ID

25338

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

Keywords

Versions (2)
  1. 9/1/17 9/1/17 -
  2. 9/1/17 9/1/17 -
Uploaded on

September 1, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

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

English

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

1 forms  
General Information
Description

General Information

Center Number
Description

Center Number

Data type

integer

Patient Number
Description

Patient Number

Data type

integer

Patient Initials
Description

Patient Initials

Data type

text

Visit Date
Description

Visit Date

Data type

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

Data type

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

Data type

boolean

Vital Signs
Description

Vital Signs

Weight (without shoes)
Description

Weight

Data type

float

Measurement units
  • kg/lbs
kg/lbs
Pulse (after 5 minutes sitting)
Description

Pulse

Data type

integer

Measurement units
  • beats/min
beats/min
Sitting Blood Pressure (after 5 minutes sitting) systolic
Description

Sitting Blood Pressure systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Sitting Blood pressure (after 5 minutes sitting) diastolic
Description

Sitting Blood pressure diastolic

Data type

integer

Measurement units
  • 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

Data type

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

Data type

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

Data type

boolean

Laboratory Evaluation
Description

Laboratory Evaluation

Date of blood sample
Description

Date of blood sample

Data type

date

Were any clinically significant abnormalities detected?
Description

Results

Data type

text

Pregnancy Dipstick
Description

Pregnancy Dipstick

Is the patient a female of childbearing potential?
Description

Pregnancy Dipstick

Data type

text

Results pregnancy dipstick
Description

Results pregnancy dipstick

Data type

text

Back to the top of the page

Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial