ID
27188
Descripción
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
Palabras clave
Versiones (1)
- 3/11/17 3/11/17 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
3 de noviembre de 2017
DOI
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Licencia
Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188
Screening
- StudyEvent: ODM
Descripción
RLS Diagnostic Criteria
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C0679228
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0596840
- UMLS CUI [2]
- C0030554
- UMLS CUI [3]
- C0392699
- UMLS CUI [4]
- C0035258
Descripción
The International RLS Study Group Criteria* defines RLS patients as having:
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0700075
Descripción
The International RLS Study Group Criteria* defines RLS patients as having:
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0026606
- UMLS CUI [1,3]
- C0564405
Descripción
The International RLS Study Group Criteria* defines RLS patients as having:
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3176727
- UMLS CUI [1,2]
- C0035258
Descripción
Demography
Alias
- UMLS CUI-1
- C0011298
Descripción
Date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Race
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0034510
Descripción
Race
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034510
Descripción
Vital signs
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0031809
Descripción
(without shoes)
Tipo de datos
float
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descripción
(without shoes)
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Sitting blood pressure systolic
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Descripción
Sitting blood pressure diastolic
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Descripción
Sitting heart rate
Tipo de datos
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0277814
Descripción
Electrocardiogram
Alias
- UMLS CUI-1
- C0013798
- UMLS CUI-2
- C0430456
Descripción
Laboratory Evaluation
Alias
- UMLS CUI-1
- C0022885
Descripción
Urine Dipstick
Alias
- UMLS CUI-1
- C0430370
Descripción
Pregnancy dipstick
Alias
- UMLS CUI-1
- C0430056
- UMLS CUI-2
- C0430370
Descripción
child-bearing potential
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1960468
Descripción
If ’Yes’, please perform a pregnancy dipstick test and record result below.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0427777
- UMLS CUI [1,2]
- C0430370
Descripción
Significant medical/surgical history and physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
- UMLS CUI-3
- C0012634
Descripción
Patient Initials
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2986440
Descripción
medical or surgical condition
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0009488
Descripción
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)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0009488
Descripción
Year of first diagnosis
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0439234
Descripción
Medical condition ongoing
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Descripción
Prior and concomitant medication
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C2826257
Descripción
If ‘Yes’, please record details below (Please print clearly)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0013227
Descripción
Drug Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2360065
Descripción
Total Daily Dose
Tipo de datos
float
Unidades de medida
- mg
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Descripción
Medical Illness/Diagnosis
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C3146298
Descripción
Start Date of medication
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Descripción
(or if Continuing mark box in upcoming question)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Descripción
Medication continuing?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Descripción
RLS pharmacotherapy history
Alias
- UMLS CUI-1
- C0013216
- UMLS CUI-2
- C0035258
Descripción
If ‘Yes’, please record details below (Please print clearly)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0035258
Descripción
Drug Name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0013216
Descripción
Start Date pharmacotherapy
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0808070
Descripción
(or if Continuing mark box in upcoming question)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0806020
Descripción
Medication continuing?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0549178
Descripción
Did the patient respond to the treatment?
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0013216
- UMLS CUI [1,3]
- C0035258
Descripción
Did the patient tolerate the treatment?
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0013220
- UMLS CUI [1,2]
- C0013216
- UMLS CUI [1,3]
- C0035258
Descripción
Screening Inclusion/Exclusion Criteria
Alias
- UMLS CUI-1
- C1710477
- UMLS CUI-2
- C0013893
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0035258
- UMLS CUI [2]
- C1512693
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C1512693
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C1512693
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0332169
- UMLS CUI [2]
- C0680251
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0236991
- UMLS CUI [2]
- C0680251
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0026650
- UMLS CUI [2]
- C0680251
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0392760
- UMLS CUI [1,3]
- C1280519
- UMLS CUI [2]
- C0680251
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0178601
- UMLS CUI [2]
- C0680251
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0038586
- UMLS CUI [2]
- C0680251
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0420837
- UMLS CUI [2]
- C0680251
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
- UMLS CUI [2]
- C0680251
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0009488
- UMLS CUI [2]
- C0680251
Descripción
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.
Tipo de datos
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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