ID

25654

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

Keywords

Versions (4)
  1. 8/12/17 8/12/17 -
  2. 8/12/17 8/12/17 -
  3. 8/18/17 8/18/17 -
  4. 9/8/17 9/8/17 -
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September 8, 2017

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License

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

English

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

1 forms  
General information
Description

General information

Protocol identifier
Description

Protocol identifier

Data type

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit date
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit Description
Description

Visit Description

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
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.

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Event
Description

Diagnosis Only (if known). Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C0441471
Start date
Description

Start date

Data type

date

Alias
UMLS CUI [1]
C0808070
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Description

Maximum Intensity

Data type

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Description

Action Taken

Data type

text

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this AE?
Description

withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

AE caused by the investigational product

Data type

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General information
Protocol identifier
Item
Protocol identifier
integer
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Visit Description
Item
Visit Description
text
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Non-serious adverse events
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Event
Item
Event
text
C0441471 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
C2826210 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
C0521108 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
Recovered/Resolved withsequelae (4)
C1709862 (UMLS CUI-1)
(Comment:en)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C2826626 (UMLS CUI [1])
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)
C1875319 (UMLS CUI-1)
(Comment:en)
CL Item
Dose reduced (2)
C1707814 (UMLS CUI-1)
(Comment:en)
CL Item
Dose increased (3)
C1707810 (UMLS CUI-1)
(Comment:en)
CL Item
Dose not changed (4)
C0178602 (UMLS CUI-1)
C0443172 (UMLS CUI-2)
(Comment:en)
CL Item
Dose interrupted (5)
C1512900 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AE caused by the investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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