0 Evaluaciones
ID

36237

Descripción

Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Palabras clave

Versiones (2)
  1. 17/4/19 17/4/19 -
  2. 23/4/19 23/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

23 de abril de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543

    Inglés

    Period 2 - 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Date of Visit
    Descripción

    Date of Visit

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    12-Lead ECG
    Descripción

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Date and Time of ECG
    Descripción

    Date and Time of ECG

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0013798
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Heart Rate
    Descripción

    Heart Rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    RR Interval
    Descripción

    RR Interval

    Tipo de datos

    integer

    Unidades de medida
    • ms
    Alias
    UMLS CUI [1]
    C0489636
    ms
    PR Interval
    Descripción

    PR Interval

    Tipo de datos

    integer

    Unidades de medida
    • ms
    Alias
    UMLS CUI [1]
    C0429087
    ms
    QRS Duration
    Descripción

    QRS Duration

    Tipo de datos

    integer

    Unidades de medida
    • ms
    Alias
    UMLS CUI [1]
    C0429025
    ms
    Uncorrected QT Interval
    Descripción

    Uncorrected QT Interval

    Tipo de datos

    integer

    Unidades de medida
    • ms
    Alias
    UMLS CUI [1]
    C1287082
    ms
    QTc (b) Interval
    Descripción

    QTc (b) Interval

    Tipo de datos

    integer

    Unidades de medida
    • ms
    Alias
    UMLS CUI [1]
    C0489625
    ms
    Method of QTc Calculation
    Descripción

    Method of QTc Calculation

    Tipo de datos

    integer

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

    Result of the ECG

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Vital Signs
    Descripción

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Actual date/ time
    Descripción

    Actual date/ time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Systolic Blood Pressure
    Descripción

    Systolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Descripción

    Diastolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Heart rate
    Descripción

    Heart rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Respiration rate
    Descripción

    Respiration rate

    Tipo de datos

    integer

    Unidades de medida
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832
    breaths/min
    Temperature
    Descripción

    Temperature

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Pharmacokinetics Blood - GW856553
    Descripción

    Pharmacokinetics Blood - GW856553

    Alias
    UMLS CUI-1
    C0031327
    UMLS CUI-2
    C0005767
    Dosing date/time
    Descripción

    Dosing date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Pre dose - Actual time
    Descripción

    Pre dose - Actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0439565
    UMLS CUI [1,2]
    C0040223
    30 mins - Actual time
    Descripción

    30 mins - Actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    1 hr - Actual time
    Descripción

    1 hr - Actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    2 hrs - Actual time
    Descripción

    2 hrs - Actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    3 hrs - Actual time
    Descripción

    3 hrs - Actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    4 hrs - Actual time
    Descripción

    4 hrs - Actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    6 hrs - Actual time
    Descripción

    6 hrs - Actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    8 hrs - Actual time
    Descripción

    8 hrs - Actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    10 hrs - Actual time
    Descripción

    10 hrs - Actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    12 hrs - Actual date/time
    Descripción

    12 hrs - Actual date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    18 hrs- Actual date/time
    Descripción

    18 hrs- Actual date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    24 hrs (Day2) - Actual date/time
    Descripción

    24 hrs (Day2) - Actual date/time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    36 hrs (Day 2) - Actual date/time
    Descripción

    36 hrs (Day 2) - Actual date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    48 hrs (Day 3) - Actual date/time
    Descripción

    48 hrs (Day 3) - Actual date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    72 hrs (Day4) - Actual date/time
    Descripción

    72 hrs (Day4) - Actual date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    Electronically Transferred Lab Data - Pre dose
    Descripción

    Electronically Transferred Lab Data - Pre dose

    Alias
    UMLS CUI-1
    C0200345
    UMLS CUI-2
    C0022885
    UMLS CUI-3
    C1320722
    UMLS CUI-4
    C0439565
    Haematology Date and time sample taken
    Descripción

    Haematology Date and time sample taken

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Haematology sampling not done
    Descripción

