0 Ratings
ID

39988

Description

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Keywords

Versions (1)
  1. 3/8/20 3/8/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 8, 2020

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License

Creative Commons BY-NC 4.0
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    GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586

    English

    V6

    1 forms  
    1. StudyEvent: ODM
      1. V6
    Date of Visit
    Description

    Date of Visit

    Alias
    UMLS CUI-1
    C1320303
    Date of visit/assessment
    Description

    Date of visit, Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Investigational Product
    Description

    Investigational Product

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

    Experimental drug, Dosage, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Treatment Confirmation
    Description

    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 the dosing interval?
    Description

    Therapeutic procedure, Confirmation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0750484
    No, record reason(s)
    Description

    Therapeutic procedure, Wrong, Reason and justification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C3827420
    UMLS CUI [1,3]
    C0566251
    ABPM
    Description

    ABPM

    Alias
    UMLS CUI-1
    C0242876
    Start date/time ambulatory blood pressure
    Description

    Blood Pressure Monitoring, Ambulatory, Start Date, Start time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0242876
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [1,3]
    C1301880
    End date/time ambulatory blood pressure
    Description

    Blood Pressure Monitoring, Ambulatory, End date, End Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0242876
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [1,3]
    C1522314
    CogState
    Description

    CogState

    Alias
    UMLS CUI-1
    C0392335
    UMLS CUI-2
    C0392366
    Dosing date/time
    Description

    Cognitive functions, Tests, Dosage, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0392335
    UMLS CUI [1,2]
    C0392366
    UMLS CUI [1,3]
    C0178602
    UMLS CUI [1,4]
    C0011008
    UMLS CUI [1,5]
    C0040223
    5H - Date and time test taken
    Description

    Cognitive functions, Tests, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0392335
    UMLS CUI [1,2]
    C0392366
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    5H - Not done
    Description

    Cognitive functions, Tests, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392335
    UMLS CUI [1,2]
    C0392366
    UMLS CUI [1,3]
    C1272696
    Holter
    Description

    Holter

    Alias
    UMLS CUI-1
    C0013801
    Start Date and Time of Holter
    Description

    Holter Electrocardiography, Start Date, Start time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [1,3]
    C1301880
    Stop Date and Time of Holter
    Description

    Holter Electrocardiography, End date, End Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [1,3]
    C1522314
    Interpretation of Holter
    Description

    Holter Electrocardiography, Clinical Interpretation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C4086187
    Summary Holter Abnormalities
    Description

    Summary Holter Abnormalities

    Alias
    UMLS CUI-1
    C0013801
    UMLS CUI-2
    C1704258
    Record clinically significant abnormalities below - Check all that apply
    Description

    Holter Electrocardiography, Abnormality

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C1704258
    Telemetry
    Description

    Telemetry

    Alias
    UMLS CUI-1
    C0039451
    Dosing date/time
    Description

    Telemetry, Dosage, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Start Date and Time of Telemetry
    Description

    Telemetry, Start Date, Start time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [1,3]
    C1301880
    Stop Date and Time of Telemetry
    Description

    Telemetry, End date, End Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [1,3]
    C1522314
    Result of Telemetry
    Description

    Telemetry, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C1274040
    Summary Telemetry Abnormalities
    Description

    Summary Telemetry Abnormalities

    Alias
    UMLS CUI-1
    C0039451
    UMLS CUI-2
    C1704258
    Summary Telemetry Abnormalities
    Description

    Telemetry, Abnormality

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C1704258
    Electronically Transferred Lab Data
    Description

    Electronically Transferred Lab Data

    Alias
    UMLS CUI-1
    C0022885
    Pre-dose - Haematology Date and time sample taken
    Description

    Hematology finding, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Pre-dose - Not Done
    Description

    Hematology finding, Sampling, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    Pre-dose - Clinical Chemistry Date and time sample taken
    Description

    Chemistry, Clinical, Sampling, Date in time, Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Pre-dose - Not Done
    Description

    Chemistry, Clinical, Sampling, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    Pre-dose - Urinalysis Date and time sample taken
    Description

    Urinalysis, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Pre-dose - Not Done
    Description

    Urinalysis, Sampling, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    24H - Haematology Date and time sample taken
    Description

    Hematology finding, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    24H - Not Done
    Description

    Hematology finding, Sampling, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    24H - Clinical Chemistry Date and time sample taken
    Description

    Chemistry, Clinical, Sampling, Date in time, Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    24H - Not Done
    Description

    Chemistry, Clinical, Sampling, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    24H - Urinalysis Date and time sample taken
    Description

    Urinalysis, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    24H - Not Done
    Description

    Urinalysis, Sampling, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    48H - Haematology Date and time sample taken
    Description

    Hematology finding, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    48H - Not Done
    Description

    Hematology finding, Sampling, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    48H - Clinical Chemistry Date and time sample taken
    Description

    Chemistry, Clinical, Sampling, Date in time, Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    48H - Not Done
    Description

    Chemistry, Clinical, Sampling, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    48H - Urinalysis Date and time sample taken
    Description

    Urinalysis, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    48H - Not Done
    Description

    Urinalysis, Sampling, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    Pulmonary Function Tests (PFT)
    Description

    Pulmonary Function Tests (PFT)

    Alias
    UMLS CUI-1
    C0024119
    Dosing date/time
    Description

    Pulmonary function test, Dosage, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Pre-dose - Date/time of test
    Description

