ID

35554

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 Previous Study Information form. It has to be filled in for screening.

Keywords

  1. 3/8/19 3/8/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 8, 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

Previous Study Information

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]
C2348585
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
Previous Study Information
Description

Previous Study Information

Alias
UMLS CUI-1
C2603343
UMLS CUI-2
C1533716
UMLS CUI-3
C0205156
Previous SB Protocol Number
Description

Protocol Number

Data type

integer

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Previous Centre Number
Description

Centre Number

Data type

integer

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

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585

Similar models

Previous Study Information

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
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Previous Study Information
C2603343 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
Protocol Number
Item
Previous SB Protocol Number
integer
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Centre Number
Item
Previous Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Previous Patient Number
text
C2348585 (UMLS CUI [1])

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