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ID

32512

Beskrivning

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Nyckelord

Versioner (3)
  1. 08/10/18 08/10/18 -
  2. 08/10/18 08/10/18 -
  3. 06/11/18 06/11/18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 novembre 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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    Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

    Engelsk

    Day 9

    1 Formulär  
    1. StudyEvent: ODM
      1. Day 9
    12-Lead ECG
    Beskrivning

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Start Date of ECG
    Beskrivning

    12 lead ECG; Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0808070
    Ventricular Rate
    Beskrivning

    12 lead ECG; Ventricular Rate

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C2189285
    bpm
    PR Interval
    Beskrivning

    12 lead ECG; PR Interval

    Datatyp

    integer

    Måttenheter
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429087
    msec
    QRS Duration
    Beskrivning

    12 lead ECG; QRS complex Duration

    Datatyp

    integer

    Måttenheter
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429025
    msec
    Uncorrected QT Interval
    Beskrivning

    12 lead ECG; QT interval finding

    Datatyp

    integer

    Måttenheter
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1287082
    msec
    QTc Interval
    Beskrivning

    12 lead ECG; QTc Interval

    Datatyp

    integer

    Måttenheter
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    msec
    Result of the ECG
    Beskrivning

    12 lead ECG; result

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    UMLS CUI [1,3]
    C1274040
    Vital Signs
    Beskrivning

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Beskrivning

    Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Blood Pressure (sitting) - Systolic
    Beskrivning

    Systolic Pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood Pressure (sitting) - Diastolic
    Beskrivning

    Diastolic blood pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate (sitting)
    Beskrivning

    Heart rate

    Datatyp

    text

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Electronically transferred laboratory data - Clinical Chemistry
    Beskrivning

    Electronically transferred laboratory data - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0008000
    Date Sample Taken
    Beskrivning

    Clinical Chemistry; Sampling; Date in time

    Datatyp

    date

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

    Clinical Chemistry; Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0040223
    Electronically transferred laboratory data - Haematology
    Beskrivning

    Electronically transferred laboratory data - Haematology

    Alias
    UMLS CUI-1
    C0474523
    Date Sample Taken
    Beskrivning

    Hematology finding; Sampling; Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Actual Time
    Beskrivning

    Hematology finding; Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0040223
    Electronically transferred laboratory data - Urinalysis
    Beskrivning

    Electronically transferred laboratory data - Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Date Sample Taken
    Beskrivning

    Urinalysis; Sampling; Date in time

    Datatyp

    date

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

    Urinalysis; Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0040223
    Capillary Blood Glucose
    Beskrivning

    Capillary Blood Glucose

    Alias
    UMLS CUI-1
    C0457578
    Date
    Beskrivning

    Capillary Blood Glucose measurement; Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0457578
    UMLS CUI [1,2]
    C0011008
    Planned relative time (e.g. prior to breakfast)
    Beskrivning

    Capillary Blood Glucose measurement; relative time

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0457578
    UMLS CUI [1,2]
    C0439564
    Time
    Beskrivning

    Capillary Blood Glucose measurement; Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0457578
    UMLS CUI [1,2]
    C0040223
    Result
    Beskrivning

    Capillary Blood Glucose measurement; Result

    Datatyp

    float

    Alias
    UMLS CUI [1,1]
    C0457578
    UMLS CUI [1,2]
    C1274040
    Unit
    Beskrivning

    Capillary Blood Glucose measurement; Unit of measure

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0457578
    UMLS CUI [1,2]
    C1519795
    Pharmacodynamics - Blood [Glucose, Glucagon, Insulin, C-Peptide]
    Beskrivning

    Pharmacodynamics - Blood [Glucose, Glucagon, Insulin, C-Peptide]

    Alias
    UMLS CUI-1
    C0851347
    UMLS CUI-2
    C0005767
    UMLS CUI-3
    C0017725
    UMLS CUI-4
    C0017687
    UMLS CUI-5
    C0021641
    UMLS CUI-6
    C0006558
    Planned Relative Time
    Beskrivning

    Pharmacodynamics; relative time

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0851347
    UMLS CUI [1,2]
    C0439564
    Date Sample Taken
    Beskrivning

    Pharmacokinetic aspects; Blood; Sampling; Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0851347
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Actual Time
    Beskrivning

    Pharmacokinetic aspects; Blood; Sampling; Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0851347
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0040223
    Sample Number
    Beskrivning

    Pharmacokinetic aspects; Blood; Sample identification number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0851347
    UMLS CUI [1,2]
    C1299222
    Pharmacodynamics - Blood [GLP-1 Total]
    Beskrivning

