Informatie:
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ID
28126
Beschrijving
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
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Versies (1)
- 20-12-17 20-12-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 december 2017
DOI
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Licentie
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 3 Visit 6 Month 6
- StudyEvent: ODM
Similar models
Module 3 Visit 6 Month 6
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Current Dose Level
Item
Record the dose level that the patient is currently taking
text
Sitting blood pressure (systolic)
Item
Sitting blood pressure (systolic)
integer
Sitting blood pressure (diastolic)
Item
Sitting blood pressure (diastolic)
integer
Sitting Heart Rate
Item
Sitting Heart Rate
integer
Concomitant Medication
Item
Concomitant Medication
text
Adverse Experiences
Item
Adverse Experiences
text
L-Dopa Rescue
Item
L-Dopa Rescue
text
Item
Has the patient been compliant with study medication? (compliance is defined as taking between approximately 80%-120% of medication)
integer
Code List
Has the patient been compliant with study medication? (compliance is defined as taking between approximately 80%-120% of medication)
CL Item
No -> If "No" consider withdrawing the patient if they have been non-compliant with study medication on two consecutive visits. (1)
CL Item
Yes (2)
Item Group
End of visit instructions for patients continuing
Date of scheduled ERG exam
Item
Schedule the patient´s next visit to the ISCEV centre for their second ERG examination.
date
Item Group
End of visit instructions for patients not continuing
End of visit instructions for patients not continuing
Item
Complete the Patient Continuation/Withdrawal section at the back of this module.
text
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Centre Number
Item
Centre Number
integer
ERG Examination Visit Date and Time
Item
datetime
Doctor´s Contact Number
Item
Doctor´s Contact Number
text
Concomitant Medication
Item
Concomitant Medication
boolean
Drug Name
Item
Drug Name (Trade Name preferred)
text
Total daily dose
Item
Total daily dose
float
Medical condition
Item
Medical condition
text
Approximate Start Date
Item
Approximate Start Date
date
End Date
Item
End Date
date
For SB
Item
For SB
text
Item
Has the patient started to take, has there been any change in or, is there any ongoing L-dopa rescue?
text
Code List
Has the patient started to take, has there been any change in or, is there any ongoing L-dopa rescue?
CL Item
No (1)
CL Item
Yes -> If "Yes" record details below, if this is the first rescue specify primary reason below. (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
float
Proprietary Preparation
Item
Proprietary Preparation
text
Ongoing adverse Experiences
Item
Have there been ongoing adverse experiences at the last visit and no adverse experiences occured 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 less than 24hrs
Item
Duration if less than 24hrs
float
Experience continuing?
Item
Experience continuing?
boolean
Course Continuation
Item
Course Continuation
boolean
If not continuing no. of episodes
Item
If not continuing no. 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
Possibly unrelated (3)
CL Item
Unrelated (4)
CL Item
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
Date
Item
Date
date
CL Item
Yes (1)
CL Item
No (If "No", mark the one most appropriate 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 below) (5)
Specification of other reason for withdrawal
Item
If Other reason for withdrawal, please specify
text
Date of last dose
Item
Date of last dose
date
Investigator´s Signature
Item
Investigator´s Signature
text
Date
Item
Date
date