ID
28126
Descripción
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
Palabras clave
Versiones (1)
- 20/12/17 20/12/17 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de diciembre de 2017
DOI
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Licencia
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
Descripción
Vital signs
Descripción
Sitting blood pressure (systolic)
Tipo de datos
integer
Unidades de medida
- mmHg
Descripción
Sitting blood pressure (diastolic)
Tipo de datos
integer
Unidades de medida
- mmHg
Descripción
Sitting Heart Rate
Tipo de datos
integer
Unidades de medida
- beats/min
Descripción
Concomitant Medication
Descripción
Adverse Experiences
Descripción
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.
Tipo de datos
text
Descripción
L-Dopa Rescue
Descripción
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.
Tipo de datos
text
Descripción
Study Medication Compliance
Descripción
End of visit instructions for patients continuing
Descripción
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.
Tipo de datos
date
Descripción
End of visit instructions for patients not continuing
Descripción
ERG Examintion Appointment Card
Descripción
Patient Number
Tipo de datos
integer
Descripción
Patient Initials
Tipo de datos
text
Descripción
Centre Number
Tipo de datos
integer
Descripción
ERG Examination Visit Date and Time
Tipo de datos
datetime
Descripción
Doctor´s Contact Number
Tipo de datos
text
Descripción
Concomitant Medication
Descripción
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.
Tipo de datos
boolean
Descripción
Details on concomitant medication
Descripción
Drug Name
Tipo de datos
text
Descripción
Total daily dose
Tipo de datos
float
Unidades de medida
- mg
Descripción
Medical condition
Tipo de datos
text
Descripción
Approximate Start Date
Tipo de datos
date
Descripción
End Date
Tipo de datos
date
Descripción
For SB
Tipo de datos
text
Descripción
Levodopa Rescue Therapy
Descripción
Details on Levodopa - rescue therapy
Descripción
Adverse Experiences
Descripción
Details on Adverse Experiences
Descripción
Experience
Tipo de datos
text
Descripción
For SB
Tipo de datos
text
Descripción
Date Started
Tipo de datos
date
Descripción
Date Stopped
Tipo de datos
date
Descripción
Duration if less than 24hrs
Tipo de datos
float
Unidades de medida
- hrs
Descripción
Experience continuing?
Tipo de datos
boolean
Descripción
Course Continuation
Tipo de datos
boolean
Descripción
If not continuing no. of episodes
Tipo de datos
integer
Descripción
Intensity
Tipo de datos
integer
Descripción
Aktion taken on Study Medication
Tipo de datos
text
Descripción
Suspected Relationship
Tipo de datos
integer
Descripción
Corrective Therapy
Tipo de datos
text
Descripción
Serious Adverse Experience
Tipo de datos
boolean
Descripción
AEGIS
Tipo de datos
text
Descripción
Investigator´s Signature
Descripción
Patient Continuation / Withdrawal
Descripción
Is the patient continuing in the study?
Tipo de datos
integer
Descripción
Specification of reason for withdrawal
Tipo de datos
integer
Descripción
Specification of other reason for withdrawal
Tipo de datos
text
Descripción
Date of last dose
Tipo de datos
date
Descripción
Investigator´s Signature
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- StudyEvent: ODM