ID

25322

Descrição

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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Versões (1)
  1. 01/09/2017 01/09/2017 -
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1 de setembro de 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 6 (Form 11)

Inglês

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 6 (Form 11)

1 Formulários  
General Information
Descrição

General Information

Center Number
Descrição

Center Number

Tipo de dados

integer

Patient Number
Descrição

Patient Number

Tipo de dados

integer

Patient Initials
Descrição

Patient Initials

Tipo de dados

text

Visit Date
Descrição

Visit Date

Tipo de dados

date

RLS rating scale
Descrição

RLS rating scale

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

RLS rating scale

Tipo de dados

text

Vital signs
Descrição

Vital signs

Pulse (after 5 minutes sitting)
Descrição

Pulse

Tipo de dados

integer

Unidades de medida
  • beats/min
beats/min
Sitting blood pressure systolic (after 5 minutes sitting)
Descrição

Sitting blood pressure (systolic)

Tipo de dados

integer

Sitting blood pressure diastolic (after 5 minutes sitting)
Descrição

Sitting blood pressure (diastolic)

Tipo de dados

text

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

Medical Procedures

Tipo de dados

text

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

Concomitant Medication

Tipo de dados

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.
Descrição

Adverse Experiences

Tipo de dados

text

Randomization Number
Descrição

Ramos Randomization and Dispensing

Tipo de dados

integer

Record the container numbers supplied by RAMOS (1)
Descrição

Container numbers I

Tipo de dados

text

Record the container numbers supplied by RAMOS (2)
Descrição

Container numbers II

Tipo de dados

text

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Similar models

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 6 (Form 11)

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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