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ID

25991

Descrição

PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

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Versões (1)
  1. 03/10/2017 03/10/2017 -
Titular dos direitos

glaxoSmithKline

Transferido a

3 de outubro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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    PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    Inglês

    PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    1 Formulários  
    Orthostatic blood pressure / Pulse - Predose
    Descrição

    Orthostatic blood pressure / Pulse - Predose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C1095971
    UMLS CUI-3
    C0232117
    UMLS CUI-4
    C3812758
    Date of visit
    Descrição

    For the pre-dose measurements in Part A, Day 1 of Periods 1 and 2, and Part B, Day 1 of Periods 1 and 2, 3 sets of semi-supine and erect blood pressure and pulse measurements will be taken, commencing approximately 40 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi- supine position. Three stable measurements should be recorded In this instance stable is defined as the three semi-supine diastolic measurements being within 15 mmHg of the lowest measurement. This rule also applies for the semi-supine systolic and erect systolic and diastolic measurements. A maximum of six attempts can be made to obtain measurements pre-dose. If three consecutive stable measurements of blood pressure cannot be obtained then the Investigator should contact the Medical Monitor to discuss whether the patient can be included/continue in the study.

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C3812758
    Heart Rate semi-supine
    Descrição

    Heart rate Semi-Supine

    Tipo de dados

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C3812758
    bpm
    Heart Rate standing
    Descrição

    Heart Rate standing

    Tipo de dados

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C2029905
    UMLS CUI [1,2]
    C3812758
    bpm
    Systolic blood pressure semi-supine
    Descrição

    Systolic blood pressure semi-supine

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C3812758
    mmHg
    Diastolic blood pressure semi-supine
    Descrição

    Diastolic blood pressure semi-supine

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C3812758
    mmHg
    Systolic blood pressure standing
    Descrição

    Systolic blood pressure standing

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    UMLS CUI [1,3]
    C3812758
    mmHg
    Diastolic blood pressure standing
    Descrição

    Diastolic blood pressure standing

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C1303019
    UMLS CUI [1,2]
    C3812758
    mmHg
    Pregnancy test
    Descrição

    Pregnancy test

    Alias
    UMLS CUI-1
    C0032976
    Was a pregnancy test performed?
    Descrição

    pregnancy test

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0032976
    If yes, what type of pregnancy test was performed?
    Descrição

    pregnancy test

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0032976
    Date of pregnancy test
    Descrição

    Date of pregnancy test

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Result
    Descrição

    Result of pregnancy test

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0427777
    Patient diary
    Descrição

    Patient diary

    Alias
    UMLS CUI-1
    C3890583
    Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
    Descrição

    Patient diary

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3890583
    Alcohol breath/ blood test
    Descrição

    Alcohol breath/ blood test

    Alias
    UMLS CUI-1
    C0202304
    Time
    Descrição

    Perform Alcohol Breath/Blood Test and attach printout

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0202304
    UMLS CUI [1,2]
    C0040223
    Result
    Descrição

    Result of alcohol test

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0202304
    UMLS CUI [1,2]
    C1274040
    Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B Has this subject consumed alcohol within the previous 24h?
    Descrição

    alcohol consumption

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0443288
    Drug screening (urine)
    Descrição

    Drug screening (urine)

    Alias
    UMLS CUI-1
    C0202274
    Time
    Descrição

    Time of drug screening

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0202274
    Cannabinoids
    Descrição

    Cannabinoids urine

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0006864
    Morphine and morphine derivates
    Descrição

    Morphine and morphine derivates urine

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0279996
    Amphetamine
    Descrição

    Amphetamine urine

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0002667
    Barbiturates
    Descrição

    Barbiturates urine

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0004745
    Benzodiazepines
    Descrição

    Benzodiazepines urine

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0005064
    Cocaine
    Descrição

    Cocaine urine

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0009170
    Tricyclic antidepressants
    Descrição

    Tricyclic antidepressants urine

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0003290
    If positive, give further details.
    Descrição

    Urine drug screening positive specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2711519
    UMLS CUI [1,2]
    C1521902
    Concomitant medication
    Descrição

    Concomitant medication

    Alias
    UMLS CUI-1
    C2347852
    Has the subject had any changes in medication since the last study visit?
    Descrição

    If 'Yes', please document on the Concomitant Medication Report Forms.

