ID

39410

Description

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Keywords

  1. 1/8/20 1/8/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 8, 2020

DOI

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License

Creative Commons BY-NC 3.0

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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease

Study Conclusion

  1. StudyEvent: ODM
    1. Study Conclusion
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Description

Study Name

Data type

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Description

Was the subject withdrawn from the study?

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Description

Primary reason for withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Was follow-up contact attempted three times?
Description

Was follow-up contact attempted three times?

Data type

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0332158
Was a follow-up letter mailed?
Description

Was a follow-up letter mailed?

Data type

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C0013849
Specify follow-up letter
Description

Specify follow-up letter

Data type

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C2348235
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Description

Was the treatment blind broken during the study?

Data type

boolean

Alias
UMLS CUI [1]
C3897431
Date/time blind broken
Description

Date/time blind broken

Data type

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C1264639
Reason blind broken
Description

Reason blind broken

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Other reason blind broken
Description

Other reason blind broken

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394

Similar models

Study Conclusion

  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Name
Item
Study Name
text
C2348560 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Study Site
Item
Study Site
text
C2825164 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion (7)
CL Item
Withdrew consent (8)
Was follow-up contact attempted three times?
Item
Was follow-up contact attempted three times?
boolean
C1522577 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
Was a follow-up letter mailed?
Item
Was a follow-up letter mailed?
boolean
C1522577 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
Specify follow-up letter
Item
Specify follow-up letter
text
C1522577 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date/time blind broken
Item
Date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason blind broken
CL Item
Medical emergency (1)
CL Item
Other (2)
Other reason blind broken
Item
Other reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

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