ID

25719

Description

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome

Keywords

Versions (1)
  1. 9/12/17 9/12/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 12, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

final examination study completion PK and tolerability of ropinirole as 5 new formulations 101468/197

English

final examination study completion PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Description

focus panel

Data type

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Treatment
Description

treatment

Data type

text

Alias
UMLS CUI [1]
C0087111
Study Completion
Description

Study Completion

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0444930
Did the subject complete the study?
Description

subject completed participation in study

Data type

text

Alias
UMLS CUI [1]
C2348577
Date of subject completion or discontinuation from the study
Description

date of subject completed participation in study

Data type

date

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0011008
Time of subject completion or discontinuation from the study
Description

time of subject completed participation in study

Data type

time

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0040223
Did the subject become pregnant during the study?
Description

If yes, record details on PREGNANCY NOTIFICATION FORM

Data type

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Did the subject dicontinue the study prematurely?
Description

discontinuation of the study

Data type

boolean

Alias
UMLS CUI [1]
C2348570
If yes, the primary reason for discontinuation
Description

Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C2348570
UMLS CUI [1,2]
C0582550
Back to the top of the page

Similar models

final examination study completion PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
focus panel
Item
Focus Panel ID
integer
C3846158 (UMLS CUI [1])
patient number
Item
Patient No
integer
C1830427 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
Item Group
Study Completion
C0008976 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Item
Did the subject complete the study?
text
C2348577 (UMLS CUI [1])
subject completed participation in study
Code List
Did the subject complete the study?
CL Item
Yes (Yes)
CL Item
No (No)
date of subject completed participation in study
Item
Date of subject completion or discontinuation from the study
date
C2348577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
time of subject completed participation in study
Item
Time of subject completion or discontinuation from the study
time
C2348577 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
pregnancy during study
Code List
Did the subject become pregnant during the study?
CL Item
Not applicable (Not of childbearing potential or male) (Not applicable)
CL Item
Yes (Yes)
CL Item
No (No)
discontinuation of the study
Item
Did the subject dicontinue the study prematurely?
boolean
C2348570 (UMLS CUI [1])
Item
If yes, the primary reason for discontinuation
text
C2348570 (UMLS CUI [1,1])
C0582550 (UMLS CUI [1,2])
reason for premature study termination
Code List
If yes, the primary reason for discontinuation
CL Item
Adverse Event (Adverse Event)
CL Item
Lost to follow up (Lost to follow up)
CL Item
Protocol violation (Protocol violation)
CL Item
Other, specify (Other, specify)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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