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ID

44013

Beskrivning

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome

Nyckelord

Versioner (2)
  1. 2017-09-05 2017-09-05 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

20 september 2021

DOI

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Creative Commons BY-NC 3.0
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    baseline signs and symptoms PK and tolerability of ropinirole as 5 new formulations 101468/197

    Engelsk

    baseline signs and symptoms PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Focus Panel ID
    Beskrivning

    focus panel

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3846158
    Patient No
    Beskrivning

    patient number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Baseline Signs and Symptoms
    Beskrivning

    Baseline Signs and Symptoms

    Alias
    UMLS CUI-1
    C0037088
    Did the subject experience any symptoms prior to the first study drug administration?
    Beskrivning

    If YES, indicate below.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1457887
    UMLS CUI [2,1]
    C0332152
    UMLS CUI [2,2]
    C3469597
    Events
    Beskrivning

    Events

    Alias
    UMLS CUI-1
    C0441471
    Diagnosis or signs/symptoms
    Beskrivning

    diagnosis or signs/symptoms

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0011900
    UMLS CUI [2]
    C0037088
    Date and time of onset
    Beskrivning

    24-hour clock

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Maximum Intensity
    Beskrivning

    maximum intensity

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0518690
    Event course
    Beskrivning

    If INTERMITTENT, record the number of episodes.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0750729
    Outcome
    Beskrivning

    outcome

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1547647
    Date and Time of Resolution
    Beskrivning

    date and time of resolution

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C1264639
    UMLS CUI [1,2]
    C2699488
    Withdrawal
    Beskrivning

    Did the subject withdraw from study as a result of this symptom?

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0422727
    Relationship to study procedere(s)
    Beskrivning

    relationship to study

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0439849
    Corrective therapy
    Beskrivning

    if YES please record on the "prior medication" page

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0087111
    Tillbaka till toppen

    Similar models

    baseline signs and symptoms PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    focus panel
    Item
    Focus Panel ID
    integer
    C3846158 (UMLS CUI [1])
    patient number
    Item
    Patient No
    integer
    C1830427 (UMLS CUI [1])
    Item Group
    Baseline Signs and Symptoms
    C0037088 (UMLS CUI-1)
    Item
    Did the subject experience any symptoms prior to the first study drug administration?
    text
    C1457887 (UMLS CUI [1])
    C0332152 (UMLS CUI [2,1])
    C3469597 (UMLS CUI [2,2])
    symptoms before first dose of study drug
    Code List
    Did the subject experience any symptoms prior to the first study drug administration?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item Group
    Events
    C0441471 (UMLS CUI-1)
    diagnosis or signs/symptoms
    Item
    Diagnosis or signs/symptoms
    text
    C0011900 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    date and time
    Item
    Date and time of onset
    datetime
    C1264639 (UMLS CUI [1])
    Item
    Maximum Intensity
    integer
    C0518690 (UMLS CUI [1])
    maximum intensity
    Code List
    Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Event course
    text
    C0750729 (UMLS CUI [1])
    event course
    Code List
    Event course
    CL Item
    Intermittent (I)
    CL Item
    Constant (C)
    Item
    Outcome
    text
    C1547647 (UMLS CUI [1])
    outcome
    Code List
    Outcome
    CL Item
    Resolved (R)
    CL Item
    Ongoing (O)
    date and time of resolution
    Item
    Date and Time of Resolution
    datetime
    C1264639 (UMLS CUI [1,1])
    C2699488 (UMLS CUI [1,2])
    Item
    Withdrawal
    text
    C0422727 (UMLS CUI [1])
    withdrawal
    Code List
    Withdrawal
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Relationship to study procedere(s)
    integer
    C0013227 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    relationship to study
    Code List
    Relationship to study procedere(s)
    CL Item
    Related (1)
    CL Item
    Possibly related (2)
    CL Item
    Probably unrelated (3)
    CL Item
    Unrelated (4)
    Item
    Corrective therapy
    text
    C0087111 (UMLS CUI [1])
    therapy
    Code List
    Corrective therapy
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Tillbaka till toppen 

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