0 Evaluaciones
ID

24745

Descripción

Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female 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: ropinirole Trade Name: Requip Study Indication : Parkinson Disease Documentation part: Treatment Period 1, Day 1/1-2

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Versiones (1)
  1. 16/8/17 16/8/17 -
Subido en

16 de agosto de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Dose strength equivalence of ropinirole CR in healthy adults Treatment Period 1 101468/219

    Inglés

    Treatment Period 1 Dose strength equivalence of ropinirole CR in healthy adults 101468/219

    1 formularios  
    Predose Checklist
    Descripción

    Predose Checklist

    Alias
    UMLS CUI-1
    C0439565
    UMLS CUI-2
    C1707357
    Has the subject refrained from taking any prescribed medications for at least 14 days and OTC medication for at least 7 days prior to the clinic visit?
    Descripción

    prescribed medications

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3166216
    UMLS CUI [1,2]
    C0443288
    Has the patient refrained from consuming alcohol for 48 hours before day 1?
    Descripción

    alcohol consumption

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0443288
    Has the subject refrained from consuming xanthine-containing beverages and foods and quinine-containing products for 48 hours before day -1?
    Descripción

    xanthine-containing beverages and foods

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0043314
    UMLS CUI [1,2]
    C0016452
    UMLS CUI [1,3]
    C0443288
    Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    Descripción

    daily alcohol consumption

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0443288
    Has the subject refrained from consuming poppy seed-containing food during the 3 days prior to their visit?
    Descripción

    poppy seed-containing food

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0453264
    UMLS CUI [1,2]
    C0016452
    UMLS CUI [1,3]
    C0443288
    Has the patient refrained from strenuous exercise from 48 hours prior to their visit?
    Descripción

    strenuous exercise

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1514989
    UMLS CUI [1,2]
    C0443288
    For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    Descripción

    concomitant medications

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3850050
    UMLS CUI [1,3]
    C0443288
    UMLS CUI [2]
    C3850068
    Pregnancy Test
    Descripción

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    UMLS CUI-2
    C0032961
    Was a pregnancy test carried out?
    Descripción

    pregnancy test

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032976
    Was a pregnancy test carried out? If No, please specify reason
    Descripción

    reason pregnancy test not done

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1272696
    UMLS CUI [1,3]
    C0392360
    Date of pregnancy test
    Descripción

    Was a pregnancy test carried out? If Yes, please specify

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Pregnancy test result
    Descripción

    Was a pregnancy test carried out? If Yes, please specify If ’Positive’, withdraw the subject from the study.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1274040
    Drug Screening
    Descripción

    Drug Screening

    Alias
    UMLS CUI-1
    C0202274
    Date of sampling
    Descripción

    Drug Screening (Urine)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0870078
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2]
    C0202274
    Time of sampling
    Descripción

    Time of sampling

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0870078
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [2]
    C0202274
    Were there any contra-indicated drugs detected?
    Descripción

    contra-indicated drugs detected

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1511790
    UMLS CUI [1,2]
    C4036061
    Type of drug
    Descripción

    Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C4036061
    UMLS CUI [1,2]
    C0457591
    Comment
    Descripción

    Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C4036061
    UMLS CUI [1,2]
    C0947611
    Alcohol Breath Test
    Descripción

    Alcohol Breath Test

    Alias
    UMLS CUI-1
    C0202306
    Was an alcohol breath test carried out?
    Descripción

    Alcohol Breath Test

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0202306
    Was an alcohol breath test carried out? If "NO", please specify reason
    Descripción

    reason alcohol breath test not done

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C1272696
    UMLS CUI [1,3]
    C0392360
    Date of alcohol breath test
    Descripción

    Was an alcohol breath test carried out? If "YES", please specify

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C0011008
    Result alcohol breath test
    Descripción

    Was an alcohol breath test carried out? If "YES", please specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C1274040
    Baseline Signs Ans Symptoms
    Descripción

    Baseline Signs Ans Symptoms

    Alias
    UMLS CUI-1
    C0037088
    UMLS CUI-2
    C1442488
    Patient Number
    Descripción

    Patient Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1830427
    Center Number
    Descripción

    Center Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Date of Visit
    Descripción

    Date of Visit

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Baseline Sign/Symptom
    Descripción

    Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to subject: “How do you feel?” Provide the diagnosis, NOT symptoms where possible. (One baseline event per column) If no baseline events experienced, please mark box NO and sign form below

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    Baseline Sign/Symptom
    Descripción

    diagnosis

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0011900
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C1442488
    Onset Date
    Descripción

    Onset Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0808070
    Onset Time
    Descripción

    Onset Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0449244
    End Date
    Descripción

    End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0806020
    End Time
    Descripción

    End Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C1522314
    Outcome (If subject dies, please inform GSK within 24 hours and complete form D)
    Descripción

    outcome

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1547647
    UMLS CUI [1,2]
    C0011900
    Event Course
    Descripción

    event course

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    UMLS CUI [1,3]
    C0011900
    Event Course, if intermittent, Number of episodes
    Descripción

    Number of episodes

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C4086638
    UMLS CUI [1,2]
    C0011900
    Intensity
    Descripción

    intensity

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0011900
    Relationship to study procedures performed prior to randomisation
    Descripción

    relationship to study procedures

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1510821
    UMLS CUI [1,2]
    C0011900
    Corrective Therapy
    Descripción

    If Yes, please record on Prior Medication form.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    UMLS CUI [2]
    C0011900
    Was subject withdrawn due to this event?
    Descripción

    subject withdrawn due to event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0877248
    Vitals Signs, Pre-Dose
    Descripción

    Vitals Signs, Pre-Dose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439565
    Date of vital sign measurement
    Descripción

    Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    Time of vital sign measurement
    Descripción

    Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Blood pressure - supine, systolic
    Descripción

    systolic Blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Blood pressure - supine, diastolic
    Descripción

    diastolic blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    mmHg
    Heart rate - supine
    Descripción

    Heart rate supine

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    beats/min
    Blood pressure - erect, systolic
    Descripción

    systolic Blood pressure erect

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    mmHg
    Blood pressure - erect, diastolic
    Descripción

    diastolic Blood pressure erect

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0231472
    mmHg
    Heart rate - erect
    Descripción

    Heart rate erect

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0231472
    beats/min
    Dosing Details
    Descripción

    Dosing Details

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0178602
    Was morning meal/snack eaten before dosing?
    Descripción

    morning meal

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0439565
    Meal finish date
    Descripción

    Was morning meal/snack eaten before dosing?

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0011008
    Meal finish time
    Descripción

    Was morning meal/snack eaten before dosing?

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0040223
    Date of study medication dosing
    Descripción

    Date of study medication dosing

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    Time of study medication dosing
    Descripción

    Time of study medication dosing

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0040223
    Container Number
    Descripción

    Container Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0180098
    UMLS CUI [1,2]
    C0013227
    Regimen
    Descripción

    Regimen

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1276413
    UMLS CUI [1,2]
    C0013227
    Dose checked and administered by
    Descripción

    Dose checked and administered by

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1621583
    UMLS CUI [2,1]
    C0178602
    UMLS CUI [2,2]
    C1283174
    Dose checked and witnessed by
    Descripción

    Dose checked and witnessed by

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1283174
    Dose checked and administered, date
    Descripción

    Dose checked and administered, date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1621583
    UMLS CUI [1,3]
    C0011008
    Vital Signs - Post-Dose
    Descripción

    Vital Signs - Post-Dose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439568
    Time Point of measurement
    Descripción

    Time Point of measurement

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0242485
    UMLS CUI [1,3]
    C2348792
    Date of vital sign measurement
    Descripción

    Please measure again according to Study time: +1hr, +4hr, +6hrs, +12hrs, +24hrs, +36hrs

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    Time of vital sign measurement
    Descripción

    Please measure again according to Study time: +1hr, +4hr, +6hrs, +12hrs, +24hrs, +36hrs

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Blood pressure - supine, systolic
    Descripción

    systolic Blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Blood pressure - supine, diastolic
    Descripción

    diastolic blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    mmHg
    Heart rate - supine
    Descripción

    Heart rate supine

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    beats/min
    Blood pressure - erect, systolic
    Descripción

    systolic Blood pressure erect

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    mmHg
    Blood pressure - erect, diastolic
    Descripción

    diastolic Blood pressure erect

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0231472
    mmHg
    Heart rate - erect
    Descripción

