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41711

Beschreibung

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

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  1. 02.01.21 02.01.21 -
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GlaxoSmithKline

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2. Januar 2021

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    Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

    Englisch

    Part 2, Period 4, Cohort 1 Day 1: Local Laboratory; Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Holter Summary; Holter Abnormalities

    1 Formulare  
    Date of visit
    Beschreibung

    Date of visit

    Alias
    UMLS CUI-1
    C1320303
    Date of visit
    Beschreibung

    Date of visit

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Local Laboratory - Haematology (Part 2 Period 4)
    Beschreibung

    Local Laboratory - Haematology (Part 2 Period 4)

    Date and time sample taken (Haematology)
    Beschreibung

    Date and time sample taken (Haematology)

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0200345
    UMLS CUI [2]
    C0018941
    Has the subject fasted? (Haematology)
    Beschreibung

    Has the subject fasted? (Haematology)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0015663
    UMLS CUI [2]
    C0018941
    Local Laboratory - Haematology (Part 2 Period 4)
    Beschreibung

    Local Laboratory - Haematology (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Haematologic test
    Beschreibung

    Haematologic test

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Numeric result (Haemoatology)
    Beschreibung

    Numeric result (Haemoatology)

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C2347373
    UMLS CUI [2]
    C0474523
    Character result (Haematology)
    Beschreibung

    Character result (Haematology)

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2350015
    UMLS CUI [2]
    C0474523
    No result (Haematology)
    Beschreibung

    No result (Haematology)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0474523
    Local Laboratory - Clinical Chemistry (Part 2 Period 4)
    Beschreibung

    Local Laboratory - Clinical Chemistry (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Date and time sample taken (Clinical Chemistry)
    Beschreibung

    Date and time sample taken (Clinical Chemistry)

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0200345
    UMLS CUI [2]
    C0008000
    Has the subject fasted? (Clinical Chemistry)
    Beschreibung

    Has the subject fasted? (Clinical Chemistry)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0015663
    UMLS CUI [2]
    C0008000
    Local Laboratory - Clinical Chemistry (Part 2 Period 4)
    Beschreibung

    Local Laboratory - Clinical Chemistry (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Clinical Chemistry Test
    Beschreibung

    Clinical Chemistry Test

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0525044
    Numeric result (Clinical Chemistry)
    Beschreibung

    Numeric result (Clinical Chemistry)

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C2347373
    UMLS CUI [2]
    C0008000
    Character result (Clinical Chemistry)
    Beschreibung

    Character result (Clinical Chemistry)

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2350015
    UMLS CUI [2]
    C0008000
    No result (Clinical Chemistry)
    Beschreibung

    No result (Clinical Chemistry)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0587081
    UMLS CUI [2]
    C0008000
    Investigational Product (Dose) (Part 2 Period 4)
    Beschreibung

    Investigational Product (Dose) (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0304229
    Date/time of dose
    Beschreibung

    Date/time of dose

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C1264639
    Number of Inhalations
    Beschreibung

    Number of Inhalations

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C0237753
    Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
    Beschreibung

    Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    If subject did not recieve the correct treatment, record reason
    Beschreibung

    If subject did not recieve the correct treatment, record reason

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2349182
    UMLS CUI [2]
    C0392360
    ECG (Part 2 Period 4)
    Beschreibung

    ECG (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C1623258
    Dosing date/time (ECG)
    Beschreibung

    Dosing date/time (ECG)

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1264639
    UMLS CUI [2]
    C1623258
    ECG (Part 2 Period 4)
    Beschreibung

    ECG (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C1623258
    ECG Timepoint
    Beschreibung

    ECG Timepoint

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C2348792
    Time of ECG
    Beschreibung

    Time of ECG

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0040223
    Heart rate
    Beschreibung

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Beschreibung

    PR Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C0429087
    ms
    QRS Duration
    Beschreibung

    QRS Duration

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C0429025
    ms
    Uncorrected QT Interval
    Beschreibung

    Uncorrected QT Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C1287082
    ms
    QTc Interval
    Beschreibung

