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ID

41679

Description

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.

Keywords

Versions (1)
  1. 12/12/20 12/12/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 12, 2020

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

    English

    Vital Signs, Follow-Up

    1 forms  
    1. StudyEvent: ODM
      1. Vital Signs, Follow-Up
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    date of visit
    Description

    date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    subject ID
    Description

    subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    actual date and time
    Description

    vital signs: actual date and time

    Data type

    datetime

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

    systolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    diastolic blood pressure
    Description

    diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    heart rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    respiration rate
    Description

    respiration rate

    Data type

    integer

    Measurement units
    • breath/min
    Alias
    UMLS CUI [1]
    C0231832 (Respiratory rate)
    SNOMED
    86290005
    LOINC
    LP20159-7
    breath/min
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    Similar models

    Vital Signs, Follow-Up

    1 forms
    1. StudyEvent: ODM
      1. Vital Signs, Follow-Up
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
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