ID

35626

Beschrijving

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 contaisn the study entry form. It has to be filled in for screening/Baseline.

Trefwoorden

  1. 16-08-17 16-08-17 -
  2. 12-03-19 12-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 maart 2019

DOI

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Licentie

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

Study Entry

  1. StudyEvent: ODM
    1. Study Entry
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C1830427
Patient initials
Beschrijving

Patient initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Centre Number
Beschrijving

Centre Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
STUDY ENTRY
Beschrijving

STUDY ENTRY

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0679823
Did the patient require a screening visit?
Beschrijving

screening visit

Datatype

text

Alias
UMLS CUI [1]
C2097637

Similar models

Study Entry

  1. StudyEvent: ODM
    1. Study Entry
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient initials
Item
Patient initials
text
C2986440 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
STUDY ENTRY
C0008976 (UMLS CUI-1)
C0679823 (UMLS CUI-2)
Item
Did the patient require a screening visit?
text
C2097637 (UMLS CUI [1])
Code List
Did the patient require a screening visit?
CL Item
Yes (Y)
CL Item
No (N)

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