0 Ratings
ID

36015

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the SAE form. It has to be filled in if the subject experience a SAE during the study trial.

Keywords

Versions (1)
  1. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

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April 9, 2019

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Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    English

    Serious Adverse Event (SAE)

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Description

    Subject No.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Description

    Panel ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846158
    GSK Receipt Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985846
    Serious Adverse Event (SAE)
    Description

    Serious Adverse Event (SAE)

    Alias
    UMLS CUI-1
    C1519255
    Person Reporting SAE
    Description

    (Please print clearly)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0335038
    UMLS CUI [1,2]
    C1519255
    AEGIS number
    Description

    GSK use

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0679918
    UMLS CUI [1,3]
    C1519255
    Serious Adverse Event
    Description

    (Please print clearly). Please specify reason(s) for considering this a SAE in the itemgroup "SAE, reason".

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519255
    Comment for GSK
    Description

    Comment for GSK

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0008961
    SAE onset Date
    Description

    day month year

    Data type

    date

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

    00:00-23:9

    Data type

    time

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

    day month year (If ongoing please leave blank)

    Data type

    date

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

    00:00-23:59 If ongoing please leave blank)

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C1519255
    Outcome SAE
    Description

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

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1624730
    UMLS CUI [1,2]
    C1519255
    Event Course SAE
    Description

    Event Course SAE

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0750729
    UMLS CUI [1,2]
    C1519255
    If event course, please note number of episodes
    Description

    Number of episodes

    Data type

    integer

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

    Mild: An event which is easily tolerated Moderate: An event which is sufficiently discomforting to interfere with daily activity Severe: An event which prevents normal everyday activities

    Data type

    integer

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

    Action Taken

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1547656
    Was study medication reintroduced (or dose increased)?
    Description

    If study medication was interrupted, stopped or dose reduced

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3854006
    UMLS CUI [1,2]
    C0580673
    UMLS CUI [2,1]
    C3854006
    UMLS CUI [2,2]
    C1611744
    If study medication reintroduced, did SAE recur?
    Description

    SAE recur

    Data type

    text

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

    If you tick "Not related" or "Unlikely" please fill in the itemgroup "Assessment". Not related: The event is definitely not related to the study procedured Unlikely: There are other more likely causes and the study procedures are not suspected as a cause Suspected (reasonable possibility): A direct cause and effect relationship between the study procedures and the event has not been demonstrated but there is a reasonable possibility that the study procedures were involved Probable: There probably is a direct cause and effect relationship between the event and the study procedures

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439849
    UMLS CUI [1,2]
    C3854006
    Corrective Therapy
    Description

    If "Yes", record details in the Concomitant Medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1519255
    Was subject withdrawn due to this specific SAE?
    Description

    Subject withdrawn

    Data type

    text

    Alias
    UMLS CUI [1]
    C0422727
    Did the SAE abate?
    Description

    SAE abate

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3853704
    UMLS CUI [1,2]
    C1519255
    SAE, reason
    Description

    SAE, reason

    Alias
    UMLS CUI-1
    C0392360
    UMLS CUI-2
    C1519255
    Results in death
    Description

    Results in death

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011065
    UMLS CUI [1,2]
    C1519255
    Life threatening
    Description

    NOTE: The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1517874
    Requires hospitalisation or prolongation of existing hospitalization
    Description

    NOTE: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is serious. When in doubt as to whether ,,hospitalisation" occurred or was necessary, the AE should be considered serious. Hospitalisation for elective treatment ofa pre-existing condition that did not worsen from baseline is not considered anAE.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0019993
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C0745041
    Results in disability/incapacity
    Description

    NOTE: The term disability means a substantial disruption ofa person's ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (e.g. sprained ankle) which may interfere or prevent everyday life functions but do not consitute a substantial disruption.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0231170
    Congenital anomaly/birth defect
    Description

    Congenital anomaly/birth defect

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C1519255
    Other reason
    Description

    Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1519255
    If other reason, please specify
    Description

    Other reason, specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1521902
    Assessment
    Description