    QTc Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C0489625
    ms
    QTc (b) Interval
    Beschreibung

    QTc (b) Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C1882512
    ms
    Method of QTc Calculation
    Beschreibung

    Method of QTc Calculation

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C2911685
    Result of the ECG
    Beschreibung

    Result of the ECG

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Vital Signs (Part 2 Period 4)
    Beschreibung

    Vital Signs (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0518766
    Dosing date/time (Vital Signs)
    Beschreibung

    Dosing date/time (Vital Signs)

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1264639
    UMLS CUI [2]
    C0518766
    Vital Signs (Part 2 Period 4)
    Beschreibung

    Vital Signs (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0518766
    Vital Signs Timepoint
    Beschreibung

    Vital Signs Timepoint

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C2348792
    Actual time
    Beschreibung

    Actual time

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Systolic Blood Pressure
    Beschreibung

    Systolic Blood Pressure

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Beschreibung

    Diastolic Blood Pressure

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Heart rate
    Beschreibung

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4)
    Beschreibung

    Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Date and time sample taken (Haematology, 24 Hr Lab)
    Beschreibung

    Date and time sample taken (Haematology, 24 Hr Lab)

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0200345
    UMLS CUI [2]
    C0018941
    Has the subject fasted? (Haematology, 24 Hr Lab)
    Beschreibung

    Has the subject fasted? (Haematology, 24 Hr Lab)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0015663
    UMLS CUI [2]
    C0018941
    Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4)
    Beschreibung

    Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Haematologic test (24 Hr Lab)
    Beschreibung

    Haematologic test (24 Hr Lab)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Numeric result (Haemoatology, 24 Hr Lab)
    Beschreibung

    Numeric result (Haemoatology, 24 Hr Lab)

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C2347373
    UMLS CUI [2]
    C0474523
    Character result (Haematology, 24 Hr Lab)
    Beschreibung

    Character result (Haematology, 24 Hr Lab)

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2350015
    UMLS CUI [2]
    C0474523
    No result (Haematology, 24 Hr Lab)
    Beschreibung

    No result (Haematology, 24 Hr Lab)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0474523
    Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4)
    Beschreibung

    Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
    Beschreibung

    Date and time sample taken (Clinical Chemistry, 24 Hr Lab)

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0200345
    UMLS CUI [2]
    C0008000
    Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
    Beschreibung

    Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0015663
    UMLS CUI [2]
    C0008000
    Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4)
    Beschreibung

    Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Clinical Chemistry Test (24 Hr Lab)
    Beschreibung

    Clinical Chemistry Test (24 Hr Lab)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0525044
    Numeric result (Clinical Chemistry, 24 Hr Lab)
    Beschreibung

    Numeric result (Clinical Chemistry, 24 Hr Lab)

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C2347373
    UMLS CUI [2]
    C0008000
    Character result (Clinical Chemistry, 24 Hr Lab)
    Beschreibung

    Character result (Clinical Chemistry, 24 Hr Lab)

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2350015
    UMLS CUI [2]
    C0008000
    No result (Clinical Chemistry, 24 Hr Lab)
    Beschreibung

    No result (Clinical Chemistry, 24 Hr Lab)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0587081
    UMLS CUI [2]
    C0008000
    Pulmonary Function Tests (Part 2 Period 4)
    Beschreibung

    Pulmonary Function Tests (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0024119
    Dosing date/time (Pulmonary Function Tests)
    Beschreibung

    Dosing date/time (Pulmonary Function Tests)

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1264639
    UMLS CUI [2]
    C0024119
    Pulmonary Function Tests (Part 2 Period 4)
    Beschreibung

    Pulmonary Function Tests (Part 2 Period 4)

    Alias
    UMLS CUI-1
    C0024119
    Pulmonary Function Tests Timepoint
    Beschreibung

    Pulmonary Function Tests Timepoint

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C2348792
    Date/time of test
    Beschreibung

    Date/time of test

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C1264639
    FEV (3 readings) - 1
    Beschreibung

