ID

25034

Description

Study part: Adverse Experiences (Non- Serious). A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Phase: phase 3. 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: 101468/192. Clinical Study ID: 101468/192

Keywords

Versions (3)
  1. 8/24/17 8/24/17 -
  2. 3/6/19 3/6/19 -
  3. 3/15/19 3/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 24, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Adverse Experiences (Non- Serious) Ropinirole Restless Legs Syndrom 101468/192

English

Adverse Experiences (Non- Serious)

1 forms  
ADVERSE EXPERIENCES (Non-serious)
Description

ADVERSE EXPERIENCES (Non-serious)

Alias
UMLS CUI-1
C1518404
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Did adverse experiences occurr during the module?
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

If patient died, STOP: go to SAE section and follow instructions given there

Data type

integer

Alias
UMLS CUI [1]
C1705586
Experience 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

y If ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate

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
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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)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Non-serious Adverse Event
Item
Did adverse experiences occurr during the module?
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)
CL Item
Died (3)
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Experience 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
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated  (3)
CL Item
Unrelated (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])
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