ID
29116
Beschrijving
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)
Trefwoorden
Versies (1)
- 26-02-18 26-02-18 -
Houder van rechten
GlaxoSmithKline (GSK)
Geüploaded op
26 februari 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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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
Beschrijving
Adverse experience
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Adverse experience
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Onset Date and Time
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826806
Beschrijving
End Date and Time
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Experience Course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
Experience Course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
Action Taken
Datatype
integer
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
If ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
Patient withdrawal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beschrijving
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Beschrijving
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschrijving
Study completion
Datatype
integer
Alias
- UMLS CUI [1]
- C0805732
Beschrijving
Study completion
Datatype
integer
Alias
- UMLS CUI [1]
- C0805732
Beschrijving
If yo answered the previous question with 'other', please specify:
Datatype
text
Alias
- UMLS CUI [1]
- C0205394
Beschrijving
Administration Investigator
Alias
- UMLS CUI-1
- C1320722
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date
Datatype
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])