    Heart rate erect

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0231472
    beats/min
    Domperidone Dosing Details
    Descripción

    Domperidone Dosing Details

    Alias
    UMLS CUI-1
    C0013015
    UMLS CUI-2
    C0178602
    Time Point administered
    Descripción

    Time Point administered

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C2348792
    Date domperidone administered
    Descripción

    2 X 10 mg tablets of domperidone are to be administered at the following timepoints. Time Point: Pre-dose - 1 hr, +7 hrs, +15 hrs Please record details below:

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013015
    UMLS CUI [1,2]
    C3469597
    UMLS CUI [1,3]
    C0011008
    Time domperidone administered
    Descripción

    2 X 10 mg tablets of domperidone are to be administered at the following timepoints. Time Point: Pre-dose - 1 hr, +7 hrs, +15 hrs Please record details below:

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0013015
    UMLS CUI [1,2]
    C3469597
    UMLS CUI [1,3]
    C0040223
    Comment domperidone administered
    Descripción

    Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013015
    UMLS CUI [1,2]
    C3469597
    UMLS CUI [1,3]
    C0947611
    PK Blood Sampling
    Descripción

    PK Blood Sampling

    Alias
    UMLS CUI-1
    C0005834
    Time relative to start of dose
    Descripción

    Time relative to start of dose

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C2348792
    Date blood sample taken
    Descripción

    Date blood sample taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0011008
    Time blood sample taken
    Descripción

    Time blood sample taken

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0040223
    Sample taken
    Descripción

    Sample taken

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1277698
    UMLS CUI [2]
    C0005834
    Comments
    Descripción

    Comments

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0947611
    Adverse Event
    Descripción

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    Time Point
    Descripción

    Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis not symptoms where possible.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2348792
    Any Adverse Event?
    Descripción

    *If "Yes" record all details on an Adverse Event page at back of CRF.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0877248
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    Treatment Period 1 Dose strength equivalence of ropinirole CR in healthy adults 101468/219

