Information:
Fel:
ID
38698
Beskrivning
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
Nyckelord
Versioner (2)
- 2017-09-08 2017-09-08 -
- 2019-10-30 2019-10-30 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
30 oktober 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Follow-up (Form 20)
GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 2 (Form 5)
Similar models
GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 2 (Form 5)
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Center Number
Item
Center Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Visit Date
Item
Visit Date
date
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
CL Item
No (1)
CL Item
Yes -> If "Yes", please record details in the Adverse Experiences and/or SAE section at the back of this book. (2)
Item Group
Investigational product and compliance record
Investigational Prod. Week No.
Item
Investigational Prod. Week No.
text
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
No (1)
CL Item
Yes (2)
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
No (1)
CL Item
Yes -> If "Yes", please record details below using standard medical terminology. (2)
Procedure
Item
Procedure
text
Indication
Item
Indication
text
Procedure Start Date
Item
Procedure Start Date
date
Procedure End Date
Item
Procedure End Date
date
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
Item Group
Specification of Adverse Experiences (Non-Serious)
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
Resoved (1)
CL Item
Ongoing (2)
CL Item
Died (If patient died, STOP: go to SAE section and follow instructions given there) (3)
CL Item
Intermittend -> please fill in No. of episodes below. (1)
CL Item
Constant (2)
Number of episodes
Item
If experience course intermittend, please fill in number of episodes
integer
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Respect to Investigational Drug
text
Code List
Action Taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
CL Item
Unrelated (4)
CL Item
No (1)
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
CL Item
Not applicable (not of childbearing potential or male) (1)
CL Item
No (2)
CL Item
Yes -> If "Yes" record details on Pregnancy Notification Form (3)
CL Item
Yes (1)
CL Item
No -> If "No" please mark the primary cause of withdrawal below. (2)
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
Date
Item
Date
date