ID

27273

Description

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of 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: Requip Study Indication: Parkinson Disease Module: Study Conclusion

Keywords

Versions (1)
  1. 11/6/17 11/6/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188

English

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C1707478
UMLS CUI-3
C0008976
UMLS CUI-4
C0035258
Did the patient complete the study according to the protocol?
Description

End of Study

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0444496
If ’No’, please mark the primary cause of withdrawal. (Mark one box only)
Description

primary cause of withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Primary cause of withdrawal: If 'Other', please specify
Description

primary cause of withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Investigator’s Signature
Description

Investigator’s Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator’s Signature Date
Description

Investigator’s Signature Date

Data type

date

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

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Conclusion
C2348568 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C0035258 (UMLS CUI-4)
End of Study
Item
Did the patient complete the study according to the protocol?
boolean
C2348568 (UMLS CUI [1,1])
C0444496 (UMLS CUI [1,2])
Item
If ’No’, please mark the primary cause of withdrawal. (Mark one box only)
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
primary cause of withdrawal
Code List
If ’No’, please mark the primary cause of withdrawal. (Mark one box only)
CL Item
Adverse experience (please complete AE page)  (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other (5)
primary cause of withdrawal
Item
Primary cause of withdrawal: If 'Other', please specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Investigator’s Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
Investigator’s Signature Date
Item
Investigator’s Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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