Informationen:
Fehler:
ID
26487
Beschreibung
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 12 form.
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- 11.10.17 11.10.17 -
- 18.10.17 18.10.17 -
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GlaxoSmithKline
Hochgeladen am
18. Oktober 2017
DOI
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Creative Commons BY-NC 3.0
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Week 12 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
Week 12 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
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Week 12 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
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])
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Were any clinically significant abnormalities detected?
integer
C1853129 (UMLS CUI [1])
CL Item
No (1)
CL Item
Yes - If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Follow-up. (2)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1])
CL Item
Negative (1)
CL Item
Positive - If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this book, send a sample to Quest Diagnostics for further evaluation and repeat at Follow-up. (2)
CLINICAL GLOBAL IMPRESSION
Item
CLINICAL GLOBAL IMPRESSION
boolean
C3639708 (UMLS CUI [1])