ID

35488

Description

Study ID: 101468/194 Clinical Study ID: 101468/194 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

Keywords

Versions (1)
  1. 3/6/19 3/6/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 6, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

English

Week 8

1 forms  
  1. StudyEvent: ODM
    1. Week 8
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Study Coordinating Center, Identification number

Data type

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Study Medication Record Since Last Visit
Description

Study Medication Record Since Last Visit

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C2734539
Please complete the study medication record in the Study Medication Section at the back of this book.
Description

Experimental drug, Medication Summary

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2734539
RLS Rating Scale
Description

RLS Rating Scale

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0449820
Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
Description

Restless Legs Syndrome, Score

Data type

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0449820
Paient Rated Scales
Description

Paient Rated Scales

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0035258
UMLS CUI-3
C0679830
Remove the following scales from appropriate visit in the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Description

Questionnaires; Restless Legs Syndrome; patient assessment

Data type

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0679830
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Pulse (after 5 minutes sitting)
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Sitting Blood Pressure (after 5 minutes sitting) - Systolic
Description

Systolic Pressure, Sitting position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure (after 5 minutes sitting) - Distolic
Description

Diastolic blood pressure, Sitting position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Medical Procedures
Description

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.
Description

Medical procedure

Data type

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Description

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.
Description

Concomitant Agent

Data type

text

Alias
UMLS CUI [1]
C2347852
Adverse Experiences
Description

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.
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
RAMOS Randomization and Dispensing
Description

RAMOS Randomization and Dispensing

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

Randomization, Numbers

Data type

integer

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

Experimental drug, Containers, Identifier

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Back to the top of the page

Similar models

Week 8

1 forms
  1. StudyEvent: ODM
    1. Week 8
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Study Medication Record Since Last Visit
C0304229 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
Experimental drug, Medication Summary
Item
Please complete the study medication record in the Study Medication Section at the back of this book.
text
C0304229 (UMLS CUI [1,1])
C2734539 (UMLS CUI [1,2])
Item Group
RLS Rating Scale
C0035258 (UMLS CUI-1)
C0449820 (UMLS CUI-2)
Restless Legs Syndrome, Score
Item
Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
text
C0035258 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Paient Rated Scales
C0034394 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
C0679830 (UMLS CUI-3)
Questionnaires; Restless Legs Syndrome; patient assessment
Item
Remove the following scales from appropriate visit in the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
text
C0035258 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0679830 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Heart rate
Item
Pulse (after 5 minutes sitting)
integer
C0018810 (UMLS CUI [1])
Systolic Pressure, Sitting position
Item
Sitting Blood Pressure (after 5 minutes sitting) - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic blood pressure, Sitting position
Item
Sitting Blood Pressure (after 5 minutes sitting) - Distolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Medical Procedures
C0199171 (UMLS CUI-1)
Medical procedure
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
text
C0199171 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Agent
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
text
C2347852 (UMLS CUI [1])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Adverse Event
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.
text
C0877248 (UMLS CUI [1])
Item Group
RAMOS Randomization and Dispensing
C0034656 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
Randomization, Numbers
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Experimental drug, Containers, Identifier
Item
Container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial