ID

25338

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 (2)
  1. 01.09.17 01.09.17 -
  2. 01.09.17 01.09.17 -
Transferido a

1. September 2017

DOI

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Licença

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)

Inglês

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

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

Investigational Product Record since last visit
Descrição

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.
Descrição

Investigational Product Record since last visit

Tipo de dados

boolean

RSL Rating Scale
Descrição

RSL Rating Scale

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

RSL Rating Scale

Tipo de dados

boolean

Vital Signs
Descrição

Vital Signs

Weight (without shoes)
Descrição

Weight

Tipo de dados

float

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

Pulse

Tipo de dados

integer

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

Sitting Blood Pressure systolic

Tipo de dados

integer

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

Sitting Blood pressure diastolic

Tipo de dados

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.
Descrição

Medical Procedures

Tipo de dados

boolean

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

Concomitant Medication

Tipo de dados

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.
Descrição

Adverse Experiences

Tipo de dados

boolean

Laboratory Evaluation
Descrição

Laboratory Evaluation

Date of blood sample
Descrição

Date of blood sample

Tipo de dados

date

Were any clinically significant abnormalities detected?
Descrição

Results

Tipo de dados

text

Pregnancy Dipstick
Descrição

Pregnancy Dipstick

Is the patient a female of childbearing potential?
Descrição

Pregnancy Dipstick

Tipo de dados

text

Results pregnancy dipstick
Descrição

Results pregnancy dipstick

Tipo de dados

text

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Similar models

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

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
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)
Item Group
Pregnancy Dipstick
Item
Is the patient a female of childbearing potential?
text
Pregnancy Dipstick
Code List
Is the patient a female of childbearing potential?
CL Item
No (1)
CL Item
Yes -> If "Yes", please perform a pregnancy dipstick test and record results below. (2)
Item
Results pregnancy dipstick
text
Results pregnancy dipstick
Code List
Results pregnancy dipstick
CL Item
Negative (1)
CL Item
Positive -> If "Posititve", please record details in the Pregnancy Information section on the Study Conclusion page at the end of this book. (2)
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