ID

35491

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

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License

Creative Commons BY-NC 3.0
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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

English

Follow-up

1 forms  
  1. StudyEvent: ODM
    1. Follow-up
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
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
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
Laboratory Evaluation
Description

Laboratory Evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0220825
Date of blood sample
Description

Collection of blood specimen for laboratory procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Description

Laboratory Procedures, Laboratory specimen identification label

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C4273937
Were any clinically significant abnormalities detected?
Description

If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Follow-up.

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1704258
Urine Dipstick
Description

Urine Dipstick

Alias
UMLS CUI-1
C0430370
UMLS CUI-2
C0456984
What was the result of the urine dipstick performed at this visit?
Description

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.

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
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Similar models

Follow-up

1 forms
  1. StudyEvent: ODM
    1. Follow-up
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
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
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
Laboratory Evaluation
C0022885 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Collection of blood specimen for laboratory procedure, Date in time
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Procedures, Laboratory specimen identification label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C0022885 (UMLS CUI [1,1])
C4273937 (UMLS CUI [1,2])
Laboratory Procedures, Abnormality
Item
Were any clinically significant abnormalities detected?
boolean
C0022885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Urine Dipstick
C0430370 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
Item
What was the result of the urine dipstick performed at this visit?
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Urine dipstick test, Test Result
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Negative (1)
CL Item
Positive (2)
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