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25739

Description

Adverse/ serious adverse event and study conclusion - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876 Study ID: 100789 Clinical Study ID: NKV100789 Study Title: A two-part, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of single intravenous doses of GW679769 when administered alone and in combination with intravenous or oral doses of dexamethasone in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

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Versions (1)
  1. 9/16/17 9/16/17 -
Copyright Holder

glaxoSmithKline

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September 16, 2017

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Creative Commons BY-NC 3.0
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    Adverse/ serious adverse event and study conclusion - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

    English

    Adverse/ serious adverse event and study conclusion - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

    1 forms  
    Adverse Event
    Description

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    This Subject has no Adverse Study Events
    Description

    Adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Adverse event/Symptom
    Description

    Adverse event symptom

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1457887
    Outcome
    Description

    If patient died -STOP , infonn GlaxoSmithKline invnediately and complete Serious AE form

    Data type

    text

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

    Adverse Event Onset Date

    Data type

    date

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

    Adverse Event Onset Time

    Data type

    time

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

    Adverse Event End Date

    Data type

    date

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

    Adverse event end time

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826658
    Event Course
    Description

    adverse event course

    Data type

    text

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

    adverse event number of episodes

    Data type

    integer

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

    Intensity of the adverse event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0518690
    Action Taken with Respect to lnvestigational Drug
    Description

    Action Taken in response to event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1547656
    UMLS CUI [1,2]
    C0877248
    Relationship to Study Procedures
    Description

    Relationship to Study Procedures

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1510821
    Check if Corrective Therapy given.
    Description

    if checked, record details in prior and concommitant medication forms and/or Resource utilization if appropriate

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0087111
    Checked if Patient Was Withdrawn Due to This Event.
    Description

    withdrawn due to event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1519255
    Serious adverse event
    Description

    Serious adverse event

    Alias
    UMLS CUI-1
    C1519255
    Verbatim SAE
    Description

    verbatim SAE

    Data type

    text

    Alias
    UMLS CUI [1]
    C2699044
    Outcome
    Description

    if patient died - STOP, inform GlaxoSmithKline immediately

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705586
    Onset Date Serious adverse event
    Description

    Onset Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C1519255
    Onset Time
    Description

    Onset time SAE

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0449244
    UMLS CUI [1,2]
    C1519255
    End Date
    Description

    End Date SAE

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1519255
    End Time
    Description

    End Time SAE

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C1519255
    Event Course
    Description

    Event course SAE

    Data type

    text

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

    Number of episodes SAE

    Data type

    integer

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

    Intensity SAE

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0518690
    Action Taken with Respect to Investigational Drug
    Description

    Action Taken with Respect to Investigational Drug

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826626
    UMLS CUI [1,2]
    C1519255
    Relationship to Study Procedures
    Description

    Relationship to Study Procedures SAE

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1510821
    UMLS CUI [1,2]
    C1519255
    Serious adverse event Code
    Description

    Serious adverse event Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0805701
    SAE association
    Description

    SAE association

    Data type

    text

    Alias
    UMLS CUI [1]
    C1706737
    Please specify SAE association
    Description

    SAE association

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1706737
    UMLS CUI [1,2]
    C1521902
    Did the SAE abate?
    Description

    SAE abate

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C3853704
    Was Medication Re-Introduced?
    Description

    medication reintroduced

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0376495
    Did SAE Recur?
    Description

    SAE recur

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1546995
    Check if Corrective Therapy given.
    Description

    if checked, record details in prior and concommitant medication forms and/or Resource utilization if appropriate

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0087111
    Checked if Patient Was Withdrawn Due to This Event.
    Description

    withdrawn due to event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1519255
    Random Code broken
    Description

    Random Code broken

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0034656
    Random number
    Description

    Random number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Remarks
    Description

    Remarks

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Investigator signature
    Description

    Investigator signature

    Alias
    UMLS CUI-1
    C2346576
    As the Principal lnvestigator (Pl), I am signing this statement after site data management activities (data entry, review and correction) are complete and the eCRFs for this subject have been monitored by GSK representatives. Either I, as the Principal lmestigator, and/or my staff have the site data management actvities.
    Description

    Investigator signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator full name
    Description

    Investigator full name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Investigator username
    Description

    Investigator username

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826689
    Investigator Signature Date
    Description

    Investigator Signature Date

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Comment
    Description

    Comment

    Alias
    UMLS CUI-1
    C0947611
    Comment date
    Description

    Comment date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0011008
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Comment category
    Description

    Comment category

    Data type

    text

    Alias
    UMLS CUI [1]
    C1547758
    Study phase
    Description

    Study phase

    Data type

    text

    Alias
    UMLS CUI [1]
    C0920321
    Session
    Description

    Session

    Data type

    text

    Alias
    UMLS CUI [1]
    C1883017
    Study conclusion
    Description

    Study conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Did subject complete study as planned?
    Description

    subject complete study as planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348577
    If 'no' mark appropriate category.
    Description

    reason for study withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0566251
    Comments on reason for withdrawal
    Description

    Comments on reason for withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0947611
    Date of withdrawal
    Description

    Date of withdrawal

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0011008
    Time of withdrawal:
    Description

    Time of withdrawal

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C2349954
    Date of last dose
    Description

    Date of last dose

    Data type

    date

    Alias
    UMLS CUI [1]
    C1762893
    Time of last dose
    Description

    Time of last dose

    Data type

    time

    Alias
    UMLS CUI [1]
    C0946444
    As the Principal lnvestigator (Pl), I am signing this statement after site data management activities (data entry, review and correction) are complete and the eCRFs for this subject have been monitored by GSK representatives. Either I, as the Principal lmestigator, and/or my staff have the site data management actvities.
    Description

    Investigator signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator full name
    Description

