ID

35649

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 Patient Enrollment Form. It has to be filled in for screening. Please fax this form to the sponsor study contact when the patient has been enroled

Keywords

Versions (2)
  1. 8/19/17 8/19/17 -
  2. 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

Patient Enrollment Form

1 forms  
Patient Enrollment
Description

Patient Enrollment

Alias
UMLS CUI-1
C4041024
Received By
Description

Received By

Data type

text

Alias
UMLS CUI [1]
C1709850
Fax No.:
Description

Fax Number

Data type

integer

Alias
UMLS CUI [1]
C1549619
The following patient has been enroled in study: 101468/
Description

study subject participation status

Data type

integer

Alias
UMLS CUI [1]
C2348568
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Date of enrollment:
Description

Date of enrollment

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0679646
UMLS CUI [1,3]
C1516879
Signed:
Description

Signed

Data type

text

Alias
UMLS CUI [1]
C1561610
Date:
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Please print name:
Description

print name

Data type

text

Alias
UMLS CUI [1]
C0027365
Institution:
Description

Institution

Data type

text

Alias
UMLS CUI [1]
C1301943
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Similar models

Patient Enrollment Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Enrollment
C4041024 (UMLS CUI-1)
Received By
Item
Received By
text
C1709850 (UMLS CUI [1])
Fax Number
Item
Fax No.:
integer
C1549619 (UMLS CUI [1])
study subject participation status
Item
The following patient has been enroled in study: 101468/
integer
C2348568 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Date of enrollment
Item
Date of enrollment:
date
C0011008 (UMLS CUI [1,1])
C0679646 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Signed
Item
Signed:
text
C1561610 (UMLS CUI [1])
Date
Item
Date:
date
C0011008 (UMLS CUI [1])
print name
Item
Please print name:
text
C0027365 (UMLS CUI [1])
Institution
Item
Institution:
text
C1301943 (UMLS CUI [1])
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