ID

41271

Beschreibung

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

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  1. 09.08.20 09.08.20 -
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GlaxoSmithKline

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9. August 2020

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    Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

    Englisch

    Randomisation Number; Treatment confirmation; Pharmacokinetics Blood; Pharmacokinetic Sampling Urine Interval Collection Data

    1 Formulare  
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Randomisation Number (Treatment Period 1)
    Beschreibung

    Randomisation Number (Treatment Period 1)

    Alias
    UMLS CUI-1
    C0034656
    UMLS CUI-2
    C0237753
    Record randomisation number
    Beschreibung

    Record randomisation number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Investigational Product
    Beschreibung

    Investigational Product

    Alias
    UMLS CUI-1
    C0304229
    Investigational Product
    Beschreibung

    Investigational Product

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0304229
    Date of Dose
    Beschreibung

    Date of Dose

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    Time of Dose
    Beschreibung

    Time of Dose

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0040223
    Dose
    Beschreibung

    Dose

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C3174092
    Medication Route
    Beschreibung

    Medication Route

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0013153
    Treatment Confirmation
    Beschreibung

    Treatment Confirmation

    Alias
    UMLS CUI-1
    C0087111
    UMLS CUI-2
    C0750484
    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 the subject did not receive the correct treatment, record reasons
    Beschreibung

    If the subject did not receive the correct treatment, record reasons

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2349182
    UMLS CUI [1,3]
    C0392360
    Pharmacokinetics - Blood (Treatment Period 1)
    Beschreibung

    Pharmacokinetics - Blood (Treatment Period 1)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Planned Relative Time

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample - check if taken
    Beschreibung

    Sample - check if taken

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1277698
    Sample number
    Beschreibung

    Sample number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Treatment Period 2)
    Beschreibung

    Pharmacokinetics - Blood (Treatment Period 2)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Planned Relative Time

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample - check if taken
    Beschreibung

    Sample - check if taken

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1277698
    Sample number
    Beschreibung

    Sample number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Treatment Period 3)
    Beschreibung

    Pharmacokinetics - Blood (Treatment Period 3)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Planned Relative Time

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample - check if taken
    Beschreibung

    Sample - check if taken

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1277698
    Sample number
    Beschreibung

    Sample number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Treatment Period 4)
    Beschreibung

    Pharmacokinetics - Blood (Treatment Period 4)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Planned Relative Time

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample - check if taken
    Beschreibung

    Sample - check if taken

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1277698
    Sample number
    Beschreibung

    Sample number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Treatment Period 5)
    Beschreibung

    Pharmacokinetics - Blood (Treatment Period 5)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Planned Relative Time

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample - check if taken
    Beschreibung

    Sample - check if taken

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1277698
    Sample number
    Beschreibung

    Sample number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 1)
    Beschreibung

    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 1)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0042036
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    Beschreibung

    Pharmacokinetic Sampling Urine - Planned Relative Time Interval

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [2]
    C0439564
    Pharmacokinetic Sampling Urine - Start Date
    Beschreibung

    Pharmacokinetic Sampling Urine - Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C0808070
    Pharmacokinetic Sampling Urine - Actual Start Time
    Beschreibung

    Pharmacokinetic Sampling Urine - Actual Start Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C1301880
    UMLS CUI [2,1]
    C0031328
    UMLS CUI [2,2]
    C0042036
    UMLS CUI [2,3]
    C0870078
    Pharmacokinetic Sampling Urine - Stop Date
    Beschreibung

    Pharmacokinetic Sampling Urine - Stop Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C0806020
    Pharmacokinetic Sampling Urine - Actual Stop Time
    Beschreibung

    Pharmacokinetic Sampling Urine - Actual Stop Time

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1522314
    Pharmacokinetic Sampling Urine - Total Sample Volume
    Beschreibung

    Pharmacokinetic Sampling Urine - Total Sample Volume

    Datentyp

    float

    Maßeinheiten
    • mL
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1278293
    mL
    Was all of the sample collected for this interval?
    Beschreibung

