolic/ diastolic)
    Description

    Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Heart rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Respiration rate
    Description

    Respiratory rate

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832
    breaths/min
    Post- dose Vital signs
    Description

    Post- dose Vital signs

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439568
    Hours Post- dose
    Description

    Post-dose; Hour

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439568
    UMLS CUI [1,2]
    C0439227
    Actual time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Blood pressure (systolic/ diastolic)
    Description

    Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Heart rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Respiration rate
    Description

    Respiratory rate

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832
    breaths/min
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    Similar models

    Vital Signs and ECG - Predose and Post- dose

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    ECG Dosing date/ time
    C1623258 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    C0178602 (UMLS CUI-3)
    C0011008 (UMLS CUI-4)
    C0040223 (UMLS CUI-5)
    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- Dose ECG
    C1623258 (UMLS CUI-1)
    C0439565 (UMLS CUI-2)
    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- Dose ECG
    C1623258 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    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)
    Item Group
    Vital Signs Dosing date and time
    C0518766 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    C0178602 (UMLS CUI-3)
    C0011008 (UMLS CUI-4)
    C0040223 (UMLS CUI-5)
    Vital signs | Pharmaceutical Preparations; Dosage; Date in time; Time
    Item
    Vital Signs Dosing date and time
    datetime
    C0518766 (UMLS CUI [1])
    C0013227 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    C0011008 (UMLS CUI [2,3])
    C0040223 (UMLS CUI [2,4])
    Item Group
    Pre- dose Vital Signs
    C0518766 (UMLS CUI-1)
    C0439565 (UMLS CUI-2)
    Time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Blood Pressure
    Item
    Blood pressure (systolic/ diastolic)
    integer
    C0005823 (UMLS CUI [1])
    heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Respiratory rate
    Item
    Respiration rate
    integer
    C0231832 (UMLS CUI [1])
    Item Group
    Post- dose Vital signs
    C0518766 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    Item
    Hours Post- dose
    integer
    C0439568 (UMLS CUI [1,1])
    C0439227 (UMLS CUI [1,2])
    Post-dose; Hour
    Code List
    Hours Post- dose
    CL Item
    1.0 hours 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
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Blood Pressure
    Item
    Blood pressure (systolic/ diastolic)
    integer
    C0005823 (UMLS CUI [1])
    heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Respiratory rate
    Item
    Respiration rate
    integer
    C0231832 (UMLS CUI [1])
    Back to the top of the page 

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