ID

35505

Beschrijving

Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title: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 Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A 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 The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the Non-serious adverse event form. It has to be filled in if a non-serious AE occurs during the study.

Trefwoorden

Versies (3)
  1. 24-08-17 24-08-17 -
  2. 06-03-19 06-03-19 -
  3. 15-03-19 15-03-19 -
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GlaxoSmithKline

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6 maart 2019

DOI

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

Engels

Non-Serious Adverse Events (AE)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beschrijving

Centre Number

Datatype

integer

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

Patient Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Non-serious Adverse Event
Beschrijving

Non-serious Adverse Event

Alias
UMLS CUI-1
C1518404
Non-serious Adverse Event
Beschrijving

Please mark this box if no adverse experiences occurred during the module.

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Onset Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1518404
Onset Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1518404
End Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
End Time
Beschrijving

00:00-23:59

Datatype

time

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

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

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Experience Course
Beschrijving

Experience Course

Datatype

integer

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

Number of episodes

Datatype

integer

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

MILD: Adverse experience which is easily tolerated MODERATE: Adverse experience sufficiently discomforting to interfere with daily activities SEVERE: Adverse experience which prevents normal everyday activities

Datatype

integer

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

Action Taken with Respect to Investigational Drug

Datatype

integer

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

RELATED: There is a direct cause and effect relationship between the adverse experience and the study drug POSSIBLY RELATED: A direct cause and effect relationship between the drug and the adverse experience has not been demonstrated but is possible or likely PROBABLY UNRELATED: Cause and effect relationship between the drug and the adverse experience has not been demonstrated, is improbable but not impossible UNRELATED: The adverse experience is definitely not related to the test drug

Datatype

integer

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

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

Datatype

boolean

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

patient withdrawn due to this specific AE

Datatype

boolean

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

Non-Serious Adverse Events (AE)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (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])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Non-serious Adverse Event
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
Non-serious Adverse Event
boolean
C1518404 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C0574845 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Onset Time
Item
Onset Time
time
C0449244 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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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