    Was all of the sample collected for this interval?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0205197
    Pharmacokinetic Sampling Urine - Check if sample taken
    Beschreibung

    Pharmacokinetic Sampling Urine - Check if sample taken

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2,1]
    C0870078
    UMLS CUI [2,2]
    C1883727
    Pharmacokinetic Sampling Urine - Sample Number
    Beschreibung

    Pharmacokinetic Sampling Urine - Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1299222
    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 2)
    Beschreibung

    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 2)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0042036
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    Beschreibung

    Pharmacokinetic Sampling Urine - Planned Relative Time Interval

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [2]
    C0439564
    Pharmacokinetic Sampling Urine - Start Date
    Beschreibung

    Pharmacokinetic Sampling Urine - Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C0808070
    Pharmacokinetic Sampling Urine - Actual Start Time
    Beschreibung

    Pharmacokinetic Sampling Urine - Actual Start Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C1301880
    UMLS CUI [2,1]
    C0031328
    UMLS CUI [2,2]
    C0042036
    UMLS CUI [2,3]
    C0870078
    Pharmacokinetic Sampling Urine - Stop Date
    Beschreibung

    Pharmacokinetic Sampling Urine - Stop Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C0806020
    Pharmacokinetic Sampling Urine - Actual Stop Time
    Beschreibung

    Pharmacokinetic Sampling Urine - Actual Stop Time

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1522314
    Pharmacokinetic Sampling Urine - Total Sample Volume
    Beschreibung

    Pharmacokinetic Sampling Urine - Total Sample Volume

    Datentyp

    float

    Maßeinheiten
    • mL
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1278293
    mL
    Was all of the sample collected for this interval?
    Beschreibung

    Was all of the sample collected for this interval?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0205197
    Pharmacokinetic Sampling Urine - Check if sample taken
    Beschreibung

    Pharmacokinetic Sampling Urine - Check if sample taken

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2,1]
    C0870078
    UMLS CUI [2,2]
    C1883727
    Pharmacokinetic Sampling Urine - Sample Number
    Beschreibung

    Pharmacokinetic Sampling Urine - Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1299222
    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 3)
    Beschreibung

    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 3)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0042036
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    Beschreibung

    Pharmacokinetic Sampling Urine - Planned Relative Time Interval

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [2]
    C0439564
    Pharmacokinetic Sampling Urine - Start Date
    Beschreibung

    Pharmacokinetic Sampling Urine - Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C0808070
    Pharmacokinetic Sampling Urine - Actual Start Time
    Beschreibung

    Pharmacokinetic Sampling Urine - Actual Start Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C1301880
    UMLS CUI [2,1]
    C0031328
    UMLS CUI [2,2]
    C0042036
    UMLS CUI [2,3]
    C0870078
    Pharmacokinetic Sampling Urine - Stop Date
    Beschreibung

    Pharmacokinetic Sampling Urine - Stop Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C0806020
    Pharmacokinetic Sampling Urine - Actual Stop Time
    Beschreibung

    Pharmacokinetic Sampling Urine - Actual Stop Time

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1522314
    Pharmacokinetic Sampling Urine - Total Sample Volume
    Beschreibung

    Pharmacokinetic Sampling Urine - Total Sample Volume

    Datentyp

    float

    Maßeinheiten
    • mL
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1278293
    mL
    Was all of the sample collected for this interval?
    Beschreibung

    Was all of the sample collected for this interval?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0205197
    Pharmacokinetic Sampling Urine - Check if sample taken
    Beschreibung

    Pharmacokinetic Sampling Urine - Check if sample taken

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2,1]
    C0870078
    UMLS CUI [2,2]
    C1883727
    Pharmacokinetic Sampling Urine - Sample Number
    Beschreibung

    Pharmacokinetic Sampling Urine - Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1299222
    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 4)
    Beschreibung

    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 4)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0042036
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    Beschreibung

    Pharmacokinetic Sampling Urine - Planned Relative Time Interval

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [2]
    C0439564
    Pharmacokinetic Sampling Urine - Start Date
    Beschreibung

