ID
29116
Descripción
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)
Palabras clave
Versiones (1)
- 26/2/18 26/2/18 -
Titular de derechos de autor
GlaxoSmithKline (GSK)
Subido en
26 de febrero de 2018
DOI
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Licencia
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
Descripción
Adverse experience
Alias
- UMLS CUI-1
- C0877248
Descripción
Adverse experience
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0877248
Descripción
Onset Date and Time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826806
Descripción
End Date and Time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826793
Descripción
Outcome
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1705586
Descripción
Experience Course
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Descripción
Experience Course
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Descripción
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
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1710066
Descripción
Action Taken
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2826626
Descripción
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
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descripción
If ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Descripción
Patient withdrawal
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Descripción
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Descripción
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Descripción
Study completion
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0805732
Descripción
Study completion
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0805732
Descripción
If yo answered the previous question with 'other', please specify:
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0205394
Descripción
Administration Investigator
Alias
- UMLS CUI-1
- C1320722
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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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])