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ID

34627

Description

TEST StudyStudy ID: 102863 Clinical Study ID: 102863 Study Title: A randomized, open-label, two-period, period-balanced, crossover study with three parallel groups to evaluate the relative bioavailability of single oral doses of SB 497115-GR phase III tablets [50 mg, 75 mg, 100 mg] compared to SB-497115-GR phase II tablets [25 mg and 50 mg] in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Trade Name: Eltrombopag Study Indication: Thrombocytopenia

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Versions (1)
  1. 1/20/19 1/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 20, 2019

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License

Creative Commons BY-NC 3.0
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    Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863

    English

    Unscheduled Assessments Form

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Description

    Vital Signs Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644
    Planned Relative Time
    Description

    Vital signs, Relative time, Planned

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439564
    UMLS CUI [1,3]
    C1301732
    Actual Time
    Description

    Vital Signs Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826762
    Blood Pressure Supine - Systolic
    Description

    Systolic Pressure, Supine Position

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Blood Pressure Supine - Diastolic
    Description

    Diastolic blood pressure, Supine Position

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    mmHg
    Heart Rate
    Description

    Heart Rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    12-Lead ECG
    Description

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    ECG Number
    Description

    12 lead ECG, Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0808070
    Start Date of ECG
    Description

    12 lead ECG, Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0808070
    Planned Relative Time
    Description

    12 lead ECG, Relative Time, Planned

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0439564
    UMLS CUI [1,3]
    C1301732
    Start time of ECG
    Description

    12 lead ECG, Start time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301880
    Ventricular Rate
    Description

    12 lead ECG, Ventricular Rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C2189285
    bpm
    PR Interval
    Description

    12 lead ECG, PR Interval

    Data type

    integer

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

    12 lead ECG, QRS complex duration

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    12 lead ECG, QT interval - finding

    Data type

    integer

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

    12 lead ECG, Electrocardiogram QT corrected interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    msec
    QRS Axis, if available
    Description

    12 lead ECG, QRS Axis

    Data type

    integer

    Measurement units
    • degrees
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429012
    degrees
    Result of the ECG
    Description

    12 lead ECG, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1274040
    Electronically transferred laboratory data (Blood) - Clinical Chemistry
    Description

    Electronically transferred laboratory data (Blood) - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0008000
    Planned Relative Time
    Description

    Chemistry, Clinical; Relative time, Planned

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0439564
    UMLS CUI [1,3]
    C1301732
    Date Sample Taken
    Description

    Chemistry, Clinical; Sampling, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Actual Time
    Description

    Chemistry, Clinical; Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0040223
    Electronically transferred laboratory data (Blood) - Haematology
    Description

    Electronically transferred laboratory data (Blood) - Haematology

    Alias
    UMLS CUI-1
    C0018941
    Planned Relative Time
    Description

    Hematologic tests, Relative time, Planned

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0439564
    UMLS CUI [1,3]
    C1301732
    Date Sample Taken
    Description

    Hematologic tests, Sampling, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Actual Time
    Description

    Hematologic tests; Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0040223
    Electronically transferred laboratory data (Urine) - Urinalysis
    Description

    Electronically transferred laboratory data (Urine) - Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Planned Relative Time
    Description

    Urinalysis, Relative time, Planned

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0439564
    UMLS CUI [1,3]
    C1301732
    Date Sample Taken
    Description

    Urinalysis, Sampling, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Actual Time
    Description

    Urinalysis, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0040223
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    Similar models

