ID

35688

Beskrivning

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 study conclusion form. It has to be filled in for the end of study or for early withdrawal.

Nyckelord

Versioner (1)
  1. 2019-03-15 2019-03-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 mars 2019

DOI

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Creative Commons BY-NC 3.0
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Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192

Engelsk

Study Conclusion

1 Formulär  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beskrivning

Centre Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit type
Beskrivning

Visit type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Study Conclusion
Beskrivning

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the patient complete the study according to the protocol?
Beskrivning

Study Conclusion

Datatyp

text

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
If no completion of study, please mark the primary cause of withdrawal.
Beskrivning

Reason of withdrawal

Datatyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0085978
If other reason for withdrawal, please specify
Beskrivning

Other reason

Datatyp

text

Alias
UMLS CUI [1]
C3840932
Serious Adverse Experiences
Beskrivning

Serious Adverse Experiences

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Beskrivning

Person Reporting SAE

Datatyp

text

Alias
UMLS CUI [1]
C0008961
AEGIS Number
Beskrivning

AEGIS Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0600091
Serious Adverse Experience
Beskrivning

Serious Adverse Experience

Datatyp

text

Alias
UMLS CUI [1]
C1519255
Results in death
Beskrivning

Specify reason(s) for considering this a serious AE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0011065
Life threatening
Beskrivning

Specify reason(s) for considering this a serious AE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2826244
Results in hospitalisation or prolongation of existing hospitalisation
Beskrivning

Specify reason(s) for considering this a serious AE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0019993
Results in disability/incapacity
Beskrivning

Specify reason(s) for considering this a serious AE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0231170
Congenital abnormality/birth defect
Beskrivning

Specify reason(s) for considering this a serious AE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0000768
Other reason
Beskrivning

Specify reason(s) for considering this a serious AE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0205394
If other reason, please specify
Beskrivning

Other reason, specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Onset Date and Time
Beskrivning

day month year 00:00-23:59

Datatyp

datetime

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

day month year 00:00-23:59

Datatyp

datetime

Alias
UMLS CUI [1]
C2826793
Outcome of SAE
Beskrivning

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

Datatyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Experience Course
Beskrivning

Experience Course

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Number of episodes
Beskrivning

Number of episodes

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Action Taken with Respect to Investigational Drug
Beskrivning

Action Taken with Respect to Investigational Drug

Datatyp

integer

Alias
UMLS CUI [1]
C2826626
Did the SAE abate?
Beskrivning

SAE abate

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
Beskrivning

dosage change

Datatyp

text

Alias
UMLS CUI [1]
C0420247
If yes, did SAE recur?
Beskrivning

Serious Adverse Experiences recurrence

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
Relationship to Investigational Drug
Beskrivning

Relationship to Investigational Drug

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
The SAE is probably associated with:
Beskrivning

Relationship to Investigational Drug

Datatyp

integer

If another drug, please specify
Beskrivning

Another drug

Datatyp

text

Alias
UMLS CUI [1]
C1115771
Corrective Therapy
Beskrivning

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

Datatyp

text

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

patient withdrawn due to this specific AE

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Relevant Laboratory Data
Beskrivning

Relevant Laboratory Data

Alias
UMLS CUI-1
C0022877
Test
Beskrivning

Test

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332307
Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Value
Beskrivning

Value

Datatyp

text

Alias
UMLS CUI [1]
C1522609
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Beskrivning

Normal Range

Datatyp

text

Alias
UMLS CUI [1]
C0086715
Remarks
Beskrivning

Remarks

Datatyp

text

Alias
UMLS CUI [1]
C0947611
If applicable, was randomisation code broken at investigational site?
Beskrivning

randomisation code broken

Datatyp

text

Alias
UMLS CUI [1,1]
C3897778
UMLS CUI [1,2]
C1272691
Randomisation Number
Beskrivning

Randomisation Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigators Signature
Beskrivning

Investigators Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Investigator's Name
Beskrivning

Investigator's Name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
SB Medical Monitor’s Signature
Beskrivning

Medical Monitor’s Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Medical Monitor's Name
Beskrivning

Medical Monitor's Name

Datatyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Date of signature
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0807937
UMLS CUI [1,2]
C1708968
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Similar models

Study Conclusion

1 Formulär
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Early wthdrawal (1)
CL Item
Follow-up (2)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Did the patient complete the study according to the protocol?
text
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Study Conclusion
Code List
Did the patient complete the study according to the protocol?
CL Item
Yes (Y)
CL Item
No (N)
Item
If no completion of study, please mark the primary cause of withdrawal.
integer
C0422727 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
cause of withdrawal
Code List
If no completion of study, please mark the primary cause of withdrawal.
CL Item
Adverse experience (please complete AE page) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other (5)
Other reason
Item
If other reason for withdrawal, please specify
text
C3840932 (UMLS CUI [1])
Item Group
Serious Adverse Experiences
C1519255 (UMLS CUI-1)
Person Reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1])
AEGIS Number
Item
AEGIS Number
integer
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Serious Adverse Experience
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
Results in death
Item
Results in death
boolean
C0392360 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Life threatening
Item
Life threatening
boolean
C0392360 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Results in hospitalisation or prolongation of existing hospitalisation
Item
Results in hospitalisation or prolongation of existing hospitalisation
boolean
C0392360 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C0392360 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Congenital abnormality/birth defect
Item
Congenital abnormality/birth defect
boolean
C0392360 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Other reason
Item
Other reason
boolean
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other reason, specification
Item
If other reason, please specify
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
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 of SAE
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome of SAE
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
Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
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
Did the SAE abate?
text
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
SAE abate
Code List
Did the SAE abate?
CL Item
No (N)
CL Item
Yes (Y)
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
text
C0420247 (UMLS CUI [1])
dosage change
Code List
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
CL Item
No (N)
CL Item
Yes (Y)
Item
If yes, did SAE recur?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Serious Adverse Experiences recurrence
Code List
If yes, did SAE recur?
CL Item
No (N)
CL Item
Yes (Y)
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)
Item
The SAE is probably associated with:
integer
Relationship to Investigational Drug
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (1)
CL Item
Another condition (eg, condition under study, intercurrent illness) (2)
CL Item
Another drug (3)
Another drug
Item
If another drug, please specify
text
C1115771 (UMLS CUI [1])
Item
Corrective Therapy
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Corrective Therapy
Code List
Corrective Therapy
CL Item
No (N)
CL Item
Yes (Y)
Item
Was patient withdrawn due to this specific AE?
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
patient withdrawn due to this specific AE
Code List
Was patient withdrawn due to this specific AE?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Relevant Laboratory Data
C0022877 (UMLS CUI-1)
Test
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Value
Item
Value
text
C1522609 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
Item
If applicable, was randomisation code broken at investigational site?
text
C3897778 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
randomisation code broken
Code List
If applicable, was randomisation code broken at investigational site?
CL Item
No (N)
CL Item
Yes (Y)
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigators Signature
Item
Investigators Signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C0011008 (UMLS CUI [1])
Investigator's Name
Item
Investigator's Name
text
C2826892 (UMLS CUI [1])
Medical Monitor’s Signature
Item
SB Medical Monitor’s Signature
text
C2346576 (UMLS CUI [1])
Medical Monitor's Name
Item
Medical Monitor's Name
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of signature
Item
Date of signature
date
C0807937 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
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