0 Ratings
ID

40751

Description

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Keywords

Versions (2)
  1. 4/29/20 4/29/20 -
  2. 5/8/20 5/8/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 8, 2020

DOI

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License

Creative Commons BY-NC 4.0
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    Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

    English

    Baseline Signs and Symptoms; Dosing Details

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Description

    Centre Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Baseline Signs and Symptoms
    Description

    Baseline Signs and Symptoms

    Alias
    UMLS CUI-1
    C0037088
    UMLS CUI-2
    C1442488
    Baseline Signs and Symptoms - Onset Date and Time
    Description

    Baseline Signs and Symptoms - Onset Date and Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2,1]
    C0574845
    UMLS CUI [2,2]
    C0449244
    Baseline Signs and Symptoms - End Date and Time
    Description

    (If ongoing please leave blank)

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2,1]
    C0806020
    UMLS CUI [2,2]
    C1522314
    Baseline Signs and Symptoms - Outcome
    Description

    Baseline Signs and Symptoms - Outcome

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2]
    C1547647
    Baseline Signs and Symptoms - Event Course
    Description

    Baseline Signs and Symptoms - Event Course

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2,1]
    C0750729
    UMLS CUI [2,2]
    C0441471
    Baseline Signs and Symptoms - Intermittent Course - number of episodes
    Description

    Baseline Signs and Symptoms - Intermittent Course - number of episodes

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2,1]
    C0750729
    UMLS CUI [2,2]
    C0205267
    UMLS CUI [3]
    C4086638
    Baseline Signs and Symptoms - Intensity (maximum)
    Description

    Baseline Signs and Symptoms - Intensity (maximum)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2,1]
    C0518690
    UMLS CUI [2,2]
    C0806909
    Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation
    Description

    Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2]
    C1510821
    UMLS CUI [3]
    C0034656
    Baseline Signs and Symptoms - Corrective Therapy
    Description

    If ‘Yes’, Please record on Prior Medication form.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2]
    C0087111
    Baseline Signs and Symptoms - Was subject withdrawn due to this event?
    Description

    Baseline Signs and Symptoms - Was subject withdrawn due to this event?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2,1]
    C0422727
    UMLS CUI [2,2]
    C0877248
    Baseline Signs and Symptoms - Investigator's Signature
    Description

    Baseline Signs and Symptoms - Investigator's Signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2]
    C2346576
    Baseline Signs and Symptoms - Investigator's Signature Date
    Description

    Baseline Signs and Symptoms - Investigator's Signature Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [2,1]
    C2346576
    UMLS CUI [2,2]
    C0011008
    Dosing Details (Day 1)
    Description

    Dosing Details (Day 1)

    Alias
    UMLS CUI-1
    C0678766
    UMLS CUI-2
    C1522508
    Was evening meal eaten before dosing?
    Description

    Was evening meal eaten before dosing?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0439550
    UMLS CUI [1,2]
    C1998602
    UMLS CUI [1,3]
    C0178602
    UMLS CUI [1,4]
    C0332152
    Meal finish date and time
    Description

    Meal finish date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C1998602
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [2,1]
    C1998602
    UMLS CUI [2,2]
    C1522314
    Date and time of dosing
    Description

    Date and time of dosing

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Randomisation Number
    Description

    Randomisation Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Number of Tablets Dispensed
    Description

    Number of Tablets Dispensed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0039225
    Dosing Details - Comments
    Description

    Dosing Details - Comments

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678766
    UMLS CUI [1,2]
    C1522508
    UMLS CUI [1,3]
    C0947611
    Dose Level
    Description

    Dose Level

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178602
    Dose checked and administered by
    Description

    Dose checked and administered by

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2]
    C2348343
    Dose checked and witnessed by
    Description

    Dose checked and witnessed by

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2,1]
    C0682356
    UMLS CUI [2,2]
    C0178602
    Dosing Details (PK Visit)
    Description

    Dosing Details (PK Visit)

    Alias
    UMLS CUI-1
    C0678766
    UMLS CUI-2
    C1522508
    Was evening meal eaten before dosing?
    Description

    Was evening meal eaten before dosing?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0439550
    UMLS CUI [1,2]
    C1998602
    UMLS CUI [1,3]
    C0178602
    UMLS CUI [1,4]
    C0332152
    Meal finish date and time
    Description

