ID

26204

Descripción

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

Palabras clave

Versiones (1)
  1. 11/10/17 11/10/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de octubre de 2017

DOI

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Licencia

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

Inglés

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

1 formularios  
General Information
Descripción

General Information

Centre Number
Descripción

Centre Number

Tipo de datos

integer

Patient Number
Descripción

Patient Number

Tipo de datos

integer

Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Visit Date
Descripción

Visit Date

Tipo de datos

date

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

Reminder laboratory test results

Tipo de datos

text

Vital signs
Descripción

Vital signs

Sitting blood pressure (systolic)
Descripción

Sitting blood pressure (systolic)

Tipo de datos

integer

Unidades de medida
  • mmHg
mmHg
Sitting blood pressure (diastolic)
Descripción

Sitting blood pressure (diastolic)

Tipo de datos

integer

Unidades de medida
  • mmHg
mmHg
Sitting heart rate
Descripción

Sitting heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
beats/min
Baseline Adverse Experiences
Descripción

Baseline Adverse Experiences

Experience
Descripción

Experience

Tipo de datos

text

For SB
Descripción

For SB

Tipo de datos

text

Date Started
Descripción

Date Started

Tipo de datos

date

Date stopped
Descripción

Date stopped

Tipo de datos

date

Duration if less than 24hrs
Descripción

Duration if less than 24hrs

Tipo de datos

float

Unidades de medida
  • hrs
hrs
Experience continuing at end of Baseline Visit
Descripción

Experience continuing at end of Baseline Visit

Tipo de datos

boolean

Course: Continuous
Descripción

Course

Tipo de datos

boolean

Course: If No, no of episodes
Descripción

Course (nr. of episodes)

Tipo de datos

integer

Intensity
Descripción

Intensity

Tipo de datos

integer

Corrective therapy
Descripción

Corrective therapy

Tipo de datos

text

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

Serious Baseline Adverse Experience

Tipo de datos

boolean

Investigator´s Signature
Descripción

Investigator´s Signature

Investigator´s Signature
Descripción

Investigator´s Signature

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

Study Medication Compliance
Descripción

Study Medication Compliance

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

Study Medication Compliance

Tipo de datos

text

Patient eligibility
Descripción

Patient eligibility

Patient eligibility
Descripción

Patient eligibility

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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