ID

35683

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 Mos-sleep, WPAI RLS Score, SF-36 (health status questionaire)and RLS Quality Of Life Questionnaire form. It has to be filled in for Baseline, Week 12, Week 24, Week 36, Week 48 and early withdrawal.

Keywords

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

GlaxoSmithKline

Uploaded on

March 15, 2019

DOI

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License

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

MOS – SLEEP, WPAI RLS Score, SF-36 (health status questionaire), RLS Quality Of Life Questionnaire

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient initials
Description

Patient initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
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
Mos-sleep Questionnaire
Description

Mos-sleep Questionnaire

Alias
UMLS CUI-1
C0034394
Mos - sleep score
Description

Mos - sleep score

Data type

integer

Alias
UMLS CUI [1]
C0034394
Work productivity and activity impairment questionaire - Restless Legs Syndrome (WPAI-(RLS))
Description

Work productivity and activity impairment questionaire - Restless Legs Syndrome (WPAI-(RLS))

Alias
UMLS CUI-1
C3639722
WPAI RLS Score
Description

WPAI RLS Score

Data type

integer

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0035258
SF-36 (Health status questionaire)
Description

SF-36 (Health status questionaire)

Alias
UMLS CUI-1
C1519136
SF-36 score (Health status questionaire)
Description

SF-36 score

Data type

integer

Alias
UMLS CUI [1]
C1519136
RLS Quality Of Life Questionnaire
Description

RLS Quality Of Life Questionnaire

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0034380
UMLS CUI-3
C0679830
UMLS CUI-4
C0035258
RLS Quality Of Life Questionnaire Score
Description

RLS Quality Of Life Questionnaire Score

Data type

integer

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C0679830
UMLS CUI [1,4]
C0035258
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Similar models

MOS – SLEEP, WPAI RLS Score, SF-36 (health status questionaire), RLS Quality Of Life Questionnaire

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (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
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Baseline (1)
CL Item
Week 12 (2)
CL Item
Week 24 (3)
CL Item
Week 36  (4)
CL Item
Week 48 (5)
CL Item
Early withdrawal (6)
Item Group
Mos-sleep Questionnaire
C0034394 (UMLS CUI-1)
Mos - sleep score
Item
Mos - sleep score
integer
C0034394 (UMLS CUI [1])
Item Group
Work productivity and activity impairment questionaire - Restless Legs Syndrome (WPAI-(RLS))
C3639722 (UMLS CUI-1)
WPAI RLS Score
Item
WPAI RLS Score
integer
C0034394 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
SF-36 (Health status questionaire)
C1519136 (UMLS CUI-1)
SF-36 score
Item
SF-36 score (Health status questionaire)
integer
C1519136 (UMLS CUI [1])
Item Group
C0034394 (UMLS CUI-1)
C0034380 (UMLS CUI-2)
C0679830 (UMLS CUI-3)
C0035258 (UMLS CUI-4)
RLS Quality Of Life Questionnaire Score
Item
RLS Quality Of Life Questionnaire Score
integer
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C0679830 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,4])
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