ID

35678

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 medical procedure form. It has to be filled in for each visit.

Keywords

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

GlaxoSmithKline

Uploaded on

March 15, 2019

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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

Medical Procedures

1 forms  
  1. StudyEvent: ODM
    1. Medical Procedures
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]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Medical Procedures
Description

Medical Procedures

Alias
UMLS CUI-1
C0199171
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
Description

If you tick yes, please record details in the following items using standard medical terminology

Data type

text

Alias
UMLS CUI [1]
C0199171
Procedure
Description

All indications for procedures should be recorded in either the Adverse Experiences and/or SAE sections as appropriate.

Data type

text

Alias
UMLS CUI [1]
C0199171
Indication
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Procedure Start Date
Description

Start Date Procedure

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0199171
Procedure End Date
Description

End Date Procedure

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0184661
Comment for SB
Description

Comment for SB

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Medical Procedures

1 forms
  1. StudyEvent: ODM
    1. Medical Procedures
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
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (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
Screening (+Baseline) (1)
CL Item
Day 2 (2)
CL Item
Week 1 (3)
CL Item
Week 2  (4)
CL Item
Week 3  (5)
CL Item
Week 4 (6)
CL Item
Week 5 (7)
CL Item
Week 6 (8)
CL Item
Week 7 (9)
CL Item
Week 8  (10)
CL Item
Week 12 (11)
CL Item
Week 24 (12)
CL Item
Week 36 (13)
CL Item
Week 48 (14)
CL Item
Week 52 (15)
CL Item
Early withdrawal (16)
CL Item
Follow-up (17)
Item Group
Medical Procedures
C0199171 (UMLS CUI-1)
Item
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
text
C0199171 (UMLS CUI [1])
Medical Procedures
Code List
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
CL Item
Yes (Y)
CL Item
No (N)
Medical Procedures
Item
Procedure
text
C0199171 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Start Date Procedure
Item
Procedure Start Date
date
C0808070 (UMLS CUI [1,1])
C0199171 (UMLS CUI [1,2])
End Date Procedure
Item
Procedure End Date
date
C0806020 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
Comment for SB
Item
Comment for SB
text
C0947611 (UMLS CUI [1])
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