    Pulmonary function tests, Pre-dose, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    UMLS CUI [1,5]
    C1442770
    Pre-dose - FEV1
    Description

    Pulmonary function tests, Pre-dose, Forced expiratory volume in 1 second finding

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0429706
    Pre-dose - VC/FCV
    Description

    Pulmonary function tests, Pre-dose, Vital capacity, Forced Vital Capacity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0042834
    UMLS CUI [1,4]
    C3714541
    Pre-dose - FEV1/VC
    Description

    Pulmonary function tests, Pre-dose, Forced expiratory volume in 1 second finding, Vital capacity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0429706
    UMLS CUI [1,4]
    C0042834
    4H - Date/time of test
    Description

    Pulmonary function tests, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    4H - FEV1
    Description

    Pulmonary function tests, Forced expiratory volume in 1 second finding

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0429706
    4H - VC/FCV
    Description

    Pulmonary function tests, Vital capacity, Forced Vital Capacity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0042834
    UMLS CUI [1,3]
    C3714541
    4H - FEV1/VC
    Description

    Pulmonary function tests, Forced expiratory volume in 1 second finding, Vital capacity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0429706
    UMLS CUI [1,3]
    C0042834
    24H - Date/time of test
    Description

    Pulmonary function tests, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    24H - FEV1
    Description

    Pulmonary function tests, Forced expiratory volume in 1 second finding

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0429706
    24H - VC/FCV
    Description

    Pulmonary function tests, Vital capacity, Forced Vital Capacity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0042834
    UMLS CUI [1,3]
    C3714541
    24H - FEV1/VC
    Description

    Pulmonary function tests, Forced expiratory volume in 1 second finding, Vital capacity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0429706
    UMLS CUI [1,3]
    C0042834
    48H - Date/time of test
    Description

    Pulmonary function tests, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    48H - FEV1
    Description

    Pulmonary function tests, Forced expiratory volume in 1 second finding

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0429706
    48H - VC/FCV
    Description

    Pulmonary function tests, Vital capacity, Forced Vital Capacity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0042834
    UMLS CUI [1,3]
    C3714541
    48H - FEV1/VC
    Description

    Pulmonary function tests, Forced expiratory volume in 1 second finding, Vital capacity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0429706
    UMLS CUI [1,3]
    C0042834
    Pharmacokinetics Blood
    Description

    Pharmacokinetics Blood

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Dosing date/time
    Description

    Pharmacokinetic aspects, Blood, Dosage, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0178602
    UMLS CUI [1,4]
    C0011008
    UMLS CUI [1,5]
    C0040223
    Pre-dose - Actual time
    Description

    Pharmacokinetic aspects, Blood, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    0.5H - Actual time
    Description

    Pharmacokinetic aspects, Blood, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    1H - Actual time
    Description

    Pharmacokinetic aspects, Blood, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    1.5H - Actual time
    Description

    Pharmacokinetic aspects, Blood, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    2H - Actual time
    Description

    Pharmacokinetic aspects, Blood, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    3H - Actual time
    Description

    Pharmacokinetic aspects, Blood, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    4H - Actual time
    Description

    Pharmacokinetic aspects, Blood, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    6H - Actual time
    Description

    Pharmacokinetic aspects, Blood, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    10H - Actual time
    Description

    Pharmacokinetic aspects, Blood, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    12H - Actual date/time
    Description

    Pharmacokinetic aspects, Blood, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    24H - Actual date/time
    Description

    Pharmacokinetic aspects, Blood, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    36H - Actual date/time
    Description

    Pharmacokinetic aspects, Blood, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    48H - Actual date/time
    Description

    Pharmacokinetic aspects, Blood, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    72H - Actual date/time
    Description

    Pharmacokinetic aspects, Blood, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    96H - Actual date/time
    Description

    Pharmacokinetic aspects, Blood, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Pharmacokinetics Urine
    Description

    Pharmacokinetics Urine

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0042036
    Dosing date/time
    Description

    Pharmacokinetic aspects, Urine, Dosage, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0178602
    UMLS CUI [1,4]
    C0011008
    UMLS CUI [1,5]
    C0040223
    Pre-dose - Was all of the sample collected for this interval?
    Description

    Pharmacokinetics aspects, Urine, Sampling, Complete

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0205197
    Pre-dose - Start date and Actual start time
    Description

    Pharmacokinetics aspects, Urine, Start Date, Start time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [1,4]
    C1301880
    Pre-dose - Stop date and Actual stop time
    Description

    Pharmacokinetics aspects, Urine, End date, End Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0806020
    UMLS CUI [1,4]
    C1522314
    Pre-dose - Total sample volume
    Description

    Pharmacokinetics aspects, Urine, Urine sample volume measurement

    Data type

    float

    Measurement units
    • ml
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C1278293
    ml
    0-12H - Was all of the sample collected for this interval?
    Description

    Pharmacokinetics aspects, Urine, Sampling, Complete

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0205197
    0-12H - Start date and Actual start time
    Description

    Pharmacokinetics aspects, Urine, Start Date, Start time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [1,4]
    C1301880
    0-12H - Stop date and Actual stop time
    Description

    Pharmacokinetics aspects, Urine, End date, End Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0806020
    UMLS CUI [1,4]
    C1522314
    0-12H - Total sample volume
    Description