    Pharmacokinetic Sampling Urine - Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C0808070
    Pharmacokinetic Sampling Urine - Actual Start Time
    Beschreibung

    Pharmacokinetic Sampling Urine - Actual Start Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C1301880
    UMLS CUI [2,1]
    C0031328
    UMLS CUI [2,2]
    C0042036
    UMLS CUI [2,3]
    C0870078
    Pharmacokinetic Sampling Urine - Stop Date
    Beschreibung

    Pharmacokinetic Sampling Urine - Stop Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C0806020
    Pharmacokinetic Sampling Urine - Actual Stop Time
    Beschreibung

    Pharmacokinetic Sampling Urine - Actual Stop Time

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1522314
    Pharmacokinetic Sampling Urine - Total Sample Volume
    Beschreibung

    Pharmacokinetic Sampling Urine - Total Sample Volume

    Datentyp

    float

    Maßeinheiten
    • mL
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1278293
    mL
    Was all of the sample collected for this interval?
    Beschreibung

    Was all of the sample collected for this interval?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0205197
    Pharmacokinetic Sampling Urine - Check if sample taken
    Beschreibung

    Pharmacokinetic Sampling Urine - Check if sample taken

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2,1]
    C0870078
    UMLS CUI [2,2]
    C1883727
    Pharmacokinetic Sampling Urine - Sample Number
    Beschreibung

    Pharmacokinetic Sampling Urine - Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1299222
    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 5)
    Beschreibung

    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 5)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0042036
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    Beschreibung

    Pharmacokinetic Sampling Urine - Planned Relative Time Interval

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [2]
    C0439564
    Pharmacokinetic Sampling Urine - Start Date
    Beschreibung

    Pharmacokinetic Sampling Urine - Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C0808070
    Pharmacokinetic Sampling Urine - Actual Start Time
    Beschreibung

    Pharmacokinetic Sampling Urine - Actual Start Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C1301880
    UMLS CUI [2,1]
    C0031328
    UMLS CUI [2,2]
    C0042036
    UMLS CUI [2,3]
    C0870078
    Pharmacokinetic Sampling Urine - Stop Date
    Beschreibung

    Pharmacokinetic Sampling Urine - Stop Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C0806020
    Pharmacokinetic Sampling Urine - Actual Stop Time
    Beschreibung

    Pharmacokinetic Sampling Urine - Actual Stop Time

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1522314
    Pharmacokinetic Sampling Urine - Total Sample Volume
    Beschreibung

    Pharmacokinetic Sampling Urine - Total Sample Volume

    Datentyp

    float

    Maßeinheiten
    • mL
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1278293
    mL
    Was all of the sample collected for this interval?
    Beschreibung

    Was all of the sample collected for this interval?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0205197
    Pharmacokinetic Sampling Urine - Check if sample taken
    Beschreibung

    Pharmacokinetic Sampling Urine - Check if sample taken

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2,1]
    C0870078
    UMLS CUI [2,2]
    C1883727
    Pharmacokinetic Sampling Urine - Sample Number
    Beschreibung

    Pharmacokinetic Sampling Urine - Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [2]
    C1299222
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    Ähnliche Modelle

    Randomisation Number; Treatment confirmation; Pharmacokinetics Blood; Pharmacokinetic Sampling Urine Interval Collection Data

