ID
26490
Beschrijving
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 Baseline form.
Trefwoorden
Versies (2)
- 09-10-17 09-10-17 -
- 18-10-17 18-10-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
18 oktober 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Baseline GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
Baseline GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
Beschrijving
INCLUSION/EXCLUSION CRITERIA
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Beschrijving
RLS Rating Scale
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0035258
Beschrijving
secondary RLS
Datatype
boolean
Alias
- UMLS CUI [1]
- C1536279
Beschrijving
Augmentation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0473305
- UMLS CUI [1,2]
- C0454417
Beschrijving
abnormal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C0438215
- UMLS CUI [1,3]
- C0522055
- UMLS CUI [1,4]
- C0031809
Beschrijving
medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0037313
- UMLS CUI [1,3]
- C0013144
Beschrijving
blood pressure
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
trial
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347449
Beschrijving
hormone replacement therapy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0207509
- UMLS CUI [1,2]
- C0282402
Beschrijving
RLS RATING SCALES
Alias
- UMLS CUI-1
- C0450973
- UMLS CUI-2
- C0035258
Beschrijving
RLS Rating Scale
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0035258
Beschrijving
RLS Rating Scale
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0035258
Beschrijving
PATIENT RATED SCALES
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C0450973
Beschrijving
Patient related scales
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0450973
Beschrijving
VITAL SIGNS
Alias
- UMLS CUI-1
- C0518766
Beschrijving
(after 5 minutes sitting)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
(after 5 minutes sitting)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0580946
- UMLS CUI [1,2]
- C0871470
Beschrijving
(after 5 minutes sitting)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0580946
- UMLS CUI [1,2]
- C0428883
Beschrijving
CONCOMITANT MEDICATION
Alias
- UMLS CUI-1
- C2347852
Beschrijving
MEDICAL PROCEDURES
Alias
- UMLS CUI-1
- C0199171
Beschrijving
BASELINE SIGNS AND SYMPTOMS
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C1442488
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C0011900
Beschrijving
no baseline event
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1442488
Beschrijving
Baseline Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1442488
Beschrijving
Onset Date and Time
Datatype
date
Alias
- UMLS CUI [1,1]
- C2981441
- UMLS CUI [1,2]
- C1442488
Beschrijving
End Date and Time
Datatype
date
Alias
- UMLS CUI [1,1]
- C2981425
- UMLS CUI [1,2]
- C1442488
Beschrijving
If patient died, STOP: go to SAE section and follow instructions given there
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1442488
Beschrijving
Event Course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C1442488
Beschrijving
Event Course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C1442488
- UMLS CUI [1,4]
- C0332189
Beschrijving
Maximum
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1442488
Beschrijving
Relationship to study procedures performed prior to randomisation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1510821
Beschrijving
If ‘Yes’, record details in Prior and ConcomitantMedication section and/or Health Care Resource Utilisation section if appropriate.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
Patient withdrawn due to event
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0877248
Beschrijving
BASELINE EMPLOYMENT STATUS
Alias
- UMLS CUI-1
- C0242271
- UMLS CUI-2
- C1442488
Beschrijving
Full time employment
Datatype
boolean
Alias
- UMLS CUI [1]
- C0682295
Beschrijving
Part-time employment
Datatype
boolean
Alias
- UMLS CUI [1]
- C0682294
Beschrijving
Part-time employment
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0682294
- UMLS CUI [1,2]
- C2584953
Beschrijving
Volunteer/Unpaid work
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2367294
- UMLS CUI [1,2]
- C0557361
Beschrijving
Volunteer/Unpaid work
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2367294
- UMLS CUI [1,2]
- C0557361
- UMLS CUI [1,3]
- C2584953
Beschrijving
Unemployed due to RLS
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0041674
- UMLS CUI [1,2]
- C0678226
- UMLS CUI [1,3]
- C0035258
Beschrijving
Unemployed due to other (NON-RLS) disability
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0041674
- UMLS CUI [1,2]
- C0678226
- UMLS CUI [1,3]
- C0231170
Beschrijving
Unemployed for other reason
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0041674
- UMLS CUI [1,2]
- C0678226
- UMLS CUI [1,3]
- C3840932
Beschrijving
Retired
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035345
Beschrijving
Retired
Datatype
date
Alias
- UMLS CUI [1,1]
- C0035345
- UMLS CUI [1,2]
- C0011008
Beschrijving
Homemaker
Datatype
boolean
Alias
- UMLS CUI [1]
- C0555052
Beschrijving
employment
Datatype
integer
Alias
- UMLS CUI [1]
- C0014003
Beschrijving
CLINICAL GLOBAL IMPRESSION
Alias
- UMLS CUI-1
- C3639708
Beschrijving
RAMOS RANDOMISATION AND DISPENSING
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0947323
- UMLS CUI-3
- C0947323
Similar models
Baseline GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
C1955348 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
C0019994 (UMLS CUI [1,2])
C0680251 (UMLS CUI-2)
C0035258 (UMLS CUI [1,2])
C0454417 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
C0037313 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C0282402 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0011900 (UMLS CUI-4)
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
C0750729 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,4])
C1510821 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C2584953 (UMLS CUI [1,2])
C0557361 (UMLS CUI [1,2])
C0557361 (UMLS CUI [1,2])
C2584953 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0947323 (UMLS CUI-2)
C0947323 (UMLS CUI-3)
C0237753 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])