    Haematology sampling not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    Clinical Chemistry Date and time sample taken
    Descripción

    Clinical Chemistry Date and time sample taken

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Clinical Chemistry sampling not done
    Descripción

    Clinical Chemistry sampling not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C1272696
    Urinalysis Date and time sample taken
    Descripción

    Urinalysis Date and time sample taken

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Urinalysis sampling not done
    Descripción

    Urinalysis sampling not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C1272696
    Electronically Transferred Lab Data - 24 hrs (Day 2)
    Descripción

    Electronically Transferred Lab Data - 24 hrs (Day 2)

    Alias
    UMLS CUI-1
    C0200345
    UMLS CUI-2
    C0022885
    UMLS CUI-3
    C1320722
    Haematology Date and time sample taken
    Descripción

    Haematology Date and time sample taken

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Haematology sampling not done
    Descripción

    Haematology sampling not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    Clinical Chemistry Date and time sample taken
    Descripción

    Clinical Chemistry Date and time sample taken

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Clinical Chemistry sampling not done
    Descripción

    Clinical Chemistry sampling not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C1272696
    Urinalysis Date and time sample taken
    Descripción

    Urinalysis Date and time sample taken

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Urinalysis sampling not done
    Descripción

    Urinalysis sampling not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C1272696
    Electronically Transferred Lab Data - 72 hrs (Day 4)
    Descripción

    Electronically Transferred Lab Data - 72 hrs (Day 4)

    Alias
    UMLS CUI-1
    C0200345
    UMLS CUI-2
    C0022885
    UMLS CUI-3
    C1320722
    AST/ ALT Date and time sample taken
    Descripción

    AST/ ALT Date and time sample taken

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [2]
    C0200345
    UMLS CUI [3]
    C0201836
    AST/ ALT sampling not done
    Descripción

    AST/ ALT sampling not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0201899
    UMLS CUI [1,2]
    C0022885
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C1272696
    UMLS CUI [2,1]
    C0201899
    UMLS CUI [2,2]
    C0022885
    UMLS CUI [2,3]
    C0870078
    UMLS CUI [2,4]
    C1272696
    Investigational Product
    Descripción

    Investigational Product

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

    Date/ time of dose

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [1,4]
    C0011008
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Descripción

    Did the subject receive the correct treatment during this dosing interval?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    If subject did not receive correct treatment, record reasons.
    Descripción

    If subject did not receive correct treatment, record reasons

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2349182
    UMLS CUI [1,3]
    C0392360
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    Similar models

