ID

35648

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 Pregnancy information, Patient Continuation/ Withdrawal and investigature's signature form.

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

Pregnancy information, Patient Continuation/ Withdrawal, investigature's signature

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 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

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Has the patient become pregnant to date?
Description

pregnancy

Data type

text

Alias
UMLS CUI [1]
C0549206
Patient Continuation/ Withdrawal
Description

Patient Continuation/ Withdrawal

Alias
UMLS CUI-1
C2348568
Is the patient continuing in the study?
Description

study subject participation status

Data type

text

Alias
UMLS CUI [1]
C2348568
If patient is not continuing in the study, please mark the primary cause of withdrawal
Description

primary reason

Data type

integer

Alias
UMLS CUI [1]
C1549995
If other reason, please specify
Description

Other reason

Data type

text

Alias
UMLS CUI [1]
C3840932
Investigator Signature
Description

Investigator Signature

Alias
UMLS CUI-1
C2346576
I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.
Description

consent form

Data type

boolean

Alias
UMLS CUI [1]
C0009797
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Description

da month year

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Pregnancy information, Patient Continuation/ Withdrawal, investigature's signature

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 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 Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Has the patient become pregnant to date?
text
C0549206 (UMLS CUI [1])
pregnancy
Code List
Has the patient become pregnant to date?
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Patient Continuation/ Withdrawal
C2348568 (UMLS CUI-1)
Item
Is the patient continuing in the study?
text
C2348568 (UMLS CUI [1])
study subject participation status
Code List
Is the patient continuing in the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If patient is not continuing in the study, please mark the primary cause of withdrawal
integer
C1549995 (UMLS CUI [1])
primary reason
Code List
If patient is not continuing in the study, please mark the primary cause of withdrawal
CL Item
Adverse experience (please complete AE page) (1)
CL Item
Does not meet inclusion/exclusion criteria (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other (5)
Other reason
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
consent form
Item
I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.
boolean
C0009797 (UMLS CUI [1])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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