    Pharmacokinetics aspects, Urine, Urine sample volume measurement

    Data type

    float

    Measurement units
    • ml
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C1278293
    ml
    12-24H - Was all of the sample collected for this interval?
    Description

    Pharmacokinetics aspects, Urine, Sampling, Complete

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0205197
    12-24H - Start date and Actual start time
    Description

    Pharmacokinetics aspects, Urine, Start Date, Start time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [1,4]
    C1301880
    12-24H - Stop date and Actual stop time
    Description

    Pharmacokinetics aspects, Urine, End date, End Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0806020
    UMLS CUI [1,4]
    C1522314
    12-24H - Total sample volume
    Description

    Pharmacokinetics aspects, Urine, Urine sample volume measurement

    Data type

    float

    Measurement units
    • ml
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C1278293
    ml
    24-48H - Was all of the sample collected for this interval?
    Description

    Pharmacokinetics aspects, Urine, Sampling, Complete

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0205197
    24-48H - Start date and Actual start time
    Description

    Pharmacokinetics aspects, Urine, Start Date, Start time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [1,4]
    C1301880
    24-48H - Stop date and Actual stop time
    Description

    Pharmacokinetics aspects, Urine, End date, End Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C0806020
    UMLS CUI [1,4]
    C1522314
    24-48H - Total sample volume
    Description

    Pharmacokinetics aspects, Urine, Urine sample volume measurement

    Data type

    float

    Measurement units
    • ml
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0042036
    UMLS CUI [1,3]
    C1278293
    ml
    Salivary Secretion
    Description

    Salivary Secretion

    Alias
    UMLS CUI-1
    C0438730
    Dosing date/time
    Description

    Saliva specimen, Dosage, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Pre-dose - Actual time of sample
    Description

    Saliva specimen, Sampling, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0040223
    Pre-dose - Total pre-test weight
    Description

    Saliva specimen, Sampling, Weight, Before

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0332152
    g
    Pre-dose - Total post-test weight
    Description

    Saliva specimen, Sampling, Weight, Post

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0687676
    g
    Pre-dose - Weight gain
    Description

    Saliva specimen, Sampling, Weight Gain

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043094
    g
    1H - Actual time of sample
    Description

    Saliva specimen, Sampling, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0040223
    1H - Total pre-test weight
    Description

    Saliva specimen, Sampling, Weight, Before

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0332152
    g
    1H - Total post-test weight
    Description

    Saliva specimen, Sampling, Weight, Post

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0687676
    g
    1H - Weight gain
    Description

    Saliva specimen, Sampling, Weight Gain

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043094
    g
    2H - Actual time of sample
    Description

    Saliva specimen, Sampling, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0040223
    2H - Total pre-test weight
    Description

    Saliva specimen, Sampling, Weight, Before

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0332152
    g
    2H - Total post-test weight
    Description

    Saliva specimen, Sampling, Weight, Post

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0687676
    g
    2H - Weight gain
    Description

    Saliva specimen, Sampling, Weight Gain

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043094
    g
    3H - Actual time of sample
    Description

    Saliva specimen, Sampling, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0040223
    3H - Total pre-test weight
    Description

    Saliva specimen, Sampling, Weight, Before

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0332152
    g
    3H - Total post-test weight
    Description

    Saliva specimen, Sampling, Weight, Post

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0687676
    g
    3H - Weight gain
    Description

    Saliva specimen, Sampling, Weight Gain

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043094
    g
    4H - Actual time of sample
    Description

    Saliva specimen, Sampling, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0040223
    4H - Total pre-test weight
    Description

    Saliva specimen, Sampling, Weight, Before

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0332152
    g
    4H - Total post-test weight
    Description

    Saliva specimen, Sampling, Weight, Post

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0687676
    g
    4H - Weight gain
    Description

    Saliva specimen, Sampling, Weight Gain

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043094
    g
    6H - Actual time of sample
    Description

    Saliva specimen, Sampling, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0040223
    6H - Total pre-test weight
    Description

    Saliva specimen, Sampling, Weight, Before

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0332152
    g
    6H - Total post-test weight
    Description

    Saliva specimen, Sampling, Weight, Post

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0687676
    g
    6H - Weight gain
    Description

    Saliva specimen, Sampling, Weight Gain

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043094
    g
    8H - Actual time of sample
    Description

    Saliva specimen, Sampling, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0040223
    8H - Total pre-test weight
    Description

    Saliva specimen, Sampling, Weight, Before

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0332152
    g
    8H - Total post-test weight
    Description

    Saliva specimen, Sampling, Weight, Post

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0687676
    g
    8H - Weight gain
    Description

    Saliva specimen, Sampling, Weight Gain

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043094
    g
    12H - Actual date and time of sample
    Description

    Saliva specimen, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    12H - Total pre-test weight
    Description

    Saliva specimen, Sampling, Weight, Before

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0332152
    g
    12H - Total post-test weight
    Description

    Saliva specimen, Sampling, Weight, Post

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0687676
    g
    12H - Weight gain
    Description

    Saliva specimen, Sampling, Weight Gain

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043094
    g
    24H - Actual date and time of sample
    Description

    Saliva specimen, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    24H - Total pre-test weight
    Description

    Saliva specimen, Sampling, Weight, Before

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0332152
    g
    24H - Total post-test weight
    Description

    Saliva specimen, Sampling, Weight, Post

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043100
    UMLS CUI [1,4]
    C0687676
    g
    24H - Weight gain
    Description

