ID

25296

Beschrijving

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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  1. 31-08-17 31-08-17 -
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31 augustus 2017

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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Day 2 (Form 3)

Engels

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Day 2 (Form 3)

1 Formulieren  
General Information
Beschrijving

General Information

Center Number
Beschrijving

Center Number

Datatype

integer

Patient Number
Beschrijving

Patient Number

Datatype

integer

Patient Initials
Beschrijving

Patient Initials

Datatype

text

Visit Date
Beschrijving

Visit Date

Datatype

date

RLS rating scale
Beschrijving

RLS rating scale

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

RLS rating scale

Datatype

text

Vital signs
Beschrijving

Vital signs

Pulse (after 5 minutes sitting)
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • beats/min
beats/min
Sitting blood pressure systolic (after 5 minutes sitting)
Beschrijving

Sitting blood pressure (systolic)

Datatype

integer

Sitting blood pressure diastolic (after 5 minutes sitting)
Beschrijving

Sitting blood pressure (diastolic)

Datatype

text

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

Medical Procedures

Datatype

text

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

Concomitant Medication

Datatype

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.
Beschrijving

Adverse Experiences

Datatype

text

Randomization Number
Beschrijving

Ramos Randomization and Dispensing

Datatype

integer

Record the container numbers supplied by RAMOS (1)
Beschrijving

Container numbers I

Datatype

text

Record the container numbers supplied by RAMOS (2)
Beschrijving

Container numbers II

Datatype

text

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Similar models

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Day 2 (Form 3)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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