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ID

41679

Beskrivning

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Follow-Up Visit.

Nyckelord

Versioner (1)
  1. 2020-12-12 2020-12-12 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

12 december 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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    GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122

    Engelsk

    Vital Signs, Follow-Up

    1 Formulär  
    1. StudyEvent: ODM
      1. Vital Signs, Follow-Up
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    date of visit
    Beskrivning

    date of visit

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    subject ID
    Beskrivning

    subject ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Vital Signs
    Beskrivning

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    actual date and time
    Beskrivning

    vital signs: actual date and time

    Datatyp

    datetime

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

    systolic blood pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    diastolic blood pressure
    Beskrivning

    diastolic blood pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    heart rate
    Beskrivning

    heart rate

    Datatyp

    integer

    Måttenheter
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    respiration rate
    Beskrivning

    respiration rate

    Datatyp

    integer

    Måttenheter
    • breath/min
    Alias
    UMLS CUI [1]
    C0231832
    breath/min
    Tillbaka till toppen

    Similar models

    Vital Signs, Follow-Up

    1 Formulär
    1. StudyEvent: ODM
      1. Vital Signs, Follow-Up
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    date of visit
    Item
    date of visit
    date
    C1320303 (UMLS CUI [1])
    subject ID
    Item
    subject ID
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    vital signs: actual date and time
    Item
    actual date and time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0518766 (UMLS CUI [2,1])
    C0040223 (UMLS CUI [2,2])
    systolic blood pressure
    Item
    systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    diastolic blood pressure
    Item
    diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    heart rate
    Item
    heart rate
    integer
    C0018810 (UMLS CUI [1])
    respiration rate
    Item
    respiration rate
    integer
    C0231832 (UMLS CUI [1])
    Tillbaka till toppen 

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