    Meal finish date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C1998602
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [2,1]
    C1998602
    UMLS CUI [2,2]
    C1522314
    Date and time of dosing
    Description

    Date and time of dosing

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Number of Tablets Dispensed
    Description

    Number of Tablets Dispensed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0039225
    Dosing Details - Comments
    Description

    Dosing Details - Comments

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678766
    UMLS CUI [1,2]
    C1522508
    UMLS CUI [1,3]
    C0947611
    Dose Level
    Description

    Dose Level

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178602
    Dose checked and administered by
    Description

    Dose checked and administered by

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2]
    C2348343
    Dose checked and witnessed by
    Description

    Dose checked and witnessed by

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2,1]
    C0682356
    UMLS CUI [2,2]
    C0178602
    Dosing Details (Day 3 - 43; Extra Clinic Visit 1 - 3)
    Description

    Dosing Details (Day 3 - 43; Extra Clinic Visit 1 - 3)

    Was evening meal eaten before dosing?
    Description

    Was evening meal eaten before dosing?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0439550
    UMLS CUI [1,2]
    C1998602
    UMLS CUI [1,3]
    C0178602
    UMLS CUI [1,4]
    C0332152
    Meal finish date and time
    Description

    Meal finish date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C1998602
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [2,1]
    C1998602
    UMLS CUI [2,2]
    C1522314
    Date and time of dosing
    Description

    Date and time of dosing

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Number of Tablets Dispensed
    Description

    Number of Tablets Dispensed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0039225
    Number of Tablets Returned
    Description

    Number of Tablets Returned

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C0039225
    Dosing Details - Comments
    Description

    Dosing Details - Comments

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678766
    UMLS CUI [1,2]
    C1522508
    UMLS CUI [1,3]
    C0947611
    Dose Level
    Description

    Dose Level

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178602
    Dose checked and administered by
    Description

    Dose checked and administered by

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2]
    C2348343
    Dose checked and witnessed by
    Description

    Dose checked and witnessed by

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2,1]
    C0682356
    UMLS CUI [2,2]
    C0178602
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    Similar models

