ID

25718

Beschrijving

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

Trefwoorden

Versies (2)
  1. 12-09-17 12-09-17 -
  2. 20-09-21 20-09-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 september 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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adverse events PK and tolerability of ropinirole as 5 new formulations 101468/197

Engels

adverse events PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Beschrijving

focus panel

Datatype

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Beschrijving

patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Adverse Events
Beschrijving

Adverse Events

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

If YES, indicate below

Datatype

text

Alias
UMLS CUI [1]
C1518404
Adverse Events
Beschrijving

Adverse Events

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

diagnosis or signs/symptoms

Datatype

text

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

24 hr - clock

Datatype

datetime

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

symptom intensity of adverse event

Datatype

integer

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

If intermittent, record the number of episodes.

Datatype

text

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

adverse event outcome

Datatype

text

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

24 hr - clock

Datatype

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
Beschrijving

medication change of study drug as result of AE

Datatype

integer

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C0877248
Withdrawal
Beschrijving

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

Datatype

text

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

relationship of adverse event to study drug

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective therapy
Beschrijving

If Yes, please record on concomitant medication page

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
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Similar models

adverse events PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
non serious adverse events
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])
symptom intensity of adverse event
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])
course of adverse event
Code List
Event course
CL Item
Intermittent (I)
CL Item
Constant (C)
Item
Outcome
text
C1705586 (UMLS CUI [1])
adverse event outcome
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])
medication change of study drug as result of AE
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])
patient withdrawn from study
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])
plasma level
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])
therapeutic procedere of adverse event
Code List
Corrective therapy
CL Item
Yes (Yes)
CL Item
No (No)
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