ID

25336

Description

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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Versions (2)
  1. 01/09/2017 01/09/2017 -
  2. 01/09/2017 01/09/2017 -
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1 septembre 2017

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Licence

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)

Anglais

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

1 Formulaires  
General Information
Description

General Information

Center Number
Description

Center Number

Type de données

integer

Patient Number
Description

Patient Number

Type de données

integer

Patient Initials
Description

Patient Initials

Type de données

text

Visit Date
Description

Visit Date

Type de données

date

Investigational Product Record since last visit
Description

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.
Description

Investigational Product Record since last visit

Type de données

boolean

RSL Rating Scale
Description

RSL Rating Scale

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

RSL Rating Scale

Type de données

boolean

Vital Signs
Description

Vital Signs

Weight (without shoes)
Description

Weight

Type de données

float

Unités de mesure
  • kg/lbs
kg/lbs
Pulse (after 5 minutes sitting)
Description

Pulse

Type de données

integer

Unités de mesure
  • beats/min
beats/min
Sitting Blood Pressure (after 5 minutes sitting) systolic
Description

Sitting Blood Pressure systolic

Type de données

integer

Unités de mesure
  • mmHg
mmHg
Sitting Blood pressure (after 5 minutes sitting) diastolic
Description

Sitting Blood pressure diastolic

Type de données

integer

Unités de mesure
  • mmHg
mmHg
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Description

Medical Procedures

Type de données

boolean

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

Concomitant Medication

Type de données

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.
Description

Adverse Experiences

Type de données

boolean

Laboratory Evaluation
Description

Laboratory Evaluation

Date of blood sample
Description

Date of blood sample

Type de données

date

Were any clinically significant abnormalities detected?
Description

Results

Type de données

text

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Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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