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Randomisation Number (Treatment Period 1)
    C0034656 (UMLS CUI-1)
    C0237753 (UMLS CUI-2)
    Record randomisation number
    Item
    Record randomisation number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    Item
    Investigational Product
    integer
    C0304229 (UMLS CUI [1])
    Investigational Product
    Code List
    Investigational Product
    CL Item
    68 (Diskus A) (1)
    CL Item
    69 (Diskus B) (2)
    CL Item
    172 (Handihaler) (3)
    Date of Dose
    Item
    Date of Dose
    date
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Time of Dose
    Item
    Time of Dose
    time
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Dose
    Item
    Dose
    float
    C3174092 (UMLS CUI [1])
    Item
    Medication Route
    integer
    C0013153 (UMLS CUI [1])
    Medication Route
    Code List
    Medication Route
    CL Item
    IH (1)
    Item Group
    Treatment Confirmation
    C0087111 (UMLS CUI-1)
    C0750484 (UMLS CUI-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 the subject did not receive the correct treatment, record reasons
    Item
    If the subject did not receive the correct treatment, record reasons
    text
    C0087111 (UMLS CUI [1,1])
    C2349182 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Item Group
    Pharmacokinetics - Blood (Treatment Period 1)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose (1)
    CL Item
    5 mins (2)
    CL Item
    15 mins (3)
    CL Item
    30 mins (4)
    CL Item
    1 hrs (5)
    CL Item
    2 hrs (6)
    CL Item
    4 hrs (7)
    CL Item
    6 hrs (8)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample - check if taken
    integer
    C1277698 (UMLS CUI [1])
    Sample - check if taken
    Code List
    Sample - check if taken
    CL Item
    Sample taken (1)
    Item
    Sample number
    integer
    C1299222 (UMLS CUI [1])
    Sample number
    Code List
    Sample number
    CL Item
    101 (1)
    CL Item
    102 (2)
    CL Item
    103 (3)
    CL Item
    104 (4)
    CL Item
    105 (5)
    CL Item
    106 (6)
    CL Item
    107 (7)
    CL Item
    108 (8)
    Item Group
    Pharmacokinetics - Blood (Treatment Period 2)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose  (1)
    CL Item
    5 mins  (2)
    CL Item
    15 mins  (3)
    CL Item
    30 mins  (4)
    CL Item
    1 hrs  (5)
    CL Item
    2 hrs  (6)
    CL Item
    4 hrs  (7)
    CL Item
    6 hrs (8)
    CL Item
    8 hrs (9)
    CL Item
    12 hrs (10)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample - check if taken
    integer
    C1277698 (UMLS CUI [1])
    Sample - check if taken
    Code List
    Sample - check if taken
    CL Item
    Sample taken (1)
    Item
    Sample number
    integer
    C1299222 (UMLS CUI [1])
    Sample number
    Code List
    Sample number
    CL Item
    201  (1)
    CL Item
    202  (2)
    CL Item
    203  (3)
    CL Item
    204  (4)
    CL Item
    205  (5)
    CL Item
    206  (6)
    CL Item
    207  (7)
    CL Item
    208  (8)
    CL Item
    209 (9)
    CL Item
    210 (10)
    Item Group
    Pharmacokinetics - Blood (Treatment Period 3)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose  (1)
    CL Item
    5 mins  (2)
    CL Item
    15 mins  (3)
    CL Item
    30 mins  (4)
    CL Item
    1 hrs  (5)
    CL Item
    2 hrs  (6)
    CL Item
    4 hrs  (7)
    CL Item
    6 hrs  (8)
    CL Item
    8 hrs  (9)
    CL Item
    12 hrs (10)
    CL Item
    16 hrs (11)
    CL Item
    24 hrs (12)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample - check if taken
    integer
    C1277698 (UMLS CUI [1])
    Sample - check if taken
    Code List
    Sample - check if taken
    CL Item
    Sample taken (1)
    Item
    Sample number
    integer
    C1299222 (UMLS CUI [1])
    Sample number
    Code List
    Sample number
    CL Item
    301  (1)
    CL Item
    302  (2)
    CL Item
    303  (3)
    CL Item
    304  (4)
    CL Item
    305  (5)
    CL Item
    306  (6)
    CL Item
    307  (7)
    CL Item
    308  (8)
    CL Item
    309  (9)
    CL Item
    310  (10)
    CL Item
    322 (11)
    CL Item
    312 (12)
    Item Group
