ID
28126
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
Stichworte
Versionen (1)
- 20.12.17 20.12.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
20. Dezember 2017
DOI
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Lizenz
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
Beschreibung
Vital signs
Beschreibung
Sitting blood pressure (systolic)
Datentyp
integer
Maßeinheiten
- mmHg
Beschreibung
Sitting blood pressure (diastolic)
Datentyp
integer
Maßeinheiten
- mmHg
Beschreibung
Sitting Heart Rate
Datentyp
integer
Maßeinheiten
- beats/min
Beschreibung
Concomitant Medication
Beschreibung
Adverse Experiences
Beschreibung
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.
Datentyp
text
Beschreibung
L-Dopa Rescue
Beschreibung
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.
Datentyp
text
Beschreibung
Study Medication Compliance
Beschreibung
End of visit instructions for patients continuing
Beschreibung
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.
Datentyp
date
Beschreibung
End of visit instructions for patients not continuing
Beschreibung
ERG Examintion Appointment Card
Beschreibung
Patient Number
Datentyp
integer
Beschreibung
Patient Initials
Datentyp
text
Beschreibung
Centre Number
Datentyp
integer
Beschreibung
ERG Examination Visit Date and Time
Datentyp
datetime
Beschreibung
Doctor´s Contact Number
Datentyp
text
Beschreibung
Concomitant Medication
Beschreibung
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.
Datentyp
boolean
Beschreibung
Details on concomitant medication
Beschreibung
Drug Name
Datentyp
text
Beschreibung
Total daily dose
Datentyp
float
Maßeinheiten
- mg
Beschreibung
Medical condition
Datentyp
text
Beschreibung
Approximate Start Date
Datentyp
date
Beschreibung
End Date
Datentyp
date
Beschreibung
For SB
Datentyp
text
Beschreibung
Levodopa Rescue Therapy
Beschreibung
Details on Levodopa - rescue therapy
Beschreibung
Adverse Experiences
Beschreibung
Details on Adverse Experiences
Beschreibung
Experience
Datentyp
text
Beschreibung
For SB
Datentyp
text
Beschreibung
Date Started
Datentyp
date
Beschreibung
Date Stopped
Datentyp
date
Beschreibung
Duration if less than 24hrs
Datentyp
float
Maßeinheiten
- hrs
Beschreibung
Experience continuing?
Datentyp
boolean
Beschreibung
Course Continuation
Datentyp
boolean
Beschreibung
If not continuing no. of episodes
Datentyp
integer
Beschreibung
Intensity
Datentyp
integer
Beschreibung
Aktion taken on Study Medication
Datentyp
text
Beschreibung
Suspected Relationship
Datentyp
integer
Beschreibung
Corrective Therapy
Datentyp
text
Beschreibung
Serious Adverse Experience
Datentyp
boolean
Beschreibung
AEGIS
Datentyp
text
Beschreibung
Investigator´s Signature
Beschreibung
Patient Continuation / Withdrawal
Beschreibung
Is the patient continuing in the study?
Datentyp
integer
Beschreibung
Specification of reason for withdrawal
Datentyp
integer
Beschreibung
Specification of other reason for withdrawal
Datentyp
text
Beschreibung
Date of last dose
Datentyp
date
Beschreibung
Investigator´s Signature
Ähnliche Modelle
Module 3 Visit 6 Month 6
- StudyEvent: ODM