    Unscheduled Assessments Form

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Vital Signs Date
    Item
    Date
    date
    C2826644 (UMLS CUI [1])
    Item
    Planned Relative Time
    text
    C0518766 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    Vital signs, Relative time, Planned
    Code List
    Planned Relative Time
    CL Item
    Unscheduled (1)
    CL Item
    Unscheduled (2)
    CL Item
    Unscheduled (3)
    CL Item
    Unscheduled (4)
    CL Item
    Unscheduled (5)
    CL Item
    Unscheduled (6)
    CL Item
    Unscheduled (7)
    CL Item
    Unscheduled (8)
    CL Item
    Unscheduled (9)
    CL Item
    Unscheduled (10)
    CL Item
    Unscheduled (11)
    CL Item
    Unscheduled (12)
    CL Item
    Unscheduled (13)
    CL Item
    Unscheduled (14)
    CL Item
    Unscheduled (15)
    CL Item
    Unscheduled (16)
    CL Item
    Unscheduled (17)
    CL Item
    Unscheduled (18)
    CL Item
    Unscheduled (19)
    CL Item
    Unscheduled (20)
    Vital Signs Time
    Item
    Actual Time
    time
    C2826762 (UMLS CUI [1])
    Systolic Pressure, Supine Position
    Item
    Blood Pressure Supine - Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Diastolic blood pressure, Supine Position
    Item
    Blood Pressure Supine - Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    Item
    ECG Number
    text
    C0430456 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    12 lead ECG, Number
    Code List
    ECG Number
    CL Item
    ECG1 (1)
    CL Item
    ECG2 (2)
    CL Item
    ECG3 (3)
    CL Item
    ECG4 (4)
    CL Item
    ECG5 (5)
    CL Item
    ECG6 (6)
    CL Item
    ECG7 (7)
    CL Item
    ECG8 (8)
    12 lead ECG, Start Date
    Item
    Start Date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Planned Relative Time
    text
    C0430456 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    12 lead ECG, Relative Time, Planned
    Code List
    Planned Relative Time
    CL Item
    Unscheduled (1)
    CL Item
    Unscheduled (2)
    CL Item
    Unscheduled (3)
    CL Item
    Unscheduled (4)
    CL Item
    Unscheduled (5)
    CL Item
    Unscheduled (6)
    CL Item
    Unscheduled (7)
    CL Item
    Unscheduled (8)
    12 lead ECG, Start time
    Item
    Start time of ECG
    time
    C0430456 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    12 lead ECG, Ventricular Rate
    Item
    Ventricular Rate
    integer
    C0430456 (UMLS CUI [1,1])
    C2189285 (UMLS CUI [1,2])
    12 lead ECG, PR Interval
    Item
    PR Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0429087 (UMLS CUI [1,2])
    12 lead ECG, QRS complex duration
    Item
    QRS Duration
    integer
    C0430456 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    12 lead ECG, QT interval - finding
    Item
    Uncorrected QT Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    12 lead ECG, Electrocardiogram QT corrected interval
    Item
    QTc Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    12 lead ECG, QRS Axis
    Item
    QRS Axis, if available
    integer
    C0430456 (UMLS CUI [1,1])
    C0429012 (UMLS CUI [1,2])
    Item
    Result of the ECG
    text
    C0430456 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    12 lead ECG, Result
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    CL Item
    No result (not available) (4)
    Item Group
    Electronically transferred laboratory data (Blood) - Clinical Chemistry
    C0008000 (UMLS CUI-1)
    Item
    Planned Relative Time
    text
    C0008000 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    Chemistry, Clinical; Relative time, Planned
    Code List
    Planned Relative Time
    CL Item
    Unscheduled (1)
    CL Item
    Unscheduled (2)
    CL Item
    Unscheduled (3)
    CL Item
    Unscheduled (4)
    CL Item
    Unscheduled (5)
    CL Item
    Unscheduled (6)
    CL Item
    Unscheduled (7)
    CL Item
    Unscheduled (8)
    CL Item
    Unscheduled (9)
    CL Item
    Unscheduled (10)
    CL Item
    Unscheduled (11)
    CL Item
    Unscheduled (12)
    CL Item
    Unscheduled (13)
    CL Item
    Unscheduled (14)
    CL Item
    Unscheduled (15)
    CL Item
    Unscheduled (16)
    CL Item
    Unscheduled (17)
    CL Item
    Unscheduled (18)
    CL Item
    Unscheduled (19)
    CL Item
    Unscheduled (20)
    Chemistry, Clinical; Sampling, Date in time
    Item
    Date Sample Taken
    date
    C0008000 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Chemistry, Clinical; Time
    Item
    Actual Time
    time
    C0008000 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Electronically transferred laboratory data (Blood) - Haematology
    C0018941 (UMLS CUI-1)
    Item
    Planned Relative Time
    text
    C0018941 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    Chemistry, Clinical; Relative time, Planned
    Code List
    Planned Relative Time
    CL Item
    Unscheduled (1)
    CL Item
    Unscheduled (2)
    CL Item
    Unscheduled (3)
    CL Item
    Unscheduled (4)
    CL Item
    Unscheduled (5)
    CL Item
    Unscheduled (6)
    CL Item
    Unscheduled (7)
    CL Item
    Unscheduled (8)
    CL Item
    Unscheduled (9)
    CL Item
    Unscheduled (10)
    CL Item
    Unscheduled (11)
    CL Item
    Unscheduled (12)
    CL Item
    Unscheduled (13)
    CL Item
    Unscheduled (14)
    CL Item
    Unscheduled (15)
    CL Item
    Unscheduled (16)
    CL Item
    Unscheduled (17)
    CL Item
    Unscheduled (18)
    CL Item
    Unscheduled (19)
    CL Item
    Unscheduled (20)
    Hematologic tests, Sampling, Date in time
    Item
    Date Sample Taken
    date
    C0018941 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Hematologic tests; Time
    Item
    Actual Time
    time
    C0018941 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Electronically transferred laboratory data (Urine) - Urinalysis
    C0042014 (UMLS CUI-1)
    Item
    Planned Relative Time
    text
    C0042014 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    Chemistry, Clinical; Relative time, Planned
    Code List
    Planned Relative Time
    CL Item
    Unscheduled (1)
    CL Item
    Unscheduled (2)
    CL Item
    Unscheduled (3)
    CL Item
    Unscheduled (4)
    CL Item
    Unscheduled (5)
    CL Item
    Unscheduled (6)
    CL Item
    Unscheduled (7)
    CL Item
    Unscheduled (8)
    CL Item
    Unscheduled (9)
    CL Item
    Unscheduled (10)
    CL Item
    Unscheduled (11)
    CL Item
    Unscheduled (12)
    CL Item
    Unscheduled (13)
    CL Item
    Unscheduled (14)
    CL Item
    Unscheduled (15)
    CL Item
    Unscheduled (16)
    CL Item
    Unscheduled (17)
    CL Item
    Unscheduled (18)
    CL Item
    Unscheduled (19)
    CL Item
    Unscheduled (20)
    Urinalysis, Sampling, Date in time
    Item
    Date Sample Taken
    date
    C0042014 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Urinalysis, Time
    Item
    Actual Time
    time
    C0042014 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
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