ID
26490
Beskrivning
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.
Nyckelord
Versioner (2)
- 2017-10-09 2017-10-09 -
- 2017-10-18 2017-10-18 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
18 oktober 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Baseline GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
Baseline GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190
Beskrivning
INCLUSION/EXCLUSION CRITERIA
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Beskrivning
RLS Rating Scale
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0035258
Beskrivning
secondary RLS
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1536279
Beskrivning
Augmentation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0473305
- UMLS CUI [1,2]
- C0454417
Beskrivning
abnormal
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C0438215
- UMLS CUI [1,3]
- C0522055
- UMLS CUI [1,4]
- C0031809
Beskrivning
medication
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0037313
- UMLS CUI [1,3]
- C0013144
Beskrivning
blood pressure
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
trial
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347449
Beskrivning
hormone replacement therapy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0207509
- UMLS CUI [1,2]
- C0282402
Beskrivning
RLS RATING SCALES
Alias
- UMLS CUI-1
- C0450973
- UMLS CUI-2
- C0035258
Beskrivning
PATIENT RATED SCALES
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C0450973
Beskrivning
Patient related scales
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0450973
Beskrivning
VITAL SIGNS
Alias
- UMLS CUI-1
- C0518766
Beskrivning
(after 5 minutes sitting)
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
(after 5 minutes sitting)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0580946
- UMLS CUI [1,2]
- C0871470
Beskrivning
(after 5 minutes sitting)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0580946
- UMLS CUI [1,2]
- C0428883
Beskrivning
CONCOMITANT MEDICATION
Alias
- UMLS CUI-1
- C2347852
Beskrivning
MEDICAL PROCEDURES
Alias
- UMLS CUI-1
- C0199171
Beskrivning
BASELINE SIGNS AND SYMPTOMS
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C1442488
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C0011900
Beskrivning
no baseline event
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1442488
Beskrivning
Baseline Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1442488
Beskrivning
Onset Date and Time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2981441
- UMLS CUI [1,2]
- C1442488
Beskrivning
End Date and Time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2981425
- UMLS CUI [1,2]
- C1442488
Beskrivning
If patient died, STOP: go to SAE section and follow instructions given there
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1442488
Beskrivning
Event Course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C1442488
Beskrivning
Event Course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C1442488
- UMLS CUI [1,4]
- C0332189
Beskrivning
Maximum
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1442488
Beskrivning
Relationship to study procedures performed prior to randomisation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1510821
Beskrivning
If ‘Yes’, record details in Prior and ConcomitantMedication section and/or Health Care Resource Utilisation section if appropriate.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
Patient withdrawn due to event
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0877248
Beskrivning
BASELINE EMPLOYMENT STATUS
Alias
- UMLS CUI-1
- C0242271
- UMLS CUI-2
- C1442488
Beskrivning
Full time employment
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0682295
Beskrivning
Part-time employment
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0682294
Beskrivning
Part-time employment
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0682294
- UMLS CUI [1,2]
- C2584953
Beskrivning
Volunteer/Unpaid work
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2367294
- UMLS CUI [1,2]
- C0557361
Beskrivning
Volunteer/Unpaid work
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2367294
- UMLS CUI [1,2]
- C0557361
- UMLS CUI [1,3]
- C2584953
Beskrivning
Unemployed due to RLS
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0041674
- UMLS CUI [1,2]
- C0678226
- UMLS CUI [1,3]
- C0035258
Beskrivning
Unemployed due to other (NON-RLS) disability
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0041674
- UMLS CUI [1,2]
- C0678226
- UMLS CUI [1,3]
- C0231170
Beskrivning
Unemployed for other reason
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0041674
- UMLS CUI [1,2]
- C0678226
- UMLS CUI [1,3]
- C3840932
Beskrivning
Retired
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0035345
Beskrivning
Retired
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0035345
- UMLS CUI [1,2]
- C0011008
Beskrivning
Homemaker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0555052
Beskrivning
employment
Datatyp
integer
Alias
- UMLS CUI [1]
- C0014003
Beskrivning
CLINICAL GLOBAL IMPRESSION
Alias
- UMLS CUI-1
- C3639708
Beskrivning
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])