ID

26204

Descrição

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

Palavras-chave

Versões (1)
  1. 11/10/2017 11/10/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

11 de outubro de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

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

Inglês

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

1 Formulários  
General Information
Descrição

General Information

Centre Number
Descrição

Centre Number

Tipo de dados

integer

Patient Number
Descrição

Patient Number

Tipo de dados

integer

Patient Initials
Descrição

Patient Initials

Tipo de dados

text

Visit Date
Descrição

Visit Date

Tipo de dados

date

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

Reminder laboratory test results

Tipo de dados

text

Vital signs
Descrição

Vital signs

Sitting blood pressure (systolic)
Descrição

Sitting blood pressure (systolic)

Tipo de dados

integer

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

Sitting blood pressure (diastolic)

Tipo de dados

integer

Unidades de medida
  • mmHg
mmHg
Sitting heart rate
Descrição

Sitting heart rate

Tipo de dados

integer

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

Baseline Adverse Experiences

Experience
Descrição

Experience

Tipo de dados

text

For SB
Descrição

For SB

Tipo de dados

text

Date Started
Descrição

Date Started

Tipo de dados

date

Date stopped
Descrição

Date stopped

Tipo de dados

date

Duration if less than 24hrs
Descrição

Duration if less than 24hrs

Tipo de dados

float

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

Experience continuing at end of Baseline Visit

Tipo de dados

boolean

Course: Continuous
Descrição

Course

Tipo de dados

boolean

Course: If No, no of episodes
Descrição

Course (nr. of episodes)

Tipo de dados

integer

Intensity
Descrição

Intensity

Tipo de dados

integer

Corrective therapy
Descrição

Corrective therapy

Tipo de dados

text

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

Serious Baseline Adverse Experience

Tipo de dados

boolean

Investigator´s Signature
Descrição

Investigator´s Signature

Investigator´s Signature
Descrição

Investigator´s Signature

Tipo de dados

text

Date
Descrição

Date

Tipo de dados

date

Study Medication Compliance
Descrição

Study Medication Compliance

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

Study Medication Compliance

Tipo de dados

text

Patient eligibility
Descrição

Patient eligibility

Patient eligibility
Descrição

Patient eligibility

Tipo de dados

boolean

Voltar ao início da página

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial