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25755

Descrizione

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Week 16 form.

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versioni (1)
  1. 2017-09-17 2017-09-17 -
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GlaxoSmithKline

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17 september 2017

DOI

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Creative Commons BY-NC 3.0
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    GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 16 101468/169 NCT00381472

    Inglese

    GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 16 101468/169 NCT00381472

    1 moduli  
    DIARY INFORMATION
    Descrizione

    DIARY INFORMATION

    Alias
    UMLS CUI-1
    C3890583
    Date of diary day 1
    Descrizione

    Date of diary day 1

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C0011008
    Total time asleep
    Descrizione

    Total time asleep

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0037313
    Total awake time ’Off’
    Descrizione

    awake time off

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    Total awake time ’On’
    Descrizione

    awake time On

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    Total awake time "On" with troublesome dyskinesias
    Descrizione

    awake time dyskinesias

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    UMLS CUI [1,3]
    C0013384
    Date of diary day 2
    Descrizione

    Date of diary day 2

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C0011008
    Total time asleep
    Descrizione

    Total time asleep

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0037313
    Total awake time ’Off’
    Descrizione

    awake time Off

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    Total awake time ’On’
    Descrizione

    awake time On

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    Total awake time "On" with troublesome dyskinesias
    Descrizione

    awake time dyskinesias

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    UMLS CUI [1,3]
    C0013384
    General Information
    Descrizione

    General Information

    Alias
    UMLS CUI-1
    C1508263
    Subject Number
    Descrizione

    Subject Number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Descrizione

    Visit Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303
    SUBJECT CONTINUATION
    Descrizione

    SUBJECT CONTINUATION

    Alias
    UMLS CUI-1
    C0805733
    If the subject is not continuing in the study, do not complete this visit but enter appropriate details on the Study Conclusion page. Continuing?
    Descrizione

    Subject continuation

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0805733
    ADVERSE EVENTS PROMPT
    Descrizione

    ADVERSE EVENTS PROMPT

    Record details of any new adverse events/serious adverse events observed or reported by the subject or any changes to ongoing adverse events in the appropriate Adverse Events/Serious Adverse Events section.
    Descrizione

    Adverse Events

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    CONCOMITANT MEDICATION PROMPT
    Descrizione

    CONCOMITANT MEDICATION PROMPT

    Alias
    UMLS CUI-1
    C2347852
    Record any changes to the subject’s concomitant medication or any new medications taken since the last visit in the appropriate Concomitant Medication section.
    Descrizione

    Concomitant Medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    L-DOPA MEDICATION CHANGES
    Descrizione

    L-DOPA MEDICATION CHANGES

    Alias
    UMLS CUI-1
    C0023570
    UMLS CUI-2
    C0023570
    Has there been any change in dose or frequency of L-Dopa medication since the last visit?
    Descrizione

    change L-Dopa medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C0023570
    If Yes, tick the primary reason for change:
    Descrizione

    reason for change

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C0023570
    UMLS CUI [1,3]
    C0392360
    Other, specify
    Descrizione

    reason for change

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C0023570
    UMLS CUI [1,3]
    C0392360
    VITAL SIGNS
    Descrizione

    VITAL SIGNS

    Alias
    UMLS CUI-1
    C0518766
    Blood Pressure Systolic
    Descrizione

    Semi-Supine

    Tipo di dati

    integer

    Unità di misura
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood Pressure Diastolic
    Descrizione

    Semi-Supine

    Tipo di dati

    integer

    Unità di misura
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart Rate
    Descrizione

    Semi-Supine

    Tipo di dati

    integer

    Unità di misura
    • beats/min
    beats/min
    Blood Pressure Systolic
    Descrizione

    Standing

    Tipo di dati

    integer

    Unità di misura
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood Pressure Diastolic
    Descrizione

    Standing

    Tipo di dati

    integer

    Unità di misura
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart Rate
    Descrizione

