ID

29116

Beskrivning

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

Nyckelord

Versioner (1)
  1. 2018-02-26 2018-02-26 -
Rättsinnehavare

GlaxoSmithKline (GSK)

Uppladdad den

26 februari 2018

DOI

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Creative Commons BY-NC 3.0
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Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

Engelsk

Non-serious adverse events and study conclusion

1 Formulär  
Administration
Beskrivning

Administration

Alias
UMLS CUI-1
C1320722
Patient number
Beskrivning

Patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Center Number
Beskrivning

Center Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Adverse experience
Beskrivning

Adverse experience

Alias
UMLS CUI-1
C0877248
Please mark this box if no adverse experiences occurred during the book.
Beskrivning

Adverse experience

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
Onset Date and Time
Beskrivning

Onset Date and Time

Datatyp

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time (If ongoing please leave blank)
Beskrivning

End Date and Time

Datatyp

datetime

Alias
UMLS CUI [1]
C2826793
Outcome If patient died, STOP: go to SAE section and follow instructions given there
Beskrivning

Outcome

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
Experience Course
Beskrivning

Experience Course

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
If intermittent please specify No. of episodes
Beskrivning

Experience Course

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity (maximum)
Beskrivning

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

Datatyp

integer

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

Action Taken

Datatyp

integer

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

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

Datatyp

integer

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

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

Datatyp

boolean

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

Patient withdrawal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Pregnancy information
Beskrivning

Pregnancy information

Alias
UMLS CUI-1
C0032961
Did the patient become pregnant during the study?
Beskrivning

If ’Yes’ record details on Pregnancy Notification Form.

Datatyp

integer

Alias
UMLS CUI [1]
C0032961
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 completion

Datatyp

integer

Alias
UMLS CUI [1]
C0805732
If ’No’, please mark the primary cause of withdrawal. (Mark one box only).
Beskrivning

Study completion

Datatyp

integer

Alias
UMLS CUI [1]
C0805732
Other - specify
Beskrivning

If yo answered the previous question with 'other', please specify:

Datatyp

text

Alias
UMLS CUI [1]
C0205394
Administration Investigator
Beskrivning

Administration Investigator

Alias
UMLS CUI-1
C1320722
Investigator Signature
Beskrivning

I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Non-serious adverse events and study conclusion

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Adverse experience
C0877248 (UMLS CUI-1)
Adverse experience
Item
Please mark this box if no adverse experiences occurred during the book.
boolean
C0877248 (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 (If ongoing please leave blank)
datetime
C2826793 (UMLS CUI [1])
Item
Outcome If patient died, STOP: go to SAE section and follow instructions given there
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome If patient died, STOP: go to SAE section and follow instructions given there
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)
Experience Course
Item
If intermittent please specify No. of episodes
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
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])
Action Taken
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 withdrawal
Item
Was patient withdrawn due to this specific AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Item
Did the patient become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did the patient become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (1)
CL Item
No (2)
CL Item
Yes (3)
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Did the patient complete the study according to the protocol?
integer
C0805732 (UMLS CUI [1])
Study completion
Code List
Did the patient complete the study according to the protocol?
CL Item
Yes (1)
CL Item
No (2)
Item
If ’No’, please mark the primary cause of withdrawal. (Mark one box only).
integer
C0805732 (UMLS CUI [1])
Study completion
Code List
If ’No’, please mark the primary cause of withdrawal. (Mark one box only).
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 - specify (5)
Other - specify
Item
Other - specify
text
C0205394 (UMLS CUI [1])
Item Group
Administration Investigator
C1320722 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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