    FEV (3 readings) - 1

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    FEV (3 readings) - 2
    Beschreibung

    FEV (3 readings) - 2

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    FEV (3 readings) - 3
    Beschreibung

    FEV (3 readings) - 3

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
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    Ähnliche Modelle

    Part 2, Period 4, Cohort 1 Day 1: Local Laboratory; Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Holter Summary; Holter Abnormalities

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Date of visit
    C1320303 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Local Laboratory - Haematology (Part 2 Period 4)
    Date and time sample taken (Haematology)
    Item
    Date and time sample taken (Haematology)
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    C0018941 (UMLS CUI [2])
    Has the subject fasted? (Haematology)
    Item
    Has the subject fasted? (Haematology)
    boolean
    C0015663 (UMLS CUI [1])
    C0018941 (UMLS CUI [2])
    Item Group
    Local Laboratory - Haematology (Part 2 Period 4)
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Item
    Haematologic test
    integer
    C0018941 (UMLS CUI [1])
    Haematologic test
    Code List
    Haematologic test
    CL Item
    WBC (1)
    CL Item
    RBC (2)
    CL Item
    Hameoglobin (3)
    CL Item
    Haematocrit (4)
    CL Item
    Neutrophils (5)
    CL Item
    Lymphocytes (6)
    CL Item
    Monocytes (7)
    CL Item
    Eosinophils (8)
    CL Item
    Basophils (9)
    CL Item
    MCV (10)
    CL Item
    MCH (11)
    CL Item
    MCHC (12)
    Numeric result (Haemoatology)
    Item
    Numeric result (Haemoatology)
    float
    C2347373 (UMLS CUI [1])
    C0474523 (UMLS CUI [2])
    Character result (Haematology)
    Item
    Character result (Haematology)
    text
    C2350015 (UMLS CUI [1])
    C0474523 (UMLS CUI [2])
    Item
    No result (Haematology)
    integer
    C0474523 (UMLS CUI [1])
    No result (Haematology)
    Code List
    No result (Haematology)
    CL Item
    No result (1)
    Item Group
    Local Laboratory - Clinical Chemistry (Part 2 Period 4)
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Date and time sample taken (Clinical Chemistry)
    Item
    Date and time sample taken (Clinical Chemistry)
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    C0008000 (UMLS CUI [2])
    Has the subject fasted? (Clinical Chemistry)
    Item
    Has the subject fasted? (Clinical Chemistry)
    boolean
    C0015663 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    Item Group
    Local Laboratory - Clinical Chemistry (Part 2 Period 4)
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Item
    Clinical Chemistry Test
    integer
    C0525044 (UMLS CUI [1])
    Clinical Chemistry Test
    Code List
    Clinical Chemistry Test
    CL Item
    ALT (1)
    CL Item
    AST (2)
    CL Item
    Total Bilrubin (3)
    CL Item
    Direct Bilirubin (4)
    CL Item
    Glucose Fasting (5)
    CL Item
    GGT (6)
    CL Item
    Total Protein (7)
    CL Item
    Albumin (8)
    CL Item
    Potassium (9)
    CL Item
    Sodium (10)
    CL Item
    Calcium (11)
    CL Item
    Urea (12)
    CL Item
    Creatinine (13)
    CL Item
    Uric Acid (14)
    CL Item
    Alkaline Phosphatase (15)
    Numeric result (Clinical Chemistry)
    Item
    Numeric result (Clinical Chemistry)
    float
    C2347373 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    Character result (Clinical Chemistry)
    Item
    Character result (Clinical Chemistry)
    text
    C2350015 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    Item
    No result (Clinical Chemistry)
    integer
    C0587081 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    No result (Clinical Chemistry)
    Code List
    No result (Clinical Chemistry)
    CL Item
    No result (1)
    Item Group
    Investigational Product (Dose) (Part 2 Period 4)
    C0304229 (UMLS CUI-1)
    Date/time of dose
