ID

27267

Beschrijving

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Adverse Experiences (Non-serious)

Trefwoorden

Versies (1)
  1. 06-11-17 06-11-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

6 november 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188

Engels

Adverse Experiences (Non-serious)

1 Formulieren  
Adverse Experiences (Non-Serious)
Beschrijving

Adverse Experiences (Non-Serious)

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C0008976
UMLS CUI-3
C0035258
Please mark this box if no adverse experiences occurred during the book.
Beschrijving

Adverse experiences occurence

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2745955
Adverse Experience
Beschrijving

Adverse Experience

Datatype

text

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

Onset Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C1301880
End Date and Time (if ongoing please leave blank)
Beschrijving

End Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C1522314
Outcome
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Experience Course
Beschrijving

Experience Course

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0750729
If experience course intermittend, please fill in number of episodes
Beschrijving

Number of episodes

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Beschrijving

Intensity (maximum)

Datatype

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Action Taken with Respect to Investigational Drug
Beschrijving

Action Taken with Respect to Investigational Drug

Datatype

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C1518404
Relationship to Investigational Drug
Beschrijving

Relationship to Investigational Drug

Datatype

integer

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

If "Yes", record details in the Concomitant Medication section and/or Medical Procedures section if appropriate.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1518404
Was patient withdrawn due to this specific AE?
Beschrijving

Withdrawal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
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Similar models

Adverse Experiences (Non-serious)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adverse Experiences (Non-Serious)
C1518404 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
Adverse experiences occurence
Item
Please mark this box if no adverse experiences occurred during the book.
boolean
C1518404 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Adverse Experience
Item
Adverse Experience
text
C1518404 (UMLS CUI [1])
Onset Date and Time
Item
Onset Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
End Date and Time
Item
End Date and Time (if ongoing please leave blank)
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resoved (1)
CL Item
Ongoing (2)
CL Item
Died (If patient died, STOP: go to SAE section and follow instructions given there) (3)
Item
Experience Course
integer
C1518404 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Experience Course
CL Item
Intermittend  (1)
CL Item
Constant (2)
Number of episodes
Item
If experience course intermittend, please fill in number of episodes
integer
C1518404 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Intensity (maximum)
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 [1,1])
C1518404 (UMLS CUI [1,2])
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
C0087111 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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