    Saliva specimen, Sampling, Weight Gain

    Data type

    integer

    Measurement units
    • g
    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0043094
    g
    Vital Signs - Respiration rate
    Description

    Vital Signs - Respiration rate

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0231832
    Dosing date/time
    Description

    Respiratory rate, Dosage, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0231832
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Pre-dose 1 - Actual date/time
    Description

    Respiratory rate, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0231832
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Respiration rate
    Description

    Respiratory rate

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832
    breaths/min
    4H - Actual date/time
    Description

    Respiratory rate, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0231832
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Respiration rate
    Description

    Respiratory rate

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832
    breaths/min
    24H - Actual date/time
    Description

    Respiratory rate, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0231832
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Respiration rate
    Description

    Respiratory rate

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832
    breaths/min
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Dosing date/time
    Description

    Vital signs, Dosage, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Actual date/time
    Description

    Vital signs, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Weight
    Description

    Vital signs, Body Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0005910
    kg
    Blood pressure - Systolic
    Description

    Vital signs, Systolic Pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0871470
    mm[Hg]
    Blood pressure - Diastolic
    Description

    Vital signs, Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0428883
    mm[Hg]
    Heart rate
    Description

    Vital signs, Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0018810
    bpm
    Respiration rate
    Description

    Vital signs, Respiratory rate

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0231832
    breaths/min
    Temperature
    Description

    Vital signs, Body Temperature

    Data type

    float

    Measurement units
    • °CC
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0005903
    °CC
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    Similar models