    Pharmacodynamics - Blood [GLP-1 Total]

    Alias
    UMLS CUI-1
    C0851347
    UMLS CUI-2
    C0005767
    UMLS CUI-3
    C0061355
    Planned Relative Time
    Beskrivning

    Pharmacodynamics; relative time

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0851347
    UMLS CUI [1,2]
    C0439564
    Date Sample Taken
    Beskrivning

    Pharmacokinetic aspects; Blood; Sampling; Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0851347
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Actual Time
    Beskrivning

    Pharmacokinetic aspects; Blood; Sampling; Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0851347
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0040223
    Sample Number
    Beskrivning

    Pharmacokinetic aspects; Blood; Sample identification number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0851347
    UMLS CUI [1,2]
    C1299222
    Bioactivity Sampling; Blood
    Beskrivning

    Bioactivity Sampling; Blood

    Alias
    UMLS CUI-1
    C0599112
    UMLS CUI-2
    C0005834
    Planned Relative Time
    Beskrivning

    drug biological activity; Collection of blood specimen for laboratory procedure; relative time

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0599112
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0439564
    Date Sample Taken
    Beskrivning

    drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0599112
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0011008
    Actual Time
    Beskrivning

    drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0599112
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0040223
    Sample Number
    Beskrivning

    drug biological activity; Collection of blood specimen for laboratory procedure; Sample identification number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0599112
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C1299222
    Pharmacokinetic aspects; Blood (GLP-1 total)
    Beskrivning

    Pharmacokinetic aspects; Blood (GLP-1 total)

    Alias
    UMLS CUI-1
    C0005834
    UMLS CUI-2
    C0031328
    UMLS CUI-3
    C0061355
    Planned Relative Time
    Beskrivning

    Pharmacokinetic aspects; Blood; relative time

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0439564
    Date Sample Taken
    Beskrivning

    Pharmacokinetic aspects; Blood; Sampling; Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Actual Time
    Beskrivning

    Pharmacokinetic aspects; Blood; Sampling; Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0040223
    Sample Number
    Beskrivning

    Pharmacokinetic aspects; Blood; Sample identification number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C1299222
    Anti-Diabetic Agent Tolerability Scale (ADATS)
    Beskrivning

    Anti-Diabetic Agent Tolerability Scale (ADATS)

    Alias
    UMLS CUI-1
    C0935929
    UMLS CUI-2
    C3274448
    Current Date
    Beskrivning

    Antidiabetics; Tolerability Study;Date in Time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0935929
    UMLS CUI [1,2]
    C3274448
    UMLS CUI [1,3]
    C0011008
    Has the subject reported any AEs/SAEs or Hypoglycaemic Events during the past two days?
    Beskrivning

    Adverse event; Serious Adverse Event; Hypoglycaemic episode

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2]
    C1519255
    UMLS CUI [3]
    C0745153
    How many AEs has the subject reported during the past two days?
    Beskrivning

    Adverse event; Quantity

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1265611
    Adverse events
    Beskrivning

    Adverse events

    Alias
    UMLS CUI-1
    C0877248
    Adverse Event
    Beskrivning

    Adverse Event

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0877248
    AE page number
    Beskrivning

    Adverse event; Page, Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1704732
    UMLS CUI [1,3]
    C0237753
    AE row number
    Beskrivning

    Adverse event; row (table), number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1552840
    UMLS CUI [1,3]
    C0237753
    Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet
    Beskrivning

    Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet

    Alias
    UMLS CUI-1
    C0935929
    UMLS CUI-2
    C3274448
    UMLS CUI-3
    C2349155
    During the past 2 days, how bothersome has your (most bothersome AE) been to you?
    Beskrivning

    Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C4489383
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C4489382
    UMLS CUI [3,1]
    C0877248
    UMLS CUI [3,2]
    C4489381
    UMLS CUI [4,1]
    C0877248
    UMLS CUI [4,2]
    C4489380
    UMLS CUI [5,1]
    C0877248
    UMLS CUI [5,2]
    C4489379
    During the past 2 days, how bothersome has your (second most bothersome AE) been to you?
    Beskrivning

    Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C4489383
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C4489382
    UMLS CUI [3,1]
    C0877248
    UMLS CUI [3,2]
    C4489381
    UMLS CUI [4,1]
    C0877248
    UMLS CUI [4,2]
    C4489380
    UMLS CUI [5,1]
    C0877248
    UMLS CUI [5,2]
    C4489379
    During the past 2 days, how bothersome has your (third most bothersome AE) been to you?
    Beskrivning

    Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C4489383
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C4489382
    UMLS CUI [3,1]
    C0877248
    UMLS CUI [3,2]
    C4489381
    UMLS CUI [4,1]
    C0877248
    UMLS CUI [4,2]
    C4489380
    UMLS CUI [5,1]
    C0877248
    UMLS CUI [5,2]
    C4489379
    During the past 2 days, overall, how much were you bothered by side effects of the study medications?
    Beskrivning

    Experimental drug; Adverse reaction to drug; Impaired

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0041755
    UMLS CUI [1,3]
    C0221099
    Tillbaka till toppen

    Similar models

    Day 9

    1 Formulär
    1. StudyEvent: ODM
      1. Day 9
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    12 lead ECG; Start Date
    Item
    Start Date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    12 lead ECG; Ventricular Rate
    Item
    Ventricular Rate
    integer
    C0430456 (UMLS CUI [1,1])
    C2189285 (UMLS CUI [1,2])
    12 lead ECG; PR Interval
    Item
    PR Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0429087 (UMLS CUI [1,2])
    12 lead ECG; QRS complex Duration
    Item
    QRS Duration
    integer
    C0430456 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    12 lead ECG; QT interval finding
    Item
    Uncorrected QT Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    12 lead ECG; QTc Interval
    Item
    QTc Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    Item
    Result of the ECG
    integer
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    12 lead ECG; result
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant  (2)
    CL Item
    Abnormal - Clinically significant (3)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date in time
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Systolic Pressure
    Item
    Blood Pressure (sitting) - Systolic
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Blood Pressure (sitting) - Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate (sitting)
    text
    C0018810 (UMLS CUI [1])
    Item Group
    Electronically transferred laboratory data - Clinical Chemistry
    C0008000 (UMLS CUI-1)
    Clinical Chemistry; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0008000 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Clinical Chemistry; Time
    Item
    Actual Time
    time
    C0008000 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Electronically transferred laboratory data - Haematology
    C0474523 (UMLS CUI-1)
    Hematology finding; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0474523 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Hematology finding; Time
    Item
    Actual Time
    time
    C0474523 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Electronically transferred laboratory data - Urinalysis
    C0042014 (UMLS CUI-1)
    Urinalysis; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0042014 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Urinalysis; Time
    Item
    Actual Time
    time
    C0042014 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Capillary Blood Glucose
    C0457578 (UMLS CUI-1)
    Capillary Blood Glucose measurement; Date in time
    Item
    Date
    date
    C0457578 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Capillary Blood Glucose measurement; relative time
    Item
    Planned relative time (e.g. prior to breakfast)
    text
    C0457578 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Capillary Blood Glucose measurement; Time
    Item
    Time
    time
    C0457578 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Capillary Blood Glucose measurement; Result
    Item
    Result
    float
    C0457578 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item
    Unit
    text
    C0457578 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Capillary Blood Glucose measurement; Unit of measure
    Code List
    Unit
    CL Item
    mmol/L (mmol/L)
    CL Item
    mg/dL (mg/dL)
    Item Group
    Pharmacodynamics - Blood [Glucose, Glucagon, Insulin, C-Peptide]
    C0851347 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    C0017725 (UMLS CUI-3)
    C0017687 (UMLS CUI-4)
    C0021641 (UMLS CUI-5)
    C0006558 (UMLS CUI-6)
    Item
    Planned Relative Time
    text
    C0851347 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Pharmacodynamics; relative time
    Code List
    Planned Relative Time
    CL Item
    Predose (Predose)
    CL Item
    0.5hr (Pre-meal) (0.5hr (Pre-meal))
    CL Item
    0.75 hr (0.75 hr)
    CL Item
    1 hr (1 hr)
    CL Item
    1.5 hr (1.5 hr)
    CL Item
    2 hr (2 hr)
    CL Item