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0580105
    Have the subject's smoking habits remained unchanged?
    Descrição

    tobacco use unchanged

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0442739
    Has the subject complied with suggested dietary restrictions?
    Descrição

    dietary restrictions

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0425422
    UMLS CUI [1,2]
    C1321605
    Adverse event
    Descrição

    Adverse event

    Alias
    UMLS CUI-1
    C0877248
    Has the subject experienced any Adverse Events since the last study contact?
    Descrição

    If 'Yes', please document on the Adverse Event Report Forms.

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0877248
    Standard Breakfast
    Descrição

    Standard Breakfast

    Alias
    UMLS CUI-1
    C2698559
    Breakfast started
    Descrição

    Breakfast started

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0439659
    Breakfast ended
    Descrição

    Breakfast ended

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0444930
    Did the subject complete the breakfast?
    Descrição

    Breakfast completed

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0814440
    UMLS CUI [1,2]
    C0205197
    If no, please comment:
    Descrição

    Breakfast not completed comment

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0814440
    UMLS CUI [1,3]
    C0205197
    Study Drug Dosing
    Descrição

    Study Drug Dosing

    Alias
    UMLS CUI-1
    C0013175
    UMLS CUI-2
    C0678766
    Dosage given
    Descrição

    The subject will not be allowed to lie down or sleep for 4 hours after the morning dose.

    Tipo de dados

    float

    Unidades de medida
    • mg/day
    Alias
    UMLS CUI [1]
    C0678766
    mg/day
    Dosage
    Descrição

    Dosage

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C3854006
    Time of dosing
    Descrição

    Time of Dosing

    Tipo de dados

    time

    Unidades de medida
    • 24hr:min
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0040223
    24hr:min
    Witness 1
    Descrição

    Witness 1

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C0001555
    Witness 2
    Descrição

    Witness 2

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C0001555
    Witness date
    Descrição

    Witness date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C4263486
    UMLS CUI [1,2]
    C0011008
    Orthostatic blood pressure / pulse measurement - post dose
    Descrição

    Orthostatic blood pressure / pulse measurement - post dose

    Alias
    UMLS CUI-1
    C1095971
    UMLS CUI-2
    C0232117
    UMLS CUI-3
    C0439568
    Time point
    Descrição

    Date of visit

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Post dose
    Descrição

    Post dose

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0439568
    Post dose
    Descrição

    Post dose

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0439568
    Time of post dose
    Descrição

    Time post dose

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0439568
    UMLS CUI [1,2]
    C0040223
    Heart Rate semi-supine
    Descrição

    Heart rate Semi-Supine

    Tipo de dados

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C0439568
    bpm
    Heart Rate standing
    Descrição

    Heart Rate standing

    Tipo de dados

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C2029905
    UMLS CUI [1,2]
    C0439568
    bpm
    Systolic blood pressure semi-supine
    Descrição

    Systolic blood pressure semi-supine

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C0439568
    mmHg
    Diastolic blood pressure semi-supine
    Descrição

    Diastolic blood pressure semi-supine

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C0439568
    mmHg
    Systolic blood pressure standing
    Descrição

    Systolic blood pressure standing

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    UMLS CUI [1,3]
    C0439568
    mmHg
    Diastolic blood pressure standing
    Descrição

    Diastolic blood pressure standing

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0231472
    UMLS CUI [1,3]
    C0439568
    mmHg
    Adverse Event - 4 hours post dosing
    Descrição

    Adverse Event - 4 hours post dosing

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C0439574
    Has the subject experienced any Adverse Events since the time of dosing?
    Descrição

    If Yes , please document on the Adverse Event Report Forms

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0877248
    Discharge
    Descrição

    Discharge

    Alias
    UMLS CUI-1
    C0030685
    Was study medication dispensed to the subject?
    Descrição

    For subjects randomized to IR formulation, please ensure sufficient medication has been dispensed and that the subject is instructed re: self administration

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C3854006
    UMLS CUI [1,2]
    C0947323
    Time of discharge from study site
    Descrição

    Discharge Time

    Tipo de dados

    time

    Alias
    UMLS CUI [1]
    C3864299
    Date of next study visit
    Descrição

    Date of next study visit

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1545257
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    PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Orthostatic blood pressure / Pulse - Predose
    C0518766 (UMLS CUI-1)
    C1095971 (UMLS CUI-2)
    C0232117 (UMLS CUI-3)
    C3812758 (UMLS CUI-4)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1,1])
    C3812758 (UMLS CUI [1,2])
    Heart rate Semi-Supine
    Item
    Heart Rate semi-supine
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Heart Rate standing
    Item
    Heart Rate standing
    integer
    C2029905 (UMLS CUI [1,1])
    C3812758 (UMLS CUI [1,2])
    Systolic blood pressure semi-supine
    Item
    Systolic blood pressure semi-supine
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Diastolic blood pressure semi-supine
    Item
    Diastolic blood pressure semi-supine
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Systolic blood pressure standing
    Item
    Systolic blood pressure standing
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Diastolic blood pressure standing
    Item
    Diastolic blood pressure standing
    integer
    C1303019 (UMLS CUI [1,1])
    C3812758 (UMLS CUI [1,2])
    Item Group
    Pregnancy test
    C0032976 (UMLS CUI-1)
    Item
    Was a pregnancy test performed?
    integer
    C0032976 (UMLS CUI [1])
    pregnancy test
    Code List
    Was a pregnancy test performed?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (3)
    Item
    If yes, what type of pregnancy test was performed?
    integer
    C0032976 (UMLS CUI [1])
    pregnancy test
    Code List
    If yes, what type of pregnancy test was performed?
    CL Item
    Serum (1)
    CL Item
    Urine (2)
    Date of pregnancy test
    Item
    Date of pregnancy test
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Result
    integer
    C0427777 (UMLS CUI [1])
    Result of pregnancy test
    Code List
    Result
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item Group
    Patient diary
    C3890583 (UMLS CUI-1)
    Patient diary
    Item
    Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
    text
    C3890583 (UMLS CUI [1])
    Item Group
    Alcohol breath/ blood test
    C0202304 (UMLS CUI-1)
    Time of alcohol test
    Item
    Time
    time
    C0202304 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Result
    integer
    C0202304 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result of alcohol test
    Code List
    Result
    CL Item
    negative (1)
    CL Item
    positive (2)
    alcohol consumption
    Item
    Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B Has this subject consumed alcohol within the previous 24h?
    boolean
    C0001948 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    Item Group
    Drug screening (urine)
    C0202274 (UMLS CUI-1)
    Time of drug screening
    Item
    Time
    time
    C0040223 (UMLS CUI [1,1])
    C0202274 (UMLS CUI [1,2])
    Item
    Cannabinoids
    integer
    C0202274 (UMLS CUI [1,1])
    C0006864 (UMLS CUI [1,2])
    Cannabinoids urine
    Code List
    Cannabinoids
    CL Item
    negative (1)
    CL Item
    positive (2)
    Item
    Morphine and morphine derivates
    integer
    C0202274 (UMLS CUI [1,1])
    C0279996 (UMLS CUI [1,2])
    Morphine and morphine derivates urine
    Code List
    Morphine and morphine derivates
    CL Item
    negative (1)
    CL Item
    positive (2)
    Item
    Amphetamine
    integer
    C0202274 (UMLS CUI [1,1])
    C0002667 (UMLS CUI [1,2])
    Amphetamine urine
    Code List
    Amphetamine
    CL Item
    negative (1)
    CL Item
    positive (2)
    Item
    Barbiturates
    integer
    C0202274 (UMLS CUI [1,1])
    C0004745 (UMLS CUI [1,2])
    Barbiturates urine
    Code List
    Barbiturates
    CL Item
    negative (1)
    CL Item
    positive (2)
    Item
    Benzodiazepines
    integer
    C0202274 (UMLS CUI [1,1])
    C0005064 (UMLS CUI [1,2])
    Benzodiazepines urine
    Code List
    Benzodiazepines
    CL Item
    negative (1)
    CL Item
    positive (2)
    Item
    Cocaine
    integer
    C0202274 (UMLS CUI [1,1])
    C0009170 (UMLS CUI [1,2])
    Cocaine urine
    Code List
    Cocaine
    CL Item
    negative (1)
    CL Item
    positive (2)
    Item
    Tricyclic antidepressants
    integer
    C0003290 (UMLS CUI [1])
    Tricyclic antidepressants urine
    Code List
    Tricyclic antidepressants
    CL Item
    negative (1)
    CL Item
    positive (2)
    Urine drug screening positive specify
    Item
    If positive, give further details.
    text
    C2711519 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Item Group
    Concomitant medication
    C2347852 (UMLS CUI-1)
    Item
    Has the subject had any changes in medication since the last study visit?
    integer
    C0580105 (UMLS CUI [1])
    changes in medication
    Code List
