ID
28126
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-12-20 2017-12-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 december 2017
DOI
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Licens
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
Beskrivning
Vital signs
Beskrivning
Sitting blood pressure (systolic)
Datatyp
integer
Måttenheter
- mmHg
Beskrivning
Sitting blood pressure (diastolic)
Datatyp
integer
Måttenheter
- mmHg
Beskrivning
Sitting Heart Rate
Datatyp
integer
Måttenheter
- beats/min
Beskrivning
Concomitant Medication
Beskrivning
Adverse Experiences
Beskrivning
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.
Datatyp
text
Beskrivning
L-Dopa Rescue
Beskrivning
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.
Datatyp
text
Beskrivning
Study Medication Compliance
Beskrivning
End of visit instructions for patients continuing
Beskrivning
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.
Datatyp
date
Beskrivning
End of visit instructions for patients not continuing
Beskrivning
ERG Examintion Appointment Card
Beskrivning
Patient Number
Datatyp
integer
Beskrivning
Patient Initials
Datatyp
text
Beskrivning
Centre Number
Datatyp
integer
Beskrivning
ERG Examination Visit Date and Time
Datatyp
datetime
Beskrivning
Doctor´s Contact Number
Datatyp
text
Beskrivning
Concomitant Medication
Beskrivning
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.
Datatyp
boolean
Beskrivning
Details on concomitant medication
Beskrivning
Drug Name
Datatyp
text
Beskrivning
Total daily dose
Datatyp
float
Måttenheter
- mg
Beskrivning
Medical condition
Datatyp
text
Beskrivning
Approximate Start Date
Datatyp
date
Beskrivning
End Date
Datatyp
date
Beskrivning
For SB
Datatyp
text
Beskrivning
Levodopa Rescue Therapy
Beskrivning
Details on Levodopa - rescue therapy
Beskrivning
Adverse Experiences
Beskrivning
Details on Adverse Experiences
Beskrivning
Experience
Datatyp
text
Beskrivning
For SB
Datatyp
text
Beskrivning
Date Started
Datatyp
date
Beskrivning
Date Stopped
Datatyp
date
Beskrivning
Duration if less than 24hrs
Datatyp
float
Måttenheter
- hrs
Beskrivning
Experience continuing?
Datatyp
boolean
Beskrivning
Course Continuation
Datatyp
boolean
Beskrivning
If not continuing no. of episodes
Datatyp
integer
Beskrivning
Intensity
Datatyp
integer
Beskrivning
Aktion taken on Study Medication
Datatyp
text
Beskrivning
Suspected Relationship
Datatyp
integer
Beskrivning
Corrective Therapy
Datatyp
text
Beskrivning
Serious Adverse Experience
Datatyp
boolean
Beskrivning
AEGIS
Datatyp
text
Beskrivning
Investigator´s Signature
Beskrivning
Patient Continuation / Withdrawal
Beskrivning
Is the patient continuing in the study?
Datatyp
integer
Beskrivning
Specification of reason for withdrawal
Datatyp
integer
Beskrivning
Specification of other reason for withdrawal
Datatyp
text
Beskrivning
Date of last dose
Datatyp
date
Beskrivning
Investigator´s Signature
Similar models
Module 3 Visit 6 Month 6
- StudyEvent: ODM