RLS rating scale
Item
Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
text
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
Date of blood sample
Item
Date of blood sample
date
Item
Were any clinically significant abnormalities detected?
text
Code List
Were any clinically significant abnormalities detected?
CL Item
Yes -> If "Yes", please record details in the Adverse Experiences and/or SAE section at the back of this book. (2)
Investigational Prod. Week No.
Item
Investigational Prod. Week No.
text
Item
Is this a Dose Reduction?
text
Code List
Is this a Dose Reduction?
CL Item
No -> if "No", continue (1)
CL Item
Yes -> if "Yes", please complete the Dose Reductions due to AE on page 60. Do not continue on this page for this visit. (2)
Dose Level
Item
Dose Level (specify 1-8)
integer
Date
Item
Date of first dose
date
Number of tablets dispensed
Item
Number of tablets dispensed
float
Number of tablets returned
Item
Number of tablets returned
float
week 6: investigational product interrupted
Item
To be completed at the Week 6 visit: Was dosing of investigational product interrupted for > 2 consecutive days during the week prior to visit 6?
boolean
week 12: investigational product interrupted
Item
To be completed at the Week 12 visit: Was dosing of investigational product interrupted for > 2 consecutive days during the week prior to visit 12?
boolean
Item
To be completed at the Early Withdrawal visit: Was dosing of investigational product interrupted for > 2 consecutive days during the week prior to the Early Withdrawal ?
text
Code List
To be completed at the Early Withdrawal visit: Was dosing of investigational product interrupted for > 2 consecutive days during the week prior to the Early Withdrawal ?
CL Item
Not Applicable (3)
Study Visit Week
Item
Study Visit Week (Specify)
integer
Dose Level
Item
Dose Level (specify)
integer
Date of first dose
Item
Date of first dose
date
Date of Last Dose
Item
Date of Last Dose
date
Number of tablets dispensed
Item
Number of tablets dispensed
integer
Number of tablets returned
Item
Number of tablets returned
integer
Item
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last clinic visit (non-PSG)? All indications for procedures should be recorded in the Adverse Experience and/or SAE section as appropriate.
text
Code List
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last clinic visit (non-PSG)? All indications for procedures should be recorded in the Adverse Experience and/or SAE section as appropriate.
CL Item
Yes -> If "Yes", please record details below using standard medical terminology. (2)
Information
Item
Information
text
New or change in concomitant medication
Item
No new or change in concomitant medication since the previous visit.
boolean
Drug Name
Item
Drug Name (Trade Name Preferred)
text
Total Daily Dose
Item
Total Daily Dose (e.g 500 mg)
float
Medical Illness / Diagnosis
Item
Medical Illness / Diagnosis (or symptom in absence of diagnosis)
text
Start Date
Item
Start Date (be as precise as possible)
date
End Date
Item
End Date (or if Continuing mark box below)
date
Continuing
Item
Continuing
boolean
No adverse experiences occured during the study
Item
No adverse experiences occured during the study
boolean
Onset Date and Time
Item
Onset Date and Time
datetime
End Date and Time
Item
End Date and Time (if ongoing please leave blank)
datetime
CL Item
Died (If patient died, STOP: go to SAE section and follow instructions given there) (3)
Item
Experience Course
text
Code List
Experience Course
CL Item
Intermittend -> please fill in No. of episodes below. (1)
Number of episodes
Item
If experience course intermittend, please fill in number of episodes
integer
Item
Intensity (maximum)
text
Code List
Intensity (maximum)
Item
Action Taken with Respect to Investigational Drug
text
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
Item
Relationship to Investigational Drug
text
Code List
Relationship to Investigational Drug
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
Item
Corrective Therapy
text
Code List
Corrective Therapy
CL Item
Yes -> If "Yes", record details in the Concomitant Medication section and/or Medical Procedures section if appropriate. (2)
Withdrawal
Item
Was patient withdrawn due to this specific AE?
boolean
Item
Didi the patient become pregnant during the study?
text
Code List
Didi the patient become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (1)
CL Item
Yes -> If "Yes" record details on Pregnancy Notification Form (3)
Item
Did the patient complete the study according to the protocol?
text
Code List
Did the patient complete the study according to the protocol?
CL Item
No -> If "No" please mark the primary cause of withdrawal below. (2)
Item
Reason for withdrawal
text
Code List
Reason for withdrawal
CL Item
Adverse experience (please complete AE page) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other (please specify below) (5)
Specification of other reason for withdrawal
Item
If other reason for withdrawal, please specify
text
Investigator signature
Item
Investigator signature: I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.
text