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ID

41678

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 Screening Visit.

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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, Screening

    1 forms  
    1. StudyEvent: ODM
      1. Vital Signs, Screening
    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
    vital signs - sequence number
    Description

    height, weight, BMI and temperature only have to be filled out once. The other items each have to be filled out for each of the three measurements.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C2348184 (Sequence Number)
    height
    Description

    height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    weight
    Description

    weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    body mass index
    Description

    body mass index

    Data type

    float

    Measurement units
    • kg/m2
    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    kg/m2
    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
    temperature
    Description

    temperature

    Data type

    integer

    Measurement units
    • degrees Celsius
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    degrees Celsius
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    Similar models

    Vital Signs, Screening

    1 forms
    1. StudyEvent: ODM
      1. Vital Signs, Screening
    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])
    Item
    vital signs - sequence number
    text
    C0518766 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    vital signs - sequence number
    Code List
    vital signs - sequence number
    CL Item
    1 of 3 (1)
    CL Item
    2 of 3 (2)
    CL Item
    3 of 3 (3)
    height
    Item
    height
    integer
    C0005890 (UMLS CUI [1])
    weight
    Item
    weight
    float
    C0005910 (UMLS CUI [1])
    body mass index
    Item
    body mass index
    float
    C1305855 (UMLS CUI [1])
    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])
    temperature
    Item
    temperature
    integer
    C0005903 (UMLS CUI [1])
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