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ID

41681

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, the P1 D1 and P2 D1, the Follow-Up Visit and whenever a repeat ECG measurement was conducted during the study.

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

    12-Lead ECG

    1 forms  
    1. StudyEvent: ODM
      1. 12-Lead ECG
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    date of visit
    Description

    date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    subject ID
    Description

    subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    visit type
    Description

    visit type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Dosing date and time
    Description

    Dosing date and time

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0178602
    UMLS CUI-3
    C0011008
    UMLS CUI-4
    C0040223
    dosing date and time
    Description

    this item only needs to be filled out for the P1 D1 and P2 D1 visit

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C0040223
    12-Lead ECG
    Description

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    date of ECG
    Description

    this item only needs to be filled out for the Screening Visit , Follow-Up Visit and possible Repeat Visits.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0011008
    time relative to dosing
    Description

    this item only has to be filled out for the P1 D1 and P2 D1 visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0178602
    time of ECG
    Description

    time of ECG

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301880
    ECG: heart rate
    Description

    ECG: heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0018810
    beats/min
    ECG: PR interval
    Description

    ECG: PR interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429087
    msec
    ECG: QRS duration
    Description

    ECG: QRS duration

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429025
    msec
    ECG: uncorrected QT-interval
    Description

    ECG: uncorrected QT-interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1287082
    msec
    ECG: QTc interval
    Description

    ECG: QTc interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    msec
    result of the ECG
    Description

    result of the ECG

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1274040
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    Similar models

    12-Lead ECG

    1 forms
    1. StudyEvent: ODM
      1. 12-Lead ECG
    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
    visit type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    visit type
    Code List
    visit type
    CL Item
    Screening Visit (1)
    CL Item
    Follow-Up Visit (2)
    CL Item
    P1 D1 (3)
    CL Item
    P2 D1 (4)
    CL Item
    Repeats (5)
    Item Group
    Dosing date and time
    C0013227 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    C0011008 (UMLS CUI-3)
    C0040223 (UMLS CUI-4)
    dosing date and time
    Item
    dosing date and time
    datetime
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    date of ECG
    Item
    date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    time relative to dosing
    text
    C0439564 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    time relative to dosing
    Code List
    time relative to dosing
    CL Item
    pre-dose 1 of 3 (1)
    CL Item
    pre-dose 2 of 3 (2)
    CL Item
    pre-dose 3 of 3 (3)
    CL Item
    3 hour (4)
    time of ECG
    Item
    time of ECG
    time
    C0430456 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    ECG: heart rate
    Item
    ECG: heart rate
    integer
    C0430456 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    ECG: PR interval
    Item
    ECG: PR interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0429087 (UMLS CUI [1,2])
    ECG: QRS duration
    Item
    ECG: QRS duration
    integer
    C0430456 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    ECG: uncorrected QT-interval
    Item
    ECG: uncorrected QT-interval
    integer
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    ECG: QTc interval
    Item
    ECG: QTc interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    Item
    result of the ECG
    text
    C0430456 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    result of the ECG
    Code List
    result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant (2)
    CL Item
    abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
    CL Item
    no result (not available) (4)
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