    2.5 hr (2.5 hr)
    CL Item
    3.5 hr (3.5 hr)
    CL Item
    4.5 hr (Pre-meal) (4.5 hr (Pre-meal))
    CL Item
    4.75 hr (4.75 hr)
    CL Item
    5 hr (5 hr)
    CL Item
    5.5 hr (5.5 hr)
    CL Item
    6 hr (6 hr)
    CL Item
    6.5 hr (6.5 hr)
    CL Item
    7.5 hr (7.5 hr)
    CL Item
    8.5 hr (8.5 hr)
    CL Item
    10 hr (10 hr)
    CL Item
    10.5 hr (Pre-meal) (10.5 hr (Pre-meal))
    CL Item
    10.75 hr (10.75 hr)
    CL Item
    11 hr (11 hr)
    CL Item
    11.5 hr (11.5 hr)
    CL Item
    12 hr (12 hr)
    CL Item
    12.5 hr (12.5 hr)
    CL Item
    13.5 hr (13.5 hr)
    CL Item
    14.5 hr (14.5 hr)
    CL Item
    18.5 hr (18.5 hr)
    CL Item
    24 hr (24 hr)
    Pharmacokinetic aspects; Blood; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0851347 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Pharmacokinetic aspects; Blood; Sampling; Time
    Item
    Actual Time
    time
    C0851347 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Sample Number
    integer
    C0851347 (UMLS CUI [1,1])
    C1299222 (UMLS CUI [1,2])
    Pharmacokinetic aspects; Blood; Sample identification 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)
    CL Item
    211 (11)
    CL Item
    212 (12)
    CL Item
    213 (13)
    CL Item
    214 (14)
    CL Item
    215 (15)
    CL Item
    216 (16)
    CL Item
    217 (17)
    CL Item
    218 (18)
    CL Item
    219 (19)
    CL Item
    220 (20)
    CL Item
    221 (21)
    CL Item
    222 (22)
    CL Item
    223 (23)
    CL Item
    224 (24)
    CL Item
    225 (25)
    CL Item
    226 (26)
    CL Item
    227 (27)
    Item Group
    Pharmacodynamics - Blood [GLP-1 Total]
    C0851347 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    C0061355 (UMLS CUI-3)
    Item
    Planned Relative Time
    text
    C0851347 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Pharmacodynamics; relative time
    Code List
    Planned Relative Time
    CL Item
    Predose (Predose)
    CL Item
    0.5hr (Pre-meal) (0.5hr (Pre-meal))
    CL Item
    0.75 hr (0.75 hr)
    CL Item
    1 hr (1 hr)
    CL Item
    1.5 hr (1.5 hr)
    CL Item
    2 hr (2 hr)
    CL Item
    4.5 hr (Pre-meal) (4.5 hr (Pre-meal))
    CL Item
    4.75 hr (4.75 hr)
    CL Item
    5.5 hr (5.5 hr)
    CL Item
    6.5 hr (6.5 hr)
    CL Item
    10.5 hr (Pre-meal) (10.5 hr (Pre-meal))
    CL Item
    10.75 hr (10.75 hr)
    CL Item
    11 hr (11 hr)
    CL Item
    11.5 hr (11.5 hr)
    CL Item
    12 hr (12 hr)
    CL Item
    12.5 hr (12.5 hr)
    Pharmacokinetic aspects; Blood; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0851347 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Pharmacokinetic aspects; Blood; Sampling; Time
    Item
    Actual Time
    time
    C0851347 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Sample Number
    integer
    C0851347 (UMLS CUI [1,1])
    C1299222 (UMLS CUI [1,2])
    Pharmacokinetic aspects; Blood; Sample identification number
    Code List
    Sample Number
    CL Item
    428 (1)
    CL Item
    429 (2)
    CL Item
    430 (3)
    CL Item
    431 (4)
    CL Item
    432 (5)
    CL Item
    433 (6)
    CL Item
    434 (7)
    CL Item
    435 (8)
    CL Item
    436 (9)
    CL Item
    437 (10)
    CL Item
    438 (11)
    CL Item
    439 (12)
    CL Item
    440 (13)
    CL Item
    441 (14)
    CL Item
    442 (15)
    CL Item
    443 (16)
    Item Group
    Bioactivity Sampling; Blood
    C0599112 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    Item
    Planned Relative Time
    text
    C0599112 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    drug biological activity; Collection of blood specimen for laboratory procedure; relative time
    Code List
    Planned Relative Time
    CL Item
    Day 9 (Day 9)
    drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0599112 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Time
    Item
    Actual Time
    time
    C0599112 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Sample Number
    integer
    C0599112 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [1,3])
    drug biological activity; Collection of blood specimen for laboratory procedure; Sample identification number
    Code List
    Sample Number
    CL Item
    604 (1)
    Item Group
    Pharmacokinetic aspects; Blood (GLP-1 total)
    C0005834 (UMLS CUI-1)
    C0031328 (UMLS CUI-2)
    C0061355 (UMLS CUI-3)
    Item
    Planned Relative Time
    text
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    Pharmacokinetic aspects; Blood; relative time
    Code List
    Planned Relative Time
    CL Item
    Predose (Predose)
    CL Item
    12 hr (12 hr)
