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32725

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-11-13 2018-11-13 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

13 november 2018

DOI

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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

    Engelsk

    Vital Signs

    1 Formulär  
    1. StudyEvent: ODM
      1. Vital Signs
    Timepoint 1 Supine
    Beskrivning

    Timepoint 1 Supine

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0038846
    Actual date/time
    Beskrivning

    Vital Signs, Date in time, Time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Height
    Beskrivning

    Body Height

    Datatyp

    integer

    Måttenheter
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Beskrivning

    Body Weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body mass index
    Beskrivning

    Body mass index

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C1305855
    Blood pressure systolic
    Beskrivning

    Systolic pressure, Supine Position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Blood pressure diastolic
    Beskrivning

    Diastolic Blood Pressure, Supine position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    mmHg
    Heart rate
    Beskrivning

    Heart rate, Supine position

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    bpm
    Standing
    Beskrivning

    Standing

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0231472
    Actual time
    Beskrivning

    Vital Signs, Date in time, Time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Blood pressure systolic
    Beskrivning

    Systolic pressure, Standing position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    mmHg
    Blood pressure diastolic
    Beskrivning

    Diastolic Blood Pressure, Standing position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0231472
    mmHg
    Heart rate
    Beskrivning

    Heart rate, Standing position

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0231472
    bpm
    Timepoint 2 Supine
    Beskrivning

    Timepoint 2 Supine

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0038846
    Actual date/time
    Beskrivning

    Vital Signs, Date in time, Time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Blood pressure systolic
    Beskrivning

    Systolic pressure, Supine Position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Blood pressure diastolic
    Beskrivning

    Diastolic Blood Pressure, Supine position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    mmHg
    Heart rate
    Beskrivning

    Heart rate, Supine position

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    bpm
    Standing
    Beskrivning

    Standing

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0231472
    Actual time
    Beskrivning

    Vital Signs, Date in time, Time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Blood pressure systolic
    Beskrivning

    Systolic pressure, Standing position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    mmHg
    Blood pressure diastolic
    Beskrivning

    Diastolic Blood Pressure, Standing position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0231472
    mmHg
    Heart rate
    Beskrivning

    Heart rate, Standing position

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0231472
    bpm
    Timepoint 3 Supine
    Beskrivning

    Timepoint 3 Supine

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0038846
    Actual date/time
    Beskrivning

    Vital Signs, Date in time, Time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Blood pressure systolic
    Beskrivning

    Systolic pressure, Supine Position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Blood pressure diastolic
    Beskrivning

    Diastolic Blood Pressure, Supine position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    mmHg
    Heart rate
    Beskrivning

    Heart rate, Supine position

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    bpm
    Standing
    Beskrivning

    Standing

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0231472
    Actual time
    Beskrivning

    Vital Signs, Date in time, Time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Blood pressure systolic
    Beskrivning

    Systolic pressure, Standing position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    mmHg
    Blood pressure diastolic
    Beskrivning

    Diastolic Blood Pressure, Standing position

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0231472
    mmHg
    Heart rate
    Beskrivning

    Heart rate, Standing position

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0231472
    bpm
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    Similar models

    Vital Signs

    1 Formulär
    1. StudyEvent: ODM
      1. Vital Signs
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Timepoint 1 Supine
    C0518766 (UMLS CUI-1)
    C0038846 (UMLS CUI-2)
    Vital Signs, Date in time, Time
    Item
    Actual date/time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Body Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body mass index
    Item
    Body mass index
    float
    C1305855 (UMLS CUI [1])
    Systolic pressure, Supine Position
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Diastolic Blood Pressure, Supine position
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate, Supine position
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Item Group
    Standing
    C0518766 (UMLS CUI-1)
    C0231472 (UMLS CUI-2)
    Vital Signs, Date in time, Time
    Item
    Actual time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Systolic pressure, Standing position
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Diastolic Blood Pressure, Standing position
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Heart rate, Standing position
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Item Group
    Timepoint 2 Supine
    C0518766 (UMLS CUI-1)
    C0038846 (UMLS CUI-2)
    Vital Signs, Date in time, Time
    Item
    Actual date/time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Systolic pressure, Supine Position
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Diastolic Blood Pressure, Supine position
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate, Supine position
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Item Group
    Standing
    C0518766 (UMLS CUI-1)
    C0231472 (UMLS CUI-2)
    Vital Signs, Date in time, Time
    Item
    Actual time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Systolic pressure, Standing position
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Diastolic Blood Pressure, Standing position
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Heart rate, Standing position
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Item Group
    Timepoint 3 Supine
    C0518766 (UMLS CUI-1)
    C0038846 (UMLS CUI-2)
    Vital Signs, Date in time, Time
    Item
    Actual date/time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Systolic pressure, Supine Position
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Diastolic Blood Pressure, Supine position
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate, Supine position
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Item Group
    Standing
    C0518766 (UMLS CUI-1)
    C0231472 (UMLS CUI-2)
    Vital Signs, Date in time, Time
    Item
    Actual time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Systolic pressure, Standing position
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Diastolic Blood Pressure, Standing position
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Heart rate, Standing position
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Tillbaka till toppen 

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