ID

27272

Beskrivning

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: Week 28

Nyckelord

Versioner (1)
  1. 2017-11-06 2017-11-06 -
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GlaxoSmithKline

Uppladdad den

6 november 2017

DOI

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

Engelsk

Week 28

1 Formulär  
  1. StudyEvent: ODM
    1. Week 28
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0031809
Sitting blood pressure systolic
Beskrivning

Sitting blood pressure systolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting blood pressure diastolic
Beskrivning

Sitting blood pressure diastolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Sitting heart rate
Beskrivning

Sitting heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0277814
beats/min
Healthcare resource utilisation - Visits/Contacts with Physicians
Beskrivning

Healthcare resource utilisation - Visits/Contacts with Physicians

Alias
UMLS CUI-1
C1704738
UMLS CUI-2
C0031831
UMLS CUI-3
C0545082
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
Beskrivning

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit

Datatyp

boolean

Alias
UMLS CUI [1]
C0583555
Date of Visit
Beskrivning

date of visit physician

Datatyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0031831
Type of physician
Beskrivning

Type of physician

Datatyp

integer

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0332307
Visit location
Beskrivning

Visit location

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0450429
Was the Visit RLS Related?
Beskrivning

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).

Datatyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Were any tests or procedures prescribed or conducted at this visit?
Beskrivning

tests or procedures prescribed

Datatyp

integer

Alias
UMLS CUI [1]
C0430022
UMLS CUI [2]
C0033080
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Beskrivning

Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners

Alias
UMLS CUI-1
C1704738
UMLS CUI-2
C0030450
UMLS CUI-3
C0545082
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
Beskrivning

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0030450
Date of visit
Beskrivning

date of visit paramedical practitioner

Datatyp

date

Alias
UMLS CUI [1,1]
C0030450
UMLS CUI [1,2]
C1320303
Type of paramedical practitioner
Beskrivning

Type of paramedical practitioner

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030450
UMLS CUI [1,2]
C0332307
Visit location
Beskrivning

Visit location

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0450429
Was the visit RLS related?
Beskrivning

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).

Datatyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Healthcare resource utilisation - Hospitalisation
Beskrivning

Healthcare resource utilisation - Hospitalisation

Alias
UMLS CUI-1
C1704738
UMLS CUI-2
C0019993
In the past 4 weeks...was the patient hospitalised?
Beskrivning

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each hospitalisation

Datatyp

boolean

Alias
UMLS CUI [1]
C0019993
Date of admission
Beskrivning

date of admission

Datatyp

date

Alias
UMLS CUI [1]
C1302393
Date of discharge
Beskrivning

date of discharge

Datatyp

date

Alias
UMLS CUI [1]
C2361123
Main reason for stay
Beskrivning

Hospitalisation cause

Datatyp

text

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0392360
Was the Visit RLS Related?
Beskrivning

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.

Datatyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Type of ward
Beskrivning

type of ward

Datatyp

integer

Alias
UMLS CUI [1,1]
C1305702
UMLS CUI [1,2]
C0332307
Length of stay on ward
Beskrivning

in days

Datatyp

integer

Måttenheter
  • days
Alias
UMLS CUI [1,1]
C1305702
UMLS CUI [1,2]
C0023303
days
Healthcare resource utilisation - accident & emergency / emergency room visits
Beskrivning

Healthcare resource utilisation - accident & emergency / emergency room visits

Alias
UMLS CUI-1
C1704738
UMLS CUI-2
C0562508
UMLS CUI-3
C0545082
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
Beskrivning

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0562508
UMLS CUI [1,2]
C0545082
Date of visit
Beskrivning

Date of visit in A&E

Datatyp

date

Alias
UMLS CUI [1,1]
C0562508
UMLS CUI [1,2]
C1320303
Was the visit RLS related?
Beskrivning

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.

Datatyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Patient Rated Scales
Beskrivning

Patient Rated Scales

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0679830
UMLS CUI-3
C0681889
Please complete the Week 28 RLS Rating Scale. Calculate total score for Week 28 by adding all 10 items and mark here:
Beskrivning

RLS Rating Scale Score

Datatyp

integer

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Is the patient’s Week 28 total score ≥ 15?
Beskrivning

RLS Rating Scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
If 'Yes", Is the Week 28 total score a 6 or more point increase compared with Week 24?
Beskrivning

'No' Please continue the assessments for this visit. 'Yes' Please withdraw the patient and complete the Early Withdrawal Section at the back of this book

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Ramos Randomisation and Dispensing
Beskrivning

Ramos Randomisation and Dispensing

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0947323
UMLS CUI-3
C0304229
Record below the randomisation number supplied by RAMOS
Beskrivning

randomisation number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Record the container number supplied by RAMOS.
Beskrivning

container number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0180098
UMLS CUI [1,2]
C0600091
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Similar models