    Investigator full name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Investigator username
    Description

    Investigator username

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826689
    Investigator Signature Date
    Description

    Investigator Signature Date

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Adverse/ serious adverse event and study conclusion - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    Adverse event
    Item
    This Subject has no Adverse Study Events
    boolean
    C0877248 (UMLS CUI [1])
    Adverse event symptom
    Item
    Adverse event/Symptom
    text
    C0877248 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    Adverse event outcome
    Item
    Outcome
    text
    C1705586 (UMLS CUI [1])
    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])
    adverse event course
    Item
    Event Course
    text
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    adverse event number of episodes
    Item
    Number of episodes
    integer
    C0877248 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Intensity of the adverse event
    Item
    Intensity (maximum)
    text
    C0877248 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Action Taken in response to event
    Item
    Action Taken with Respect to lnvestigational Drug
    text
    C1547656 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Relationship to Study Procedures
    Item
    Relationship to Study Procedures
    text
    C0877248 (UMLS CUI [1,1])
    C1510821 (UMLS CUI [1,2])
    corrective therapy
    Item
    Check if Corrective Therapy given.
    boolean
    C1519255 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    withdrawn due to event
    Item
    Checked if Patient Was Withdrawn Due to This Event.
    boolean
    C0422727 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    Serious adverse event
    C1519255 (UMLS CUI-1)
    verbatim SAE
    Item
    Verbatim SAE
    text
    C2699044 (UMLS CUI [1])
    Outcome SAE
    Item
    Outcome
    text
    C1705586 (UMLS CUI [1])
    Onset Date Serious adverse event
    Item
    date
    C0574845 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Onset time SAE
    Item
    Onset Time
    time
    C0449244 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    End Date SAE
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    End Time SAE
    Item
    End Time
    time
    C1522314 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Event course SAE
    Item
    Event Course
    text
    C1519255 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Number of episodes SAE
    Item
    Number of episodes
    integer
    C1519255 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Intensity SAE
    Item
    Intensity (maximum)
    text
    C1519255 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Action Taken with Respect to Investigational Drug
    Item
    Action Taken with Respect to Investigational Drug
    text
    C2826626 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Relationship to Study Procedures SAE
    Item
    Relationship to Study Procedures
    text
    C1510821 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Serious adverse event Code
    Item
    Serious adverse event Code
    text
    C1519255 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    SAE association
    Item
    SAE association
    text
    C1706737 (UMLS CUI [1])
    SAE association
    Item
    Please specify SAE association
    text
    C1706737 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    SAE abate
    Item
    Did the SAE abate?
    boolean
    C1519255 (UMLS CUI [1,1])
    C3853704 (UMLS CUI [1,2])
    medication reintroduced
    Item
    Was Medication Re-Introduced?
    boolean
    C0013227 (UMLS CUI [1,1])
    C0376495 (UMLS CUI [1,2])
    SAE recur
    Item
    Did SAE Recur?
    boolean
    C1546995 (UMLS CUI [1])
    corrective therapy
    Item
    Check if Corrective Therapy given.
    boolean
    C1519255 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    withdrawn due to event
    Item
    Checked if Patient Was Withdrawn Due to This Event.
    boolean
    C0422727 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Random Code broken
    Item
    Random Code broken
    boolean
    C0034656 (UMLS CUI [1])
    Random number
    Item
    Random number
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Remarks
    Item
    Remarks
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Investigator signature
    C2346576 (UMLS CUI-1)
    Investigator signature
    Item
    As the Principal lnvestigator (Pl), I am signing this statement after site data management activities (data entry, review and correction) are complete and the eCRFs for this subject have been monitored by GSK representatives. Either I, as the Principal lmestigator, and/or my staff have the site data management actvities.
    text
    C2346576 (UMLS CUI [1])
    Investigator full name
    Item
    Investigator full name
    text
    C2826892 (UMLS CUI [1])
    Investigator username
    Item
    Investigator username
    text
    C2826689 (UMLS CUI [1])
    Investigator Signature Date
    Item
    Investigator Signature Date
    datetime
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Comment
    C0947611 (UMLS CUI-1)
    Comment date
    Item
    Comment date
    date
    C0947611 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Comment category
    Item
    Comment category
    text
    C1547758 (UMLS CUI [1])
    Study phase
    Item
    Study phase
    text
    C0920321 (UMLS CUI [1])
    Session
    Item
    Session
    text
    C1883017 (UMLS CUI [1])
    Item Group
    Study conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    subject complete study as planned
    Item
    Did subject complete study as planned?
    boolean
    C2348577 (UMLS CUI [1])
    reason for study withdrawal
    Item
    If 'no' mark appropriate category.
    text
    C2348568 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Comments on reason for withdrawal
    Item
    Comments on reason for withdrawal
    text
    C2348568 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Date of withdrawal
    Item
    Date of withdrawal
    date
    C2349954 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of withdrawal
    Item
    Time of withdrawal:
    time
    C0040223 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Date of last dose
    Item
    Date of last dose
    date
    C1762893 (UMLS CUI [1])
    Time of last dose
    Item
    Time of last dose
    time
    C0946444 (UMLS CUI [1])
    Investigator signature
    Item
    As the Principal lnvestigator (Pl), I am signing this statement after site data management activities (data entry, review and correction) are complete and the eCRFs for this subject have been monitored by GSK representatives. Either I, as the Principal lmestigator, and/or my staff have the site data management actvities.
    text
    C2346576 (UMLS CUI [1])
    Investigator full name
    Item
    Investigator full name
    text
    C2826892 (UMLS CUI [1])
    Investigator username
    Item
    Investigator username
    text
    C2826689 (UMLS CUI [1])
    Investigator Signature Date
    Item
    Investigator Signature Date
    datetime
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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