    Baseline Signs and Symptoms; Dosing Details

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item Group
    Baseline Signs and Symptoms
    C0037088 (UMLS CUI-1)
    C1442488 (UMLS CUI-2)
    Baseline Signs and Symptoms - Onset Date and Time
    Item
    Baseline Signs and Symptoms - Onset Date and Time
    datetime
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C0574845 (UMLS CUI [2,1])
    C0449244 (UMLS CUI [2,2])
    Baseline Signs and Symptoms - End Date and Time
    Item
    Baseline Signs and Symptoms - End Date and Time
    datetime
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [2,1])
    C1522314 (UMLS CUI [2,2])
    Item
    Baseline Signs and Symptoms - Outcome
    integer
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C1547647 (UMLS CUI [2])
    Baseline Signs and Symptoms - Outcome
    Code List
    Baseline Signs and Symptoms - Outcome
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    CL Item
    Died (3)
    Item
    Baseline Signs and Symptoms - Event Course
    integer
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C0750729 (UMLS CUI [2,1])
    C0441471 (UMLS CUI [2,2])
    Baseline Signs and Symptoms - Event Course
    Code List
    Baseline Signs and Symptoms - Event Course
    CL Item
    Intermittent (1)
    CL Item
    Constant (2)
    Baseline Signs and Symptoms - Intermittent Course - number of episodes
    Item
    Baseline Signs and Symptoms - Intermittent Course - number of episodes
    integer
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C0750729 (UMLS CUI [2,1])
    C0205267 (UMLS CUI [2,2])
    C4086638 (UMLS CUI [3])
    Item
    Baseline Signs and Symptoms - Intensity (maximum)
    integer
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [2,1])
    C0806909 (UMLS CUI [2,2])
    Baseline Signs and Symptoms - Intensity (maximum)
    Code List
    Baseline Signs and Symptoms - Intensity (maximum)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation
    integer
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C1510821 (UMLS CUI [2])
    C0034656 (UMLS CUI [3])
    Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation
    Code List
    Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation
    CL Item
    Not related (1)
    CL Item
    Unlikely (2)
    CL Item
    Suspected (reasonable possibility) (3)
    CL Item
    Probable (4)
    Baseline Signs and Symptoms - Corrective Therapy
    Item
    Baseline Signs and Symptoms - Corrective Therapy
    boolean
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2])
    Baseline Signs and Symptoms - Was subject withdrawn due to this event?
    Item
    Baseline Signs and Symptoms - Was subject withdrawn due to this event?
    boolean
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C0422727 (UMLS CUI [2,1])
    C0877248 (UMLS CUI [2,2])
    Baseline Signs and Symptoms - Investigator's Signature
    Item
    Baseline Signs and Symptoms - Investigator's Signature
    text
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C2346576 (UMLS CUI [2])
    Baseline Signs and Symptoms - Investigator's Signature Date
    Item
    Baseline Signs and Symptoms - Investigator's Signature Date
    date
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C2346576 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    Item Group
    Dosing Details (Day 1)
    C0678766 (UMLS CUI-1)
    C1522508 (UMLS CUI-2)
    Was evening meal eaten before dosing?
    Item
    Was evening meal eaten before dosing?
    boolean
    C0439550 (UMLS CUI [1,1])
    C1998602 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Meal finish date and time
    Item
    Meal finish date and time
    datetime
    C1998602 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C1998602 (UMLS CUI [2,1])
    C1522314 (UMLS CUI [2,2])
    Date and time of dosing
    Item
    Date and time of dosing
    datetime
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Randomisation Number
    Item
    Randomisation Number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Number of Tablets Dispensed
    Item
    Number of Tablets Dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Dosing Details - Comments
    Item
    Dosing Details - Comments
    text
    C0678766 (UMLS CUI [1,1])
    C1522508 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Dose Level
    Item
    Dose Level
    text
    C0178602 (UMLS CUI [1])
    Dose checked and administered by
    Item
    Dose checked and administered by
    text
    C1283174 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C2348343 (UMLS CUI [2])
    Dose checked and witnessed by
    Item
    Dose checked and witnessed by
    text
    C1283174 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0682356 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    Item Group
    Dosing Details (PK Visit)
    C0678766 (UMLS CUI-1)
    C1522508 (UMLS CUI-2)
    Was evening meal eaten before dosing?
    Item
    Was evening meal eaten before dosing?
    boolean
    C0439550 (UMLS CUI [1,1])
    C1998602 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Meal finish date and time
    Item
    Meal finish date and time
    datetime
    C1998602 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C1998602 (UMLS CUI [2,1])
    C1522314 (UMLS CUI [2,2])
    Date and time of dosing
    Item
    Date and time of dosing
    datetime
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Number of Tablets Dispensed
    Item
    Number of Tablets Dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Dosing Details - Comments
    Item
    Dosing Details - Comments
    text
    C0678766 (UMLS CUI [1,1])
    C1522508 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Dose Level
    Item
    Dose Level
    text
    C0178602 (UMLS CUI [1])
    Dose checked and administered by
    Item
    Dose checked and administered by
    text
    C1283174 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C2348343 (UMLS CUI [2])
    Dose checked and witnessed by
    Item
    Dose checked and witnessed by
    text
    C1283174 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0682356 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    Item Group
    Dosing Details (Day 3 - 43; Extra Clinic Visit 1 - 3)
    Was evening meal eaten before dosing?
    Item
    Was evening meal eaten before dosing?
    boolean
    C0439550 (UMLS CUI [1,1])
    C1998602 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])
    Meal finish date and time
    Item
    Meal finish date and time
    datetime
    C1998602 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C1998602 (UMLS CUI [2,1])
    C1522314 (UMLS CUI [2,2])
    Date and time of dosing
    Item
    Date and time of dosing
    datetime
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Number of Tablets Dispensed
    Item
    Number of Tablets Dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Number of Tablets Returned
    Item
    Number of Tablets Returned
    integer
    C2699071 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Dosing Details - Comments
    Item
    Dosing Details - Comments
    text
    C0678766 (UMLS CUI [1,1])
    C1522508 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Dose Level
    Item
    Dose Level
    text
    C0178602 (UMLS CUI [1])
    Dose checked and administered by
    Item
    Dose checked and administered by
    text
    C1283174 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C2348343 (UMLS CUI [2])
    Dose checked and witnessed by
    Item
    Dose checked and witnessed by
    text
    C1283174 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0682356 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
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