ID

26297

Beschreibung

Study ID: 101468/190 Clinical Study ID: SKF-101468/190 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: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Medical Procedures assessment form.

Stichworte

Versionen (2)
  1. 16.10.17 16.10.17 -
  2. 18.10.17 18.10.17 -
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GlaxoSmithKline

Hochgeladen am

16. Oktober 2017

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26072_GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Medical Procedures 101468/190

Englisch

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Medical Procedures 101468/190

1 Formulare  
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
Centre Number
Beschreibung

Centre Number

Datentyp

text

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

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
MEDICAL PROCEDURES
Beschreibung

MEDICAL PROCEDURES

Alias
UMLS CUI-1
C0199171
UMLS CUI-2
C0087111
UMLS CUI-3
C0430022
UMLS CUI-4
C0543467
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit?
Beschreibung

Medical Procedures

Datentyp

integer

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0430022
UMLS CUI [1,4]
C0543467
Procedure
Beschreibung

Procedure

Datentyp

text

Alias
UMLS CUI [1]
C0199171
Indication
Beschreibung

Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C3146298
Procedure Start Date
Beschreibung

Procedure Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0808070
Procedure End Date
Beschreibung

Procedure End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0184661
CONCOMITANT MEDICATION
Beschreibung

CONCOMITANT MEDICATION

Alias
UMLS CUI-1
C2347852
Please mark if no new or change in concomitant medication since the previous visit.
Beschreibung

concomitant medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1514463
Drug Name
Beschreibung

Trade name preferred

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C2347852
Medical Illness/ Diagnosis
Beschreibung

or symptom in absence of diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Start Date
Beschreibung

be as precise as possible

Datentyp

date

Alias
UMLS CUI [1]
C2826734
End Date
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Continuing
Beschreibung

Continuing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2347852
ADVERSE EXPERIENCES
Beschreibung

ADVERSE EXPERIENCES

Alias
UMLS CUI-1
C1518404
Please mark this box if no adverse experiences occurred during the book.
Beschreibung

Adverse Experiences

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Adverse Experience
Beschreibung

Adverse Experience

Datentyp

text

Alias
UMLS CUI [1]
C0559546
Onset Date and Time
Beschreibung

Onset Date and Time

Datentyp

datetime

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

(If ongoing please leave blank)

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Experience Course
Beschreibung

Experience Course

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0750729
Experience Course Number of episodes
Beschreibung

Experience Course Episodes

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C4086638
Intensity
Beschreibung

Maximum

Datentyp

integer

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

Action Taken with Respect to Investigational Drug

Datentyp

integer

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

Relationship to Investigational Drug

Datentyp

integer

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

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

Datentyp

boolean

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

Was patient withdrawn due to this specific AE?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
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Ähnliche Modelle

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Medical Procedures 101468/190

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
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 Group
MEDICAL PROCEDURES
C0199171 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0543467 (UMLS CUI-4)
Item
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit?
integer
C0199171 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
Medical Procedures
Code List
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit?
CL Item
No (1)
CL Item
Yes If ‘Yes’, please record details below using standard medical terminology (Please print clearly) (2)
Procedure
Item
Procedure
text
C0199171 (UMLS CUI [1])
Indication
Item
Indication
text
C0199171 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Procedure Start Date
Item
Procedure Start Date
date
C0199171 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Procedure End Date
Item
Procedure End Date
date
C0806020 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
Item Group
CONCOMITANT MEDICATION
C2347852 (UMLS CUI-1)
concomitant medication
Item
Please mark if no new or change in concomitant medication since the previous visit.
boolean
C2347852 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis
text
C0011900 (UMLS CUI [1])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Continuing
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
ADVERSE EXPERIENCES
C1518404 (UMLS CUI-1)
Adverse Experiences
Item
Please mark this box if no adverse experiences occurred during the book.
boolean
C1518404 (UMLS CUI [1])
Adverse Experience
Item
Adverse Experience
text
C0559546 (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
C1518404 (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 Episodes
Item
Experience Course Number of episodes
integer
C1518404 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity
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
C1518404 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was 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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