ID

26204

Descrizione

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

versioni (1)
  1. 11/10/17 11/10/17 -
Titolare del copyright

GlaxoSmithKline

Caricato su

11 ottobre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

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

1 moduli  
General Information
Descrizione

General Information

Centre Number
Descrizione

Centre Number

Tipo di dati

integer

Patient Number
Descrizione

Patient Number

Tipo di dati

integer

Patient Initials
Descrizione

Patient Initials

Tipo di dati

text

Visit Date
Descrizione

Visit Date

Tipo di dati

date

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

Reminder laboratory test results

Tipo di dati

text

Vital signs
Descrizione

Vital signs

Sitting blood pressure (systolic)
Descrizione

Sitting blood pressure (systolic)

Tipo di dati

integer

Unità di misura
  • mmHg
mmHg
Sitting blood pressure (diastolic)
Descrizione

Sitting blood pressure (diastolic)

Tipo di dati

integer

Unità di misura
  • mmHg
mmHg
Sitting heart rate
Descrizione

Sitting heart rate

Tipo di dati

integer

Unità di misura
  • beats/min
beats/min
Baseline Adverse Experiences
Descrizione

Baseline Adverse Experiences

Experience
Descrizione

Experience

Tipo di dati

text

For SB
Descrizione

For SB

Tipo di dati

text

Date Started
Descrizione

Date Started

Tipo di dati

date

Date stopped
Descrizione

Date stopped

Tipo di dati

date

Duration if less than 24hrs
Descrizione

Duration if less than 24hrs

Tipo di dati

float

Unità di misura
  • hrs
hrs
Experience continuing at end of Baseline Visit
Descrizione

Experience continuing at end of Baseline Visit

Tipo di dati

boolean

Course: Continuous
Descrizione

Course

Tipo di dati

boolean

Course: If No, no of episodes
Descrizione

Course (nr. of episodes)

Tipo di dati

integer

Intensity
Descrizione

Intensity

Tipo di dati

integer

Corrective therapy
Descrizione

Corrective therapy

Tipo di dati

text

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

Serious Baseline Adverse Experience

Tipo di dati

boolean

Investigator´s Signature
Descrizione

Investigator´s Signature

Investigator´s Signature
Descrizione

Investigator´s Signature

Tipo di dati

text

Date
Descrizione

Date

Tipo di dati

date

Study Medication Compliance
Descrizione

Study Medication Compliance

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

Study Medication Compliance

Tipo di dati

text

Patient eligibility
Descrizione

Patient eligibility

Patient eligibility
Descrizione

Patient eligibility

Tipo di dati

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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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