    Standing

    Tipo di dati

    integer

    Unità di misura
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING
    Descrizione

    SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING

    Alias
    UMLS CUI-1
    C0458244
    Date of food diary
    Descrizione

    Date of food diary

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0458244
    UMLS CUI [1,2]
    C0458244
    Time study medication taken
    Descrizione

    Time study medication taken

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013227
    Time of finishing breakfast:
    Descrizione

    Time of finishing breakfast

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C2698559
    Time of finishing lunch:
    Descrizione

    Time of finishing lunch

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C2697949
    Time of finishing dinner:
    Descrizione

    Time of finishing dinner

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C4048877
    SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING
    Descrizione

    SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING

    Alias
    UMLS CUI-1
    C0458244
    Date of food diary
    Descrizione

    Date of food diary

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0458244
    UMLS CUI [1,2]
    C0458244
    Time study medication taken
    Descrizione

    Time study medication taken

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013227
    Time of finishing breakfast:
    Descrizione

    Time of finishing breakfast

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C2698559
    Time of finishing lunch:
    Descrizione

    Time of finishing lunch

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C2697949
    Time of finishing dinner:
    Descrizione

    Time of finishing dinner

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C4048877
    PHARMACOKINETICS - BLOOD
    Descrizione

    PHARMACOKINETICS - BLOOD

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    If week 16 is a morning clinic : • A pre-dose blood sample should be taken as soon as possible after the subject arrives at the clinic. The morning dose of study medication should be taken as soon as is practical after this blood sample (please record exact time in the CRF on the previous page). • Record the exact time that the blood sample was taken in the "am" section of the CRF • No further blood samples are required at this visit.
    Descrizione

    morning clinic

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0178913
    If Week 16 is an afternoon clinic : • A blood sample should be taken during the afternoon clinic between 5 and 10 hours after the morning dose. • Record the exact time that the blood sample was taken in the "pm" section of the CRF • No further blood samples are required at this visit.
    Descrizione

    afternoon clinic

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0178913
    UMLS CUI [1,2]
    C0178913
    Pre-dose Date Sample Taken AM visit
    Descrizione

    Pre-dose Date Sample Taken AM visit

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0439565
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0178913
    Pre-dose Actual Time AM visit
    Descrizione

    Pre-dose Actual Time AM visit

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0439565
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0178913
    Pre-Dose Attach Sample Identifier Label Here AM visit
    Descrizione

    Pre-Dose Attach Sample Identifier Label Here AM visit

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0439565
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0600091
    5-10 hrs Post-dose Date Sample Taken PM visit
    Descrizione

    5-10 hrs Post-dose Date Sample Taken PM visit

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0439568
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0178913
    5-10 hrs Post-dose Actual Time PM visit
    Descrizione

    5-10 hrs Post-dose Actual Time PM visit

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0439568
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0178913
    Attach Sample Identifier Label Here PM visit
    Descrizione

    Attach Sample Identifier Label Here PM visit

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0439568
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0600091
    CLINICAL GLOBAL IMPRESSION
    Descrizione

    CLINICAL GLOBAL IMPRESSION

    Alias
    UMLS CUI-1
    C3639708
    CLINICAL GLOBAL IMPRESSION
    Descrizione

    CLINICAL GLOBAL IMPRESSION

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3639708
    INVESTIGATIONAL PRODUCT
    Descrizione

    INVESTIGATIONAL PRODUCT

    Alias
    UMLS CUI-1
    C0304229
    Blinded Dose Level
    Descrizione

    Blinded Dose Level

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0304229
    Start Date
    Descrizione

    Start Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0304229
    Stop Date
    Descrizione

    Stop Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0304229
    Investigational product Container Number
    Descrizione

    Investigational product Container Number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C3898691
    UMLS CUI [1,2]
    C0449788
    COMPLIANCE
    Descrizione

    COMPLIANCE

    Alias
    UMLS CUI-1
    C1321605
    Total number of Tablets Dispensed
    Descrizione

    Total number of Tablets Dispensed

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0039225
    Total number of Tablets Returned
    Descrizione

    Total number of Tablets Returned

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C0039225
    Has the subject missed investigational product for more than 3 consecutive days?
    Descrizione

    Has the subject missed investigational product for more than 3 consecutive days?

