0 Ratings
ID

32730

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. 11/13/18 11/13/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 13, 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

    PGx-Pharmacogenetic Research Consent

    1 forms  
    PGx-Pharmacogenetic Research Consent
    Description

    PGx-Pharmacogenetic Research Consent

    Alias
    UMLS CUI-1
    C2347500 (Pharmacogenetic Test)
    UMLS CUI-2
    C0021430 (Informed Consent)
    Has informed consent been obtained for PGx- Pharmacogenetic research?
    Description

    Pharmacogenetic Test, Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    Date informed consent obtained for PGx-Pharmacogenetic research
    Description

    Pharmacogenetic Test, Informed Consent, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    No informed consent for PGx- Pharmacogenetic research obtained - Reason
    Description

    Pharmacogenetic Test, Informed Consent, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031325 (Pharmacogenetics)
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    UMLS CUI [1,3]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Description

    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0031325 (Pharmacogenetics)
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    Date sample taken
    Description

    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0031325 (Pharmacogenetics)
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Withdrawal of Consent for PGx (DNA) Sample Destruction
    Description

    Withdrawal of Consent for PGx (DNA) Sample Destruction

    Alias
    UMLS CUI-1
    C0444245 (Deoxyribonucleic acid sample)
    SNOMED
    258566005
    UMLS CUI-2
    C1948029 (Destruction (action))
    UMLS CUI-3
    C1707492 (Consent Withdrawn)
    Has subject withdrawn consent for PGx research?
    Description

    Pharmacogenetic Test, Consent withdrawn

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,2]
    C1707492 (Consent Withdrawn)
    Date informed consent withdrawn
    Description

    Pharmacogenetic Test, Consent withdrawn, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,2]
    C1707492 (Consent Withdrawn)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Has a request been made for sample destruction?
    Description

    DNA sample, Destruction, Request

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0444245 (Deoxyribonucleic acid sample)
    SNOMED
    258566005
    UMLS CUI [1,2]
    C1948029 (Destruction (action))
    UMLS CUI [1,3]
    C1272683 (Request - action)
    SNOMED
    385644000
    Has a request been made for sample destruction? - Reason
    Description

    DNA sample, Destruction, Request, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0444245 (Deoxyribonucleic acid sample)
    SNOMED
    258566005
    UMLS CUI [1,2]
    C1948029 (Destruction (action))
    UMLS CUI [1,3]
    C1272683 (Request - action)
    SNOMED
    385644000
    UMLS CUI [1,4]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
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    Similar models

    PGx-Pharmacogenetic Research Consent

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    PGx-Pharmacogenetic Research Consent
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    Pharmacogenetic Test, Informed Consent
    Item
    Has informed consent been obtained for PGx- Pharmacogenetic research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    Pharmacogenetic Test, Informed Consent, Date in time
    Item
    Date informed consent obtained for PGx-Pharmacogenetic research
    date
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    No informed consent for PGx- Pharmacogenetic research obtained - Reason
    text
    C0031325 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Pharmacogenetic Test, Informed Consent, Indication
    Code List
    No informed consent for PGx- Pharmacogenetic research obtained - Reason
    CL Item
    Subject declined (Subject declined)
    CL Item
    Subject not asked by Investigator (Subject not asked by Investigator)
    CL Item
    Other (Other)
    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
    Item
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    boolean
    C0031325 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time
    Item
    Date sample taken
    date
    C0031325 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Withdrawal of Consent for PGx (DNA) Sample Destruction
    C0444245 (UMLS CUI-1)
    C1948029 (UMLS CUI-2)
    C1707492 (UMLS CUI-3)
    Pharmacogenetic Test, Consent withdrawn
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    Pharmacogenetic Test, Consent withdrawn, Date in time
    Item
    Date informed consent withdrawn
    date
    C2347500 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    DNA sample, Destruction, Request
    Item
    Has a request been made for sample destruction?
    boolean
    C0444245 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    Item
    Has a request been made for sample destruction? - Reason
    text
    C0444245 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    DNA sample, Destruction, Request, Indication
    Code List
    Has a request been made for sample destruction? - Reason
    CL Item
    Subject withdrew consent for PGx (Subject withdrew consent for PGx)
    CL Item
    Screen failure (Screen failure)
    CL Item
    Other (Other)
    Back to the top of the page 

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