ID

25718

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

  1. 9/12/17 9/12/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 12, 2017

DOI

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License

Creative Commons BY-NC 3.0

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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

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
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Did the subject experience any non-serious adverse events during the study?
Description

If YES, indicate below

Data type

text

Alias
UMLS CUI [1]
C1518404
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Diagnosis or signs/symptoms
Description

diagnosis or signs/symptoms

Data type

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0037088
Date and time of onset
Description

24 hr - clock

Data type

datetime

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1717740
Maximum intensity
Description

symptom intensity of adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Event course
Description

If intermittent, record the number of episodes.

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Outcome
Description

adverse event outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
Date and time of resolution
Description

24 hr - clock

Data type

datetime

Alias
UMLS CUI [1,1]
C1717740
UMLS CUI [1,2]
C2699488
Action taken with study drug(s) as a result of the non-serious AE
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
Withdrawal
Description

Did the subject withdraw from study as a result of this non-serious AE?

Data type

text

Alias
UMLS CUI [1]
C0422727
Relationship to study drug(s)
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
Corrective therapy
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

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])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
diagnosis or signs/symptoms
Item
Diagnosis or signs/symptoms
text
C0011900 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
date and time of onset of adverse event
Item
Date and time of onset
datetime
C0332162 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1717740 (UMLS CUI [1,3])
Item
Maximum intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Maximum intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Event course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Event course
CL Item
Intermittent (I)
CL Item
Constant (C)
Item
Outcome
text
C1705586 (UMLS CUI [1])
Code List
Outcome
CL Item
Resolved (R)
CL Item
Ongoing (O)
date and time of resolution
Item
Date and time of resolution
datetime
C1717740 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
Item
Action taken with study drug(s) as a result of the non-serious AE
integer
C0580105 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2])
Code List
Action taken with study drug(s) as a result of the non-serious AE
CL Item
None (0)
CL Item
Dose reduced (1)
CL Item
Dose increased (2)
CL Item
Drug interrupted/restarted (3)
CL Item
Drug stopped (4)
Item
Withdrawal
text
C0422727 (UMLS CUI [1])
Code List
Withdrawal
CL Item
Yes (Yes)
CL Item
No (No)
Item
Relationship to study drug(s)
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to study drug(s)
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
CL Item
Unrelated (4)
Item
Corrective therapy
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Corrective therapy
CL Item
Yes (Yes)
CL Item
No (No)

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