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ID

26112

Descrição

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: Serious Adverse Event

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Versões (1)
  1. 09/10/2017 09/10/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

9 de outubro de 2017

DOI

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

    Inglês

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

    1 Formulários  
    Serious Adverse Event
    Descrição

    Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255
    Patient Number
    Descrição

    Patient Number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Center Number
    Descrição

    Center Number

    Tipo de dados

    integer

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

    Visit Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Person Reporting SAE
    Descrição

    Person Reporting SAE

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C1519255
    Serious Adverse Event
    Descrição

    Serious Adverse Event

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Serious Adverse Event
    Descrição

    Specify reason(s) for considering this a serious AE. Mark all that apply.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519255
    Serious Adverse Event
    Descrição

    Specify reason(s) for considering this a serious AE. If Other, please specify.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519255
    Outcome
    Descrição

    *If subject died, please inform GSK within 24 hours and complete Form D

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1705586
    UMLS CUI [1,2]
    C1519255
    Adverse Event Onset Date
    Descrição

    Adverse Event Onset Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2985916
    UMLS CUI [1,2]
    C1519255
    Adverse Event Onset Time
    Descrição

    Adverse Event Onset Time

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C2697889
    UMLS CUI [1,2]
    C1519255
    Adverse Event End Date
    Descrição

    Adverse Event End Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2697886
    UMLS CUI [1,2]
    C1519255
    Adverse event end time
    Descrição

    Adverse event end time

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C2826658
    UMLS CUI [1,2]
    C1519255
    Event Course
    Descrição

    adverse event course

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0750729
    Number of episodes
    Descrição

    If Intermittent = "Yes"

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C4086638
    Intensity (maximum)
    Descrição

    Intensity of the adverse event

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1710066
    UMLS CUI [1,2]
    C1519255
    Action Taken with Respect to lnvestigational Drug
    Descrição

    Action Taken in response to event

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1547656
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [2]
    C1519255
    Relationship to lnvestigational Drug
    Descrição

    Relationship to lnvestigational Drug

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0304229
    Corrective Therapy
    Descrição

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0087111
    Was subject withdrawn due to this AE?
    Descrição

    withdrawn due to event

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1519255
    Did the SAE abate?
    Descrição

    SAE abate

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0547047
    Was study medication reintroduced (or dose increased)?
    Descrição

    If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0304229
    UMLS CUI [2]
    C1519255
    If yes, did SAE recur?
    Descrição

    If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0034897
    Is the SAE is probably associated with: Protocol design or procedures (but not to study drug)
    Descrição

    SAE associated with protocol procedures

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0087111
    If Yes, please specify
    Descrição

    Is the SAE is probably associated with: Protocol design or procedures (but not to study drug)

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0087111
    Is the SAE is probably associated with: Another condition (eg, condition under study, intercurrent illness)
    Descrição

    SAE associated with other condition

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0012634
    If Yes, please specify
    Descrição

    Is the SAE is probably associated with: Another condition (eg, condition under study, intercurrent illness)

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0012634
    Is the SAE is probably associated with: Another drug
    Descrição

    SAE associated with other drug

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0013227
    If Yes, please specify
    Descrição

    Is the SAE is probably associated with: Another drug

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0013227
    Remarks
    Descrição

    (Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0947611
    Relevant Laboratory Data
    Descrição

    Relevant Laboratory Data

    Alias
    UMLS CUI-1
    C0587081
    UMLS CUI-2
    C1519255
    Test
    Descrição

    Test

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0022885
    Date
    Descrição

    Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0011008
    Value
    Descrição

    Value

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0587081
    Units
    Descrição

    Units

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519795
    Normal Range
    Descrição

    Normal Range

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0086715
    UMLS CUI [1,2]
    C0587081
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    Similar models

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

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Serious Adverse Event
    C1519255 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    integer
    C2348585 (UMLS CUI [1])
    Center Number
    Item
    Center Number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Person Reporting SAE
    Item
    Person Reporting SAE
    text
    C0008961 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Serious Adverse Event
    Item
    Serious Adverse Event
    boolean
    C1519255 (UMLS CUI [1])
    Item
    Serious Adverse Event
    text
    C1519255 (UMLS CUI [1])
    Serious Adverse Event
    Code List
    Serious Adverse Event
    CL Item
    results in Death (A)
    CL Item
    life threatening (B)
    CL Item
    requires hospitalisation or prolongationof existing hospitalization (C)
    CL Item
    results in disability/incapacity (D)
    CL Item
    congenital anomaly/birth defect (E)
    CL Item
    other (see definition) (F)
    Serious Adverse Event
    Item
    Serious Adverse Event
    text
    C1519255 (UMLS CUI [1])
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Adverse event outcome
    Code List
    Outcome
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    CL Item
    Died (3)
    Adverse Event Onset Date
    Item
    Adverse Event Onset Date
    date
    C2985916 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Adverse Event Onset Time
    Item
    Adverse Event Onset Time
    time
    C2697889 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Adverse Event End Date
    Item
    Adverse Event End Date
    date
    C2697886 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Adverse event end time
    Item
    Adverse event end time
    time
    C2826658 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Event Course
    integer
    C1519255 (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
    C1519255 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Item
    Intensity (maximum)
    integer
    C1710066 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    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])
    C1519255 (UMLS CUI [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
    C1519255 (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
    C1519255 (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])
    C1519255 (UMLS CUI [1,2])
    SAE abate
    Item
    Did the SAE abate?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0547047 (UMLS CUI [1,2])
    study medication reintroduced
    Item
    Was study medication reintroduced (or dose increased)?
    boolean
    C0304229 (UMLS CUI [1])
    C1519255 (UMLS CUI [2])
    SAE recur
    Item
    If yes, did SAE recur?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    SAE associated with protocol procedures
    Item
    Is the SAE is probably associated with: Protocol design or procedures (but not to study drug)
    boolean
    C1519255 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    SAE associated with protocol procedures
    Item
    If Yes, please specify
    text
    C1519255 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    SAE associated with other condition
    Item
    Is the SAE is probably associated with: Another condition (eg, condition under study, intercurrent illness)
    boolean
    C1519255 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [1,3])
    SAE associated with other condition
    Item
    If Yes, please specify
    text
    C1519255 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [1,3])
    SAE associated with other drug
    Item
    Is the SAE is probably associated with: Another drug
    boolean
    C1519255 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    SAE associated with other drug
    Item
    If Yes, please specify
    text
    C1519255 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    Remarks
    Item
    Remarks
    text
    C1519255 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Relevant Laboratory Data
    C0587081 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Test
    Item
    Test
    text
    C0022885 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0022885 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Value
    Item
    Value
    text
    C0587081 (UMLS CUI [1])
    Units
    Item
    Units
    text
    C1519795 (UMLS CUI [1])
    Normal Range
    Item
    Normal Range
    text
    C0086715 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
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