ID

26298

Description

Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients 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: Requip Study Indication: Restless Legs Syndrome This is the Study Conclusion assessment form.

Keywords

Versions (2)
  1. 10/16/17 10/16/17 -
  2. 10/16/17 10/16/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Study Conclusion 26072_GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

English

Study Conclusion 26072_GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 forms  
General Information
Description

General Information

Alias
UMLS CUI-1
C1508263
Centre Number
Description

Centre Number

Data type

text

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 Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
STUDY CONCLUSION
Description

STUDY CONCLUSION

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the patient complete the study according to the protocol?
Description

If ’No’, please mark the primary cause of withdrawal.

Data type

boolean

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C2732579
Did the patient complete the study according to the protocol?
Description

If ’No’, please mark the primary cause of withdrawal.

Data type

integer

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C2732579
UMLS CUI [1,4]
C0392360
Primary Cause - Other, specify:
Description

If ’No’, please mark the primary cause of withdrawal.

Data type

text

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C2732579
UMLS CUI [1,4]
C0392360
INVESTIGATOR SIGNATURE
Description

INVESTIGATOR SIGNATURE

Alias
UMLS CUI-1
C2346576
Investigator’s Signature
Description

Investigator’s Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

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

Study Conclusion 26072_GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
STUDY CONCLUSION
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study conclusion
Item
Did the patient complete the study according to the protocol?
boolean
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Item
Did the patient complete the study according to the protocol?
integer
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
trial completion
Code List
Did the patient complete the study according to the protocol?
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 - specify (5)
trial completion cause other
Item
Primary Cause - Other, specify:
text
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Item Group
INVESTIGATOR SIGNATURE
C2346576 (UMLS CUI-1)
Investigator’s Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
Date
Item
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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