    Pharmacokinetics - Blood (Treatment Period 4)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose  (1)
    CL Item
    5 mins  (2)
    CL Item
    15 mins  (3)
    CL Item
    30 mins  (4)
    CL Item
    1 hrs  (5)
    CL Item
    2 hrs  (6)
    CL Item
    4 hrs  (7)
    CL Item
    6 hrs  (8)
    CL Item
    8 hrs  (9)
    CL Item
    12 hrs (10)
    CL Item
    16 hrs (11)
    CL Item
    24 hrs (12)
    CL Item
    48 - 60 hrs (13)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample - check if taken
    integer
    C1277698 (UMLS CUI [1])
    Sample - check if taken
    Code List
    Sample - check if taken
    CL Item
    Sample taken (1)
    Item
    Sample number
    integer
    C1299222 (UMLS CUI [1])
    Sample number
    Code List
    Sample number
    CL Item
    401  (1)
    CL Item
    402  (2)
    CL Item
    403  (3)
    CL Item
    404  (4)
    CL Item
    405  (5)
    CL Item
    406  (6)
    CL Item
    407  (7)
    CL Item
    408  (8)
    CL Item
    409  (9)
    CL Item
    410  (10)
    CL Item
    411 (11)
    CL Item
    412 (12)
    CL Item
    413 (13)
    Item Group
    Pharmacokinetics - Blood (Treatment Period 5)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose  (1)
    CL Item
    5 mins  (2)
    CL Item
    15 mins  (3)
    CL Item
    30 mins  (4)
    CL Item
    1 hrs  (5)
    CL Item
    2 hrs  (6)
    CL Item
    4 hrs  (7)
    CL Item
    6 hrs  (8)
    CL Item
    8 hrs  (9)
    CL Item
    12 hrs (10)
    CL Item
    16 hrs (11)
    CL Item
    24 hrs (12)
    CL Item
    48 - 60 hrs (13)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample - check if taken
    integer
    C1277698 (UMLS CUI [1])
    Sample - check if taken
    Code List
    Sample - check if taken
    CL Item
    Sample taken (1)
    Item
    Sample number
    integer
    C1299222 (UMLS CUI [1])
    Sample number
    Code List
    Sample number
    CL Item
    501  (1)
    CL Item
    502  (2)
    CL Item
    503  (3)
    CL Item
    504  (4)
    CL Item
    505  (5)
    CL Item
    506  (6)
    CL Item
    507  (7)
    CL Item
    508  (8)
    CL Item
    509  (9)
    CL Item
    510 (10)
    CL Item
    511 (11)
    CL Item
    512 (12)
    CL Item
    513 (13)
    Item Group
    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 1)
    C0031328 (UMLS CUI-1)
    C0042036 (UMLS CUI-2)
    Item
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C0439564 (UMLS CUI [2])
    Planned Relative Time Interval
    Code List
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    CL Item
    0hr - 2 hrs (1)
    CL Item
    2hrs - 8 hrs (2)
    CL Item
    8hrs - 24hrs (3)
    Pharmacokinetic Sampling Urine - Start Date
    Item
    Pharmacokinetic Sampling Urine - Start Date
    date
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Actual Start Time
    Item
    Pharmacokinetic Sampling Urine - Actual Start Time
    time
    C1301880 (UMLS CUI [1])
    C0031328 (UMLS CUI [2,1])
    C0042036 (UMLS CUI [2,2])
    C0870078 (UMLS CUI [2,3])
    Pharmacokinetic Sampling Urine - Stop Date
    Item
    Pharmacokinetic Sampling Urine - Stop Date
    date
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Actual Stop Time
    Item
    Pharmacokinetic Sampling Urine - Actual Stop Time
    time
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Total Sample Volume
    Item
    Pharmacokinetic Sampling Urine - Total Sample Volume
    float
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1278293 (UMLS CUI [2])
    Was all of the sample collected for this interval?
    Item
    Was all of the sample collected for this interval?
    boolean
    C0200354 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item
    Pharmacokinetic Sampling Urine - Check if sample taken
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [2,1])
    C1883727 (UMLS CUI [2,2])
    Pharmacokinetic Sampling Urine - Check if sample taken
    Code List
    Pharmacokinetic Sampling Urine - Check if sample taken
    CL Item
    Sample taken (1)
    Item
    Pharmacokinetic Sampling Urine - Sample Number
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Sample Number
    Code List
    Pharmacokinetic Sampling Urine - Sample Number
    CL Item
