ID

26224

Beschreibung

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

Stichworte

Versionen (1)
  1. 12.10.17 12.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. Oktober 2017

DOI

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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

Englisch

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 Formulare  
Concomitant Medication Information
Beschreibung

Concomitant Medication Information

Concomitant Medication Information noticed
Beschreibung

Concomitant Medication Information

Datentyp

boolean

Concomitant Medication
Beschreibung

Concomitant Medication

Drug Name (Trade Name Preferred)
Beschreibung

Drug Name (Trade Name Preferred)

Datentyp

text

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

Total daily dose

Datentyp

integer

Maßeinheiten
  • mg
mg
Medical Condition
Beschreibung

Medical Condition

Datentyp

text

Approximate Start Date
Beschreibung

Approximate Start Date

Datentyp

date

End Date (leave blank if continuing)
Beschreibung

End Date

Datentyp

date

Continuing
Beschreibung

Continuing

Datentyp

boolean

For SB
Beschreibung

For SB

Datentyp

text

Adverse Experiences
Beschreibung

Adverse Experiences

Definition of serious adverse experiences
Beschreibung

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

Datentyp

boolean

Adverse Experience Details
Beschreibung

Adverse Experience Details

Experience
Beschreibung

Experience

Datentyp

text

For SB
Beschreibung

For SB

Datentyp

text

Date Started
Beschreibung

Date Started

Datentyp

date

Date Stopped
Beschreibung

Date Stopped

Datentyp

date

Duration (if less than 24hrs)
Beschreibung

Duration

Datentyp

float

Maßeinheiten
  • hrs
hrs
Experience continuing
Beschreibung

Experience continuing

Datentyp

boolean

Course: Continuous
Beschreibung

Course

Datentyp

boolean

If No, no. of episodes
Beschreibung

No. of episodes

Datentyp

integer

Intensity
Beschreibung

Intensity

Datentyp

text

Action taken on Study Medication
Beschreibung

Action taken on Study Medication

Datentyp

integer

Suspected Relationship
Beschreibung

Suspected Relationship

Datentyp

text

Corrective Therapy
Beschreibung

Corrective Therapy

Datentyp

text

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

If patient died complete Form D

Datentyp

integer

Investigator´s Signature
Beschreibung

Investigator´s Signature

Investigator´s Signature
Beschreibung

Investigator´s Signature

Datentyp

text

Date
Beschreibung

Date

Datentyp

date

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Ähnliche Modelle

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 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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