    Assessment

    Alias
    UMLS CUI-1
    C0220825
    Protocol design or procedures (but not to study drug)
    Description

    The SAE is probably associated with:

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332281
    UMLS CUI [1,2]
    C0184661
    Another condition (eg. condition under study intercurrent illness)
    Description

    The SAE is probably associated with:

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332281
    UMLS CUI [1,2]
    C2707304
    Another drug
    Description

    The SAE is probably associated with:

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332281
    UMLS CUI [1,2]
    C1115771
    If there is an association, Please specify
    Description

    Please specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521902
    Relevant Laboratory Data
    Description

    Relevant Laboratory Data

    Alias
    UMLS CUI-1
    C0022877
    Laboratory Test
    Description

    Laboratory Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C3891717
    Date of test
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0011008
    Laboratory Value
    Description

    Laboratory Value

    Data type

    float

    Alias
    UMLS CUI [1]
    C0587081
    Units
    Description

    Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795
    Normal Range
    Description

    Normal Range

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0086715
    UMLS CUI [1,2]
    C0587081
    Details SAE
    Description

    Details SAE

    Alias
    UMLS CUI-1
    C1522508
    UMLS CUI-2
    C1519255
    Remarks SAE
    Description

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

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C1519255
    If applicable, was randomization code broken at investigational site?
    Description

    Randomization code broken

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0443289
    Randomisation/Study Medication Number
    Description

    Randomisation/Study Medication Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0600091
    Investigator's Signature
    Description

    (confirming that the above data are accurate and complete)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Print name
    Description

    Print name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1555464
    UMLS CUI [1,2]
    C0027365
    GSK Medical Monitor's Signature
    Description

    GSK Medical Monitor's Signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519316
    UMLS CUI [1,2]
    C1708968
    UMLS CUI [1,3]
    C0008961
    Date of Medical Monitor's signature
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1519316
    UMLS CUI [1,2]
    C1708968
    UMLS CUI [1,3]
    C0008961
    Print Name of Medical Monitor
    Description

    Print Name of Medical Monitor

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C1708968
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    Similar models

