Dyskinesias GSK study Dyskinesia in Parkinson's disease NCT00363727

General information
Beschrijving

General information

Protocol Identifier
Beschrijving

Protocol Identifier

Datatype

text

Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Visit Date
Beschrijving

Visit Date

Datatype

date

Visit Description
Beschrijving

Visit Description

Datatype

text

Dyskinesia
Beschrijving

Dyskinesia

Is dyskinesia present?
Beschrijving

Complete the Dyskinesia panel at each visit. Determine, using your own clinical judgement whether the subject has dyskinesia. Do not confuse morning dystonia for dyskinesia. If dyskinesia is Yes, make sure all information is transferred to the Early Withdrawal Visit and that the Study Conclusion page is completed correctly.

Datatype

boolean

If yes, check only one box below and complete Study Conclusion page.
Beschrijving

If you have determined that the subject has dyskinesia, Check Yes for dyskinesia and complete the bottom part of the dyskinesia panel to explain how you reach your conclusion. That is, (1) you observed the subject in clinic with dyskinesia, or (2) the verbal history that the subject related to you at this visit clearly and unequivocally provided an account of dyskinesia even though it was not present during the visit. Where there is doubt as to whether the verbal description provided by the subject was not clear enough to be considered dyskinesia. then make a note to this effect in your source documents and check No on the dyskinesia panel. If at the next consecutive visit the subject provides you with a similar account, you may then note this subject as dyskinetic and check the third check box, History suspicious and noted at 2 consecutive visits.

Datatype

integer

Date of Onset
Beschrijving

Make sure the date of onset of dyskinesia is between the last visit date and this visit date.

Datatype

date

Similar models

Dyskinesias GSK study Dyskinesia in Parkinson's disease NCT00363727

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General information
Protocol Identifier
Item
Protocol Identifier
text
Subject Identifier
Item
Subject Identifier
text
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description
text
Item Group
Dyskinesia
Presence of dyskinesia
Item
Is dyskinesia present?
boolean
Item
If yes, check only one box below and complete Study Conclusion page.
integer
Code List
If yes, check only one box below and complete Study Conclusion page.
CL Item
Dyskinesia present at clinic visit and observed by Pl (1)
CL Item
Dyskinesia history is unequivocal (2)
CL Item
History suspicious and reported at 2 consecutive visits (3)
Onset of dyskinesia
Item
Date of Onset
date