0 Bedömningar
ID

36391

Beskrivning

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the SAE form. It has to be filled in if the subject experiences SAE during the study.

Nyckelord

Versioner (2)
  1. 2017-09-08 2017-09-08 -
  2. 2019-05-10 2019-05-10 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 maj 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

    Engelsk

    Serious Adverse Experiences (SAE)

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beskrivning

    Subject number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    SERIOUS ADVERSE EVENT (SAE)
    Beskrivning

    SERIOUS ADVERSE EVENT (SAE)

    Alias
    UMLS CUI-1
    C1519255
    Person Reporting SAE
    Beskrivning

    Person Reporting SAE

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0008961
    AEGIS Number
    Beskrivning

    AEGIS Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0600091
    Serious Adverse Event
    Beskrivning

    Serious Adverse Experience

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519255
    Results in death
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C0011065
    Life threatening
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C2826244
    Results in hospitalisation or prolongation of existing hospitalisation
    Beskrivning

    Specify reason(s) for considering this a serious AE. Mark all that apply. 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 of a preexisting condition that did not worsen from baseline is not considered an AE.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C0019993
    Results in disability/incapacity
    Beskrivning

    Specify reason(s) for considering this a serious AE. Mark all that apply. NOTE: The term disability means a substantial disruption of a 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 constitute a substantial disruption.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C0231170
    Congenital abnormality/birth defect
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C0000768
    If there is an other reason, please specify
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3840932
    Onset Date of SAE
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C1519255
    Onset Time of SAE
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0449244
    UMLS CUI [1,2]
    C1519255
    End Date of SAE
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1519255
    End Time of SAE
    Beskrivning

    00:00-23:59

    Datatyp

    time

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

    NOTE: If subject died, please inform GSK within 24 hours and complete form D

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1705586
    Event course
    Beskrivning

    Experience Course

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    If SAE is intermittent, please specify number of episodes
    Beskrivning

    Number of episodes

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C4086638
    Intensity of SAE (maximum)
    Beskrivning

    INTENSITY (Maximum) Definition: MILD: Adverse Event which is easily tolerated. MODERATE: Adverse Event sufficiently discomforting to interfere with daily activity. SEVERE: Adverse Event which prevents normal everyday activities.

    Datatyp

    integer

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

    Action Taken with Respect to Investigational Drug

    Datatyp

    integer

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

    SAE abate

    Datatyp

    text

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

    dosage change of study medication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0420247
    UMLS CUI [1,2]
    C0304229
    If study medication was reintroduced (or dose increased), did SAE recur?
    Beskrivning

    Serious Adverse Experiences recurrence

    Datatyp

    text

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

    Definition: NOT RELATED: The adverse event is definitely not related to the test drug. UNLIKELY: There are more likely causes and the drug is not suspected as a cause. SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the drug and the adverse event has not been demonstrated but there is a reasonable possibility that the event was caused by the drug. PROBABLE: There is probably a direct cause and effect relationship between the adverse event and the study drug.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    If SAE is "not related" or "unlikely" related to investigational durg, please specify the probably association
    Beskrivning

    Relationship to Investigational Drug, Assessment

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    UMLS CUI [1,4]
    C1516048
    If there is a SAE association, please specify
    Beskrivning

    Another contition: eg, condition under study, intercurrent illness

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348235
    Corrective Therapy
    Beskrivning

    If ‘Yes’, record details in the Concomitant Medication section and/or Healthcare Resource Utilisation form if appropriate

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    Was patient withdrawn due to this specific AE?
    Beskrivning

    Patient withdrawn due to this specific AE

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1518404
    Relevant laboratory data
    Beskrivning

    Relevant laboratory data

    Alias
    UMLS CUI-1
    C0022877
    UMLS CUI-2
    C1519255
    Test
    Beskrivning

    Test

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0332307
    Date of test
    Beskrivning

    day month year

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826247
    Value
    Beskrivning

    Value

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1522609
    Units
    Beskrivning

    Units

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519795
    Normal Range
    Beskrivning

    Normal Range

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0086715
    Remarks
    Beskrivning

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

    Datatyp

    text

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

    Randomisation code broken

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3897778
    UMLS CUI [1,2]
    C1272691
    Randomisation/Study medication number
    Beskrivning

    Randomisation Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Investigator’s Signature
    Beskrivning

    Confirming that the above data are accurate and complete

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Name of investigator
    Beskrivning

    Please PRINT Name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    GSK Medical Monitor’s Signature
    Beskrivning

    Medical Monitor’s Signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Name of GSK Medical Monitor
    Beskrivning

    Please PRINT Name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C1708968
    Date of Medical Monitor’s signature
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1708968
    UMLS CUI [1,2]
    C1519316
    Tillbaka till toppen

    Similar models

    Serious Adverse Experiences (SAE)