Week 28

1 Formulär
  1. StudyEvent: ODM
    1. Week 28
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Sitting blood pressure systolic
Item
Sitting blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting blood pressure diastolic
Item
Sitting blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting heart rate
Item
Sitting heart rate
integer
C0018810 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Healthcare resource utilisation - Visits/Contacts with Physicians
C1704738 (UMLS CUI-1)
C0031831 (UMLS CUI-2)
C0545082 (UMLS CUI-3)
Visits with physicians
Item
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
boolean
C0583555 (UMLS CUI [1])
date of visit physician
Item
Date of Visit
date
C1320303 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Item
Type of physician
integer
C0031831 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of physician
Code List
Type of physician
CL Item
Cardiologist (1)
CL Item
Diabetologist (2)
CL Item
Dermatologist (3)
CL Item
Endocrinologist (4)
CL Item
ENT (Ear Nose & Throat) (5)
CL Item
Gastroenterologist (6)
CL Item
General/Internal Medical (7)
CL Item
General Practitioner/Family Practitioner  (8)
CL Item
Geriatrician (9)
CL Item
Gynaecologist (10)
CL Item
Infectious Disease (11)
CL Item
Nephrologist (12)
CL Item
Neurologist (13)
CL Item
Psychiatrist (14)
CL Item
Orthopaedic (15)
CL Item
Oncologist (16)
CL Item
Ophthalmologist (17)
CL Item
Respiratory/Chest Physician  (18)
CL Item
Rheumatologist (19)
CL Item
Urologist (20)
CL Item
Sleep Disorder Specialist  (21)
CL Item
Other (99)
Item
Visit location
integer
C0545082 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Visit location
Code List
Visit location
CL Item
Non hospital Office visit (eg GP surgery, Specialist's office etc) (1)
CL Item
Hospital Out Patient visit (2)
CL Item
At the Patient's home / domiciliary visit (3)
Item
Was the Visit RLS Related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the Visit RLS Related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item
Were any tests or procedures prescribed or conducted at this visit?
integer
C0430022 (UMLS CUI [1])
C0033080 (UMLS CUI [2])
tests or procedures during visit
Code List
Were any tests or procedures prescribed or conducted at this visit?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item Group
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
C1704738 (UMLS CUI-1)
C0030450 (UMLS CUI-2)
C0545082 (UMLS CUI-3)
patient visit with paramedical practitioners
Item
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
boolean
C0545082 (UMLS CUI [1,1])
C0030450 (UMLS CUI [1,2])
date of visit paramedical practitioner
Item
Date of visit
date
C0030450 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])
Item
Type of paramedical practitioner
integer
C0030450 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of paramedical practitioner
Code List
Type of paramedical practitioner
CL Item
Acupuncturist (1)
CL Item
Chiropodist/ Footcare Practitioner (2)
CL Item
Chiropractor (3)
CL Item
Dentist (4)
CL Item
Dietician (5)
CL Item
Homeopath/Herbalist (6)
CL Item
Nurse (7)
CL Item
Osteopath (8)
CL Item
Physiotherapist (9)
CL Item
Other (99)
Item
Visit location
integer
C0545082 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Visit location
Code List
Visit location
CL Item
Non hospital Office visit (eg GP surgery, Specialist's office etc) (1)
CL Item
Hospital Out Patient visit (2)
CL Item
At the Patient's home / domiciliary visit (3)
Item
Was the visit RLS related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the visit RLS related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item Group
Healthcare resource utilisation - Hospitalisation
C1704738 (UMLS CUI-1)
C0019993 (UMLS CUI-2)
Hospitalisation
Item
In the past 4 weeks...was the patient hospitalised?
boolean
C0019993 (UMLS CUI [1])
date of admission
Item
Date of admission
date
C1302393 (UMLS CUI [1])
date of discharge
Item
Date of discharge
date
C2361123 (UMLS CUI [1])
Hospitalisation cause
Item
Main reason for stay
text
C0019993 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item
Was the Visit RLS Related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the Visit RLS Related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item
Type of ward
integer
C1305702 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
type of ward
Code List
Type of ward
CL Item
Cardiovascular (1)
CL Item
Dermatological (2)
CL Item
Endocrinological (3)
CL Item
ENT (Ear, Nose & Throat)  (4)
CL Item
Gastroenterological (5)
CL Item
General Medical (6)
CL Item
Geriatric (7)
CL Item
Gynaecological (8)
CL Item
Infectious Disease  (9)
CL Item
Nephrological (10)
CL Item
Intensive Care  (11)
CL Item
Neurological  (12)
CL Item
Psychiatric (13)
CL Item
Orthopaedic  (14)
CL Item
Oncology (15)
CL Item
Ophthalmological  (16)
CL Item
Respiratory/Chest  (17)
CL Item
Rheumatological  (18)
CL Item
Urological (19)
CL Item
Other (99)
length of stay on ward
Item
Length of stay on ward
integer
C1305702 (UMLS CUI [1,1])
C0023303 (UMLS CUI [1,2])
Item Group
Healthcare resource utilisation - accident & emergency / emergency room visits
C1704738 (UMLS CUI-1)
C0562508 (UMLS CUI-2)
C0545082 (UMLS CUI-3)
A&E visits
Item
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
boolean
C0562508 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Date of visit in A&E
Item
Date of visit
date
C0562508 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])
Item
Was the visit RLS related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the visit RLS related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item Group
Patient Rated Scales
C0035258 (UMLS CUI-1)
C0679830 (UMLS CUI-2)
C0681889 (UMLS CUI-3)
RLS Rating Scale Score
Item
Please complete the Week 28 RLS Rating Scale. Calculate total score for Week 28 by adding all 10 items and mark here:
integer
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
RLS Rating Scale
Item
Is the patient’s Week 28 total score ≥ 15?
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
RLS Rating Scale
Item
If 'Yes", Is the Week 28 total score a 6 or more point increase compared with Week 24?
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Ramos Randomisation and Dispensing
C0034656 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
randomisation number
Item
Record below the randomisation number supplied by RAMOS
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
container number
Item
Record the container number supplied by RAMOS.
integer
C0180098 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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