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ID

24157

Descrição

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Serious Adverse Event, Investigator's Statement

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Versões (1)
  1. 26/07/2017 26/07/2017 -
Titular dos direitos

GlaxoSmithKline

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26 de julho de 2017

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Creative Commons BY-NC 3.0
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    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Serious Adverse Event (SAE), Investigator's Statement

    Inglês

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Serious Adverse Event (SAE), Investigator's Statement

    1 Formulários  
    Serious Adverse Event (SAE)
    Descrição

    Serious Adverse Event (SAE)

    Alias
    UMLS CUI-1
    C1519255
    Person Reporting SAE
    Descrição

    person reporting SAE

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0008961
    Serious Adverse Event
    Descrição

    serious adverse event

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519255
    Onset Date and Time
    Descrição

    onset date and time

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1]
    C2985916
    End Date and Time (If ongoing please leave blank)
    Descrição

    end date and time

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1,1]
    C2981425
    UMLS CUI [1,2]
    C1442488
    Outcome
    Descrição

    If yubject died, please inform GSK within 24 hours and complete Form D.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1705586
    Event Course
    Descrição

    event course

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    Intensity (maximum)
    Descrição

    intesity

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0522510
    UMLS CUI [1,2]
    C0877248
    Specify reason(s) for considering this a serious AE. Mark all that apply.
    Descrição

    serious adverse event reason

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3828190
    Please specify other:
    Descrição

    serious adverse event reason

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3828190
    Action Taken with Respect to Investigational Drug
    Descrição

    action taken

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826626
    Did the SAE abate?
    Descrição

    SAE abate

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C3853704
    If the study medication was interrupted, stopped or dose reduced: Was study medication reintroduced or dose increased)?
    Descrição

    study medication reintroduced

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0580673
    If Yes, did SAE recur?
    Descrição

    SAE recur

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0034897
    Relationship to Investigational Drug
    Descrição

    relationship to investigational drug

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C1519255
    The SAE is probably associated with:
    Descrição

    SAE association

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1706737
    Please specify:
    Descrição

    SAE association

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1706737
    Corrective Therapy
    Descrição

    If Yes, please record on Concomitant Medication form

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0559546
    UMLS CUI [1,2]
    C0087111
    Was subject withdrawn due to this AE?
    Descrição

    subject withdrawn due to event

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0877248
    Laboratory Data: Test
    Descrição

    laboratory test

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0022885
    Laboratory Data: Date
    Descrição

    laboratory date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0011008
    Laboratory Data: Value
    Descrição

    laboratory value

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0022877
    Laboratory Data: Units
    Descrição

    unit

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519795
    Laboratory Data: Normal Range
    Descrição

    normal range

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826705
    Remarks
    Descrição

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

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0947611
    If applicable, was randomisation code broken at investigational site?
    Descrição

    randomisation code broken

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0034656
    Randomisation/ Study Medication Number
    Descrição

    randomisation number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Investigator
    Descrição

    investigator

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826892
    Investigator's Checklist
    Descrição

    Investigator's Checklist

    Alias
    UMLS CUI-1
    C1707357
    UMLS CUI-2
    C0008961
    Check all Baseline Signs and Symptoms form is up to date and complete
    Descrição

    baseline signs and symptoms

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0037088
    Check that the Prior Medication form is up to date
    Descrição

    prior medication

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    Check that all appropriate pages are sgined (thus indicating completition) and dated
    Descrição

    signatures and dates

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2346576
    UMLS CUI [2]
    C0011008
    Check that laboratory results are included
    Descrição

    laboratory

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0022877
    I certify that the observations and findings are recorded correctly and completely in this CRF.
    Descrição

    correct, complete recording

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0034869
    UMLS CUI [1,2]
    C2349182
    UMLS CUI [1,3]
    C0205197
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    Similar models

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Serious Adverse Event (SAE), Investigator's Statement

