ID

35511

Description

Study ID: 101468/194 Clinical Study ID: 101468/194 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

Keywords

Versions (1)
  1. 3/6/19 3/6/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 6, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

English

Study Conclusion

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

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Study Coordinating Center, Identification number

Data type

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Description

Date of visit

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

Clinical Research, Complete, Protocol compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0525058
If 'No', please mark the primary cause of withdrawal.
Description

Clinical Research, Withdraw, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C3146298
Investigator Signature
Description

Investigator Signature

Alias
UMLS CUI-1
C2346576
Investigator’s Signature
Description

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.

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature, Date in time

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
Administrative data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Clinical Research, Complete, Protocol compliance
Item
Did the patient complete the study according to the protocol?
boolean
C0008972 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Item
If 'No', please mark the primary cause of withdrawal.
text
C0008972 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Clinical Research, Withdraw, Indication
Code List
If 'No', please mark the primary cause of withdrawal.
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)
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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