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Predose Checklist
    C0439565 (UMLS CUI-1)
    C1707357 (UMLS CUI-2)
    prescribed medications
    Item
    Has the subject refrained from taking any prescribed medications for at least 14 days and OTC medication for at least 7 days prior to the clinic visit?
    boolean
    C3166216 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    alcohol consumption
    Item
    Has the patient refrained from consuming alcohol for 48 hours before day 1?
    boolean
    C0001948 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    xanthine-containing beverages and foods
    Item
    Has the subject refrained from consuming xanthine-containing beverages and foods and quinine-containing products for 48 hours before day -1?
    boolean
    C0043314 (UMLS CUI [1,1])
    C0016452 (UMLS CUI [1,2])
    C0443288 (UMLS CUI [1,3])
    daily alcohol consumption
    Item
    Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    boolean
    C0001948 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    poppy seed-containing food
    Item
    Has the subject refrained from consuming poppy seed-containing food during the 3 days prior to their visit?
    boolean
    C0453264 (UMLS CUI [1,1])
    C0016452 (UMLS CUI [1,2])
    C0443288 (UMLS CUI [1,3])
    strenuous exercise
    Item
    Has the patient refrained from strenuous exercise from 48 hours prior to their visit?
    boolean
    C1514989 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    concomitant medications
    Item
    For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    boolean
    C2347852 (UMLS CUI [1,1])
    C3850050 (UMLS CUI [1,2])
    C0443288 (UMLS CUI [1,3])
    C3850068 (UMLS CUI [2])
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    C0032961 (UMLS CUI-2)
    pregnancy test
    Item
    Was a pregnancy test carried out?
    boolean
    C0032976 (UMLS CUI [1])
    reason pregnancy test not done
    Item
    Was a pregnancy test carried out? If No, please specify reason
    text
    C0032976 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Date of pregnancy test
    Item
    Date of pregnancy test
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Pregnancy test result
    integer
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Pregnancy test result
    Code List
    Pregnancy test result
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Drug Screening
    C0202274 (UMLS CUI-1)
    Date of sampling
    Item
    Date of sampling
    date
    C0870078 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0202274 (UMLS CUI [2])
    Time of sampling
    Item
    Time of sampling
    time
    C0870078 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0202274 (UMLS CUI [2])
    contra-indicated drugs detected
    Item
    Were there any contra-indicated drugs detected?
    boolean
    C1511790 (UMLS CUI [1,1])
    C4036061 (UMLS CUI [1,2])
    Type of drug
    Item
    Type of drug
    text
    C4036061 (UMLS CUI [1,1])
    C0457591 (UMLS CUI [1,2])
    drug
    Item
    Comment
    text
    C4036061 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Alcohol Breath Test
    C0202306 (UMLS CUI-1)
    Alcohol Breath Test
    Item
    Was an alcohol breath test carried out?
    boolean
    C0202306 (UMLS CUI [1])
    reason alcohol breath test not done
    Item
    Was an alcohol breath test carried out? If "NO", please specify reason
    text
    C0202306 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Date of alcohol breath test
    Item
    Date of alcohol breath test
    date
    C0202306 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Result alcohol breath test
    Item
    Result alcohol breath test
    text
    C0202306 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item Group
    Baseline Signs Ans Symptoms
    C0037088 (UMLS CUI-1)
    C1442488 (UMLS CUI-2)
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Center Number
    Item
    Center Number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Baseline Sign/Symptom
    Item
    Baseline Sign/Symptom
    boolean
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    diagnosis
    Item
    Baseline Sign/Symptom
    text
    C0011900 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C1442488 (UMLS CUI [2,2])
    Onset Date
    Item
    Onset Date
    date
    C0011900 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Onset Time
    Item
    Onset Time
    time
    C0011900 (UMLS CUI [1,1])
    C0449244 (UMLS CUI [1,2])
    End Date
    Item
    End Date
    date
    C0011900 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    End Time
    Item
    End Time
    time
    C0011900 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Outcome (If subject dies, please inform GSK within 24 hours and complete form D)
    text
    C1547647 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    outcome
    Code List
    Outcome (If subject dies, please inform GSK within 24 hours and complete form D)
    CL Item
    Resolved (R)
    CL Item
    Ongoing (O)
    CL Item
    Died (D)
    Item
    Event Course
    text
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [1,3])
    event course
    Code List
    Event Course
    CL Item
    Intermittent (I)
    CL Item
    Constant (C)
    Number of episodes
    Item
    Event Course, if intermittent, Number of episodes
    integer
    C4086638 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Item
    Intensity
    integer
    C0518690 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    intensity
    Code List
    Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Relationship to study procedures performed prior to randomisation
    integer
    C1510821 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    relationship to study procedures
    Code List
    Relationship to study procedures performed prior to randomisation
    CL Item
    Not related (1)
    CL Item
    Unlikely (2)
    CL Item
    Suspected (3)
    CL Item
    Probable (4)
    corrective therapy
    Item
    Corrective Therapy
    boolean
    C0087111 (UMLS CUI [1])
    C0011900 (UMLS CUI [2])
    subject withdrawn due to event
    Item
    Was subject withdrawn due to this event?
    boolean
    C0422727 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item Group
    Vitals Signs, Pre-Dose
    C0518766 (UMLS CUI-1)
    C0439565 (UMLS CUI-2)
    Date
    Item
    Date of vital sign measurement
    date
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time
    Item
    Time of vital sign measurement