    Item
    Date/time of dose
    datetime
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Number of Inhalations
    Item
    Number of Inhalations
    integer
    C0354922 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
    Item
    Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
    boolean
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    If subject did not recieve the correct treatment, record reason
    Item
    If subject did not recieve the correct treatment, record reason
    text
    C0087111 (UMLS CUI [1,1])
    C2349182 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [2])
    Item Group
    ECG (Part 2 Period 4)
    C1623258 (UMLS CUI-1)
    Dosing date/time (ECG)
    Item
    Dosing date/time (ECG)
    datetime
    C0178602 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C1623258 (UMLS CUI [2])
    Item Group
    ECG (Part 2 Period 4)
    C1623258 (UMLS CUI-1)
    Item
    ECG Timepoint
    integer
    C1623258 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    ECG Timepoint
    Code List
    ECG Timepoint
    CL Item
    Pre-Dose 1 (1)
    CL Item
    Pre-Dose 2 (2)
    CL Item
    Pre-Dose 3 (3)
    CL Item
    15 mins Post-Dose (4)
    CL Item
    45 mins Post-Dose (5)
    CL Item
    90 mins Post-Dose (6)
    CL Item
    4 hours Post-Dose (7)
    CL Item
    8 hours Post-Dose (8)
    CL Item
    12 hours Post-Dose (9)
    Time of ECG
    Item
    Time of ECG
    time
    C0013798 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR Interval
    Item
    PR Interval
    integer
    C0429087 (UMLS CUI [1])
    QRS Duration
    Item
    QRS Duration
    integer
    C0429025 (UMLS CUI [1])
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    integer
    C1287082 (UMLS CUI [1])
    QTc Interval
    Item
    QTc Interval
    integer
    C0489625 (UMLS CUI [1])
    QTc (b) Interval
    Item
    QTc (b) Interval
    integer
    C1882512 (UMLS CUI [1])
    Item
    Method of QTc Calculation
    integer
    C0855331 (UMLS CUI [1,1])
    C2911685 (UMLS CUI [1,2])
    Method of QTc Calculation
    Code List
    Method of QTc Calculation
    CL Item
    Machine (1)
    CL Item
    Manual (2)
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    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 ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
    CL Item
    No result (not available) (4)
    Item Group
    Vital Signs (Part 2 Period 4)
    C0518766 (UMLS CUI-1)
    Dosing date/time (Vital Signs)
    Item
    Dosing date/time (Vital Signs)
    datetime
    C0178602 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C0518766 (UMLS CUI [2])
    Item Group
    Vital Signs (Part 2 Period 4)
    C0518766 (UMLS CUI-1)
    Item
    Vital Signs Timepoint
    integer
    C0518766 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Vital Signs Timepoint
    Code List
    Vital Signs Timepoint
    CL Item
    Pre-Dose 1 (1)
    CL Item
    Pre-Dose 2 (2)
    CL Item
    Pre-Dose 3 (3)
    CL Item
    15 mins Post-Dose (4)
    CL Item
    45 mins Post-Dose (5)
    CL Item
    90 mins Post-Dose (6)
    CL Item
    4 hours Post-Dose (7)
    CL Item
    8 hours Post-Dose (8)
    CL Item
    12 hours Post-Dose (9)
    Actual time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    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])
    Item Group
    Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4)
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Date and time sample taken (Haematology, 24 Hr Lab)
    Item
    Date and time sample taken (Haematology, 24 Hr Lab)
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    C0018941 (UMLS CUI [2])
    Has the subject fasted? (Haematology, 24 Hr Lab)
    Item
    Has the subject fasted? (Haematology, 24 Hr Lab)
    boolean
    C0015663 (UMLS CUI [1])
    C0018941 (UMLS CUI [2])
    Item Group
    Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4)
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Item
    Haematologic test (24 Hr Lab)
    integer
