ID

26487

Descrizione

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.

Keywords

versioni (2)
  1. 11/10/17 11/10/17 -
  2. 18/10/17 18/10/17 -
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GlaxoSmithKline

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18 ottobre 2017

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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

Inglese

Week 12 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 moduli  
STUDY MEDICATION RECORD SINCE LAST VISIT
Descrizione

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.
Descrizione

STUDY MEDICATION RECORD SINCE LAST VISIT

Tipo di dati

boolean

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

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
Descrizione

study continuitation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
RLS RATING SCALE
Descrizione

RLS RATING SCALE

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

RLS RATING SCALE

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
PATIENT RATED SCALES
Descrizione

PATIENT RATED SCALES

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0035258
UMLS CUI-3
C0679830
RLS Quality of Life Questionnaire
Descrizione

RLS Quality of Life Questionnaire

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C0679830
UMLS CUI [1,4]
C0035258
SF36 Health Status Survey
Descrizione

SF36 Health Status Survey

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0679830
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C3640521
Medical Outcome Study Sleep Scale
Descrizione

Medical Outcome Study Sleep Scale

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0679830
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0349674
UMLS CUI [1,4]
C0037313
VITAL SIGNS
Descrizione

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Pulse
Descrizione

after 5 minutes sitting

Tipo di dati

integer

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

after 5 minutes sitting

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure diastolic
Descrizione

after 5 minutes sitting

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Weight
Descrizione

without shoes

Tipo di dati

integer

Unità di misura
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight
Descrizione

without shoes

Tipo di dati

integer

Unità di misura
  • lbs
Alias
UMLS CUI [1]
C0005910
lbs
MEDICAL PROCEDURES
Descrizione

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.
Descrizione

MEDICAL PROCEDURES

Tipo di dati

boolean

CONCOMITANT MEDICATION
Descrizione

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.
Descrizione

CONCOMITANT MEDICATION

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2347852
ADVERSE EXPERIENCES
Descrizione

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.
Descrizione

ADVERSE EXPERIENCES

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0877248
LABORATORY EVALUATION
Descrizione

LABORATORY EVALUATION

Alias
UMLS CUI-1
C0022885
Date of blood sample
Descrizione

Date of blood sample

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Were any clinically significant abnormalities detected?
Descrizione

laboratory abnormalities

Tipo di dati

integer

Alias
UMLS CUI [1]
C1853129
URINE DIPSTICK
Descrizione

URINE DIPSTICK

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Descrizione

Urine Dipstick

Tipo di dati

integer

Alias
UMLS CUI [1]
C0430370
CLINICAL GLOBAL IMPRESSION
Descrizione

CLINICAL GLOBAL IMPRESSION

Alias
UMLS CUI-1
C3639708
CLINICAL GLOBAL IMPRESSION
Descrizione

CLINICAL GLOBAL IMPRESSION

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3639708
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Similar models

Week 12 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
PATIENT RATED SCALES
C0034394 (UMLS CUI-1)
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])
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])
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])
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])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
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
LABORATORY EVALUATION
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Were any clinically significant abnormalities detected?
integer
C1853129 (UMLS CUI [1])
laboratory abnormalities
Code List
Were any clinically significant abnormalities detected?
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 Group
URINE DIPSTICK
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1])
Urine Dipstick
Code List
What was the result of the urine dipstick performed at this visit?
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)
Item Group
CLINICAL GLOBAL IMPRESSION
C3639708 (UMLS CUI-1)
CLINICAL GLOBAL IMPRESSION
Item
CLINICAL GLOBAL IMPRESSION
boolean
C3639708 (UMLS CUI [1])
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