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Serious Adverse Event (SAE)
    C1519255 (UMLS CUI-1)
    person reporting SAE
    Item
    Person Reporting SAE
    text
    C0008961 (UMLS CUI [1])
    serious adverse event
    Item
    Serious Adverse Event
    text
    C1519255 (UMLS CUI [1])
    onset date and time
    Item
    Onset Date and Time
    datetime
    C2985916 (UMLS CUI [1])
    end date and time
    Item
    End Date and Time (If ongoing please leave blank)
    datetime
    C2981425 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Item
    Outcome
    text
    C1705586 (UMLS CUI [1])
    outcome
    Code List
    Outcome
    CL Item
    Resolved (Resolved)
    CL Item
    Ongoing (Ongoing)
    CL Item
    Died (Died)
    Item
    Event Course
    text
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    event course
    Code List
    Event Course
    CL Item
    Intermittent (Intermittent)
    CL Item
    Consistant (Consistant)
    Item
    Intensity (maximum)
    text
    C0522510 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    intesity
    Code List
    Intensity (maximum)
    CL Item
    Mild (Mild)
    CL Item
    Moderate (Moderate)
    CL Item
    Severe (Severe)
    Item
    Specify reason(s) for considering this a serious AE. Mark all that apply.
    text
    C3828190 (UMLS CUI [1])
    serious adverse event reason
    Code List
    Specify reason(s) for considering this a serious AE. Mark all that apply.
    CL Item
    results in Death (A)
    CL Item
    life threatening (B)
    CL Item
    requires hospitalisation or prolongation of existing hospitalisation (C)
    CL Item
    results in disability/incapacity (D)
    CL Item
    congenital anomaly/birth defect (E)
    CL Item
    other (see definition= (F)
    serious adverse event reason
    Item
    Please specify other:
    text
    C3828190 (UMLS CUI [1])
    Item
    Action Taken with Respect to Investigational Drug
    text
    C2826626 (UMLS CUI [1])
    action taken
    Code List
    Action Taken with Respect to Investigational Drug
    CL Item
    None (None)
    CL Item
    Dose reduced (Dose reduced)
    CL Item
    Dose increased (Dose increased)
    CL Item
    Drug interrupted/restarted (Drug interrupted/restarted)
    CL Item
    Drug stopped (Drug stopped)
    SAE abate
    Item
    Did the SAE abate?
    boolean
    C1519255 (UMLS CUI [1,1])
    C3853704 (UMLS CUI [1,2])
    study medication reintroduced
    Item
    If the study medication was interrupted, stopped or dose reduced: Was study medication reintroduced or dose increased)?
    boolean
    C0013230 (UMLS CUI [1,1])
    C0580673 (UMLS CUI [1,2])
    SAE recur
    Item
    If Yes, did SAE recur?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    Item
    Relationship to Investigational Drug
    text
    C0013230 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    relationship to investigational drug
    Code List
    Relationship to Investigational Drug
    CL Item
    Not related (Not related)
    CL Item
    Unlikely (Unlikely)
    CL Item
    Suspected (reasonable possibility) (Suspected (reasonable possibility))
    CL Item
    Probable (Probable)
    Item
    The SAE is probably associated with:
    text
    C1706737 (UMLS CUI [1])
    SAE association
    Code List
    The SAE is probably associated with:
    CL Item
    Protocol design or procedures (but not to study drug) (Protocol design or procedures (but not to study drug))
    CL Item
    Another condition (e.g. condition under study, intercurrent illness) (Another condition (e.g. condition under study, intercurrent illness))
    CL Item
    Another drug (Another drug)
    SAE association
    Item
    Please specify:
    text
    C1706737 (UMLS CUI [1])
    corrective therapy
    Item
    Corrective Therapy
    boolean
    C0559546 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    subject withdrawn due to event
    Item
    Was subject withdrawn due to this AE?
    boolean
    C0422727 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    laboratory test
    Item
    Laboratory Data: Test
    text
    C0022885 (UMLS CUI [1])
    laboratory date
    Item
    Laboratory Data: Date
    date
    C0022877 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    laboratory value
    Item
    Laboratory Data: Value
    text
    C0022877 (UMLS CUI [1])
    unit
    Item
    Laboratory Data: Units
    text
    C1519795 (UMLS CUI [1])
    normal range
    Item
    Laboratory Data: Normal Range
    text
    C2826705 (UMLS CUI [1])
    serious adverse event remarks
    Item
    Remarks
    text
    C1519255 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    randomisation code broken
    Item
    If applicable, was randomisation code broken at investigational site?
    boolean
    C0034656 (UMLS CUI [1])
    randomisation number
    Item
    Randomisation/ Study Medication Number
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    investigator
    Item
    Investigator
    text
    C2826892 (UMLS CUI [1])
    Item Group
    Investigator's Checklist
    C1707357 (UMLS CUI-1)
    C0008961 (UMLS CUI-2)
    baseline signs and symptoms
    Item
    Check all Baseline Signs and Symptoms form is up to date and complete
    boolean
    C0037088 (UMLS CUI [1])
    prior medication
    Item
    Check that the Prior Medication form is up to date
    boolean
    C0013227 (UMLS CUI [1])
    signatures and dates
    Item
    Check that all appropriate pages are sgined (thus indicating completition) and dated
    boolean
    C2346576 (UMLS CUI [1])
    C0011008 (UMLS CUI [2])
    laboratory
    Item
    Check that laboratory results are included
    boolean
    C0022877 (UMLS CUI [1])
    correct, complete recording
    Item
    I certify that the observations and findings are recorded correctly and completely in this CRF.
    text
    C0034869 (UMLS CUI [1,1])
    C2349182 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
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