ID
29116
Description
Study ID: 101468/249 Clinical Study ID: 101468/249 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: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)
Keywords
Versions (1)
- 2/26/18 2/26/18 -
Copyright Holder
GlaxoSmithKline (GSK)
Uploaded on
February 26, 2018
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857
Non-serious adverse events and study conclusion
- StudyEvent: ODM
Description
Adverse experience
Alias
- UMLS CUI-1
- C0877248
Description
Adverse experience
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Onset Date and Time
Data type
datetime
Alias
- UMLS CUI [1]
- C2826806
Description
End Date and Time
Data type
datetime
Alias
- UMLS CUI [1]
- C2826793
Description
Outcome
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Experience Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
Experience Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
MILD Adverse experience which is easily tolerated MODERATE Adverse experience sufficiently discomforting to interfere with daily activities SEVERE Adverse experience which prevents normal everyday activities
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
Action Taken
Data type
integer
Alias
- UMLS CUI [1]
- C2826626
Description
RELATED There is a direct cause and effect relationship between the adverse experience and the study drug POSSIBLY RELATED A direct cause and effect relationship between the drug and the adverse experience has not been demonstrated but is possible or likely PROBABLY UNRELATED Cause and effect relationship between the drug and the adverse experience has not been demonstrated, is improbable but not impossible UNRELATED The adverse experience is definitely not related to the test drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
If ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
Patient withdrawal
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Description
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
Study completion
Data type
integer
Alias
- UMLS CUI [1]
- C0805732
Description
Study completion
Data type
integer
Alias
- UMLS CUI [1]
- C0805732
Description
If yo answered the previous question with 'other', please specify:
Data type
text
Alias
- UMLS CUI [1]
- C0205394
Description
Administration Investigator
Alias
- UMLS CUI-1
- C1320722
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
Description
Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Non-serious adverse events and study conclusion
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])