    101 (1)
    CL Item
    102 (2)
    CL Item
    103 (3)
    Item Group
    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 2)
    C0031328 (UMLS CUI-1)
    C0042036 (UMLS CUI-2)
    Item
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C0439564 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    Code List
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    CL Item
    0hr - 2 hrs  (1)
    CL Item
    2hrs - 8 hrs  (2)
    CL Item
    8hrs - 24hrs (3)
    Pharmacokinetic Sampling Urine - Start Date
    Item
    Pharmacokinetic Sampling Urine - Start Date
    date
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Actual Start Time
    Item
    Pharmacokinetic Sampling Urine - Actual Start Time
    time
    C1301880 (UMLS CUI [1])
    C0031328 (UMLS CUI [2,1])
    C0042036 (UMLS CUI [2,2])
    C0870078 (UMLS CUI [2,3])
    Pharmacokinetic Sampling Urine - Stop Date
    Item
    Pharmacokinetic Sampling Urine - Stop Date
    date
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Actual Stop Time
    Item
    Pharmacokinetic Sampling Urine - Actual Stop Time
    time
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Total Sample Volume
    Item
    Pharmacokinetic Sampling Urine - Total Sample Volume
    float
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1278293 (UMLS CUI [2])
    Was all of the sample collected for this interval?
    Item
    Was all of the sample collected for this interval?
    boolean
    C0200354 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item
    Pharmacokinetic Sampling Urine - Check if sample taken
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [2,1])
    C1883727 (UMLS CUI [2,2])
    Pharmacokinetic Sampling Urine - Check if sample taken
    Code List
    Pharmacokinetic Sampling Urine - Check if sample taken
    CL Item
    Sample taken (1)
    Item
    Pharmacokinetic Sampling Urine - Sample Number
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Sample Number
    Code List
    Pharmacokinetic Sampling Urine - Sample Number
    CL Item
    201  (1)
    CL Item
    202  (2)
    CL Item
    203 (3)
    Item Group
    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 3)
    C0031328 (UMLS CUI-1)
    C0042036 (UMLS CUI-2)
    Item
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C0439564 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    Code List
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    CL Item
    0hr - 2 hrs  (1)
    CL Item
    2hrs - 8 hrs  (2)
    CL Item
    8hrs - 24hrs (3)
    Pharmacokinetic Sampling Urine - Start Date
    Item
    Pharmacokinetic Sampling Urine - Start Date
    date
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Actual Start Time
    Item
    Pharmacokinetic Sampling Urine - Actual Start Time
    time
    C1301880 (UMLS CUI [1])
    C0031328 (UMLS CUI [2,1])
    C0042036 (UMLS CUI [2,2])
    C0870078 (UMLS CUI [2,3])
    Pharmacokinetic Sampling Urine - Stop Date
    Item
    Pharmacokinetic Sampling Urine - Stop Date
    date
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Actual Stop Time
    Item
    Pharmacokinetic Sampling Urine - Actual Stop Time
    time
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Total Sample Volume
    Item
    Pharmacokinetic Sampling Urine - Total Sample Volume
    float
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1278293 (UMLS CUI [2])
    Was all of the sample collected for this interval?
    Item
    Was all of the sample collected for this interval?
    boolean
    C0200354 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item
    Pharmacokinetic Sampling Urine - Check if sample taken
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [2,1])
    C1883727 (UMLS CUI [2,2])
    Pharmacokinetic Sampling Urine - Check if sample taken
    Code List
    Pharmacokinetic Sampling Urine - Check if sample taken
    CL Item
    Sample taken (1)
    Item
    Pharmacokinetic Sampling Urine - Sample Number
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Sample Number
    Code List
    Pharmacokinetic Sampling Urine - Sample Number
    CL Item
    301  (1)
    CL Item
    302  (2)
    CL Item
    303 (3)
    Item Group
    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 4)
