ID

25325

Description

Study ID: 101468/191 Clinical Study ID: SKF-101468/191 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS) 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

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Versions (1)
  1. 9/1/17 9/1/17 -
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September 1, 2017

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Creative Commons BY-NC 3.0
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 8 (Form 13)

English

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 8 (Form 13)

1 forms  
General Information
Description

General Information

Center Number
Description

Center Number

Data type

integer

Patient Number
Description

Patient Number

Data type

integer

Patient Initials
Description

Patient Initials

Data type

text

Visit Date
Description

Visit Date

Data type

date

RLS rating scale
Description

RLS rating scale

Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
Description

RLS rating scale

Data type

text

Vital signs
Description

Vital signs

Pulse (after 5 minutes sitting)
Description

Pulse

Data type

integer

Measurement units
  • beats/min
beats/min
Sitting blood pressure systolic (after 5 minutes sitting)
Description

Sitting blood pressure (systolic)

Data type

integer

Sitting blood pressure diastolic (after 5 minutes sitting)
Description

Sitting blood pressure (diastolic)

Data type

text

Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Description

Medical Procedures

Data type

text

Please record any medical procedures performed since the last visit in the Concomitant Medication section at the end of this book.
Description

Concomitant Medication

Data type

text

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 Experiences

Data type

text

Randomization Number
Description

Ramos Randomization and Dispensing

Data type

integer

Record the container numbers supplied by RAMOS (1)
Description

Container numbers I

Data type

text

Record the container numbers supplied by RAMOS (2)
Description

Container numbers II

Data type

text

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Similar models

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 8 (Form 13)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
Center Number
Item
Center Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Visit Date
Item
Visit Date
date
Item Group
RLS rating scale
RLS rating scale
Item
Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
text
Item Group
Vital signs
Pulse
Item
Pulse (after 5 minutes sitting)
integer
Sitting blood pressure (systolic)
Item
Sitting blood pressure systolic (after 5 minutes sitting)
integer
Sitting blood pressure (diastolic)
Item
Sitting blood pressure diastolic (after 5 minutes sitting)
text
Medical Procedures
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
text
Concomitant Medication
Item
Please record any medical procedures performed since the last visit in the Concomitant Medication section at the end of this book.
text
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.
text
Ramos Randomization and Dispensing
Item
Randomization Number
integer
Container numbers I
Item
Record the container numbers supplied by RAMOS (1)
text
Container numbers II
Item
Record the container numbers supplied by RAMOS (2)
text
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