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ID
26766
Beschreibung
Study ID: 101468/125 Clinical Study ID: SKF-101468/125 Study Title: A double-blind, multicentre, flexible dose, L-dopa controlled study of ropinirole to investigate A) neuroprotective effect as measured by 3D PET scanning, and B) ophthalmological safety, in patients with early Parkinson’s disease 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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Versionen (1)
- 24.10.17 24.10.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. Oktober 2017
DOI
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Creative Commons BY-NC 3.0
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L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 2 Visit 5 Month 3
L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 2 Visit 5 Month 3
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L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 2 Visit 5 Month 3
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Centre Number
Item
Centre Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Item Group
Flexible Dose Start Date and Current Dose Level
Start Date
Item
Record the date on which the patient started taking study medication from the flexible dose pack
date
Dose currently taken
Item
Record the dose level that the patient is currently taking
text
Sitting Blood Pressure
Item
Sitting Blood Pressure (Systolic)
integer
Sitting Blood Pressure
Item
Sitting Blood Pressure (diastolic)
integer
Sitting Heart Rate
Item
Sitting Heart Rate
integer
Concomitant Medication
Item
Transcribe any ongoing concomitant medications from the previous module, and , record any change in the patient's concomitant medication since the last visit in the Concomitant Medication´s section towards the back of this module.
text
Adverse Experiences
Item
Have there been any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since your last visit"?
boolean
CL Item
No -> If "No" consider withdrawing the patient if they have been non-compliant with study medication (1)
CL Item
Yes (2)
End of visit instructions for patients continuing
Item
End of visit instructions for patients continuing: Arrange for the patient to return for their next visit in three month time. Complete the Patient Continuation/Withdrawal section at the back of this module.
text
End of visit constructions for patients not continuing
Item
Complete the Patient Continuation/Withdrawal section at the back of this module.
text
Permitted Concomitant medication
Item
Concomitant use of the following medication is permitted in this study: - Anti-Parkinson medication, with the exception of amantadine or anticho inergics, which is only permitted at an established and continuous dose. - Selegiline -Medication which has known or suspected retinal toxicity.
text
Concomitant medication used
Item
Concomitant medication used
boolean
Drug Name
Item
Drug Name (Trade Name Preferred)
text
Total Daily Dose
Item
Total Daily Dose
integer
Medical Condition
Item
Medical Condition
text
Approximate Start Date
Item
Approximate Start Date
date
End Date
Item
End Date
date
Continuing
Item
Continuing
boolean
For SB
Item
For SB
text
Levodopa rescue
Item
Levodopa rescue
text
Item
Has the patient started, or is about to start to take L-dopa rescue?
text
Code List
Has the patient started, or is about to start to take L-dopa rescue?
CL Item
No (1)
CL Item
Yes -> If "Yes" specify primary reason and record details (2)
Item
Has the patient started, or is about to start to take L-dopa rescue?
text
Code List
Has the patient started, or is about to start to take L-dopa rescue?
CL Item
No (1)
CL Item
Yes -> If "Yes" specify primary reason and record details (2)
CL Item
Lack of efficacy of study medication (1)
CL Item
Intolerance to study medication (2)
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Total Daily L-dopa Dose
Item
Total Daily L-dopa Dose
integer
Proprietary Preparation
Item
Proprietary Preparation (e.g. Sinemat, Prolopa)
text
Ongoing adverse experiences at the last visit
Item
no ongoing adverse experiences at the last visit and no adverse experience occurred since
boolean
Experience
Item
Experience
text
For SB
Item
For SB
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Duration if if less than 24 hrs
Item
Duration if if less than 24 hrs
integer
Experience continuing
Item
Experience continuing
boolean
Course
Item
Continuous
boolean
Number of episodes
Item
If no, Number of episodes
integer
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (1)
CL Item
Dose decreased (2)
CL Item
Dose increased (3)
CL Item
Drug stopped (4)
CL Item
Dose interrupted (5)
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
CL Item
Unrelated (4)
CL Item
Yes (If "yes" record on Medication form) (1)
CL Item
No (2)
Serious adverse experience
Item
Do you consider this a serious adverse experience by the definitions on the tab?
boolean
AEGIS
Item
AEGIS
text
Investigator´s signature
Item
Investigator´s signature
text
CL Item
Yes (1)
CL Item
No (If "No" mark the one most appropriate reason below, and record the date the patient last took study medication) (2)
CL Item
Adverse experience (complete Adverse Experience section) (1)
CL Item
Lack of Efficacy (2)
CL Item
Deviation from protocol (including non-compliance/protocol violation) (3)
CL Item
Lost to follow-up (4)
CL Item
Other (please specify) (5)
Specification of other
Item
Specification of other
text
Date of last dose
Item
Date of last dose
date
Investigator´s signature
Item
I certify that I have reviewed the data in this module and that all the information is complete and accurate.
text
Date
Item
Date
date