ID

26149

Beskrivning

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 5 form.

Nyckelord

Versioner (2)
  1. 2017-10-10 2017-10-10 -
  2. 2017-10-18 2017-10-18 -
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GlaxoSmithKline

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10 oktober 2017

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26072_GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Week 5 101468/190

Engelsk

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Week 5 101468/190

1 Formulär  
STUDY MEDICATION RECORD SINCE LAST VISIT
Beskrivning

STUDY MEDICATION RECORD SINCE LAST VISIT

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
Please complete the study medication record in the Study Medication Section at the back of this book.
Beskrivning

STUDY MEDICATION RECORD SINCE LAST VISIT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2734539
UMLS CUI [1,2]
C0008972
CHECK FOR STUDY CONTINUATION
Beskrivning

CHECK FOR STUDY CONTINUATION

Alias
UMLS CUI-1
C2348568
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
Beskrivning

study continuitation

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
RLS RATING SCALE
Beskrivning

RLS RATING SCALE

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
RLS RATING SCALE
Beskrivning

RLS RATING SCALE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
WPAI
Beskrivning

WPAI

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0035258
WPAI
Beskrivning

WPAI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0035258
VITAL SIGNS
Beskrivning

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Pulse
Beskrivning

after 5 minutes sitting

Datatyp

integer

Alias
UMLS CUI [1]
C0232117
Sitting Blood Pressure systolic
Beskrivning

after 5 minutes sitting

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure diastolic
Beskrivning

after 5 minutes sitting

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
MEDICAL PROCEDURES
Beskrivning

MEDICAL PROCEDURES

Alias
UMLS CUI-1
C0199171
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Beskrivning

MEDICAL PROCEDURES

Datatyp

boolean

CONCOMITANT MEDICATION
Beskrivning

CONCOMITANT MEDICATION

Alias
UMLS CUI-1
C2347852
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
Beskrivning

CONCOMITANT MEDICATION

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
ADVERSE EXPERIENCES
Beskrivning

ADVERSE EXPERIENCES

Alias
UMLS CUI-1
C0877248
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.
Beskrivning

ADVERSE EXPERIENCES

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX
Beskrivning

CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX

Alias
UMLS CUI-1
C3639708
UMLS CUI-2
C1280519
CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX
Beskrivning

CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3639708
UMLS CUI [1,2]
C1280519
CLINICAL GLOBAL IMPRESSION
Beskrivning

CLINICAL GLOBAL IMPRESSION

Alias
UMLS CUI-1
C3639708
CLINICAL GLOBAL IMPRESSION
Beskrivning

CLINICAL GLOBAL IMPRESSION

Datatyp

boolean

Alias
UMLS CUI [1]
C3639708
DOSE REDUCTION BETWEEN SCHEDULED VISITS
Beskrivning

DOSE REDUCTION BETWEEN SCHEDULED VISITS

Alias
UMLS CUI-1
C1707814
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.
Beskrivning

DOSE REDUCTION BETWEEN SCHEDULED VISITS

Datatyp

boolean

Alias
UMLS CUI [1]
C1707814
RAMOS RANDOMISATION AND DISPENSING
Beskrivning

RAMOS RANDOMISATION AND DISPENSING

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0947323
Randomisation number
Beskrivning

Randomisation number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Container number
Beskrivning

Container number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0180098
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0237753
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Similar models

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Week 5 101468/190

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
STUDY MEDICATION RECORD SINCE LAST VISIT
C2734539 (UMLS CUI-1)
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])
Item Group
CHECK FOR STUDY CONTINUATION
C2348568 (UMLS CUI-1)
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])
Item Group
RLS RATING SCALE
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS RATING SCALE
Item
RLS RATING SCALE
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
WPAI
C0034394 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
WPAI
Item
WPAI
boolean
C0034394 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
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])
Sitting Blood Pressure diastolic
Item
Sitting Blood Pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
MEDICAL PROCEDURES
C0199171 (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
Item Group
CONCOMITANT MEDICATION
C2347852 (UMLS CUI-1)
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])
Item Group
ADVERSE EXPERIENCES
C0877248 (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)
CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX
Item
CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX
boolean
C3639708 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
Item Group
CLINICAL GLOBAL IMPRESSION
C3639708 (UMLS CUI-1)
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)
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
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])
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