ID

35647

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 Medication Record and Dose reduction form. Study Medication Record has to be filled in for Day 2, Week 1-52 and for early withdrawal. Dose reduction ha to be filled in for Week 1-48.

Keywords

Versions (1)
  1. 3/13/19 3/13/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 13, 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

Study Medication Record, Dose reduction

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Centre Number

Data type

text

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
Visit Type
Description

Visit Type

Data type

integer

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

Study Medication Record

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
Please complete the study medication record in the Study Medication and Compliance Section
Description

Study Medication Record

Data type

boolean

Alias
UMLS CUI [1,1]
C2734539
UMLS CUI [1,2]
C0008972
Dose Reduction Between Scheduled Visits
Description

Dose Reduction Between Scheduled Visits

Alias
UMLS CUI-1
C1707814
If the patient requires a dose reduction between this and the next visit please complete Dose Reductions Due To Adverse Experiences pages
Description

Dose reduction

Data type

boolean

Alias
UMLS CUI [1]
C1707814
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Similar models

Study Medication Record, Dose reduction

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
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
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Day 2 (1)
CL Item
Week 1 (2)
CL Item
Week 2  (3)
CL Item
Week 3  (4)
CL Item
Week 4 (5)
CL Item
Week 5 (6)
CL Item
Week 6 (7)
CL Item
Week 7 (8)
CL Item
Week 8  (9)
CL Item
Week 12 (10)
CL Item
Week 24 (11)
CL Item
Week 36 (12)
CL Item
Week 48 (13)
CL Item
Week 52 (14)
CL Item
Early withdrawal (15)
Item Group
Study Medication Record
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study Medication Record
Item
Please complete the study medication record in the Study Medication and Compliance Section
boolean
C2734539 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Item Group
Dose Reduction Between Scheduled Visits
C1707814 (UMLS CUI-1)
Dose reduction
Item
If the patient requires a dose reduction between this and the next visit please complete Dose Reductions Due To Adverse Experiences pages
boolean
C1707814 (UMLS CUI [1])
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