ID

24801

Description

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

Mots-clés

Versions (4)
  1. 12/08/2017 12/08/2017 -
  2. 12/08/2017 12/08/2017 -
  3. 18/08/2017 18/08/2017 -
  4. 08/09/2017 08/09/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

18 août 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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Non-serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

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

1 Formulaires  
General information
Description

General information

Protocol indentifier
Description

Protocol indentifier

Type de données

text

Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit date
Description

Visit date

Type de données

date

Visit Description
Description

Visit Description

Type de données

text

Non-serious adverse events
Description

Non-serious adverse events

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

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.

Type de données

boolean

Event
Description

Diagnosis Only (if known). Otherwise Sign/Symptom

Type de données

text

Start date
Description

Start date

Type de données

date

Outcome
Description

Outcome

Type de données

integer

End Date
Description

End Date

Type de données

date

Maximum Intensity
Description

Maximum Intensity

Type de données

text

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

Action Taken

Type de données

text

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

withdrawal

Type de données

boolean

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

AE caused by the investigational product

Type de données

boolean

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Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
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