    V6

    1 forms
    1. StudyEvent: ODM
      1. V6
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of Visit
    C1320303 (UMLS CUI-1)
    Date of visit, Assessment Date
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    Experimental drug, Dosage, Date in time, Time
    Item
    Date/time of dose
    datetime
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item Group
    Treatment Confirmation
    C0087111 (UMLS CUI-1)
    C0750484 (UMLS CUI-2)
    Therapeutic procedure, Confirmation
    Item
    Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during the dosing interval?
    boolean
    C0087111 (UMLS CUI [1,1])
    C0750484 (UMLS CUI [1,2])
    Therapeutic procedure, Wrong, Reason and justification
    Item
    No, record reason(s)
    boolean
    C0087111 (UMLS CUI [1,1])
    C3827420 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Item Group
    ABPM
    C0242876 (UMLS CUI-1)
    Blood Pressure Monitoring, Ambulatory, Start Date, Start time
    Item
    Start date/time ambulatory blood pressure
    datetime
    C0242876 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C1301880 (UMLS CUI [1,3])
    Blood Pressure Monitoring, Ambulatory, End date, End Time
    Item
    End date/time ambulatory blood pressure
    datetime
    C0242876 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [1,3])
    Item Group
    CogState
    C0392335 (UMLS CUI-1)
    C0392366 (UMLS CUI-2)
    Cognitive functions, Tests, Dosage, Date in time, Time
    Item
    Dosing date/time
    datetime
    C0392335 (UMLS CUI [1,1])
    C0392366 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    C0040223 (UMLS CUI [1,5])
    Cognitive functions, Tests, Date in time, Time
    Item
    5H - Date and time test taken
    datetime
    C0392335 (UMLS CUI [1,1])
    C0392366 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Cognitive functions, Tests, Not Done
    Item
    5H - Not done
    boolean
    C0392335 (UMLS CUI [1,1])
    C0392366 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item Group
    Holter
    C0013801 (UMLS CUI-1)
    Holter Electrocardiography, Start Date, Start time
    Item
    Start Date and Time of Holter
    datetime
    C0013801 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C1301880 (UMLS CUI [1,3])
    Holter Electrocardiography, End date, End Time
    Item
    Stop Date and Time of Holter
    datetime
    C0013801 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [1,3])
    Item
    Interpretation of Holter
    text
    C0013801 (UMLS CUI [1,1])
    C4086187 (UMLS CUI [1,2])
    Holter Electrocardiography, Clinical Interpretation
    Code List
    Interpretation of Holter
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    CL Item
    No result (4)
    CL Item
    Unable to evaluate (5)
    Item Group
    Summary Holter Abnormalities
    C0013801 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Item
    Record clinically significant abnormalities below - Check all that apply
    text
    C0013801 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Holter Electrocardiography, Abnormality
    Code List
    Record clinically significant abnormalities below - Check all that apply
    CL Item
    No abnormalities (1)
    CL Item
    Sinus bradycardia (50-59 beats/min) (2)
    CL Item
    Sinus bradycardia (40-49 beats/min) (3)
    CL Item
    Sinus bradycardia (30-39 beats/min) (4)
    CL Item
    Sinus bradycardia (<30 beats/min) (5)
    CL Item
    Sinus pause (6)
    CL Item
    Sinus tachycardia (>100 beats/min) (7)
    CL Item
    Ectopic supraventricular beats (8)
    CL Item
    Ectopic supraventricular rhythm (9)
    CL Item
    Wandering atrial pacemaker (10)
    CL Item
    Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (11)
    CL Item
    Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (12)
    CL Item
    Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (13)
    CL Item
    Atrial flutter (14)
    CL Item
    Atrial fibrillation (15)
    CL Item
    Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (16)
    CL Item
    Junctional tachycardia (>100 beats/min) (17)
    CL Item
    Ventricular premature deplorisation (18)
    CL Item
    Ventricular couplets (19)
    CL Item
    Bigeminy (20)
    CL Item
    Trigeminy (21)
    CL Item
    Electrical alternans (22)
    CL Item
    R on T phenomenon (23)
    CL Item
    Ventricular fibrillation (24)
    CL Item
    Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (25)
    CL Item
    Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (26)
    CL Item
    Sustained ventricular tachycardia (>100 beats/min, >30 beats) (27)
    CL Item
    Wide QRS tachycardia (diagnosis unknown (28)
    CL Item
    Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (29)
    CL Item
    Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (30)
    CL Item
    Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (31)
    CL Item
    Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (32)
    CL Item
    Torsades de Pointes (TdP) (33)
    CL Item
    Pacemaker (34)
    CL Item
    First degree AV block (PR interval >200msec) (35)
    CL Item
    Short PR Intervak (36)
    CL Item
    Second degree AV block (Mobitz type 1) (37)
    CL Item
    Second degree AV block (Mobitz type 2) (38)
    CL Item
    2:1 AV block (39)
    CL Item
    Third degree AV block (40)
    CL Item
    Left axis deviation (QRS axis more negative than -30 degrees) (41)
    CL Item
    Right axis deviation (QRS axis more positive than +100 degrees) (42)
    CL Item
    Incomplete left bundle branch block (43)
    CL Item
    Incomplete left bundle branch block (44)
    CL Item
    Right bundle branch block (45)
    CL Item
    Left anterior hemiblock (46)
    CL Item
    Left posterior hemiblock (47)
    CL Item
    Left bundle branch block (48)
    CL Item
    Bifascicular block (49)
    CL Item
    Non-specific intraventricular conduction delay (QRS >=120 msec) (50)
    CL Item
    Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine (51)
    CL Item
    QTc prolongation >=500 msec (52)
    CL Item
    AV dissociation (53)
    CL Item
    Myocardial infarction, old (54)
    CL Item
    Myocardial infarction, non Q-wave (55)
    CL Item
    Non-specific ST-T changes (56)
    CL Item
    J point elevation (57)
    CL Item
    ST elevation (58)
    CL Item
    ST depression (59)
    CL Item
    ST segment abnormality (60)
    CL Item
    U waves (61)
    CL Item
    T wave inversion (62)
    CL Item
    T wave peaked (63)
    CL Item
    T waves biphasic (64)
    CL Item
    T waves flat (65)
    CL Item
    66)Notched T-waves (66)Notched T-waves)
    CL Item
    Low QRS voltage (67)
    CL Item
    T wave abnormality (68)
    CL Item
    Other abnormal rhythm (69)
    CL Item
    Other morphology (70)
    CL Item
    Other conduction (71)
    CL Item
    Other myocardial infarction (72)
    CL Item
    Other depolarization/repolarisation (73)
    CL Item
    Other abnormality/Cardiologist comments (74)
    Item Group
    Telemetry
    C0039451 (UMLS CUI-1)
    Telemetry, Dosage, Date in time, Time
    Item
    Dosing date/time
    datetime
    C0039451 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Telemetry, Start Date, Start time
    Item
    Start Date and Time of Telemetry
    datetime
    C0039451 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C1301880 (UMLS CUI [1,3])
    Telemetry, End date, End Time
    Item
    Stop Date and Time of Telemetry
    datetime
    C0039451 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [1,3])
    Item
    Result of Telemetry
    text
    C0039451 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Telemetry, Result
    Code List
    Result of Telemetry