    Period 2 - 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    Date and Time of ECG
    Item
    Date and Time of ECG
    datetime
    C0430456 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    RR Interval
    Item
    RR Interval
    integer
    C0489636 (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 (b) Interval
    Item
    QTc (b) Interval
    integer
    C0489625 (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 (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (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
    C0518766 (UMLS CUI-1)
    Actual date/ time
    Item
    Actual date/ time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Weight
    Item
    Weight
    float
    C0005910 (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])
    Respiration rate
    Item
    Respiration rate
    integer
    C0231832 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    Pharmacokinetics Blood - GW856553
    C0031327 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Dosing date/time
    Item
    Dosing date/time
    datetime
    C0178602 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pre dose - Actual time
    Item
    Pre dose - Actual time
    time
    C0439565 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    30 mins - Actual time
    Item
    30 mins - Actual time
    time
    C0040223 (UMLS CUI [1])
    1 hr - Actual time
    Item
    1 hr - Actual time
    time
    C0040223 (UMLS CUI [1])
    2 hrs - Actual time
    Item
    2 hrs - Actual time
    time
    C0040223 (UMLS CUI [1])
    3 hrs - Actual time
    Item
    3 hrs - Actual time
    time
    C0040223 (UMLS CUI [1])
    4 hrs - Actual time
    Item
    4 hrs - Actual time
    time
    C0040223 (UMLS CUI [1])
    6 hrs - Actual time
    Item
    6 hrs - Actual time
    time
    C0040223 (UMLS CUI [1])
    8 hrs - Actual time
    Item
    8 hrs - Actual time
    time
    C0040223 (UMLS CUI [1])
    10 hrs - Actual time
    Item
    10 hrs - Actual time
    time
    C0040223 (UMLS CUI [1])
    12 hrs - Actual date/time
    Item
    12 hrs - Actual date/time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    18 hrs- Actual date/time
    Item
    18 hrs- Actual date/time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    24 hrs (Day2) - Actual date/time
    Item
    24 hrs (Day2) - Actual date/time
    time
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    36 hrs (Day 2) - Actual date/time
    Item
    36 hrs (Day 2) - Actual date/time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    48 hrs (Day 3) - Actual date/time
    Item
    48 hrs (Day 3) - Actual date/time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    72 hrs (Day4) - Actual date/time
    Item
    72 hrs (Day4) - Actual date/time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Electronically Transferred Lab Data - Pre dose
    C0200345 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    C1320722 (UMLS CUI-3)
    C0439565 (UMLS CUI-4)
    Haematology Date and time sample taken
    Item
    Haematology Date and time sample taken
    datetime
    C0018941 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Haematology sampling not done
    integer
    C0018941 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Haematology sample not done
    Code List
    Haematology sampling not done
    CL Item
    Haematology sampling not done (1)
    Clinical Chemistry Date and time sample taken
    Item
    Clinical Chemistry Date and time sample taken
    datetime
    C0008000 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Clinical Chemistry sampling not done
    integer
    C0008000 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Clinical Chemistry sampling not done
    Code List
    Clinical Chemistry sampling not done
    CL Item
    Clinical Chemistry sampling not done (1)
    Urinalysis Date and time sample taken
    Item
    Urinalysis Date and time sample taken
    datetime
    C0042014 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Urinalysis sampling not done
    integer
    C0042014 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Urinalysis sampling not done
    Code List
    Urinalysis sampling not done
    CL Item
    Urinalysis sampling not done (1)
    Item Group
    Electronically Transferred Lab Data - 24 hrs (Day 2)
    C0200345 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    C1320722 (UMLS CUI-3)
    Haematology Date and time sample taken
    Item
    Haematology Date and time sample taken
    datetime
    C0018941 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Haematology sampling not done
    integer
    C0018941 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Haematology sampling not done
    Code List
    Haematology sampling not done
    CL Item
    Haematology sampling not done (1)
    Clinical Chemistry Date and time sample taken
    Item
    Clinical Chemistry Date and time sample taken
    datetime
    C0008000 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Clinical Chemistry sampling not done
    integer
    C0008000 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Clinical Chemistry sampling not done
    Code List
    Clinical Chemistry sampling not done
    CL Item
    Clinical Chemistry sampling not done (1)
    Urinalysis Date and time sample taken
    Item
    Urinalysis Date and time sample taken
    datetime
    C0042014 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Urinalysis sampling not done
    integer
    C0042014 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Urinalysis sampling not done
    Code List
    Urinalysis sampling not done
    CL Item
    Urinalysis sampling not done (1)
    Item Group
    Electronically Transferred Lab Data - 72 hrs (Day 4)
    C0200345 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    C1320722 (UMLS CUI-3)
    AST/ ALT Date and time sample taken
    Item
    AST/ ALT Date and time sample taken
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    Item
    AST/ ALT sampling not done
    integer
    C0201899 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C1272696 (UMLS CUI [1,4])
    C0201899 (UMLS CUI [2,1])
    C0022885 (UMLS CUI [2,2])
    C0870078 (UMLS CUI [2,3])
    C1272696 (UMLS CUI [2,4])
    AST/ ALT sampling not done
    Code List
    AST/ ALT sampling not done
    CL Item
    AST/ ALT sampling not done (1)
    Item Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    Date/ time of dose
    Item
    Date/ time of dose
    datetime
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Did the subject receive the correct treatment 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 receive correct treatment, record reasons
    Item
    If subject did not receive correct treatment, record reasons.
    text
    C0087111 (UMLS CUI [1,1])
    C2349182 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
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