ID
29116
Beschreibung
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)
Stichworte
Versionen (1)
- 26.02.18 26.02.18 -
Rechteinhaber
GlaxoSmithKline (GSK)
Hochgeladen am
26. Februar 2018
DOI
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Lizenz
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
Beschreibung
Adverse experience
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Adverse experience
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Onset Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826806
Beschreibung
End Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschreibung
Outcome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
Experience Course
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschreibung
Experience Course
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beschreibung
Action Taken
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
If ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschreibung
Patient withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beschreibung
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Beschreibung
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschreibung
Study completion
Datentyp
integer
Alias
- UMLS CUI [1]
- C0805732
Beschreibung
Study completion
Datentyp
integer
Alias
- UMLS CUI [1]
- C0805732
Beschreibung
If yo answered the previous question with 'other', please specify:
Datentyp
text
Alias
- UMLS CUI [1]
- C0205394
Beschreibung
Administration Investigator
Alias
- UMLS CUI-1
- C1320722
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
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])