ID

35557

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 Significant Medical/ Surgical History,Physical Examination form. It has to be filled in for screening (Baseline).

Keywords

Versions (1)
  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

English

Significant Medical/ Surgical History,Physical Examination

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]
C2348585
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Significant medical/surgical history and physical examination
Description

Significant medical/surgical history and physical examination

Alias
UMLS CUI-1
C0262926
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
Description

If you tick Yes , please list one diagnosis per line in the following items. (Please print clearly). Only in the absence of a diagnosis, record the signs and symptoms on separate lines.

Data type

text

Alias
UMLS CUI [1]
C0009488
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Year of first diagnosis
Description

Year of first diagnosis

Data type

partialDate

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Medical condition
Description

Medical condition

Data type

integer

Alias
UMLS CUI [1]
C0012634
Comment for SB
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Significant Medical/ Surgical History,Physical Examination

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
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
Item
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
text
C0009488 (UMLS CUI [1])
Comorbidity
Code List
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
CL Item
Yes (Y)
CL Item
No (N)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Medical condition
integer
C0012634 (UMLS CUI [1])
Medical condition
Code List
Medical condition
CL Item
Past (1)
CL Item
Ongoing (2)
CL Item
Past + Ongoing (3)
Comment
Item
Comment for SB
text
C0947611 (UMLS CUI [1])
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