ID
43571
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 (2)
- 9/12/17 9/12/17 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 20, 2021
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.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
adverse events PK and tolerability of ropinirole as 5 new formulations 101468/197
adverse events PK and tolerability of ropinirole as 5 new formulations 101468/197
Description
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
diagnosis or signs/symptoms
Data type
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0037088
Description
24 hr - clock
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1264639
Description
symptom intensity of adverse event
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Description
If intermittent, record the number of episodes.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
adverse event outcome
Data type
text
Alias
- UMLS CUI [1]
- C1705586
Description
24 hr - clock
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C2699488
Description
medication change of study drug as result of AE
Data type
integer
Alias
- UMLS CUI [1,1]
- C0580105
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0877248
Description
Did the subject withdraw from study as a result of this non-serious AE?
Data type
text
Alias
- UMLS CUI [1]
- C0422727
Description
relationship of adverse event to study drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
If Yes, please record on concomitant medication page
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Similar models
adverse events PK and tolerability of ropinirole as 5 new formulations 101468/197
C0037088 (UMLS CUI [2])
C0877248 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C2699488 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])