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    CL Item
    No result (4)
    CL Item
    Unable to evaluate (5)
    Item Group
    Summary Telemetry Abnormalities
    C0039451 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Item
    Summary Telemetry Abnormalities
    text
    C0039451 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Telemetry, Abnormality
    Code List
    Summary Telemetry Abnormalities
    CL Item
    No abnormalities (1)
    CL Item
    Sinus bradycardia (50-59 beats/min) (2)
    CL Item
    Sinus bradycardia (40-49 beats/min) (3)
    CL Item
    Sinus bradycardia (30-39 beats/min) (4)
    CL Item
    Sinus bradycardia (<30 beats/min) (5)
    CL Item
    Sinus pause (6)
    CL Item
    Sinus tachycardia (>100 beats/min) (7)
    CL Item
    Ectopic supraventricular beats (8)
    CL Item
    Ectopic supraventricular rhythm (9)
    CL Item
    Wandering atrial pacemaker (10)
    CL Item
    Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (11)
    CL Item
    Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (12)
    CL Item
    Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (13)
    CL Item
    Atrial flutter (14)
    CL Item
    Atrial fibrillation (15)
    CL Item
    Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (16)
    CL Item
    Junctional tachycardia (>100 beats/min) (17)
    CL Item
    Ventricular premature deplorisation (18)
    CL Item
    Ventricular couplets (19)
    CL Item
    Bigeminy (20)
    CL Item
    Trigeminy (21)
    CL Item
    Electrical alternans (22)
    CL Item
    R on T phenomenon (23)
    CL Item
    Ventricular fibrillation (24)
    CL Item
    Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (25)
    CL Item
    Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (26)
    CL Item
    Sustained ventricular tachycardia (>100 beats/min, >30 beats) (27)
    CL Item
    Wide QRS tachycardia (diagnosis unknown (28)
    CL Item
    Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (29)
    CL Item
    Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (30)
    CL Item
    Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (31)
    CL Item
    Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (32)
    CL Item
    Torsades de Pointes (TdP) (33)
    CL Item
    Pacemaker (34)
    CL Item
    First degree AV block (PR interval >200msec) (35)
    CL Item
    Short PR Intervak (36)
    CL Item
    Second degree AV block (Mobitz type 1) (37)
    CL Item
    Second degree AV block (Mobitz type 2) (38)
    CL Item
    2:1 AV block (39)
    CL Item
    Third degree AV block (40)
    CL Item
    Left axis deviation (QRS axis more negative than -30 degrees) (41)
    CL Item
    Right axis deviation (QRS axis more positive than +100 degrees) (42)
    CL Item
    Incomplete left bundle branch block (43)
    CL Item
    Incomplete left bundle branch block (44)
    CL Item
    Right bundle branch block (45)
    CL Item
    Left anterior hemiblock (46)
    CL Item
    Left posterior hemiblock (47)
    CL Item
    Left bundle branch block (48)
    CL Item
    Bifascicular block (49)
    CL Item
    Non-specific intraventricular conduction delay (QRS >=120 msec) (50)
    CL Item
    Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine (51)
    CL Item
    QTc prolongation >=500 msec (52)
    CL Item
    AV dissociation (53)
    CL Item
    Myocardial infarction, old (54)
    CL Item
    Myocardial infarction, non Q-wave (55)
    CL Item
    Non-specific ST-T changes (56)
    CL Item
    J point elevation (57)
    CL Item
    ST elevation (58)
    CL Item
    ST depression (59)
    CL Item
    ST segment abnormality (60)
    CL Item
    U waves (61)
    CL Item
    T wave inversion (62)
    CL Item
    T wave peaked (63)
    CL Item
    T waves biphasic (64)
    CL Item
    T waves flat (65)
    CL Item
    Notched T-waves = 66)Notched T-waves (66)
    CL Item
    Low QRS voltage (67)
    CL Item
    T wave abnormality (68)
    CL Item
    Other abnormal rhythm (69)
    CL Item
    Other morphology (70)
    CL Item
    Other conduction (71)
    CL Item
    Other myocardial infarction (72)
    CL Item
    Other depolarization/repolarisation (73)
    CL Item
    Other abnormality/Cardiologist comments (74)
    Item Group
    Electronically Transferred Lab Data
    C0022885 (UMLS CUI-1)
    Hematology finding, Sampling, Date in time, Time
    Item
    Pre-dose - Haematology Date and time sample taken
    datetime
    C0474523 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Hematology finding, Sampling, Not Done
    Item
    Pre-dose - Not Done
    boolean
    C0474523 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item
    Pre-dose - Clinical Chemistry Date and time sample taken
    text
    C0008000 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Chemistry, Clinical, Sampling, Date in time, Time
    Code List
    Pre-dose - Clinical Chemistry Date and time sample taken
    CL Item
    Same as the Haematology sample (1)
    Chemistry, Clinical, Sampling, Not Done
    Item
    Pre-dose - Not Done
    boolean
    C0008000 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Urinalysis, Sampling, Date in time, Time
    Item
    Pre-dose - 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])
    Urinalysis, Sampling, Not Done
    Item
    Pre-dose - Not Done
    boolean
    C0042014 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Hematology finding, Sampling, Date in time, Time
    Item
    24H - Haematology Date and time sample taken
    datetime
    C0474523 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Hematology finding, Sampling, Not Done
    Item
    24H - Not Done
    boolean
    C0474523 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item
    24H - Clinical Chemistry Date and time sample taken
    text
    C0008000 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Chemistry, Clinical, Sampling, Date in time, Time
    Code List
    24H - Clinical Chemistry Date and time sample taken
    CL Item
    Same as the Haematology sample (1)
    Chemistry, Clinical, Sampling, Not Done
    Item
    24H - Not Done
    boolean
    C0008000 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Urinalysis, Sampling, Date in time, Time
    Item
    24H - 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])
    Urinalysis, Sampling, Not Done
    Item
    24H - Not Done
    boolean
    C0042014 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Hematology finding, Sampling, Date in time, Time
    Item
    48H - Haematology Date and time sample taken
    datetime
    C0474523 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Hematology finding, Sampling, Not Done
    Item
    48H - Not Done
    boolean
    C0474523 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item
    48H - Clinical Chemistry Date and time sample taken
    text
    C0008000 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Chemistry, Clinical, Sampling, Date in time, Time
    Code List
    48H - Clinical Chemistry Date and time sample taken
    CL Item
    Same as the Haematology sample (1)
    Chemistry, Clinical, Sampling, Not Done
    Item
    48H - Not Done
    boolean
    C0008000 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Urinalysis, Sampling, Date in time, Time
    Item
    48H - 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])
    Urinalysis, Sampling, Not Done
    Item
    48H - Not Done
    boolean
    C0042014 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item Group
    Pulmonary Function Tests (PFT)
    C0024119 (UMLS CUI-1)
    Pulmonary function test, Dosage, Date in time, Time
    Item
    Dosing date/time
    datetime
