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32724

Beschreibung

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

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  1. 13.11.18 13.11.18 -
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GlaxoSmithKline

Hochgeladen am

13. November 2018

DOI

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    Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

    Englisch

    Vital Signs

    1 Formulare  
    1. StudyEvent: ODM
      1. Vital Signs
    Measurement 1 Supine
    Beschreibung

    Measurement 1 Supine

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI-2
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    Actual date/time
    Beschreibung

    Vital Signs, Date in time, Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Height
    Beschreibung

    Body Height

    Datentyp

    integer

    Maßeinheiten
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Weight
    Beschreibung

    Body Weight

    Datentyp

    float

    Maßeinheiten
    • kg/m2
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg/m2
    Body mass index
    Beschreibung

    Body mass index

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    Blood pressure systolic
    Beschreibung

    Systolic pressure, Supine Position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Blood pressure diastolic
    Beschreibung

    Diastolic Blood Pressure, Supine position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Heart rate
    Beschreibung

    Heart rate, Supine position

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    bpm
    Standing
    Beschreibung

    Standing

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI-2
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    Actual time
    Beschreibung

    Vital Signs, Date in time, Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood pressure systolic
    Beschreibung

    Systolic pressure, Standing position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    mmHg
    Blood pressure diastolic
    Beschreibung

    Diastolic Blood Pressure, Standing position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    mmHg
    Heart rate
    Beschreibung

    Heart rate, Standing position

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    bpm
    Measurement 2 Supine
    Beschreibung

    Measurement 2 Supine

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI-2
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    Actual date/time
    Beschreibung

    Vital Signs, Date in time, Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood pressure systolic
    Beschreibung

    Systolic pressure, Supine Position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Blood pressure diastolic
    Beschreibung

    Diastolic Blood Pressure, Supine position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Heart rate
    Beschreibung

    Heart rate, Supine position

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    bpm
    Standing
    Beschreibung

    Standing

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI-2
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    Actual time
    Beschreibung

    Vital Signs, Date in time, Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood pressure systolic
    Beschreibung

    Systolic pressure, Standing position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    mmHg
    Blood pressure diastolic
    Beschreibung

    Diastolic Blood Pressure, Standing position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    mmHg
    Heart rate
    Beschreibung

    Heart rate, Standing position

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    bpm
    Measurement 3 Supine
    Beschreibung

    Measurement 3 Supine

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI-2
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    Actual date/time
    Beschreibung

    Vital Signs, Date in time, Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood pressure systolic
    Beschreibung

    Systolic pressure, Supine Position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Blood pressure diastolic
    Beschreibung

    Diastolic Blood Pressure, Supine position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Heart rate
    Beschreibung

    Heart rate, Supine position

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    bpm
    Standing
    Beschreibung

    Standing

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI-2
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    Actual time
    Beschreibung

    Vital Signs, Date in time, Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood pressure systolic
    Beschreibung

    Systolic pressure, Standing position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    mmHg
    Blood pressure diastolic
    Beschreibung

    Diastolic Blood Pressure, Standing position

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    mmHg
    Heart rate
    Beschreibung

    Heart rate, Standing position

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    bpm
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Vital Signs

    1 Formulare
    1. StudyEvent: ODM
      1. Vital Signs
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Measurement 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
    Measurement 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
    Measurement 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])
    Zum Seitenanfang zurückkehren 

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