ID
26766
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 Study Indication: Restless Legs Syndrome
Nyckelord
Versioner (1)
- 2017-10-24 2017-10-24 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
24 oktober 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 2 Visit 5 Month 3
L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 2 Visit 5 Month 3
Beskrivning
Flexible Dose Start Date and Current Dose Level
Beskrivning
Vital signs
Beskrivning
Sitting Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Beskrivning
Sitting Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Beskrivning
Sitting Heart Rate
Datatyp
integer
Måttenheter
- beats/min
Beskrivning
Concomitant Medication
Beskrivning
Adverse Experiences
Beskrivning
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
boolean
Beskrivning
Study Medication Compliance
Beskrivning
Compliance is defined as taking between approximately 80-120% of medication.
Datatyp
integer
Beskrivning
End of visit instructions for patients continuing
Datatyp
text
Beskrivning
End of visit constructions for patients not continuing
Datatyp
text
Beskrivning
Concomitant medication
Beskrivning
Permitted Concomitant medication
Datatyp
text
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. lf 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.
Datatyp
boolean
Beskrivning
Details of Concomitant Medication
Beskrivning
Drug Name
Datatyp
text
Beskrivning
Total Daily Dose
Datatyp
integer
Måttenheter
- mg
Beskrivning
Medical Condition
Datatyp
text
Beskrivning
Approximate Start Date
Datatyp
date
Beskrivning
End Date
Datatyp
date
Beskrivning
Continuing
Datatyp
boolean
Beskrivning
For SB
Datatyp
text
Beskrivning
Levodopa rescue
Beskrivning
Patients must complete as a minimum the initial dose level 5. Titration of the dose of study medication to the maximum tolerated dose is encouraged. However if the patient´s symptoms remain inadequately controlled, open label L-dopa may be prescribed as a rescue medication.
Datatyp
text
Beskrivning
Levodopa - Rescue Therapy
Datatyp
text
Beskrivning
Levodopa - Rescue Therapy
Datatyp
text
Beskrivning
Primary reason
Datatyp
text
Beskrivning
Details of Ledopa 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 if less than 24 hrs
Datatyp
integer
Beskrivning
Experience continuing
Datatyp
boolean
Beskrivning
Course
Datatyp
boolean
Beskrivning
Number of episodes
Datatyp
integer
Beskrivning
Intensity
Datatyp
text
Beskrivning
Action taken on Study Medication
Datatyp
text
Beskrivning
Suspected relationship
Datatyp
text
Beskrivning
Corrective therapy
Datatyp
integer
Beskrivning
Serious adverse experience
Datatyp
boolean
Beskrivning
AEGIS
Datatyp
text
Beskrivning
Investigator´s signature
Datatyp
text
Beskrivning
Patient Continuation/Withdrawal
Beskrivning
Patient Continuation/Withdrawal
Datatyp
integer
Beskrivning
Most appropriate reason for withdrawal
Datatyp
integer
Beskrivning
Specification of other
Datatyp
text
Beskrivning
Date of last dose
Datatyp
date
Beskrivning
Investigator´s signature
Datatyp
text
Beskrivning
Date
Datatyp
date