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    SERIOUS ADVERSE EVENT (SAE)
    C1519255 (UMLS CUI-1)
    Person Reporting SAE
    Item
    Person Reporting SAE
    text
    C0008961 (UMLS CUI [1])
    AEGIS Number
    Item
    AEGIS Number
    integer
    C0237753 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Serious Adverse Experience
    Item
    Serious Adverse Event
    text
    C1519255 (UMLS CUI [1])
    Reason: death
    Item
    Results in death
    boolean
    C0566251 (UMLS CUI [1,1])
    C0011065 (UMLS CUI [1,2])
    Reason: life threatening
    Item
    Life threatening
    boolean
    C0566251 (UMLS CUI [1,1])
    C2826244 (UMLS CUI [1,2])
    Reason: hospitalization
    Item
    Results in hospitalisation or prolongation of existing hospitalisation
    boolean
    C0566251 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    Reason: disability
    Item
    Results in disability/incapacity
    boolean
    C0566251 (UMLS CUI [1,1])
    C0231170 (UMLS CUI [1,2])
    Reason: congenital abnormality
    Item
    Congenital abnormality/birth defect
    boolean
    C0566251 (UMLS CUI [1,1])
    C0000768 (UMLS CUI [1,2])
    Other reason
    Item
    If there is an other reason, please specify
    text
    C3840932 (UMLS CUI [1])
    Onset Date of SAE
    Item
    Onset Date of SAE
    date
    C0574845 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Onset Time of SAE
    Item
    Onset Time of SAE
    time
    C0449244 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    End Date of SAE
    Item
    End Date of SAE
    date
    C0806020 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    End Time of SAE
    Item
    End Time of SAE
    time
    C1522314 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Outcome of SAE
    integer
    C1519255 (UMLS CUI [1,1])
    C1705586 (UMLS CUI [1,2])
    Outcome
    Code List
    Outcome of SAE
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    CL Item
    Died (3)
    Item
    Event course
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Experience Course
    Code List
    Event course
    CL Item
    Intermittent (1)
    CL Item
    Constant (2)
    Number of episodes
    Item
    If SAE is intermittent, please specify number of episodes
    integer
    C0877248 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Item
    Intensity of SAE (maximum)
    integer
    C1710066 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Intensity
    Code List
    Intensity of SAE (maximum)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Action Taken with Respect to Investigational Drug
    integer
    C2826626 (UMLS CUI [1])
    Action Taken with Respect to Investigational Drug
    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
    Did the SAE abate?
    text
    C1519255 (UMLS CUI [1,1])
    C3853704 (UMLS CUI [1,2])
    SAE abate
    Code List
    Did the SAE abate?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
    text
    C0420247 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    dosage change of study medication
    Code List
    If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If study medication was reintroduced (or dose increased), did SAE recur?
    text
    C1519255 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    Serious Adverse Experiences recurrence
    Code List
    If study medication was reintroduced (or dose increased), did SAE recur?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Relationship to Investigational Drug
    integer
    C1518404 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Relationship to Investigational Drug
    Code List
    Relationship to Investigational Drug
    CL Item
    Not related (1)
    CL Item
    Dose reduced  (2)
    CL Item
    Dose increased  (3)
    CL Item
    Drug interrupted/restarted (4)
    CL Item
    Drug stopped  (5)
    Item
    If SAE is "not related" or "unlikely" related to investigational durg, please specify the probably association
    integer
    C1519255 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    C1516048 (UMLS CUI [1,4])
    undefined item
    Code List
    If SAE is "not related" or "unlikely" related to investigational durg, please specify the probably association
    CL Item
    Protocol design or procedures (1)
    CL Item
    Another condition  (2)
    CL Item
    Another drug (3)
    SAE association, Specification
    Item
    If there is a SAE association, please specify
    text
    C1519255 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item
    Corrective Therapy
    text
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Corrective Therapy
    Code List
    Corrective Therapy
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was patient withdrawn due to this specific AE?
    text
    C0422727 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Patient withdrawn due to this specific AE
    Code List
    Was patient withdrawn due to this specific AE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Relevant laboratory data
    C0022877 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Test
    Item
    Test
    text
    C0022885 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Date of test
    Item
    Date of test
    text
    C2826247 (UMLS CUI [1])
    Value
    Item
    Value
    text
    C1522609 (UMLS CUI [1])
    Units
    Item
    Units
    text
    C1519795 (UMLS CUI [1])
    Normal Range
    Item
    Normal Range
    text
    C0086715 (UMLS CUI [1])
    Remarks
    Item
    Remarks
    text
    C0947611 (UMLS CUI [1])
    Item
    If applicable, was randomisation code broken at investigational site?
    text
    C3897778 (UMLS CUI [1,1])
    C1272691 (UMLS CUI [1,2])
    Randomisation code broken
    Code List
    If applicable, was randomisation code broken at investigational site?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Randomisation Number
    Item
    Randomisation/Study medication number
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Investigators 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])
    Name of investigator
    Item
    Name of investigator
    text
    C2826892 (UMLS CUI [1])
    Medical Monitor’s Signature
    Item
    GSK Medical Monitor’s Signature
    text
    C2346576 (UMLS CUI [1])
    Name of GSK Medical Monitor
    Item
    Name of GSK Medical Monitor
    text
    C0027365 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    Date of Medical Monitor’s signature
    Item
    Date of Medical Monitor’s signature
    date
    C1708968 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial