ID

25336

Descripción

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

Palabras clave

Versiones (2)
  1. 1/9/17 1/9/17 -
  2. 1/9/17 1/9/17 -
Subido en

1 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 12 Day (Form 16)

Inglés

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 12 Day (Form 16)

1 formularios  
General Information
Descripción

General Information

Center Number
Descripción

Center Number

Tipo de datos

integer

Patient Number
Descripción

Patient Number

Tipo de datos

integer

Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Visit Date
Descripción

Visit Date

Tipo de datos

date

Investigational Product Record since last visit
Descripción

Investigational Product Record since last visit

Please complete the investigational product record in the Investigational Product and Compliance Section at the back of this book. Please complete the Investigational Product Interruption record in the Investigational Product and Compliance Section at the back of this book.
Descripción

Investigational Product Record since last visit

Tipo de datos

boolean

RSL Rating Scale
Descripción

RSL Rating Scale

INVESTIGATOR: Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
Descripción

RSL Rating Scale

Tipo de datos

boolean

Vital Signs
Descripción

Vital Signs

Weight (without shoes)
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg/lbs
kg/lbs
Pulse (after 5 minutes sitting)
Descripción

Pulse

Tipo de datos

integer

Unidades de medida
  • beats/min
beats/min
Sitting Blood Pressure (after 5 minutes sitting) systolic
Descripción

Sitting Blood Pressure systolic

Tipo de datos

integer

Unidades de medida
  • mmHg
mmHg
Sitting Blood pressure (after 5 minutes sitting) diastolic
Descripción

Sitting Blood pressure diastolic

Tipo de datos

integer

Unidades de medida
  • mmHg
mmHg
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Descripción

Medical Procedures

Tipo de datos

boolean

Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
Descripción

Concomitant Medication

Tipo de datos

boolean

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 Week 8 Visit?" in the Adverse Experience section at the back of this book.
Descripción

Adverse Experiences

Tipo de datos

boolean

Laboratory Evaluation
Descripción

Laboratory Evaluation

Date of blood sample
Descripción

Date of blood sample

Tipo de datos

date

Were any clinically significant abnormalities detected?
Descripción

Results

Tipo de datos

text

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Similar models

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 12 Day (Form 16)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Investigational Product Record since last visit
Investigational Product Record since last visit
Item
Please complete the investigational product record in the Investigational Product and Compliance Section at the back of this book. Please complete the Investigational Product Interruption record in the Investigational Product and Compliance Section at the back of this book.
boolean
Item Group
RSL Rating Scale
RSL Rating Scale
Item
INVESTIGATOR: Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
boolean
Item Group
Vital Signs
Weight
Item
Weight (without shoes)
float
Pulse
Item
Pulse (after 5 minutes sitting)
integer
Sitting Blood Pressure systolic
Item
Sitting Blood Pressure (after 5 minutes sitting) systolic
integer
Sitting Blood pressure diastolic
Item
Sitting Blood pressure (after 5 minutes sitting) diastolic
integer
Medical Procedures
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
boolean
Concomitant Medication
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
boolean
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 Week 8 Visit?" in the Adverse Experience section at the back of this book.
boolean
Item Group
Laboratory Evaluation
Date of blood sample
Item
Date of blood sample
date
Item
Were any clinically significant abnormalities detected?
text
Results
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes -> If "Positive", please record details in the Pregnancy Information section on the Study Conclusion page at the back of this book. (2)
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