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ID

31833

Description

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Mots-clés

  1. 01/10/2018 01/10/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

1 octobre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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    Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

    Concomitant Medication

    1. StudyEvent: ODM
      1. Concomitant Medication
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Description

    Concomitant Agent Before Screening procedure; Concomitant Agent During Clinical Trials

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [1,3]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [2,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [2,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [2,3]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    Drug Name
    Description

    Concomitant agent; medication name

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Unit Dose
    Description

    Concomitant agent; dosage

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Unit
    Description

    Concomitant agent; Unit

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0439148 (Unit)
    SNOMED
    767525000
    Frequency
    Description

    Concomitant agent; Frequency

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    Route
    Description

    Concomitant agent; Drug Administration Routes

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Reason for Medication
    Description

    Concomitant agent; Indication

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C3146298 (Indication)
    Start Date
    Description

    Concomitant agent; Start Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    Start Time
    Description

    Concomitant agent; Start Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    Taken prior to study?
    Description

    Concomitant agent; before; clinical trial period

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [1,3]
    C2347804 (Clinical Trial Period)
    Stop date
    Description

    Concomitant agent; Stop date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Stop time
    Description

    Concomitant agent; Stop time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C1522314 (End Time)
    SNOMED
    397898000
    Ongoing medication?
    Description

    Concomitant medication ongoing

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)

    Similar models

    Concomitant Medication

    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant Agent Before Screening procedure; Concomitant Agent During Clinical Trials
    Item
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    boolean
    C2347852 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0220908 (UMLS CUI [1,3])
    C2347852 (UMLS CUI [2,1])
    C0347984 (UMLS CUI [2,2])
    C0008976 (UMLS CUI [2,3])
    Concomitant agent; medication name
    Item
    Drug Name
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant agent; dosage
    Item
    Unit Dose
    float
    C2347852 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Concomitant agent; Unit
    Item
    Unit
    text
    C2347852 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    Concomitant agent; Frequency
    Item
    Frequency
    text
    C2347852 (UMLS CUI [1,1])
    C3476109 (UMLS CUI [1,2])
    Concomitant agent; Drug Administration Routes
    Item
    Route
    text
    C2347852 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Concomitant agent; Indication
    Item
    Reason for Medication
    text
    C2347852 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Concomitant agent; Start Date
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1])
    Concomitant agent; Start Time
    Item
    Start Time
    time
    C2347852 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Concomitant agent; before; clinical trial period
    Item
    Taken prior to study?
    boolean
    C2347852 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Concomitant agent; Stop date
    Item
    Stop date
    date
    C2347852 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Concomitant agent; Stop time
    Item
    Stop time
    time
    C2347852 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Concomitant medication ongoing
    Item
    Ongoing medication?
    boolean
    C2826666 (UMLS CUI [1])

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