ID

26204

Description

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

Keywords

Versions (1)
  1. 10/11/17 10/11/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 11, 2017

DOI

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License

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

English

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

1 forms  
General Information
Description

General Information

Centre Number
Description

Centre Number

Data type

integer

Patient Number
Description

Patient Number

Data type

integer

Patient Initials
Description

Patient Initials

Data type

text

Visit Date
Description

Visit Date

Data type

date

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

Reminder laboratory test results

Data type

text

Vital signs
Description

Vital signs

Sitting blood pressure (systolic)
Description

Sitting blood pressure (systolic)

Data type

integer

Measurement units
  • mmHg
mmHg
Sitting blood pressure (diastolic)
Description

Sitting blood pressure (diastolic)

Data type

integer

Measurement units
  • mmHg
mmHg
Sitting heart rate
Description

Sitting heart rate

Data type

integer

Measurement units
  • beats/min
beats/min
Baseline Adverse Experiences
Description

Baseline Adverse Experiences

Experience
Description

Experience

Data type

text

For SB
Description

For SB

Data type

text

Date Started
Description

Date Started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Duration if less than 24hrs
Description

Duration if less than 24hrs

Data type

float

Measurement units
  • hrs
hrs
Experience continuing at end of Baseline Visit
Description

Experience continuing at end of Baseline Visit

Data type

boolean

Course: Continuous
Description

Course

Data type

boolean

Course: If No, no of episodes
Description

Course (nr. of episodes)

Data type

integer

Intensity
Description

Intensity

Data type

integer

Corrective therapy
Description

Corrective therapy

Data type

text

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

Serious Baseline Adverse Experience

Data type

boolean

Investigator´s Signature
Description

Investigator´s Signature

Investigator´s Signature
Description

Investigator´s Signature

Data type

text

Date
Description

Date

Data type

date

Study Medication Compliance
Description

Study Medication Compliance

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

Study Medication Compliance

Data type

text

Patient eligibility
Description

Patient eligibility

Patient eligibility
Description

Patient eligibility

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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