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ID

41678

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 Screening 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, Screening

    1 Formulär  
    1. StudyEvent: ODM
      1. Vital Signs, Screening
    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
    vital signs - sequence number
    Beskrivning

    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.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C2348184
    height
    Beskrivning

    height

    Datatyp

    integer

    Måttenheter
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    weight
    Beskrivning

    weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    body mass index
    Beskrivning

    body mass index

    Datatyp

    float

    Måttenheter
    • kg/m2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m2
    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
    temperature
    Beskrivning

    temperature

    Datatyp

    integer

    Måttenheter
    • degrees Celsius
    Alias
    UMLS CUI [1]
    C0005903
    degrees Celsius
    Tillbaka till toppen

    Similar models

    Vital Signs, Screening

    1 Formulär
    1. StudyEvent: ODM
      1. Vital Signs, Screening
    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])
    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])
    Tillbaka till toppen 

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