ID

26224

Beschrijving

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

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Versies (1)
  1. 12-10-17 12-10-17 -
Houder van rechten

GlaxoSmithKline

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12 oktober 2017

DOI

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Licentie

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

Engels

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 Formulieren  
Concomitant Medication Information
Beschrijving

Concomitant Medication Information

Concomitant Medication Information noticed
Beschrijving

Concomitant Medication Information

Datatype

boolean

Concomitant Medication
Beschrijving

Concomitant Medication

Drug Name (Trade Name Preferred)
Beschrijving

Drug Name (Trade Name Preferred)

Datatype

text

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

Total daily dose

Datatype

integer

Maateenheden
  • mg
mg
Medical Condition
Beschrijving

Medical Condition

Datatype

text

Approximate Start Date
Beschrijving

Approximate Start Date

Datatype

date

End Date (leave blank if continuing)
Beschrijving

End Date

Datatype

date

Continuing
Beschrijving

Continuing

Datatype

boolean

For SB
Beschrijving

For SB

Datatype

text

Adverse Experiences
Beschrijving

Adverse Experiences

Definition of serious adverse experiences
Beschrijving

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

Datatype

boolean

Adverse Experience Details
Beschrijving

Adverse Experience Details

Experience
Beschrijving

Experience

Datatype

text

For SB
Beschrijving

For SB

Datatype

text

Date Started
Beschrijving

Date Started

Datatype

date

Date Stopped
Beschrijving

Date Stopped

Datatype

date

Duration (if less than 24hrs)
Beschrijving

Duration

Datatype

float

Maateenheden
  • hrs
hrs
Experience continuing
Beschrijving

Experience continuing

Datatype

boolean

Course: Continuous
Beschrijving

Course

Datatype

boolean

If No, no. of episodes
Beschrijving

No. of episodes

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

text

Action taken on Study Medication
Beschrijving

Action taken on Study Medication

Datatype

integer

Suspected Relationship
Beschrijving

Suspected Relationship

Datatype

text

Corrective Therapy
Beschrijving

Corrective Therapy

Datatype

text

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

If patient died complete Form D

Datatype

integer

Investigator´s Signature
Beschrijving

Investigator´s Signature

Investigator´s Signature
Beschrijving

Investigator´s Signature

Datatype

text

Date
Beschrijving

Date

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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