ID

26204

Beschrijving

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

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Versies (1)
  1. 11-10-17 11-10-17 -
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GlaxoSmithKline

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11 oktober 2017

DOI

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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 2 Baseline

Engels

L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 1 Visit 2 Baseline

1 Formulieren  
General Information
Beschrijving

General Information

Centre Number
Beschrijving

Centre Number

Datatype

integer

Patient Number
Beschrijving

Patient Number

Datatype

integer

Patient Initials
Beschrijving

Patient Initials

Datatype

text

Visit Date
Beschrijving

Visit Date

Datatype

date

Reminder laboratory test results: Ensure that the clinically significant laboratory values question on page 8 has been answered.
Beschrijving

Reminder laboratory test results

Datatype

text

Vital signs
Beschrijving

Vital signs

Sitting blood pressure (systolic)
Beschrijving

Sitting blood pressure (systolic)

Datatype

integer

Maateenheden
  • mmHg
mmHg
Sitting blood pressure (diastolic)
Beschrijving

Sitting blood pressure (diastolic)

Datatype

integer

Maateenheden
  • mmHg
mmHg
Sitting heart rate
Beschrijving

Sitting heart rate

Datatype

integer

Maateenheden
  • beats/min
beats/min
Baseline Adverse Experiences
Beschrijving

Baseline Adverse Experiences

Experience
Beschrijving

Experience

Datatype

text

For SB
Beschrijving

For SB

Datatype

text

Date Started
Beschrijving

Date Started

Datatype

date

Date stopped
Beschrijving

Date stopped

Datatype

date

Duration if less than 24hrs
Beschrijving

Duration if less than 24hrs

Datatype

float

Maateenheden
  • hrs
hrs
Experience continuing at end of Baseline Visit
Beschrijving

Experience continuing at end of Baseline Visit

Datatype

boolean

Course: Continuous
Beschrijving

Course

Datatype

boolean

Course: If No, no of episodes
Beschrijving

Course (nr. of episodes)

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

integer

Corrective therapy
Beschrijving

Corrective therapy

Datatype

text

Do you consider this a serious baseline adverse experience by the Baseline Adverse Experience Definitions
Beschrijving

Serious Baseline Adverse Experience

Datatype

boolean

Investigator´s Signature
Beschrijving

Investigator´s Signature

Investigator´s Signature
Beschrijving

Investigator´s Signature

Datatype

text

Date
Beschrijving

Date

Datatype

date

Study Medication Compliance
Beschrijving

Study Medication Compliance

Has the patient been compliant with study medication? (Compliance is defined as taking between approximately 80%-120% of medication)
Beschrijving

Study Medication Compliance

Datatype

text

Patient eligibility
Beschrijving

Patient eligibility

Patient eligibility
Beschrijving

Patient eligibility

Datatype

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 2 Baseline

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General Information
Centre Number
Item
Centre Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Visit Date
Item
Visit Date
date
Reminder laboratory test results
Item
Reminder laboratory test results: Ensure that the clinically significant laboratory values question on page 8 has been answered.
text
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
Baseline Adverse Experiences
Experience
Item
Experience
text
For SB
Item
For SB
text
Date Started
Item
Date Started
date
Date stopped
Item
Date stopped
date
Duration if less than 24hrs
Item
Duration if less than 24hrs
float
Experience continuing at end of Baseline Visit
Item
Experience continuing at end of Baseline Visit
boolean
Course
Item
Course: Continuous
boolean
Course (nr. of episodes)
Item
Course: If No, no of episodes
integer
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Corrective therapy
text
Corrective therapy
Code List
Corrective therapy
CL Item
Yes (If "Yes" record any medication on Concomitant Medication form) (1)
CL Item
No (2)
Serious Baseline Adverse Experience
Item
Do you consider this a serious baseline adverse experience by the Baseline Adverse Experience Definitions
boolean
Item Group
Investigator´s Signature
Investigator´s Signature
Item
Investigator´s Signature
text
Date
Item
Date
date
Item Group
Study Medication Compliance
Item
Has the patient been compliant with study medication? (Compliance is defined as taking between approximately 80%-120% of medication)
text
Study Medication Compliance
Code List
Has the patient been compliant with study medication? (Compliance is defined as taking between approximately 80%-120% of medication)
CL Item
No (If "No" the patient is not eligible to continue in the study.) (1)
CL Item
Yes (2)
Item Group
Patient eligibility
Patient eligibility
Item
Patient eligibility
boolean
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