ID

35688

Description

Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 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 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the study conclusion form. It has to be filled in for the end of study or for early withdrawal.

Keywords

Versions (1)
  1. 3/15/19 3/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 15, 2019

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Creative Commons BY-NC 3.0
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    Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192

    English

    Study Conclusion

    1 forms  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Description

    Centre Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Visit Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Visit type
    Description

    Visit type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Did the patient complete the study according to the protocol?
    Description

    Study Conclusion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1707478
    UMLS CUI [1,2]
    C0008972
    If no completion of study, please mark the primary cause of withdrawal.
    Description

    Reason of withdrawal

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0085978
    If other reason for withdrawal, please specify
    Description

    Other reason

    Data type

    text

    Alias
    UMLS CUI [1]
    C3840932
    Serious Adverse Experiences
    Description

    Serious Adverse Experiences

    Alias
    UMLS CUI-1
    C1519255
    Person Reporting SAE
    Description

    Person Reporting SAE

    Data type

    text

    Alias
    UMLS CUI [1]
    C0008961
    AEGIS Number
    Description

    AEGIS Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0600091
    Serious Adverse Experience
    Description

    Serious Adverse Experience

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519255
    Results in death
    Description

    Specify reason(s) for considering this a serious AE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0011065
    Life threatening
    Description

    Specify reason(s) for considering this a serious AE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C2826244
    Results in hospitalisation or prolongation of existing hospitalisation
    Description

    Specify reason(s) for considering this a serious AE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0019993
    Results in disability/incapacity
    Description

    Specify reason(s) for considering this a serious AE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0231170
    Congenital abnormality/birth defect
    Description

    Specify reason(s) for considering this a serious AE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0000768
    Other reason
    Description

    Specify reason(s) for considering this a serious AE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0205394
    If other reason, please specify
    Description

    Other reason, specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C3840932
    UMLS CUI [1,3]
    C1521902
    Onset Date and Time
    Description

    day month year 00:00-23:59

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826806
    End Date and Time
    Description

    day month year 00:00-23:59

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826793
    Outcome of SAE
    Description

    If patient died, STOP: go to SAE section and follow instructions given there

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1705586
    UMLS CUI [1,2]
    C1519255
    Experience Course
    Description

    Experience Course

    Data type

    integer

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

    Number of episodes

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C4086638
    Action Taken with Respect to Investigational Drug
    Description

    Action Taken with Respect to Investigational Drug

    Data type

    integer

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

    SAE abate

    Data type

    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)?
    Description

    dosage change

    Data type

    text

    Alias
    UMLS CUI [1]
    C0420247
    If yes, did SAE recur?
    Description

    Serious Adverse Experiences recurrence

    Data type

    text

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

    Relationship to Investigational Drug

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    The SAE is probably associated with:
    Description

    Relationship to Investigational Drug

    Data type

    integer

    If another drug, please specify
    Description

    Another drug

    Data type

    text

    Alias
    UMLS CUI [1]
    C1115771
    Corrective Therapy
    Description

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

    Data type

    text

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

    patient withdrawn due to this specific AE

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1518404
    Relevant Laboratory Data
    Description

    Relevant Laboratory Data

    Alias
    UMLS CUI-1
    C0022877
    Test
    Description

    Test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0332307
    Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Value
    Description

    Value

    Data type

    text

    Alias
    UMLS CUI [1]
    C1522609
    Units
    Description

    Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795
    Normal Range
    Description

    Normal Range

    Data type

    text

    Alias
    UMLS CUI [1]
    C0086715
    Remarks
    Description

    Remarks

    Data type

    text

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

    randomisation code broken

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897778
    UMLS CUI [1,2]
    C1272691
    Randomisation Number
    Description

    Randomisation Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Investigators Signature
    Description

    Investigators Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Investigator's Name
    Description

    Investigator's Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    SB Medical Monitor’s Signature
    Description

    Medical Monitor’s Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Medical Monitor's Name
    Description

    Medical Monitor's Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C1708968
    Date of signature
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0807937
    UMLS CUI [1,2]
    C1708968
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    Similar models

