0 Ratings
ID

32732

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

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Versions (1)
  1. 11/13/18 11/13/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 13, 2018

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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

    IP Compliance

    1 forms  
    1. StudyEvent: ODM
      1. IP Compliance
    IP Compliance - Previous Visit
    Description

    IP Compliance - Previous Visit

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI-3
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    Returned IP was Dispensed at
    Description

    Experimental Drug, Return, Dispense

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    UMLS CUI [1,3]
    C1880359 (Dispense (Activity))
    IP return date
    Description

    Experimental Drug, Return, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    First Blister Card Number
    Description

    Experimental Drug, Blister Pack, First, Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,3]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    UMLS CUI [1,4]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Total number of tablets returned from first blister card
    Description

    Experimental Drug, Blister Pack, First, Count of entities, Return

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,3]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    UMLS CUI [1,4]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,5]
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    Second Blister Card Number
    Description

    Experimental Drug, Dispense, Blister Pack, Second, Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1880359 (Dispense (Activity))
    UMLS CUI [1,3]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,4]
    C0205436 (second (number))
    SNOMED
    81170007
    LOINC
    LP35057-6
    UMLS CUI [1,5]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Total Number of Tablets from second blister card dispensed
    Description

    Experimental Drug, Blister Pack, Second, Count of entities, Return

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,3]
    C0205436 (second (number))
    SNOMED
    81170007
    LOINC
    LP35057-6
    UMLS CUI [1,4]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,5]
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    Has the subject taken all the medication not returned?
    Description

    Experimental Drug, Medication Taken

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1290952 (Taking medication (activity))
    SNOMED
    129019007
    If no, specify number taken
    Description

    Experimental Drug, Medication Taken, Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1290952 (Taking medication (activity))
    SNOMED
    129019007
    UMLS CUI [1,3]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
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    Similar models

    IP Compliance

    1 forms
    1. StudyEvent: ODM
      1. IP Compliance
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    IP Compliance - Previous Visit
    C0304229 (UMLS CUI-1)
    C1321605 (UMLS CUI-2)
    C0332156 (UMLS CUI-3)
    Experimental Drug, Return, Dispense
    Item
    Returned IP was Dispensed at
    text
    C0304229 (UMLS CUI [1,1])
    C0332156 (UMLS CUI [1,2])
    C1880359 (UMLS CUI [1,3])
    Experimental Drug, Return, Date in time
    Item
    IP return date
    date
    C0304229 (UMLS CUI [1,1])
    C0332156 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Experimental Drug, Blister Pack, First, Number
    Item
    First Blister Card Number
    integer
    C0304229 (UMLS CUI [1,1])
    C1706080 (UMLS CUI [1,2])
    C0205435 (UMLS CUI [1,3])
    C0237753 (UMLS CUI [1,4])
    Experimental Drug, Blister Pack, First, Count of entities, Return
    Item
    Total number of tablets returned from first blister card
    integer
    C0304229 (UMLS CUI [1,1])
    C1706080 (UMLS CUI [1,2])
    C0205435 (UMLS CUI [1,3])
    C0449788 (UMLS CUI [1,4])
    C0332156 (UMLS CUI [1,5])
    Experimental Drug, Dispense, Blister Pack, Second, Number
    Item
    Second Blister Card Number
    integer
    C0304229 (UMLS CUI [1,1])
    C1880359 (UMLS CUI [1,2])
    C1706080 (UMLS CUI [1,3])
    C0205436 (UMLS CUI [1,4])
    C0237753 (UMLS CUI [1,5])
    Experimental Drug, Blister Pack, Second, Count of entities, Return
    Item
    Total Number of Tablets from second blister card dispensed
    integer
    C0304229 (UMLS CUI [1,1])
    C1706080 (UMLS CUI [1,2])
    C0205436 (UMLS CUI [1,3])
    C0449788 (UMLS CUI [1,4])
    C0332156 (UMLS CUI [1,5])
    Experimental Drug, Medication Taken
    Item
    Has the subject taken all the medication not returned?
    boolean
    C0304229 (UMLS CUI [1,1])
    C1290952 (UMLS CUI [1,2])
    Experimental Drug, Medication Taken, Number
    Item
    If no, specify number taken
    integer
    C0304229 (UMLS CUI [1,1])
    C1290952 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
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