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0304229
    DISPENSING
    Descrizione

    DISPENSING

    Alias
    UMLS CUI-1
    C0947323
    Record dispensing information in the Investigational Product and Compliance sections at the next visit.
    Descrizione

    Dispense investigational product

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0947323
    UMLS CUI [1,2]
    C0013230
    DIARY CARD
    Descrizione

    DIARY CARD

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C3812666
    UMLS CUI-3
    C1457887
    Issue the subject with Week 20 Diary Card
    Descrizione

    Diary Card

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C3812666
    UMLS CUI [1,3]
    C1457887
    CONTINUATION
    Descrizione

    CONTINUATION

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0947630
    Remind the subject of the scheduled appointment time for the Week 20 Visit.
    Descrizione

    appointments

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0947630
    UMLS CUI [1,3]
    C0545082
    If the Week 20 clinic is a morning visit, remind the subject not to take their morning dose of study medication at home on the day of the next clinic.
    Descrizione

    dose of study medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0947630
    UMLS CUI [1,3]
    C0545082
    UMLS CUI [1,4]
    C0013230
    If the Week 20 clinic is an afternoon visit, remind the subject to take their morning dose as usual.
    Descrizione

    morning dose

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0947630
    UMLS CUI [1,3]
    C0545082
    UMLS CUI [1,4]
    C0013230
    Remind the subject. To record the exact time that they took their medication on the day prior to the visit and, for afternoon appointments, on the visit day.
    Descrizione

    medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0947630
    UMLS CUI [1,3]
    C0545082
    UMLS CUI [1,4]
    C0013230
    UMLS CUI [1,5]
    C0040223
    Remind the subject. To record the time that they finished their meals on the day prior to the visit.
    Descrizione

    meals

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0947630
    UMLS CUI [1,3]
    C0545082
    UMLS CUI [1,4]
    C1998602
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    Similar models

    GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 16 101468/169 NCT00381472

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    DIARY INFORMATION
    C3890583 (UMLS CUI-1)
    Date of diary day 1
    Item
    Date of diary day 1
    date
    C3890583 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Total time asleep
    Item
    Total time asleep
    time
    C0040223 (UMLS CUI [1,1])
    C0037313 (UMLS CUI [1,2])
    awake time off
    Item
    Total awake time ’Off’
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    awake time On
    Item
    Total awake time ’On’
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    awake time dyskinesias
    Item
    Total awake time "On" with troublesome dyskinesias
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    C0013384 (UMLS CUI [1,3])
    Date of diary day 2
    Item
    Date of diary day 2
    date
    C3890583 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Total time asleep
    Item
    Total time asleep
    time
    C0040223 (UMLS CUI [1,1])
    C0037313 (UMLS CUI [1,2])
    awake time Off
    Item
    Total awake time ’Off’
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    awake time On
    Item
    Total awake time ’On’
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    awake time dyskinesias
    Item
    Total awake time "On" with troublesome dyskinesias
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    C0013384 (UMLS CUI [1,3])
    Item Group
    General Information
    C1508263 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    SUBJECT CONTINUATION
    C0805733 (UMLS CUI-1)
    Subject continuation
    Item
    If the subject is not continuing in the study, do not complete this visit but enter appropriate details on the Study Conclusion page. Continuing?
    boolean
    C0805733 (UMLS CUI [1])
    Item Group
    ADVERSE EVENTS PROMPT
    Adverse Events
    Item
    Record details of any new adverse events/serious adverse events observed or reported by the subject or any changes to ongoing adverse events in the appropriate Adverse Events/Serious Adverse Events section.
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    CONCOMITANT MEDICATION PROMPT
    C2347852 (UMLS CUI-1)
    Concomitant Medication
    Item
    Record any changes to the subject’s concomitant medication or any new medications taken since the last visit in the appropriate Concomitant Medication section.
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    L-DOPA MEDICATION CHANGES
    C0023570 (UMLS CUI-1)
    C0023570 (UMLS CUI-2)
    change L-Dopa medication
    Item
    Has there been any change in dose or frequency of L-Dopa medication since the last visit?
    boolean
    C0023570 (UMLS CUI [1,1])
    C0023570 (UMLS CUI [1,2])
    Item
    If Yes, tick the primary reason for change:
    integer
    C0023570 (UMLS CUI [1,1])
    C0023570 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    reason for change
    Code List
    If Yes, tick the primary reason for change:
    CL Item
    Reduction required by protocol (starting at dose level 4)  (1)
    CL Item
    Unacceptable dopaminergic side-effect (Record in the Adverse Events section)  (2)
    CL Item
    Loss of efficacy  (3)
    CL Item
    Other, specify (4)
    reason for change
    Item
    Other, specify
    text
    C0023570 (UMLS CUI [1,1])
    C0023570 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Item Group
    VITAL SIGNS
    C0518766 (UMLS CUI-1)
    Blood Pressure Systolic
    Item
    Blood Pressure Systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood Pressure Diastolic
    Item
    Blood Pressure Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    integer
    Blood Pressure Systolic
    Item
    Blood Pressure Systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood Pressure Diastolic
    Item
    Blood Pressure Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING
    C0458244 (UMLS CUI-1)
    Date of food diary
    Item
    Date of food diary
    date
    C0458244 (UMLS CUI [1,1])
    C0458244 (UMLS CUI [1,2])
    Time study medication taken
    Item
    Time study medication taken
    time
    C0040223 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Time of finishing breakfast
    Item
    Time of finishing breakfast:
    time
    C0040223 (UMLS CUI [1,1])
    C2698559 (UMLS CUI [1,2])
    Time of finishing lunch
    Item
    Time of finishing lunch:
    time
    C0040223 (UMLS CUI [1,1])
    C2697949 (UMLS CUI [1,2])
    Time of finishing dinner
    Item
    Time of finishing dinner:
    time
    C0040223 (UMLS CUI [1,1])
    C4048877 (UMLS CUI [1,2])
    Item Group
    SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING
    C0458244 (UMLS CUI-1)
    Date of food diary
    Item
    Date of food diary
    date
    C0458244 (UMLS CUI [1,1])
    C0458244 (UMLS CUI [1,2])
    Time study medication taken
    Item
    Time study medication taken
    time
    C0040223 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Time of finishing breakfast
    Item
    Time of finishing breakfast:
    time
    C0040223 (UMLS CUI [1,1])
    C2698559 (UMLS CUI [1,2])
    Time of finishing lunch
    Item
    Time of finishing lunch:
    time
    C0040223 (UMLS CUI [1,1])
    C2697949 (UMLS CUI [1,2])
    Time of finishing dinner
    Item
    Time of finishing dinner:
    time
