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ID

35553

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 Pregnancy Dipstick form. It has to be filled in for Screening (+Baseline), Week 24, Week 52 and fpr early withdrawal.

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Versions (1)
  1. 3/8/19 3/8/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 8, 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

    Pregnancy Dipstick

    1 forms  
    1. StudyEvent: ODM
      1. Pregnancy Dipstick
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Centre Number
    Description

    Centre Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    UMLS CUI [1,2]
    C0019994 (Hospitals)
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit type
    Description

    Visit type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Pregnancy Dipstick
    Description

    Pregnancy Dipstick

    Alias
    UMLS CUI-1
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    Is the patient a female of child-bearing potential?
    Description

    child-bearing potential

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1960468 (Female of child bearing age)
    SNOMED
    427504007
    Pregnancy Dipstick Result
    Description

    If patient is of child-bearing potential, please perform a pregnancy dipstick test and record result below. If ’Positive’, please record details on the Pregnancy Notification Form and withdraw the patient.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
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    Similar models

    Pregnancy Dipstick

    1 forms
    1. StudyEvent: ODM
      1. Pregnancy Dipstick
    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 Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Patient Number
    Item
    Patient Number
    text
    C2348585 (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
    Screening (+Baseline) (1)
    CL Item
    Week 24  (2)
    CL Item
    Week 52 (3)
    CL Item
    Early withdrawal (4)
    Item Group
    Pregnancy Dipstick
    C0430056 (UMLS CUI-1)
    child-bearing potential
    Item
    Is the patient a female of child-bearing potential?
    boolean
    C1960468 (UMLS CUI [1])
    Item
    Pregnancy Dipstick Result
    text
    C0430056 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Pregnancy Dipstick Result
    Code List
    Pregnancy Dipstick Result
    CL Item
    Positive (P)
    CL Item
    Negative (N)
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