ID

35690

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 contaisn the CRF Tracking/ Review Form (TRF) Study Conclusion form. It has to be filled in for the end of study.

Keywords

Versions (2)
  1. 8/28/17 8/28/17 -
  2. 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

CRF Tracking/ Review Form (TRF) Study Conclusion

1 forms  
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 Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
CRF TRACKING/REVIEW FORM (TRF)
Description

CRF TRACKING/REVIEW FORM (TRF)

Alias
UMLS CUI-1
C3258859
Investigator
Description

Investigator

Data type

text

Alias
UMLS CUI [1]
C2826892
Screening Failure (archive only)
Description

Screening Failure

Data type

boolean

Alias
UMLS CUI [1]
C1512714
MOD6
Description

Module Description: Wk 12 - Wk 24 to Cont/Wthd

Data type

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Description

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
MOD6A
Description

Module Description: Wk 12

Data type

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Description

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
MOD6B
Description

Module Description: Wk 24

Data type

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Description

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
MOD7
Description

Module Description: Wk 12 - Wk 24 RLS Scale

Data type

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Description

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
MOD8
Description

Module Description: Wk 12 - Wk 24 Patient Rating Scale

Data type

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Description

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
SAE3
Description

Module Description: Serious Adverse Experiences

Data type

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Description

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
SAE4
Description

Module Description: Serious Adverse Experiences

Data type

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Description

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
FORMD
Description

Module Description: Form D

Data type

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Description

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
Site Monitor’s comments (eg. protocol violations or deviations)
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Site Monitor’s Name
Description

Name

Data type

text

Alias
UMLS CUI [1]
C0027365
Site Monitor’s Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Date Submitted
Description

Date Submitted

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1515022
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Similar models

CRF Tracking/ Review Form (TRF) Study Conclusion

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
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
C1830427 (UMLS CUI [1])
Item Group
CRF TRACKING/REVIEW FORM (TRF)
C3258859 (UMLS CUI-1)
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Screening Failure
Item
Screening Failure (archive only)
boolean
C1512714 (UMLS CUI [1])
Item
MOD6
text
C1709061 (UMLS CUI [1])
Module
Code List
MOD6
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
MOD6A
text
C1709061 (UMLS CUI [1])
Module
Code List
MOD6A
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
MOD6B
text
C1709061 (UMLS CUI [1])
Module
Code List
MOD6B
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
MOD7
text
C1709061 (UMLS CUI [1])
Module
Code List
MOD7
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
MOD8
text
C1709061 (UMLS CUI [1])
Module
Code List
MOD8
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
SAE3
text
C1709061 (UMLS CUI [1])
Module
Code List
SAE3
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
SAE4
text
C1709061 (UMLS CUI [1])
Module
Code List
SAE4
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
FORMD
text
C1709061 (UMLS CUI [1])
Module
Code List
FORMD
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
comment
Item
Site Monitor’s comments (eg. protocol violations or deviations)
text
C0947611 (UMLS CUI [1])
Name
Item
Site Monitor’s Name
text
C0027365 (UMLS CUI [1])
Signature
Item
Site Monitor’s Signature
text
C1519316 (UMLS CUI [1])
Date Submitted
Item
Date Submitted
date
C0011008 (UMLS CUI [1,1])
C1515022 (UMLS CUI [1,2])
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