ID

26224

Description

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

Mots-clés

Versions (1)
  1. 12/10/2017 12/10/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

12 octobre 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

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

Anglais

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 Formulaires  
Concomitant Medication Information
Description

Concomitant Medication Information

Concomitant Medication Information noticed
Description

Concomitant Medication Information

Type de données

boolean

Concomitant Medication
Description

Concomitant Medication

Drug Name (Trade Name Preferred)
Description

Drug Name (Trade Name Preferred)

Type de données

text

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

Total daily dose

Type de données

integer

Unités de mesure
  • mg
mg
Medical Condition
Description

Medical Condition

Type de données

text

Approximate Start Date
Description

Approximate Start Date

Type de données

date

End Date (leave blank if continuing)
Description

End Date

Type de données

date

Continuing
Description

Continuing

Type de données

boolean

For SB
Description

For SB

Type de données

text

Adverse Experiences
Description

Adverse Experiences

Definition of serious adverse experiences
Description

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

Type de données

boolean

Adverse Experience Details
Description

Adverse Experience Details

Experience
Description

Experience

Type de données

text

For SB
Description

For SB

Type de données

text

Date Started
Description

Date Started

Type de données

date

Date Stopped
Description

Date Stopped

Type de données

date

Duration (if less than 24hrs)
Description

Duration

Type de données

float

Unités de mesure
  • hrs
hrs
Experience continuing
Description

Experience continuing

Type de données

boolean

Course: Continuous
Description

Course

Type de données

boolean

If No, no. of episodes
Description

No. of episodes

Type de données

integer

Intensity
Description

Intensity

Type de données

text

Action taken on Study Medication
Description

Action taken on Study Medication

Type de données

integer

Suspected Relationship
Description

Suspected Relationship

Type de données

text

Corrective Therapy
Description

Corrective Therapy

Type de données

text

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

If patient died complete Form D

Type de données

integer

Investigator´s Signature
Description

Investigator´s Signature

Investigator´s Signature
Description

Investigator´s Signature

Type de données

text

Date
Description

Date

Type de données

date

Retour au début de la page

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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