ID

26223

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)
  1. 2017-10-12 2017-10-12 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

12 oktober 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 1 Visit 3 Week 2 (optional visit)

Engelsk

L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 1 Visit 3 Week 2 (optional visit)

1 Formulär  
Vital signs
Beskrivning

Vital signs

Sitting blood pressure (systolic)
Beskrivning

Sitting blood pressure (systolic)

Datatyp

integer

Måttenheter
  • mmHg
mmHg
Sitting blood pressure (diastolic)
Beskrivning

Sitting blood pressure (diastolic)

Datatyp

integer

Måttenheter
  • mmHg
mmHg
Sitting Heart Rate
Beskrivning

Sitting Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
beats/min
Concomitant medication
Beskrivning

Concomitant medication

Concomitant medication
Beskrivning

Record any change in the patient´s concomitant medication since the last visit in the Concomitant Medication section towards the back of this module.

Datatyp

text

Adverse Experiences
Beskrivning

Adverse Experiences

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 Baseline Adverse Experiences recorded on page 10, record any changes to ongoing Baseline Adverse Experiences section towards the back of this module.

Datatyp

text

Study Medication Compliance
Beskrivning

Study Medication Compliance

Record the date on which the patient started to take study medication in the space provided at the top of page 18. Has the patient been compliant with study medication? (Compliance is defined as taking between approximately 80%-120% of medication)
Beskrivning

Study Medication Compliance

Datatyp

boolean

Patient continuation
Beskrivning

Patient continuation

Remind the patient of the date and time of their next visit.
Beskrivning

Patients continuing

Datatyp

boolean

Complete the Patient Continuation/Withdrawal section at the back of this module.
Beskrivning

Patients withdrawing

Datatyp

boolean

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Similar models

L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 1 Visit 3 Week 2 (optional visit)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Vital signs
Sitting blood pressure (systolic)
Item
Sitting blood pressure (systolic)
integer
Sitting blood pressure (diastolic)
Item
Sitting blood pressure (diastolic)
integer
Sitting Heart Rate
Item
Sitting Heart Rate
integer
Item Group
Concomitant medication
Concomitant medication
Item
Concomitant medication
text
Item Group
Adverse Experiences
Adverse Experiences
Item
text
Item Group
Study Medication Compliance
Study Medication Compliance
Item
Record the date on which the patient started to take study medication in the space provided at the top of page 18. Has the patient been compliant with study medication? (Compliance is defined as taking between approximately 80%-120% of medication)
boolean
Item Group
Patient continuation
Patients continuing
Item
Remind the patient of the date and time of their next visit.
boolean
Patients withdrawing
Item
Complete the Patient Continuation/Withdrawal section at the back of this module.
boolean
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