    Serious Adverse Event (SAE)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    GSK Receipt Date
    Item
    GSK Receipt Date
    date
    C2985846 (UMLS CUI [1])
    Item Group
    Serious Adverse Event (SAE)
    C1519255 (UMLS CUI-1)
    Person Reporting SAE
    Item
    Person Reporting SAE
    text
    C0335038 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    AEGIS number
    Item
    AEGIS number
    text
    C0600091 (UMLS CUI [1,1])
    C0679918 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Serious Adverse Event
    Item
    Serious Adverse Event
    text
    C1519255 (UMLS CUI [1])
    Comment for GSK
    Item
    Comment for GSK
    text
    C0947611 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    SAE onset Date
    Item
    SAE onset Date
    date
    C0574845 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE onset Time
    Item
    SAE onset Time
    time
    C0449244 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE end Date
    Item
    SAE end Date
    date
    C0806020 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE end Time
    Item
    SAE end Time
    time
    C1522314 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Outcome SAE
    integer
    C1624730 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Outcome
    Code List
    Outcome SAE
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    CL Item
    Died (3)
    Item
    Event Course SAE
    integer
    C0750729 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Event Course
    Code List
    Event Course SAE
    CL Item
    Intermittent (1)
    CL Item
    Constant (2)
    Number of episodes
    Item
    If event course, please note number of episodes
    integer
    C4086638 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    SAE intensity (maximum)
    integer
    C0518690 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Intensity (maximum)
    Code List
    SAE intensity (maximum)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Action Taken with Respect to Investigational Drug
    integer
    C1547656 (UMLS CUI [1])
    Action Taken
    Code List
    Action Taken with Respect to Investigational 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
    Was study medication reintroduced (or dose increased)?
    text
    C3854006 (UMLS CUI [1,1])
    C0580673 (UMLS CUI [1,2])
    C3854006 (UMLS CUI [2,1])
    C1611744 (UMLS CUI [2,2])
    Study medication reintroduced
    Code List
    Was study medication reintroduced (or dose increased)?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If study medication reintroduced, did SAE recur?
    text
    C0034897 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE recur
    Code List
    If study medication reintroduced, did SAE recur?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Relationship to Investigational Drug
    integer
    C0439849 (UMLS CUI [1,1])
    C3854006 (UMLS CUI [1,2])
    Relationship
    Code List
    Relationship to Investigational Drug
    CL Item
    Not related (1)
    CL Item
    Unlikely (2)
    CL Item
    Suspected (reasonable possibility) (3)
    CL Item
    Probable (4)
    Item
    Corrective Therapy
    text
    C0087111 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Corrective Therapy
    Code List
    Corrective Therapy
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was subject withdrawn due to this specific SAE?
    text
    C0422727 (UMLS CUI [1])
    Subject withdrawn
    Code List
    Was subject withdrawn due to this specific SAE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Did the SAE abate?
    text
    C3853704 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Did the SAE abate?
    Code List
    Did the SAE abate?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    SAE, reason
    C0392360 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Results in death
    Item
    Results in death
    boolean
    C0011065 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Life threatening
    Item
    Life threatening
    boolean
    C1517874 (UMLS CUI [1])
    Requires hospitalisation or prolongation of existing hospitalization
    Item
    Requires hospitalisation or prolongation of existing hospitalization
    boolean
    C1519255 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2,1])
    C0745041 (UMLS CUI [2,2])
    Results in disability/incapacity
    Item
    Results in disability/incapacity
    boolean
    C1519255 (UMLS CUI [1,1])
    C0231170 (UMLS CUI [1,2])
    Congenital anomaly/birth defect
    Item
    Congenital anomaly/birth defect
    boolean
    C0000768 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Other reason
    Item
    Other reason
    boolean
    C3840932 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Other reason, specification
    Item
    If other reason, please specify
    text
    C3840932 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Item Group
    Assessment
    C0220825 (UMLS CUI-1)
    Association with protocol design
    Item
    Protocol design or procedures (but not to study drug)
    boolean
    C0332281 (UMLS CUI [1,1])
    C0184661 (UMLS CUI [1,2])
    Association with another condition
    Item
    Another condition (eg. condition under study intercurrent illness)
    boolean
    C0332281 (UMLS CUI [1,1])
    C2707304 (UMLS CUI [1,2])
    Association with another drug
    Item
    Another drug
    boolean
    C0332281 (UMLS CUI [1,1])
    C1115771 (UMLS CUI [1,2])
    Please specify
    Item
    If there is an association, Please specify
    text
    C1521902 (UMLS CUI [1])
    Item Group
    Relevant Laboratory Data
    C0022877 (UMLS CUI-1)
    Laboratory Test
    Item
    Laboratory Test
    text
    C3891717 (UMLS CUI [1])
    Date of test
    Item
    Date of test
    date
    C0022885 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Laboratory Value
    Item
    Laboratory Value
    float
    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])
    Item Group
    Details SAE
    C1522508 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Remarks SAE
    Item
    Remarks SAE
    text
    C0678257 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    If applicable, was randomization code broken at investigational site?
    text
    C0034656 (UMLS CUI [1,1])
    C0443289 (UMLS CUI [1,2])
    Randomization code broken
    Code List
    If applicable, was randomization code broken at investigational site?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Randomisation/Study Medication Number
    Item
    Randomisation/Study Medication Number
    text
    C0034656 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Investigator's Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Print name
    Item
    Print name
    text
    C1555464 (UMLS CUI [1,1])
    C0027365 (UMLS CUI [1,2])
    GSK Medical Monitor's Signature
    Item
    GSK Medical Monitor's Signature
    text
    C1519316 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    C0008961 (UMLS CUI [1,3])
    Date of Medical Monitor's signature
    Item
    Date of Medical Monitor's signature
    date
    C1519316 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    C0008961 (UMLS CUI [1,3])
    Print Name of Medical Monitor
    Item
    Print Name of Medical Monitor
    text
    C0027365 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
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