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ID

26112

Beschrijving

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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  1. 09-10-17 09-10-17 -
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GlaxoSmithKline

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9 oktober 2017

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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

    Engels

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

    1 Formulieren  
    Serious Adverse Event
    Beschrijving

    Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255
    Patient Number
    Beschrijving

    Patient Number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Center Number
    Beschrijving

    Center Number

    Datatype

    integer

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

    Visit Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Person Reporting SAE
    Beschrijving

    Person Reporting SAE

    Datatype

    text

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

    Serious Adverse Event

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Serious Adverse Event
    Beschrijving

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

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1519255
    Serious Adverse Event
    Beschrijving

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

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1519255
    Outcome
    Beschrijving

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

    Datatype

    integer

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

    Adverse Event Onset Date

    Datatype

    date

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

    Adverse Event Onset Time

    Datatype

    time

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

    Adverse Event End Date

    Datatype

    date

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

    Adverse event end time

    Datatype

    time

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

    adverse event course

    Datatype

    integer

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

    If Intermittent = "Yes"

    Datatype

    integer

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

    Intensity of the adverse event

    Datatype

    integer

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

    Action Taken in response to event

    Datatype

    integer

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

    Relationship to lnvestigational Drug

    Datatype

    integer

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

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

    Datatype

    boolean

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

    withdrawn due to event

    Datatype

    boolean

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

    SAE abate

    Datatype

    boolean

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

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

    Datatype

    boolean

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

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

    Datatype

    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)
    Beschrijving

    SAE associated with protocol procedures

    Datatype

    boolean

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

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

    Datatype

    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)
    Beschrijving

    SAE associated with other condition

    Datatype

    boolean

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

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

    Datatype

    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
    Beschrijving

    SAE associated with other drug

    Datatype

    boolean

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

    Is the SAE is probably associated with: Another drug

    Datatype

    text

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

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

    Datatype

    text

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

    Relevant Laboratory Data

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

    Test

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0022885
    Date
    Beschrijving

    Date

    Datatype

    date

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

    Value

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0587081
    Units
    Beschrijving

    Units

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1519795
    Normal Range
    Beschrijving

    Normal Range

    Datatype

    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 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

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