    Pharmacokinetic aspects; Blood; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Pharmacokinetic aspects; Blood; Sampling; Time
    Item
    Actual Time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Sample Number
    integer
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [1,3])
    Pharmacokinetic aspects; Blood; Sample identification number
    Code List
    Sample Number
    CL Item
    113 (1)
    CL Item
    114 (2)
    Item Group
    Anti-Diabetic Agent Tolerability Scale (ADATS)
    C0935929 (UMLS CUI-1)
    C3274448 (UMLS CUI-2)
    Antidiabetics; Tolerability Study;Date in Time
    Item
    Current Date
    date
    C0935929 (UMLS CUI [1,1])
    C3274448 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Adverse event; Serious Adverse Event; Hypoglycaemic episode
    Item
    Has the subject reported any AEs/SAEs or Hypoglycaemic Events during the past two days?
    boolean
    C0877248 (UMLS CUI [1])
    C1519255 (UMLS CUI [2])
    C0745153 (UMLS CUI [3])
    Adverse event; Quantity
    Item
    How many AEs has the subject reported during the past two days?
    integer
    C0877248 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    Item Group
    Adverse events
    C0877248 (UMLS CUI-1)
    Adverse Event
    Item
    Adverse Event
    text
    C0877248 (UMLS CUI [1])
    Adverse event; Page, Number
    Item
    AE page number
    integer
    C0877248 (UMLS CUI [1,1])
    C1704732 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Adverse event; row (table), number
    Item
    AE row number
    integer
    C0877248 (UMLS CUI [1,1])
    C1552840 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Item Group
    Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet
    C0935929 (UMLS CUI-1)
    C3274448 (UMLS CUI-2)
    C2349155 (UMLS CUI-3)
    Item
    During the past 2 days, how bothersome has your (most bothersome AE) been to you?
    text
    C0877248 (UMLS CUI [1,1])
    C4489383 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [2,1])
    C4489382 (UMLS CUI [2,2])
    C0877248 (UMLS CUI [3,1])
    C4489381 (UMLS CUI [3,2])
    C0877248 (UMLS CUI [4,1])
    C4489380 (UMLS CUI [4,2])
    C0877248 (UMLS CUI [5,1])
    C4489379 (UMLS CUI [5,2])
    undefined item
    Code List
    During the past 2 days, how bothersome has your (most bothersome AE) been to you?
    CL Item
    Not at all bothersome (0)
    CL Item
    A little bit bothersome (1)
    CL Item
    Moderately bothersome (2)
    CL Item
    Quite bothersome (3)
    CL Item
    Extremely bothersome (4)
    Item
    During the past 2 days, how bothersome has your (second most bothersome AE) been to you?
    text
    C0877248 (UMLS CUI [1,1])
    C4489383 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [2,1])
    C4489382 (UMLS CUI [2,2])
    C0877248 (UMLS CUI [3,1])
    C4489381 (UMLS CUI [3,2])
    C0877248 (UMLS CUI [4,1])
    C4489380 (UMLS CUI [4,2])
    C0877248 (UMLS CUI [5,1])
    C4489379 (UMLS CUI [5,2])
    undefined item
    Code List
    During the past 2 days, how bothersome has your (second most bothersome AE) been to you?
    CL Item
    Not at all bothersome (0)
    CL Item
    A little bit bothersome (1)
    CL Item
    Moderately bothersome (2)
    CL Item
    Quite bothersome (3)
    CL Item
    Extremely bothersome (4)
    Item
    During the past 2 days, how bothersome has your (third most bothersome AE) been to you?
    text
    C0877248 (UMLS CUI [1,1])
    C4489383 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [2,1])
    C4489382 (UMLS CUI [2,2])
    C0877248 (UMLS CUI [3,1])
    C4489381 (UMLS CUI [3,2])
    C0877248 (UMLS CUI [4,1])
    C4489380 (UMLS CUI [4,2])
    C0877248 (UMLS CUI [5,1])
    C4489379 (UMLS CUI [5,2])
    undefined item
    Code List
    During the past 2 days, how bothersome has your (third most bothersome AE) been to you?
    CL Item
    Not at all bothersome (0)
    CL Item
    A little bit bothersome (1)
    CL Item
    Moderately bothersome (2)
    CL Item
    Quite bothersome (3)
    CL Item
    Extremely bothersome (4)
    Item
    During the past 2 days, overall, how much were you bothered by side effects of the study medications?
    text
    C0304229 (UMLS CUI [1,1])
    C0041755 (UMLS CUI [1,2])
    C0221099 (UMLS CUI [1,3])
    undefined item
    Code List
    During the past 2 days, overall, how much were you bothered by side effects of the study medications?
    CL Item
    Not at all bothersome (0)
    CL Item
    A little bothered  (1)
    CL Item
    Moderately bothered  (2)
    CL Item
    Quite bothered  (3)
    CL Item
    Extremely bothered (4)
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