ID

25562

Description

Study part: Adverse Experiences (Non- Serious). A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Phase: phase 1. Study Recruitment Status: Completed Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP, Zygara; Zygara, ZIPEREVE, ZEPREVE, Requip Depot, REQUIP, REPREVE, Modutab, ADARTREL. Study Indication : Restless Legs Syndrome. Study ID: 101468/201. Clinical Study ID: 101468/201

Keywords

Versions (2)
  1. 9/5/17 9/5/17 -
  2. 5/10/19 5/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 5, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Adverse Experiences (Non- Serious) Ropinirole Restless Legs Syndrome 101468/201

English

Adverse Experiences (Non- Serious)

1 forms  
ADVERSE EXPERIENCES (Non-serious)
Description

ADVERSE EXPERIENCES (Non-serious)

Alias
UMLS CUI-1
C1518404
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Did adverse experiences occurr?
Description

Non-serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Onset Date and Time
Description

Onset Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time
Description

End Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Event course
Description

Experience Course

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
No. of episodes
Description

Number of episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Description

Intensity

Data type

integer

Alias
UMLS CUI [1]
C1710066
Action Taken with Respect to Investigational Drug
Description

Action Taken with Respect to Investigational Drug

Data type

integer

Alias
UMLS CUI [1]
C2826626
Relationship to Investigational Drug
Description

Relationship to Investigational Drug

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Therapy
Description

Corrective Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific AE?
Description

patient withdrawn due to this specific AE

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Investigator signature:
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date:
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Adverse Experiences (Non- Serious)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ADVERSE EXPERIENCES (Non-serious)
C1518404 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Non-serious Adverse Event
Item
Did adverse experiences occurr?
boolean
C1518404 (UMLS CUI [1])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
Item
Event course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Event course
CL Item
Intermittent (1)
CL Item
Constant (2)
Number of episodes
Item
No. of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Action Taken with Respect to Investigational Drug
Code List
Action Taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Investigational Drug
Code List
Relationship to Investigational Drug
CL Item
Not related  (1)
CL Item
Unlikely  (2)
CL Item
Suspected  (3)
CL Item
Probable  (4)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
patient withdrawn due to this specific AE
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date:
date
C0011008 (UMLS CUI [1])
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