ID

25323

Beschreibung

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. 01.09.17 01.09.17 -
Hochgeladen am

1. September 2017

DOI

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

Englisch

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

1 Formulare  
General Information
Beschreibung

General Information

Center Number
Beschreibung

Center Number

Datentyp

integer

Patient Number
Beschreibung

Patient Number

Datentyp

integer

Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Visit Date
Beschreibung

Visit Date

Datentyp

date

RLS rating scale
Beschreibung

RLS rating scale

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

RLS rating scale

Datentyp

text

Vital signs
Beschreibung

Vital signs

Pulse (after 5 minutes sitting)
Beschreibung

Pulse

Datentyp

integer

Maßeinheiten
  • beats/min
beats/min
Sitting blood pressure systolic (after 5 minutes sitting)
Beschreibung

Sitting blood pressure (systolic)

Datentyp

integer

Sitting blood pressure diastolic (after 5 minutes sitting)
Beschreibung

Sitting blood pressure (diastolic)

Datentyp

text

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

Medical Procedures

Datentyp

text

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

Concomitant Medication

Datentyp

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.
Beschreibung

Adverse Experiences

Datentyp

text

Randomization Number
Beschreibung

Ramos Randomization and Dispensing

Datentyp

integer

Record the container numbers supplied by RAMOS (1)
Beschreibung

Container numbers I

Datentyp

text

Record the container numbers supplied by RAMOS (2)
Beschreibung

Container numbers II

Datentyp

text

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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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