0 Ratings
ID

32554

Description

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Keywords

Versions (1)
  1. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

    English

    12-Lead-ECG

    1 forms  
    1. StudyEvent: ODM
      1. 12-Lead-ECG
    12-Lead-ECG
    Description

    12-Lead-ECG

    Alias
    UMLS CUI-1
    C0430456
    Date and Time of ECG
    Description

    12 lead ECG, date in time, time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Heart rate
    Description

    12 lead ECG, Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0018810
    bpm
    PR Interval
    Description

    12 lead ECG, PR Interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429087
    msec
    QRS Duration
    Description

    12 lead ECG, QRS Complex Duration

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    12 lead ECG, QT Interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1287082
    msec
    Method of QTC Measurement
    Description

    12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    UMLS CUI [1,3]
    C2911685
    Machine: QTcB
    Description

    12 lead ECG, Electrocardiogram QT corrected interval, QTcB Bazett's Correction Formula

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    UMLS CUI [1,3]
    C1882512
    msec
    Machine: QTcF
    Description

    12 lead ECG, Electrocardiogram QT corrected interval, Fridiricia Formula

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    UMLS CUI [1,3]
    C4037934
    msec
    Manual: RR interval
    Description

    12 lead ECG, Electrocardiogram QT corrected interval, RR interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    UMLS CUI [1,3]
    C0489636
    msec
    Result of the ECG
    Description

    12 lead ECG, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    UMLS CUI [1,3]
    C0489636
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    Similar models

    12-Lead-ECG

    1 forms
    1. StudyEvent: ODM
      1. 12-Lead-ECG
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    12-Lead-ECG
    C0430456 (UMLS CUI-1)
    12 lead ECG, date in time, time
    Item
    Date and Time of ECG
    datetime
    C0430456 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    12 lead ECG, Heart rate
    Item
    Heart rate
    integer
    C0430456 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    12 lead ECG, PR Interval
    Item
    PR Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0429087 (UMLS CUI [1,2])
    12 lead ECG, QRS Complex Duration
    Item
    QRS Duration
    integer
    C0430456 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    12 lead ECG, QT Interval
    Item
    Uncorrected QT Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    Item
    Method of QTC Measurement
    text
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    C2911685 (UMLS CUI [1,3])
    12 lead ECG, Result
    Code List
    Method of QTC Measurement
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    CL Item
    No result (not available) (4)
    12 lead ECG, Electrocardiogram QT corrected interval, QTcB Bazett's Correction Formula
    Item
    Machine: QTcB
    integer
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    C1882512 (UMLS CUI [1,3])
    12 lead ECG, Electrocardiogram QT corrected interval, Fridiricia Formula
    Item
    Machine: QTcF
    integer
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    C4037934 (UMLS CUI [1,3])
    12 lead ECG, Electrocardiogram QT corrected interval, RR interval
    Item
    Manual: RR interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    C0489636 (UMLS CUI [1,3])
    Item
    Result of the ECG
    text
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    C0489636 (UMLS CUI [1,3])
    12 lead ECG, Result
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    CL Item
    No result (not available) (4)
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