ID

24801

Beschrijving

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Non-serious adverse events

Trefwoorden

Versies (4)
  1. 12-08-17 12-08-17 -
  2. 12-08-17 12-08-17 -
  3. 18-08-17 18-08-17 -
  4. 08-09-17 08-09-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

18 augustus 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Non-serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

Engels

Non-serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulieren  
General information
Beschrijving

General information

Protocol indentifier
Beschrijving

Protocol indentifier

Datatype

text

Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit date
Beschrijving

Visit date

Datatype

date

Visit Description
Beschrijving

Visit Description

Datatype

text

Non-serious adverse events
Beschrijving

Non-serious adverse events

Did the subject experience any non-serious adverse events during the study?
Beschrijving

If Yes, record details below. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.

Datatype

boolean

Event
Beschrijving

Diagnosis Only (if known). Otherwise Sign/Symptom

Datatype

text

Start date
Beschrijving

Start date

Datatype

date

Outcome
Beschrijving

Outcome

Datatype

integer

End Date
Beschrijving

End Date

Datatype

date

Maximum Intensity
Beschrijving

Maximum Intensity

Datatype

text

Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschrijving

Action Taken

Datatype

text

Did the subject withdraw from study as a result of this AE?
Beschrijving

withdrawal

Datatype

boolean

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

AE caused by the investigational product

Datatype

boolean

Terug naar het begin van de pagina

Similar models

Non-serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General information
Protocol indentifier
Item
Protocol indentifier
text
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit date
Item
Visit date
date
Visit Description
Item
Visit Description
text
Item Group
Non-serious adverse events
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
Event
Item
Event
text
Start date
Item
Start date
date
Item
Outcome
integer
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved withsequelae (4)
End Date
Item
End Date
date
Item
Maximum Intensity
text
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
AE caused by the investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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