    C0018941 (UMLS CUI [1])
    Haematologic test (24 Hr Lab)
    Code List
    Haematologic test (24 Hr Lab)
    CL Item
    WBC  (1)
    CL Item
    RBC  (2)
    CL Item
    Hameoglobin  (3)
    CL Item
    Haematocrit  (4)
    CL Item
    Neutrophils  (5)
    CL Item
    Lymphocytes  (6)
    CL Item
    Monocytes  (7)
    CL Item
    Eosinophils  (8)
    CL Item
    Basophils  (9)
    CL Item
    MCV (10)
    CL Item
    MCH (11)
    CL Item
    MCHC (12)
    Numeric result (Haemoatology, 24 Hr Lab)
    Item
    Numeric result (Haemoatology, 24 Hr Lab)
    float
    C2347373 (UMLS CUI [1])
    C0474523 (UMLS CUI [2])
    Character result (Haematology, 24 Hr Lab)
    Item
    Character result (Haematology, 24 Hr Lab)
    text
    C2350015 (UMLS CUI [1])
    C0474523 (UMLS CUI [2])
    Item
    No result (Haematology, 24 Hr Lab)
    integer
    C0474523 (UMLS CUI [1])
    No result (Haematology, 24 Hr Lab)
    Code List
    No result (Haematology, 24 Hr Lab)
    CL Item
    No result (1)
    Item Group
    Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4)
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
    Item
    Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    C0008000 (UMLS CUI [2])
    Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
    Item
    Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
    boolean
    C0015663 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    Item Group
    Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4)
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Item
    Clinical Chemistry Test (24 Hr Lab)
    integer
    C0525044 (UMLS CUI [1])
    Clinical Chemistry Test (24 Hr Lab)
    Code List
    Clinical Chemistry Test (24 Hr Lab)
    CL Item
    ALT  (1)
    CL Item
    AST  (2)
    CL Item
    Total Bilrubin  (3)
    CL Item
    Direct Bilirubin  (4)
    CL Item
    Glucose Fasting  (5)
    CL Item
    GGT  (6)
    CL Item
    Total Protein  (7)
    CL Item
    Albumin  (8)
    CL Item
    Potassium  (9)
    CL Item
    Sodium (10)
    CL Item
    Calcium (11)
    CL Item
    Urea (12)
    CL Item
    Creatinine (13)
    CL Item
    Uric Acid (14)
    CL Item
    Alkaline Phosphatase (15)
    Numeric result (Clinical Chemistry, 24 Hr Lab)
    Item
    Numeric result (Clinical Chemistry, 24 Hr Lab)
    float
    C2347373 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    Character result (Clinical Chemistry, 24 Hr Lab)
    Item
    Character result (Clinical Chemistry, 24 Hr Lab)
    text
    C2350015 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    Item
    No result (Clinical Chemistry, 24 Hr Lab)
    integer
    C0587081 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    No result (Clinical Chemistry, 24 Hr Lab)
    Code List
    No result (Clinical Chemistry, 24 Hr Lab)
    CL Item
    No result (1)
    Item Group
    Pulmonary Function Tests (Part 2 Period 4)
    C0024119 (UMLS CUI-1)
    Dosing date/time (Pulmonary Function Tests)
    Item
    Dosing date/time (Pulmonary Function Tests)
    datetime
    C0178602 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C0024119 (UMLS CUI [2])
    Item Group
    Pulmonary Function Tests (Part 2 Period 4)
    C0024119 (UMLS CUI-1)
    Item
    Pulmonary Function Tests Timepoint
    integer
    C0024119 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Pulmonary Function Tests Timepoint
    Code List
    Pulmonary Function Tests Timepoint
    CL Item
    Pre-Dose (1)
    CL Item
    30 mins Post-Dose (2)
    CL Item
    2 hours Post-Dose (3)
    Date/time of test
    Item
    Date/time of test
    datetime
    C0024119 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    FEV (3 readings) - 1
    Item
    FEV (3 readings) - 1
    integer
    C0748133 (UMLS CUI [1])
    FEV (3 readings) - 2
    Item
    FEV (3 readings) - 2
    integer
    C0748133 (UMLS CUI [1])
    FEV (3 readings) - 3
    Item
    FEV (3 readings) - 3
    integer
    C0748133 (UMLS CUI [1])
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