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26111

Description

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: Adverse Event

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Versions (1)
  1. 09/10/2017 09/10/2017 -
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GlaxoSmithKline

Téléchargé le

9 octobre 2017

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Creative Commons BY-NC 3.0
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    Dose strength equivalence of ropinirole CR in healthy adults Adverse Event 101468/219

    Anglais

    Adverse Event Dose strength equivalence of ropinirole CR in healthy adults 101468/219

    1 Formulaires  
    Adverse Event
    Description

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    Adverse Event
    Description

    Record any Adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: "Do you feel different in any way since starting the treatment or since the last visit?" Provide the diagnosis not symptoms where possible.

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Outcome
    Description

    Adverse event outcome

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1705586
    Adverse Event Onset Date
    Description

    Adverse Event Onset Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2985916
    Adverse Event Onset Time
    Description

    Adverse Event Onset Time

    Type de données

    time

    Alias
    UMLS CUI [1]
    C2697889
    Adverse Event End Date
    Description

    Adverse Event End Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2697886
    Adverse event end time
    Description

    Adverse event end time

    Type de données

    time

    Alias
    UMLS CUI [1]
    C2826658
    Event Course
    Description

    adverse event course

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    Number of episodes
    Description

    If Intermittent = "Yes"

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C4086638
    Intensity (maximum)
    Description

    Intensity of the adverse event

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1710066
    Action Taken with Respect to lnvestigational Drug
    Description

    Action Taken in response to event

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1547656
    UMLS CUI [1,2]
    C0304229
    Relationship to lnvestigational Drug
    Description

    Relationship to lnvestigational Drug

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0304229
    Corrective Therapy
    Description

    Corrective Therapy. If "Yes", Please record on Concomitant Medication form

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    Was subject withdrawn due to this AE?
    Description

    withdrawn due to event

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0877248
    Retour au début de la page

    Similar models

    Adverse Event Dose strength equivalence of ropinirole CR in healthy adults 101468/219

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    Adverse Event
    Item
    Adverse Event
    boolean
    C0877248 (UMLS CUI [1])
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1])
    Adverse event outcome
    Code List
    Outcome
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    Adverse Event Onset Date
    Item
    Adverse Event Onset Date
    date
    C2985916 (UMLS CUI [1])
    Adverse Event Onset Time
    Item
    Adverse Event Onset Time
    time
    C2697889 (UMLS CUI [1])
    Adverse Event End Date
    Item
    Adverse Event End Date
    date
    C2697886 (UMLS CUI [1])
    Adverse event end time
    Item
    Adverse event end time
    time
    C2826658 (UMLS CUI [1])
    Item
    Event Course
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    adverse event course
    Code List
    Event Course
    CL Item
    Intermittent (1)
    CL Item
    Constant (2)
    adverse event number of episodes
    Item
    Number of episodes
    integer
    C0877248 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Item
    Intensity (maximum)
    integer
    C1710066 (UMLS CUI [1])
    Intensity of the adverse event
    Code List
    Intensity (maximum)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Action Taken with Respect to lnvestigational Drug
    integer
    C1547656 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Action Taken in response to event
    Code List
    Action Taken with Respect to lnvestigational Drug
    CL Item
    None (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose increased (3)
    CL Item
    Drug interrupted/restarted (4)
    CL Item
    Drug stopped (5)
    Item
    Relationship to lnvestigational Drug
    integer
    C0877248 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Relationship to lnvestigational Drug
    Code List
    Relationship to lnvestigational Drug
    CL Item
    Related (1)
    CL Item
    Possibly related (2)
    CL Item
    Probably unrelated  (3)
    CL Item
    Unrelated (4)
    corrective therapy
    Item
    Corrective Therapy
    boolean
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    withdrawn due to event
    Item
    Was subject withdrawn due to this AE?
    boolean
    C0422727 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Retour au début de la page 

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