ID
27188
Description
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: Screening
Keywords
Versions (1)
- 11/3/17 11/3/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 3, 2017
DOI
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License
Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188
Screening
- StudyEvent: ODM
Description
RLS Diagnostic Criteria
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C0679228
Description
The International RLS Study Group Criteria* defines RLS patients as having: Answer to all four diagnostic criteria must be ’Yes’ for the patient to be diagnosed with RLS
Data type
boolean
Alias
- UMLS CUI [1]
- C0596840
- UMLS CUI [2]
- C0030554
- UMLS CUI [3]
- C0392699
- UMLS CUI [4]
- C0035258
Description
The International RLS Study Group Criteria* defines RLS patients as having:
Data type
boolean
Alias
- UMLS CUI [1]
- C0700075
Description
The International RLS Study Group Criteria* defines RLS patients as having:
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0026606
- UMLS CUI [1,3]
- C0564405
Description
The International RLS Study Group Criteria* defines RLS patients as having:
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3176727
- UMLS CUI [1,2]
- C0035258
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
integer
Alias
- UMLS CUI [1]
- C0034510
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Vital signs
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0031809
Description
(without shoes)
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
(without shoes)
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Sitting blood pressure systolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Description
Sitting blood pressure diastolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Description
Sitting heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0277814
Description
Electrocardiogram
Alias
- UMLS CUI-1
- C0013798
- UMLS CUI-2
- C0430456
Description
Laboratory Evaluation
Alias
- UMLS CUI-1
- C0022885
Description
Urine Dipstick
Alias
- UMLS CUI-1
- C0430370
Description
Pregnancy dipstick
Alias
- UMLS CUI-1
- C0430056
- UMLS CUI-2
- C0430370
Description
child-bearing potential
Data type
boolean
Alias
- UMLS CUI [1]
- C1960468
Description
If ’Yes’, please perform a pregnancy dipstick test and record result below.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0427777
- UMLS CUI [1,2]
- C0430370
Description
Significant medical/surgical history and physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
- UMLS CUI-3
- C0012634
Description
Patient Initials
Data type
text
Alias
- UMLS CUI [1]
- C2986440
Description
medical or surgical condition
Data type
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0009488
Description
If the patient is suffering from or has ever suffered from any significant medical or surgical condition please list below one diagnosis per line. (Please print clearly)
Data type
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0009488
Description
Year of first diagnosis
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0439234
Description
Medical condition ongoing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Description
Prior and concomitant medication
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C2826257
Description
If ‘Yes’, please record details below (Please print clearly)
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Total Daily Dose
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Description
Medical Illness/Diagnosis
Data type
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C3146298
Description
Start Date of medication
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
(or if Continuing mark box in upcoming question)
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Medication continuing?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Description
RLS pharmacotherapy history
Alias
- UMLS CUI-1
- C0013216
- UMLS CUI-2
- C0035258
Description
If ‘Yes’, please record details below (Please print clearly)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0035258
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0013216
Description
Start Date pharmacotherapy
Data type
date
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0808070
Description
(or if Continuing mark box in upcoming question)
Data type
date
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0806020
Description
Medication continuing?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0549178
Description
Did the patient respond to the treatment?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0013216
- UMLS CUI [1,3]
- C0035258
Description
Did the patient tolerate the treatment?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013220
- UMLS CUI [1,2]
- C0013216
- UMLS CUI [1,3]
- C0035258
Description
Screening Inclusion/Exclusion Criteria
Alias
- UMLS CUI-1
- C1710477
- UMLS CUI-2
- C0013893
Description
Please complete the following inclusion criteria. If any of the above questions have been answered ’No’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1]
- C0035258
- UMLS CUI [2]
- C1512693
Description
Please complete the following inclusion criteria. If any of the above questions have been answered ’No’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C1512693
Description
Please complete the following inclusion criteria. If any of the above questions have been answered ’No’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C1512693
Description
Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0332169
- UMLS CUI [2]
- C0680251
Description
Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1]
- C0236991
- UMLS CUI [2]
- C0680251
Description
Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1]
- C0026650
- UMLS CUI [2]
- C0680251
Description
Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0392760
- UMLS CUI [1,3]
- C1280519
- UMLS CUI [2]
- C0680251
Description
Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0178601
- UMLS CUI [2]
- C0680251
Description
Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
- UMLS CUI [2]
- C0680251
Description
Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1]
- C0420837
- UMLS CUI [2]
- C0680251
Description
Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
- UMLS CUI [2]
- C0680251
Description
Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0009488
- UMLS CUI [2]
- C0680251
Description
Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.
Data type
boolean
Alias
- UMLS CUI [1]
- C1321605
- UMLS CUI [2]
- C0680251
Similar models
Screening
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0206132 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0037313 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2])
C0596840 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2])
C0560579 (UMLS CUI [1,2])
C0220952 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0679228 (UMLS CUI-2)
C0030554 (UMLS CUI [2])
C0392699 (UMLS CUI [3])
C0035258 (UMLS CUI [4])
C0026606 (UMLS CUI [1,2])
C0564405 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C0009488 (UMLS CUI [2])
C0009488 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C2826257 (UMLS CUI-3)
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0035258 (UMLS CUI-2)
C0035258 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013893 (UMLS CUI-2)
C1512693 (UMLS CUI [2])
C1512693 (UMLS CUI [2])
C1512693 (UMLS CUI [2])
C1457887 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
C0392760 (UMLS CUI [1,2])
C1280519 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2])
C0178601 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
C0006147 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
C0009488 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
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