    C0024119 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Pulmonary function tests, Pre-dose, Date in time, Time
    Item
    Pre-dose - Date/time of test
    datetime
    C0024119 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    C1442770 (UMLS CUI [1,5])
    Pulmonary function tests, Pre-dose, Forced expiratory volume in 1 second finding
    Item
    Pre-dose - FEV1
    text
    C0024119 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0429706 (UMLS CUI [1,3])
    Pulmonary function tests, Pre-dose, Vital capacity, Forced Vital Capacity
    Item
    Pre-dose - VC/FCV
    text
    C0024119 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0042834 (UMLS CUI [1,3])
    C3714541 (UMLS CUI [1,4])
    Pulmonary function tests, Pre-dose, Forced expiratory volume in 1 second finding, Vital capacity
    Item
    Pre-dose - FEV1/VC
    text
    C0024119 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0429706 (UMLS CUI [1,3])
    C0042834 (UMLS CUI [1,4])
    Pulmonary function tests, Date in time, Time
    Item
    4H - Date/time of test
    datetime
    C0024119 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pulmonary function tests, Forced expiratory volume in 1 second finding
    Item
    4H - FEV1
    text
    C0024119 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Pulmonary function tests, Vital capacity, Forced Vital Capacity
    Item
    4H - VC/FCV
    text
    C0024119 (UMLS CUI [1,1])
    C0042834 (UMLS CUI [1,2])
    C3714541 (UMLS CUI [1,3])
    Pulmonary function tests, Forced expiratory volume in 1 second finding, Vital capacity
    Item
    4H - FEV1/VC
    text
    C0024119 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    C0042834 (UMLS CUI [1,3])
    Pulmonary function tests, Date in time, Time
    Item
    24H - Date/time of test
    datetime
    C0024119 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pulmonary function tests, Forced expiratory volume in 1 second finding
    Item
    24H - FEV1
    text
    C0024119 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Pulmonary function tests, Vital capacity, Forced Vital Capacity
    Item
    24H - VC/FCV
    text
    C0024119 (UMLS CUI [1,1])
    C0042834 (UMLS CUI [1,2])
    C3714541 (UMLS CUI [1,3])
    Pulmonary function tests, Forced expiratory volume in 1 second finding, Vital capacity
    Item
    24H - FEV1/VC
    text
    C0024119 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    C0042834 (UMLS CUI [1,3])
    Pulmonary function tests, Date in time, Time
    Item
    48H - Date/time of test
    datetime
    C0024119 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pulmonary function tests, Forced expiratory volume in 1 second finding
    Item
    48H - FEV1
    text
    C0024119 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Pulmonary function tests, Vital capacity, Forced Vital Capacity
    Item
    48H - VC/FCV
    text
    C0024119 (UMLS CUI [1,1])
    C0042834 (UMLS CUI [1,2])
    C3714541 (UMLS CUI [1,3])
    Pulmonary function tests, Forced expiratory volume in 1 second finding, Vital capacity
    Item
    48H - FEV1/VC
    text
    C0024119 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    C0042834 (UMLS CUI [1,3])
    Item Group
    Pharmacokinetics Blood
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Pharmacokinetic aspects, Blood, Dosage, Date in time, Time
    Item
    Dosing date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    C0040223 (UMLS CUI [1,5])
    Pharmacokinetic aspects, Blood, Time
    Item
    Pre-dose - Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Blood, Time
    Item
    0.5H - Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Blood, Time
    Item
    1H - Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Blood, Time
    Item
    1.5H - Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Blood, Time
    Item
    2H - Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Blood, Time
    Item
    3H - Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Blood, Time
    Item
    4H - Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Blood, Time
    Item
    6H - Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Blood, Time
    Item
    10H - Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Blood, Date in time, Time
    Item
    12H - Actual date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Pharmacokinetic aspects, Blood, Date in time, Time
    Item
    24H - Actual date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Pharmacokinetic aspects, Blood, Date in time, Time
    Item
    36H - Actual date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Pharmacokinetic aspects, Blood, Date in time, Time
    Item
    48H - Actual date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Pharmacokinetic aspects, Blood, Date in time, Time
    Item
    72H - Actual date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Pharmacokinetic aspects, Blood, Date in time, Time
    Item
    96H - Actual date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item Group
    Pharmacokinetics Urine
    C0031328 (UMLS CUI-1)
    C0042036 (UMLS CUI-2)
    Pharmacokinetic aspects, Urine, Dosage, Date in time, Time
    Item
    Dosing date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    C0040223 (UMLS CUI [1,5])
    Pharmacokinetics aspects, Urine, Sampling, Complete
    Item
    Pre-dose - Was all of the sample collected for this interval?
    boolean
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0205197 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, Start Date, Start time
    Item
    Pre-dose - Start date and Actual start time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C1301880 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, End date, End Time
    Item
    Pre-dose - Stop date and Actual stop time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    C1522314 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, Urine sample volume measurement
    Item
    Pre-dose - Total sample volume
    float
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1278293 (UMLS CUI [1,3])
    Pharmacokinetics aspects, Urine, Sampling, Complete
    Item
    0-12H - Was all of the sample collected for this interval?
    boolean
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0205197 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, Start Date, Start time
    Item
    0-12H - Start date and Actual start time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C1301880 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, End date, End Time
    Item
    0-12H - Stop date and Actual stop time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    C1522314 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, Urine sample volume measurement
    Item
    0-12H - Total sample volume
    float
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1278293 (UMLS CUI [1,3])
    Pharmacokinetics aspects, Urine, Sampling, Complete
    Item
    12-24H - Was all of the sample collected for this interval?
    boolean
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0205197 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, Start Date, Start time
    Item
    12-24H - Start date and Actual start time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C1301880 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, End date, End Time
    Item
    12-24H - Stop date and Actual stop time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    C1522314 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, Urine sample volume measurement
    Item
    12-24H - Total sample volume
    float
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1278293 (UMLS CUI [1,3])
    Pharmacokinetics aspects, Urine, Sampling, Complete
    Item
