ID

26224

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. 12/10/17 12/10/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 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 Concomitant Medication/Adverse Experiences

Inglés

L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 1 Concomitant Medication/Adverse Experiences

1 formularios  
Concomitant Medication Information
Descripción

Concomitant Medication Information

Concomitant Medication Information noticed
Descripción

Concomitant Medication Information

Tipo de datos

boolean

Concomitant Medication
Descripción

Concomitant Medication

Drug Name (Trade Name Preferred)
Descripción

Drug Name (Trade Name Preferred)

Tipo de datos

text

Total daily dose (e.g. 500 mg)
Descripción

Total daily dose

Tipo de datos

integer

Unidades de medida
  • mg
mg
Medical Condition
Descripción

Medical Condition

Tipo de datos

text

Approximate Start Date
Descripción

Approximate Start Date

Tipo de datos

date

End Date (leave blank if continuing)
Descripción

End Date

Tipo de datos

date

Continuing
Descripción

Continuing

Tipo de datos

boolean

For SB
Descripción

For SB

Tipo de datos

text

Adverse Experiences
Descripción

Adverse Experiences

Definition of serious adverse experiences
Descripción

A serious adverse experience is any experience which is -fatal -life threatening - disabling - incapacitating - results in hospitalization - prolongs a hospital stay - associated with congenital abnormality, carcinoma or overdose

Tipo de datos

boolean

Adverse Experience Details
Descripción

Adverse Experience Details

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

Tipo de datos

float

Unidades de medida
  • hrs
hrs
Experience continuing
Descripción

Experience continuing

Tipo de datos

boolean

Course: Continuous
Descripción

Course

Tipo de datos

boolean

If No, no. of episodes
Descripción

No. of episodes

Tipo de datos

integer

Intensity
Descripción

Intensity

Tipo de datos

text

Action taken on Study Medication
Descripción

Action taken on Study Medication

Tipo de datos

integer

Suspected Relationship
Descripción

Suspected Relationship

Tipo de datos

text

Corrective Therapy
Descripción

Corrective Therapy

Tipo de datos

text

Do you consider this a serious adverse experience by the definitions on the tab?
Descripción

If patient died complete Form D

Tipo de datos

integer

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

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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 Concomitant Medication/Adverse Experiences

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Concomitant Medication Information
Concomitant Medication Information
Item
Concomitant Medication Information noticed
boolean
Item Group
Concomitant Medication
Drug Name (Trade Name Preferred)
Item
Drug Name (Trade Name Preferred)
text
Total daily dose
Item
Total daily dose (e.g. 500 mg)
integer
Medical Condition
Item
Medical Condition
text
Approximate Start Date
Item
Approximate Start Date
date
End Date
Item
End Date (leave blank if continuing)
date
Continuing
Item
Continuing
boolean
For SB
Item
For SB
text
Item Group
Adverse Experiences
Definition of serious adverse experiences
Item
Definition of serious adverse experiences
boolean
Item Group
Adverse Experience Details
Experience
Item
Experience
text
For SB
Item
For SB
text
Date Started
Item
Date Started
date
Date Stopped
Item
Date Stopped
date
Duration
Item
Duration (if less than 24hrs)
float
Experience continuing
Item
Experience continuing
boolean
Course
Item
Course: Continuous
boolean
No. of episodes
Item
If No, no. of episodes
integer
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action taken on Study Medication
integer
Action taken on Study Medication
Code List
Action taken on Study Medication
CL Item
None (1)
CL Item
Dose decreased  (2)
CL Item
Dose increased (3)
CL Item
Drug stopped (4)
CL Item
Dose interrupted (5)
Item
Suspected Relationship
text
Suspected Relationship
Code List
Suspected Relationship
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated  (3)
CL Item
Unrelated (4)
Item
Corrective Therapy
text
Corrective Therapy
Code List
Corrective Therapy
CL Item
Yes (If "Yes" record on Medication form) (1)
CL Item
No (2)
Item
Do you consider this a serious adverse experience by the definitions on the tab?
integer
Serious Adverse Experience by Definition
Code List
Do you consider this a serious adverse experience by the definitions on the tab?
CL Item
Yes (If "Yes", report to SB by telephone within 24 hours) (1)
CL Item
No (2)
Item Group
Investigator´s Signature
Investigator´s Signature
Item
Investigator´s Signature
text
Date
Item
Date
date
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