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    systolic Blood pressure
    Item
    Blood pressure - supine, systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    diastolic blood pressure
    Item
    Blood pressure - supine, diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate supine
    Item
    Heart rate - supine
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    systolic Blood pressure erect
    Item
    Blood pressure - erect, systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    diastolic Blood pressure erect
    Item
    Blood pressure - erect, diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Heart rate erect
    Item
    Heart rate - erect
    integer
    C0018810 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Item Group
    Dosing Details
    C0013227 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    morning meal
    Item
    Was morning meal/snack eaten before dosing?
    boolean
    C2698559 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    Meal finish date
    Item
    Meal finish date
    date
    C2698559 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Meal finish time
    Item
    Meal finish time
    time
    C2698559 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Date of study medication dosing
    Item
    Date of study medication dosing
    date
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Time of study medication dosing
    Item
    Time of study medication dosing
    time
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Container Number
    Item
    Container Number
    text
    C0180098 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Item
    Regimen
    text
    C1276413 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Regimen
    Code List
    Regimen
    CL Item
    Ropinirole CR 1mg (1 tablet) (A)
    CL Item
    Ropinirole CR 1+1mg (2 tablets) (B)
    CL Item
    Ropinirole CR 2mg (1 tablet) (C)
    CL Item
    Ropinirole CR 1+1+1mg (3 tablets) (D)
    CL Item
    Ropinirole CR 3mg (1 tablet) (E)
    Dose checked and administered by
    Item
    Dose checked and administered by
    text
    C0178602 (UMLS CUI [1,1])
    C1621583 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [2,1])
    C1283174 (UMLS CUI [2,2])
    Dose checked and witnessed by
    Item
    Dose checked and witnessed by
    text
    C0178602 (UMLS CUI [1,1])
    C1283174 (UMLS CUI [1,2])
    Dose checked and administered, date
    Item
    Dose checked and administered, date
    date
    C0178602 (UMLS CUI [1,1])
    C1621583 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Vital Signs - Post-Dose
    C0518766 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    Item
    Time Point of measurement
    integer
    C0518766 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    C2348792 (UMLS CUI [1,3])
    Time Point of measurement
    Code List
    Time Point of measurement
    CL Item
    Study time +1hr (1)
    CL Item
    +4hr (2)
    CL Item
    +6hrs (3)
    CL Item
    +12hrs (4)
    CL Item
    +24hrs (5)
    CL Item
    +36hrs (6)
    Date
    Item
    Date of vital sign measurement
    date
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time
    Item
    Time of vital sign measurement
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    systolic Blood pressure
    Item
    Blood pressure - supine, systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    diastolic blood pressure
    Item
    Blood pressure - supine, diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate supine
    Item
    Heart rate - supine
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    systolic Blood pressure erect
    Item
    Blood pressure - erect, systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    diastolic Blood pressure erect
    Item
    Blood pressure - erect, diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Heart rate erect
    Item
    Heart rate - erect
    integer
    C0018810 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Item Group
    Domperidone Dosing Details
    C0013015 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    Item
    Time Point administered
    integer
    C3469597 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Time Point administered
    Code List
    Time Point administered
    CL Item
    Pre-dose - 1 hr (1)
    CL Item
    +7 hrs (2)
    CL Item
    +15 hrs (3)
    Date domperidone administered
    Item
    Date domperidone administered
    date
    C0013015 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Time domperidone administered
    Item
    Time domperidone administered
    time
    C0013015 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Comment
    Item
    Comment domperidone administered
    text
    C0013015 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item Group
    PK Blood Sampling
    C0005834 (UMLS CUI-1)
    Item
    Time relative to start of dose
    integer
    C0005834 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Time relative to start of dose
    Code List
    Time relative to start of dose
    CL Item
    Pre-dose (1)
    CL Item
    +1 hr (2)
    CL Item
    +2 hrs (3)
    CL Item
    +3 hrs (4)
    CL Item
    +4 hrs (5)
    CL Item
    +6 hrs (6)
    CL Item
    +8 hrs (7)
    CL Item
    +10 hrs (8)
    CL Item
    +12 hrs (9)
    CL Item
    +14 hrs (10)
    CL Item
    +16 hrs (11)
    CL Item
    +18 hrs (12)
    CL Item
    +20 hrs (13)
    CL Item
    +22 hrs (14)
    CL Item
    +24 hrs (15)
    CL Item
    +26 hrs (16)
    CL Item
    +28 hrs (17)
    CL Item
    +32 hrs (18)
    CL Item
    +36 hrs (19)
    Date blood sample taken
    Item
    Date blood sample taken
    date
    C1277698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time blood sample taken
    Item
    Time blood sample taken
    time
    C1277698 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Sample taken
    Item
    Sample taken
    boolean
    C1277698 (UMLS CUI [1])
    C0005834 (UMLS CUI [2])
    Comments
    Item
    Comments
    text
    C0005834 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    Item
    Time Point
    integer
    C0877248 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Time Point
    Code List
    Time Point
    CL Item
    Pre-dose (1)
    CL Item
    +1 hrs (2)
    CL Item
    +4 hrs (3)
    CL Item
    +6 hrs (4)
    CL Item
    +12 hrs (5)
    CL Item
    +24 hrs (6)
    CL Item
    +36 hrs (7)
    Adverse Event
    Item
    Any Adverse Event?
    boolean
    C0877248 (UMLS CUI [1])
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