    Study Conclusion

    1 forms
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Centre Number
    Item
    Centre Number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Early wthdrawal (1)
    CL Item
    Follow-up (2)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Item
    Did the patient complete the study according to the protocol?
    text
    C1707478 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    Study Conclusion
    Code List
    Did the patient complete the study according to the protocol?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If no completion of study, please mark the primary cause of withdrawal.
    integer
    C0422727 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    cause of withdrawal
    Code List
    If no completion of study, please mark the primary cause of withdrawal.
    CL Item
    Adverse experience (please complete AE page) (1)
    CL Item
    Insufficient therapeutic effect (2)
    CL Item
    Protocol deviation (including non-compliance) (3)
    CL Item
    Lost to follow-up (4)
    CL Item
    Other (5)
    Other reason
    Item
    If other reason for withdrawal, please specify
    text
    C3840932 (UMLS CUI [1])
    Item Group
    Serious Adverse Experiences
    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 Experience
    text
    C1519255 (UMLS CUI [1])
    Results in death
    Item
    Results in death
    boolean
    C0392360 (UMLS CUI [1,1])
    C0011065 (UMLS CUI [1,2])
    Life threatening
    Item
    Life threatening
    boolean
    C0392360 (UMLS CUI [1,1])
    C2826244 (UMLS CUI [1,2])
    Results in hospitalisation or prolongation of existing hospitalisation
    Item
    Results in hospitalisation or prolongation of existing hospitalisation
    boolean
    C0392360 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    Results in disability/incapacity
    Item
    Results in disability/incapacity
    boolean
    C0392360 (UMLS CUI [1,1])
    C0231170 (UMLS CUI [1,2])
    Congenital abnormality/birth defect
    Item
    Congenital abnormality/birth defect
    boolean
    C0392360 (UMLS CUI [1,1])
    C0000768 (UMLS CUI [1,2])
    Other reason
    Item
    Other reason
    boolean
    C0392360 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other reason, specification
    Item
    If other reason, please specify
    text
    C0422727 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Onset Date and Time
    Item
    Onset Date and Time
    datetime
    C2826806 (UMLS CUI [1])
    End Date and Time
    Item
    End Date and Time
    datetime
    C2826793 (UMLS CUI [1])
    Item
    Outcome of SAE
    integer
    C1705586 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Outcome
    Code List
    Outcome of SAE
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    CL Item
    Died (3)
    Item
    Experience Course
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Experience Course
    Code List
    Experience Course
    CL Item
    Intermittent (1)
    CL Item
    Constant (2)
    Number of episodes
    Item
    Number of episodes
    integer
    C0877248 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    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
    No (N)
    CL Item
    Yes (Y)
    Item
    If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
    text
    C0420247 (UMLS CUI [1])
    dosage change
    Code List
    If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    If yes, did SAE recur?
    text
    C1519255 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    Serious Adverse Experiences recurrence
    Code List
    If yes, did SAE recur?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    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
    Related (1)
    CL Item
    Possibly related (2)
    CL Item
    Probably unrelated  (3)
    CL Item
    Unrelated (4)
    Item
    The SAE is probably associated with:
    integer
    Relationship to Investigational Drug
    Code List
    The SAE is probably associated with:
    CL Item
    Protocol design or procedures (1)
    CL Item
    Another condition (eg, condition under study, intercurrent illness) (2)
    CL Item
    Another drug (3)
    Another drug
    Item
    If another drug, please specify
    text
    C1115771 (UMLS CUI [1])
    Item
    Corrective Therapy
    text
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Corrective Therapy
    Code List
    Corrective Therapy
    CL Item
    No (N)
    CL Item
    Yes (Y)
    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
    No (N)
    CL Item
    Yes (Y)
    Item Group
    Relevant Laboratory Data
    C0022877 (UMLS CUI-1)
    Test
    Item
    Test
    text
    C0022885 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Date
    Item
    Date
    date
    C0011008 (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
    No (N)
    CL Item
    Yes (Y)
    Randomisation Number
    Item
    Randomisation Number
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Investigators Signature
    Item
    Investigators Signature
    text
    C2346576 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C0011008 (UMLS CUI [1])
    Investigator's Name
    Item
    Investigator's Name
    text
    C2826892 (UMLS CUI [1])
    Medical Monitor’s Signature
    Item
    SB Medical Monitor’s Signature
    text
    C2346576 (UMLS CUI [1])
    Medical Monitor's Name
    Item
    Medical Monitor's Name
    text
    C0027365 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    Date of signature
    Item
    Date of signature
    date
    C0807937 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
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