    24-48H - Was all of the sample collected for this interval?
    boolean
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0205197 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, Start Date, Start time
    Item
    24-48H - Start date and Actual start time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C1301880 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, End date, End Time
    Item
    24-48H - Stop date and Actual stop time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    C1522314 (UMLS CUI [1,4])
    Pharmacokinetics aspects, Urine, Urine sample volume measurement
    Item
    24-48H - Total sample volume
    float
    C0031328 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    C1278293 (UMLS CUI [1,3])
    Item Group
    Salivary Secretion
    C0438730 (UMLS CUI-1)
    Saliva specimen, Dosage, Date in time, Time
    Item
    Dosing date/time
    datetime
    C0438730 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Time
    Item
    Pre-dose - Actual time of sample
    time
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Weight, Before
    Item
    Pre-dose - Total pre-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Post
    Item
    Pre-dose - Total post-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0687676 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight Gain
    Item
    Pre-dose - Weight gain
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043094 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Time
    Item
    1H - Actual time of sample
    time
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Weight, Before
    Item
    1H - Total pre-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Post
    Item
    1H - Total post-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0687676 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight Gain
    Item
    1H - Weight gain
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043094 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Time
    Item
    2H - Actual time of sample
    time
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Weight, Before
    Item
    2H - Total pre-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Post
    Item
    2H - Total post-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0687676 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight Gain
    Item
    2H - Weight gain
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043094 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Time
    Item
    3H - Actual time of sample
    time
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Weight, Before
    Item
    3H - Total pre-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Post
    Item
    3H - Total post-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0687676 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight Gain
    Item
    3H - Weight gain
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043094 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Time
    Item
    4H - Actual time of sample
    time
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Weight, Before
    Item
    4H - Total pre-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Post
    Item
    4H - Total post-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0687676 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight Gain
    Item
    4H - Weight gain
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043094 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Time
    Item
    6H - Actual time of sample
    time
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Weight, Before
    Item
    6H - Total pre-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Post
    Item
    6H - Total post-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0687676 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight Gain
    Item
    6H - Weight gain
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043094 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Time
    Item
    8H - Actual time of sample
    time
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Weight, Before
    Item
    8H - Total pre-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Post
    Item
    8H - Total post-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0687676 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight Gain
    Item
    8H - Weight gain
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043094 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Date in time, Time
    Item
    12H - Actual date and time of sample
    datetime
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Before
    Item
    12H - Total pre-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Post
    Item
    12H - Total post-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0687676 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight Gain
    Item
    12H - Weight gain
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043094 (UMLS CUI [1,3])
    Saliva specimen, Sampling, Date in time, Time
    Item
    24H - Actual date and time of sample
    datetime
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Before
    Item
    24H - Total pre-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight, Post
    Item
    24H - Total post-test weight
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043100 (UMLS CUI [1,3])
    C0687676 (UMLS CUI [1,4])
    Saliva specimen, Sampling, Weight Gain
    Item
    24H - Weight gain
    integer
    C0438730 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0043094 (UMLS CUI [1,3])
    Item Group
    Vital Signs - Respiration rate
    C0518766 (UMLS CUI-1)
    C0231832 (UMLS CUI-2)
    Respiratory rate, Dosage, Date in time, Time
    Item
    Dosing date/time
    datetime
    C0231832 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Respiratory rate, Date in time, Time
    Item
    Pre-dose 1 - Actual date/time
    datetime
    C0231832 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Respiratory rate
    Item
    Respiration rate
    integer
    C0231832 (UMLS CUI [1])
    Respiratory rate, Date in time, Time
    Item
    4H - Actual date/time
    datetime
    C0231832 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Respiratory rate
    Item
    Respiration rate
    integer
    C0231832 (UMLS CUI [1])
    Respiratory rate, Date in time, Time
    Item
    24H - Actual date/time
    datetime
    C0231832 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Respiratory rate
    Item
    Respiration rate
    integer
    C0231832 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Vital signs, Dosage, Date in time, Time
    Item
    Dosing date/time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Vital signs, Date in time, Time
    Item
    Actual date/time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Vital signs, Body Weight
    Item
    Weight
    float
    C0518766 (UMLS CUI [1,1])
    C0005910 (UMLS CUI [1,2])
    Vital signs, Systolic Pressure
    Item
    Blood pressure - Systolic
    integer
    C0518766 (UMLS CUI [1,1])
    C0871470 (UMLS CUI [1,2])
    Vital signs, Diastolic blood pressure
    Item
    Blood pressure - Diastolic
    integer
    C0518766 (UMLS CUI [1,1])
    C0428883 (UMLS CUI [1,2])
    Vital signs, Heart rate
    Item
    Heart rate
    integer
    C0518766 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    Vital signs, Respiratory rate
    Item
    Respiration rate
    integer
    C0518766 (UMLS CUI [1,1])
    C0231832 (UMLS CUI [1,2])
    Vital signs, Body Temperature
    Item
    Temperature
    float
    C0518766 (UMLS CUI [1,1])
    C0005903 (UMLS CUI [1,2])
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