Informações:
Falhas:
ID
26486
Descrição
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 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 This is the Week 8 form.
Palavras-chave
Versões (2)
- 10/10/2017 10/10/2017 -
- 18/10/2017 18/10/2017 -
Titular dos direitos
GlaxoSmithKline
Transferido a
18 de outubro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Week 8 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
Week 8 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
Similar models
Week 8 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
STUDY MEDICATION RECORD SINCE LAST VISIT
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0008972 (UMLS CUI-2)
STUDY MEDICATION RECORD SINCE LAST VISIT
Item
Please complete the study medication record in the Study Medication Section at the back of this book.
boolean
C2734539 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])
study continuitation
Item
ONLY COMPLETE THE REST OF THIS VISIT IF THE PATIENT IS CONTINUING IN THE STUDY FOR WITHDRAWALS PLEASE COMPLETE THE EARLY WITHDRAWAL SECTION AT THE BACK OF THIS BOOK
boolean
C2348568 (UMLS CUI [1])
RLS RATING SCALE
Item
RLS RATING SCALE
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
Item Group
PATIENT RATED SCALES
C0034394 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
C0679830 (UMLS CUI-3)
C0035258 (UMLS CUI-2)
C0679830 (UMLS CUI-3)
RLS Quality of Life Questionnaire
Item
RLS Quality of Life Questionnaire
boolean
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C0679830 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,4])
C0034380 (UMLS CUI [1,2])
C0679830 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,4])
SF36 Health Status Survey
Item
SF36 Health Status Survey
boolean
C0679830 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C3640521 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,2])
C3640521 (UMLS CUI [1,3])
Medical Outcome Study Sleep Scale
Item
Medical Outcome Study Sleep Scale
boolean
C0679830 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0349674 (UMLS CUI [1,3])
C0037313 (UMLS CUI [1,4])
C0035258 (UMLS CUI [1,2])
C0349674 (UMLS CUI [1,3])
C0037313 (UMLS CUI [1,4])
Work Productivity and Activity Impairment Questionnaire
Item
Work Productivity and Activity Impairment Questionnaire
boolean
C0679830 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C3639722 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,2])
C3639722 (UMLS CUI [1,3])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting Blood Pressure systolic
Item
Sitting Blood Pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
Sitting Blood Pressure diastolic
Item
Sitting Blood Pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
MEDICAL PROCEDURES
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
boolean
CONCOMITANT MEDICATION
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
boolean
C2347852 (UMLS CUI [1])
ADVERSE EXPERIENCES
Item
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
boolean
C0877248 (UMLS CUI [1])
Item Group
CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX
C3639708 (UMLS CUI-1)
C1280519 (UMLS CUI-2)
C1280519 (UMLS CUI-2)
CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX
Item
CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX
boolean
C3639708 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
C1280519 (UMLS CUI [1,2])
CLINICAL GLOBAL IMPRESSION
Item
CLINICAL GLOBAL IMPRESSION
boolean
C3639708 (UMLS CUI [1])
Item Group
DOSE REDUCTION BETWEEN SCHEDULED VISITS
C1707814 (UMLS CUI-1)
DOSE REDUCTION BETWEEN SCHEDULED VISITS
Item
If the patient requires a dose reduction between this and the next visit please complete the Study Medication Record and Dose Reductions Due To Adverse Experiences pages at the back of this book.
boolean
C1707814 (UMLS CUI [1])
Item Group
RAMOS RANDOMISATION AND DISPENSING
C0034656 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
C0947323 (UMLS CUI-2)
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Container number
Item
Container number
integer
C0180098 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Container number 2
Item
Container number 2
integer
C0180098 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Container number 3
Item
Container number 3
integer
C0180098 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Container number 4
Item
Container number 4
integer
C0180098 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])