    C0040223 (UMLS CUI [1,1])
    C4048877 (UMLS CUI [1,2])
    Item Group
    PHARMACOKINETICS - BLOOD
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    morning clinic
    Item
    If week 16 is a morning clinic : • A pre-dose blood sample should be taken as soon as possible after the subject arrives at the clinic. The morning dose of study medication should be taken as soon as is practical after this blood sample (please record exact time in the CRF on the previous page). • Record the exact time that the blood sample was taken in the "am" section of the CRF • No further blood samples are required at this visit.
    boolean
    C0178913 (UMLS CUI [1])
    afternoon clinic
    Item
    If Week 16 is an afternoon clinic : • A blood sample should be taken during the afternoon clinic between 5 and 10 hours after the morning dose. • Record the exact time that the blood sample was taken in the "pm" section of the CRF • No further blood samples are required at this visit.
    boolean
    C0178913 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    Pre-dose Date Sample Taken AM visit
    Item
    Pre-dose Date Sample Taken AM visit
    date
    C0439565 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    Pre-dose Actual Time AM visit
    Item
    Pre-dose Actual Time AM visit
    time
    C0439565 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    Pre-Dose Attach Sample Identifier Label Here AM visit
    Item
    Pre-Dose Attach Sample Identifier Label Here AM visit
    text
    C0439565 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    5-10 hrs Post-dose Date Sample Taken PM visit
    Item
    5-10 hrs Post-dose Date Sample Taken PM visit
    date
    C0439568 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    5-10 hrs Post-dose Actual Time PM visit
    Item
    5-10 hrs Post-dose Actual Time PM visit
    time
    C0439568 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    Attach Sample Identifier Label Here PM visit
    Item
    Attach Sample Identifier Label Here PM visit
    text
    C0439568 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Item Group
    CLINICAL GLOBAL IMPRESSION
    C3639708 (UMLS CUI-1)
    CLINICAL GLOBAL IMPRESSION
    Item
    CLINICAL GLOBAL IMPRESSION
    boolean
    C3639708 (UMLS CUI [1])
    Item Group
    INVESTIGATIONAL PRODUCT
    C0304229 (UMLS CUI-1)
    Blinded Dose Level
    Item
    Blinded Dose Level
    integer
    C0178602 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Investigational product Container Number
    Item
    Investigational product Container Number
    integer
    C3898691 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    COMPLIANCE
    C1321605 (UMLS CUI-1)
    Total number of Tablets Dispensed
    Item
    Total number of Tablets Dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Total number of Tablets Returned
    Item
    Total number of Tablets Returned
    integer
    C2699071 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Has the subject missed investigational product for more than 3 consecutive days?
    Item
    Has the subject missed investigational product for more than 3 consecutive days?
    boolean
    C1321605 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item Group
    DISPENSING
    C0947323 (UMLS CUI-1)
    Dispense investigational product
    Item
    Record dispensing information in the Investigational Product and Compliance sections at the next visit.
    boolean
    C0947323 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    Item Group
    DIARY CARD
    C3890583 (UMLS CUI-1)
    C3812666 (UMLS CUI-2)
    C1457887 (UMLS CUI-3)
    Diary Card
    Item
    Issue the subject with Week 20 Diary Card
    boolean
    C3890583 (UMLS CUI [1,1])
    C3812666 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    Item Group
    CONTINUATION
    C0805733 (UMLS CUI-1)
    C0947630 (UMLS CUI-2)
    appointments
    Item
    Remind the subject of the scheduled appointment time for the Week 20 Visit.
    boolean
    C0805733 (UMLS CUI [1,1])
    C0947630 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    dose of study medication
    Item
    If the Week 20 clinic is a morning visit, remind the subject not to take their morning dose of study medication at home on the day of the next clinic.
    boolean
    C0805733 (UMLS CUI [1,1])
    C0947630 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    C0013230 (UMLS CUI [1,4])
    morning dose
    Item
    If the Week 20 clinic is an afternoon visit, remind the subject to take their morning dose as usual.
    boolean
    C0805733 (UMLS CUI [1,1])
    C0947630 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    C0013230 (UMLS CUI [1,4])
    medication
    Item
    Remind the subject. To record the exact time that they took their medication on the day prior to the visit and, for afternoon appointments, on the visit day.
    boolean
    C0805733 (UMLS CUI [1,1])
    C0947630 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    C0013230 (UMLS CUI [1,4])
    C0040223 (UMLS CUI [1,5])
    meals
    Item
    Remind the subject. To record the time that they finished their meals on the day prior to the visit.
    boolean
    C0805733 (UMLS CUI [1,1])
    C0947630 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    C1998602 (UMLS CUI [1,4])
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