ID

25323

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-09-01 2017-09-01 -
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1 september 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 7 (Form 12)

Engelsk

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 7 (Form 12)

1 Formulär  
General Information
Beskrivning

General Information

Center Number
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Center Number

Datatyp

integer

Patient Number
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Patient Number

Datatyp

integer

Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Visit Date
Beskrivning

Visit Date

Datatyp

date

RLS rating scale
Beskrivning

RLS rating scale

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

RLS rating scale

Datatyp

text

Vital signs
Beskrivning

Vital signs

Pulse (after 5 minutes sitting)
Beskrivning

Pulse

Datatyp

integer

Måttenheter
  • beats/min
beats/min
Sitting blood pressure systolic (after 5 minutes sitting)
Beskrivning

Sitting blood pressure (systolic)

Datatyp

integer

Sitting blood pressure diastolic (after 5 minutes sitting)
Beskrivning

Sitting blood pressure (diastolic)

Datatyp

text

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

Medical Procedures

Datatyp

text

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

Concomitant Medication

Datatyp

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.
Beskrivning

Adverse Experiences

Datatyp

text

Randomization Number
Beskrivning

Ramos Randomization and Dispensing

Datatyp

integer

Record the container numbers supplied by RAMOS (1)
Beskrivning

Container numbers I

Datatyp

text

Record the container numbers supplied by RAMOS (2)
Beskrivning

Container numbers II

Datatyp

text

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Similar models

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 7 (Form 12)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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