ID
28126
Description
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
Keywords
Versions (1)
- 12/20/17 12/20/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 20, 2017
DOI
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License
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
Description
Vital signs
Description
Sitting blood pressure (systolic)
Data type
integer
Measurement units
- mmHg
Description
Sitting blood pressure (diastolic)
Data type
integer
Measurement units
- mmHg
Description
Sitting Heart Rate
Data type
integer
Measurement units
- beats/min
Description
Concomitant Medication
Description
Adverse Experiences
Description
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?" Transcribe any ongoing adverse experiences from the previous module, record any changes to ongoing adverse experiences, and details of any new adverse experiences observed or reported by the patient in the Adverse Experiences section towards the back of this module.
Data type
text
Description
L-Dopa Rescue
Description
Patients must complete as a minimum the initial titration to dose level 5. Titration of the dose of study medication to the maximum tolerated dose is encouraged. However if the patients symptoms remain inadequately controlled, open label L-dopa may be prescribed as rescue medication. Transcribe any ongoing L-dopa medication from the previous module, record any changes in L-dopa since the last visit, and details of any L-dopa that the patient has started, or is about to start taking, in the L-dopa Rescue section towards the back of this module.
Data type
text
Description
Study Medication Compliance
Description
End of visit instructions for patients continuing
Description
NB. this visit must take place at least 6 months after the initial ERG examination. • Tear-out the patient's appointment card (next page) and record the date and time of the appointment and your centre number on the card. If the date and time of the patient's second ERG examination is not yet known, please remember to inform the patient of this information when it becomes available. • lnstruct the patient that they must take their appointment card to their ERG examination visit. • Depending on the dose level that the patient is to take from today, order the second 6 month supply of medication for the patient. • Arrange for the patient to return for their next clinic visit in six months time. • Complete the Patient Continuation/Withdrawal section at the back of this module.
Data type
date
Description
End of visit instructions for patients not continuing
Description
ERG Examintion Appointment Card
Description
Patient Number
Data type
integer
Description
Patient Initials
Data type
text
Description
Centre Number
Data type
integer
Description
ERG Examination Visit Date and Time
Data type
datetime
Description
Doctor´s Contact Number
Data type
text
Description
Concomitant Medication
Description
Transcribe any ongoing concomitant medication from the previous module, and record any concomitant medication changes since the last visit. Any new medical illness/diagnosis or symptoms in the absence of a diagnosis should be recorded in the Adverse Experience section utilising the same terminology. If a medication was marked "Continuing" at the last visit, but has since had a dosage change or has been stopped, it must be recorded as a change with the start and end date. If no concomitant medication answer question appropriately.
Data type
boolean
Description
Details on concomitant medication
Description
Drug Name
Data type
text
Description
Total daily dose
Data type
float
Measurement units
- mg
Description
Medical condition
Data type
text
Description
Approximate Start Date
Data type
date
Description
End Date
Data type
date
Description
For SB
Data type
text
Description
Levodopa Rescue Therapy
Description
Details on Levodopa - rescue therapy
Description
Adverse Experiences
Description
Details on Adverse Experiences
Description
Experience
Data type
text
Description
For SB
Data type
text
Description
Date Started
Data type
date
Description
Date Stopped
Data type
date
Description
Duration if less than 24hrs
Data type
float
Measurement units
- hrs
Description
Experience continuing?
Data type
boolean
Description
Course Continuation
Data type
boolean
Description
If not continuing no. of episodes
Data type
integer
Description
Intensity
Data type
integer
Description
Aktion taken on Study Medication
Data type
text
Description
Suspected Relationship
Data type
integer
Description
Corrective Therapy
Data type
text
Description
Serious Adverse Experience
Data type
boolean
Description
AEGIS
Data type
text
Description
Investigator´s Signature
Description
Patient Continuation / Withdrawal
Description
Is the patient continuing in the study?
Data type
integer
Description
Specification of reason for withdrawal
Data type
integer
Description
Specification of other reason for withdrawal
Data type
text
Description
Date of last dose
Data type
date
Description
Investigator´s Signature
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Module 3 Visit 6 Month 6
- StudyEvent: ODM