    C0031328 (UMLS CUI-1)
    C0042036 (UMLS CUI-2)
    Item
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C0439564 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    Code List
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    CL Item
    0hr - 2 hrs  (1)
    CL Item
    2hrs - 8 hrs  (2)
    CL Item
    8hrs - 24hrs (3)
    Pharmacokinetic Sampling Urine - Start Date
    Item
    Pharmacokinetic Sampling Urine - Start Date
    date
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Actual Start Time
    Item
    Pharmacokinetic Sampling Urine - Actual Start Time
    time
    C1301880 (UMLS CUI [1])
    C0031328 (UMLS CUI [2,1])
    C0042036 (UMLS CUI [2,2])
    C0870078 (UMLS CUI [2,3])
    Pharmacokinetic Sampling Urine - Stop Date
    Item
    Pharmacokinetic Sampling Urine - Stop Date
    date
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Actual Stop Time
    Item
    Pharmacokinetic Sampling Urine - Actual Stop Time
    time
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Total Sample Volume
    Item
    Pharmacokinetic Sampling Urine - Total Sample Volume
    float
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1278293 (UMLS CUI [2])
    Was all of the sample collected for this interval?
    Item
    Was all of the sample collected for this interval?
    boolean
    C0200354 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item
    Pharmacokinetic Sampling Urine - Check if sample taken
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [2,1])
    C1883727 (UMLS CUI [2,2])
    Pharmacokinetic Sampling Urine - Check if sample taken
    Code List
    Pharmacokinetic Sampling Urine - Check if sample taken
    CL Item
    Sample taken (1)
    Item
    Pharmacokinetic Sampling Urine - Sample Number
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Sample Number
    Code List
    Pharmacokinetic Sampling Urine - Sample Number
    CL Item
    401  (1)
    CL Item
    402  (2)
    CL Item
    403 (3)
    Item Group
    Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 5)
    C0031328 (UMLS CUI-1)
    C0042036 (UMLS CUI-2)
    Item
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C0439564 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    Code List
    Pharmacokinetic Sampling Urine - Planned Relative Time Interval
    CL Item
    0hr - 2 hrs  (1)
    CL Item
    2hrs - 8 hrs  (2)
    CL Item
    8hrs - 24hrs (3)
    CL Item
    24hrs - 48hrs (4)
    Pharmacokinetic Sampling Urine - Start Date
    Item
    Pharmacokinetic Sampling Urine - Start Date
    date
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Actual Start Time
    Item
    Pharmacokinetic Sampling Urine - Actual Start Time
    time
    C1301880 (UMLS CUI [1])
    C0031328 (UMLS CUI [2,1])
    C0042036 (UMLS CUI [2,2])
    C0870078 (UMLS CUI [2,3])
    Pharmacokinetic Sampling Urine - Stop Date
    Item
    Pharmacokinetic Sampling Urine - Stop Date
    date
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Actual Stop Time
    Item
    Pharmacokinetic Sampling Urine - Actual Stop Time
    time
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Total Sample Volume
    Item
    Pharmacokinetic Sampling Urine - Total Sample Volume
    float
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1278293 (UMLS CUI [2])
    Was all of the sample collected for this interval?
    Item
    Was all of the sample collected for this interval?
    boolean
    C0200354 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item
    Pharmacokinetic Sampling Urine - Check if sample taken
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [2,1])
    C1883727 (UMLS CUI [2,2])
    Pharmacokinetic Sampling Urine - Check if sample taken
    Code List
    Pharmacokinetic Sampling Urine - Check if sample taken
    CL Item
    Sample taken (1)
    Item
    Pharmacokinetic Sampling Urine - Sample Number
    integer
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [2])
    Pharmacokinetic Sampling Urine - Sample Number
    Code List
    Pharmacokinetic Sampling Urine - Sample Number
    CL Item
    501  (1)
    CL Item
    502  (2)
    CL Item
    503 (3)
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