ID

25667

Beskrivning

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: Study conclusion.

Nyckelord

Versioner (2)
  1. 2017-08-25 2017-08-25 -
  2. 2017-09-08 2017-09-08 -
Uppladdad den

8 september 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

Engelsk

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulär  
General information
Beskrivning

General information

Protocol identifier
Beskrivning

Protocol identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Beskrivning

Visit Description

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Pregnancy information
Beskrivning

Pregnancy information

Did the subject become pregnant during the study?
Beskrivning

If Yes, complete Pregnancy Notification form.

Datatyp

text

Alias
UMLS CUI [1]
C0032961
Study conclusion
Beskrivning

Study conclusion

Date of subject completion or withdrawal
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Was the subject withdrawn from the study?
Beskrivning

Withdrawal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
If Yes, check the primary reason for withdrawal:
Beskrivning

reason withdrawal

Datatyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
If other reason, specify
Beskrivning

other reason withdrawal

Datatyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C3840932
Investigator comment log
Beskrivning

Investigator comment log

CRF page number if applicable
Beskrivning

CRF page number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C1516308
UMLS CUI [1,3]
C1515022
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Investigator's signature
Beskrivning

Investigator's signature

Investigator’s Signature
Beskrivning

Investigator Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beskrivning

signature date

Datatyp

date

Alias
UMLS CUI [1]
C0807937
Investigator’s name (print)
Beskrivning

Investigator name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Tillbaka till toppen

Similar models

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 Description
Item
Visit Description
text
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Pregnancy information
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Did the subject become pregnant during the study?
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
C0549206 (UMLS CUI-1)
(Comment:en)
CL Item
No (N)
C0232973 (UMLS CUI-1)
(Comment:en)
CL Item
Not Applicable (not of childbearing potential or male) (x)
C1272460 (UMLS CUI-1)
(Comment:en)
Item Group
Study conclusion
Date
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1])
Withdrawal
Item
Was the subject withdrawn from the study?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
If Yes, check the primary reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason withdrawal
Code List
If Yes, check the primary reason for withdrawal:
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (1)
C0877248 (UMLS CUI-1)
(Comment:en)
CL Item
Lost to follow-up (2)
C1302313 (UMLS CUI-1)
(Comment:en)
CL Item
Protocol violation (3)
C1709750 (UMLS CUI-1)
(Comment:en)
CL Item
Subject decided to withdraw from the study (4)
C2348571 (UMLS CUI-1)
(Comment:en)
CL Item
Lack of efficacy (5)
C0235828 (UMLS CUI-1)
(Comment:en)
CL Item
Sponsor terminated study (6)
C1710224 (UMLS CUI-1)
(Comment:en)
CL Item
Dyskinesia (28)
C0013384 (UMLS CUI-1)
(Comment:en)
CL Item
Other (Z)
C0205394 (UMLS CUI-1)
(Comment:en)
other reason withdrawal
Item
If other reason, specify
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Item Group
Investigator comment log
CRF page number
Item
CRF page number if applicable
integer
C0237753 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
C1515022 (UMLS CUI [1,3])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's signature
Investigator Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
signature date
Item
Date
date
C0807937 (UMLS CUI [1])
Investigator name
Item
Investigator’s name (print)
text
C2826892 (UMLS CUI [1])
Tillbaka till toppen 

Hjälp

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