    Has the subject had any changes in medication since the last study visit?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Have the subject's smoking habits remained unchanged?
    integer
    C0543414 (UMLS CUI [1,1])
    C0442739 (UMLS CUI [1,2])
    tobacco use unchanged
    Code List
    Have the subject's smoking habits remained unchanged?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Has the subject complied with suggested dietary restrictions?
    integer
    C0425422 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    dietary restrictions
    Code List
    Has the subject complied with suggested dietary restrictions?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Adverse event
    C0877248 (UMLS CUI-1)
    Item
    Has the subject experienced any Adverse Events since the last study contact?
    integer
    C0877248 (UMLS CUI [1])
    adverse event
    Code List
    Has the subject experienced any Adverse Events since the last study contact?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Standard Breakfast
    C2698559 (UMLS CUI-1)
    Breakfast started
    Item
    Breakfast started
    time
    C2698559 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    Breakfast ended
    Item
    Breakfast ended
    time
    C2698559 (UMLS CUI [1,1])
    C0444930 (UMLS CUI [1,2])
    Breakfast completed
    Item
    Did the subject complete the breakfast?
    boolean
    C0814440 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Breakfast not completed comment
    Item
    If no, please comment:
    text
    C0947611 (UMLS CUI [1,1])
    C0814440 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
    Item Group
    Study Drug Dosing
    C0013175 (UMLS CUI-1)
    C0678766 (UMLS CUI-2)
    Dosage given
    Item
    Dosage given
    float
    C0678766 (UMLS CUI [1])
    Item
    Dosage
    integer
    C0178602 (UMLS CUI [1,1])
    C3854006 (UMLS CUI [1,2])
    Dosage
    Code List
    Dosage
    CL Item
    CR (1)
    CL Item
    IR (2)
    Time of Dosing
    Item
    Time of dosing
    time
    C0178602 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Witness 1
    Item
    Witness 1
    text
    C0682356 (UMLS CUI [1,1])
    C0001555 (UMLS CUI [1,2])
    Witness 2
    Item
    Witness 2
    text
    C0682356 (UMLS CUI [1,1])
    C0001555 (UMLS CUI [1,2])
    Witness date
    Item
    Witness date
    date
    C4263486 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Orthostatic blood pressure / pulse measurement - post dose
    C1095971 (UMLS CUI-1)
    C0232117 (UMLS CUI-2)
    C0439568 (UMLS CUI-3)
    Date of visit
    Item
    Time point
    date
    C1320303 (UMLS CUI [1])
    Item
    Post dose
    integer
    C0439568 (UMLS CUI [1])
    Post dose
    Code List
    Post dose
    CL Item
    1h post dose (1)
    CL Item
    2h post dose (2)
    CL Item
    3h post dose (3)
    CL Item
    4h post dose (4)
    Item
    Post dose
    integer
    C0439568 (UMLS CUI [1])
    Post dose
    Code List
    Post dose
    CL Item
    1h post dose (1)
    CL Item
    2h post dose (2)
    CL Item
    3h post dose (3)
    CL Item
    4h post dose (4)
    Time post dose
    Item
    Time of post dose
    time
    C0439568 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Heart rate Semi-Supine
    Item
    Heart Rate semi-supine
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Heart Rate standing
    Item
    Heart Rate standing
    integer
    C2029905 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    Systolic blood pressure semi-supine
    Item
    Systolic blood pressure semi-supine
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Diastolic blood pressure semi-supine
    Item
    Diastolic blood pressure semi-supine
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Systolic blood pressure standing
    Item
    Systolic blood pressure standing
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Diastolic blood pressure standing
    Item
    Diastolic blood pressure standing
    integer
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Item Group
    Adverse Event - 4 hours post dosing
    C0877248 (UMLS CUI-1)
    C0439574 (UMLS CUI-2)
    Item
    Has the subject experienced any Adverse Events since the time of dosing?
    integer
    C0877248 (UMLS CUI [1])
    adverse event
    Code List
    Has the subject experienced any Adverse Events since the time of dosing?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Discharge
    C0030685 (UMLS CUI-1)
    Item
    Was study medication dispensed to the subject?
    integer
    C3854006 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    Study medication dispensed
    Code List
    Was study medication dispensed to the subject?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (3)
    Discharge Time
    Item
    Time of discharge from study site
    time
    C3864299 (UMLS CUI [1])
    Date of next study visit
    Item
    Date of next study visit
    date
    C1545257 (UMLS CUI [1])
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