ID
35476
Description
Study ID: 101468/194 Clinical Study ID: 101468/194 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
Keywords
Versions (2)
- 3/6/19 3/6/19 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 6, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)
Baseline
- StudyEvent: ODM
Description
Inclusion/Exclusion Criteria
Alias
- UMLS CUI-1
- C0013893
Description
Restless Legs Syndrome, Score
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0449820
Description
Secondary Restless Legs Syndrome; Iron deficiency anemia; Pregnancy
Data type
boolean
Alias
- UMLS CUI [1]
- C0035258
- UMLS CUI [2]
- C0162316
- UMLS CUI [3]
- C0032961
Description
Augmentation procedure; Rebound effect
Data type
boolean
Alias
- UMLS CUI [1]
- C1293122
- UMLS CUI [2]
- C0549262
Description
Laboratory Procedures, Abnormality; ECG abnormality; Physical Examination, Abnormality
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C1832603
- UMLS CUI [3,1]
- C0031809
- UMLS CUI [3,2]
- C1704258
Description
Pharmaceutical Preparations, Drowsiness, Relationships; Pharmaceutical Preparations, Restless Legs Syndrome, Relationships; Pharmaceutical Preparations, Sleep, Relationships
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0013144
- UMLS CUI [1,3]
- C0439849
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0035258
- UMLS CUI [2,3]
- C0439849
- UMLS CUI [3,1]
- C0013227
- UMLS CUI [3,2]
- C0037313
- UMLS CUI [3,3]
- C0439849
Description
Systolic Pressure; Diastolic blood pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
Description
Study Subject Participation Status
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Hormon Replacement Therapy; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 CYP1A2 Inhibitors
Data type
boolean
Alias
- UMLS CUI [1]
- C0282402
- UMLS CUI [2]
- C3850050
- UMLS CUI [3]
- C3850068
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Systolic Pressure, Sitting position
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Description
Diastolic blood pressure, Sitting position
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Medical Procedures
Alias
- UMLS CUI-1
- C0199171
Description
Baseline Signs and Symptoms (or events, or diagnoses)
Alias
- UMLS CUI-1
- C0037088
Description
No signs/symptoms, Baseline
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3846032
- UMLS CUI [1,2]
- C1442488
Description
Event, Baseline, Signs and Symptoms
Data type
text
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C0037088
Description
Event,Baseline, Date of onset, Time of onset
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C0574845
- UMLS CUI [1,4]
- C0449244
Description
If patient died, STOP: go to SAE section and follow instructions given there
Data type
text
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C1274040
Description
Event, Baseline, Course
Data type
text
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C0750729
Description
Event, Baseline, Number of Episodes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C4086638
Description
Event, Baseline, Symptom intensity
Data type
text
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C0518690
Description
Event, Baseline, Study Subject Participation Status, Relationships
Data type
text
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C2348568
- UMLS CUI [1,4]
- C0439849
Description
If ‘Yes’, record details in Prior and Concomitant Medication section and/or Health Care Resource Utilisation section if appropriate.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C0087111
Description
Event, Baseline, Patient withdrawn from trial
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C0422727
Description
Baseline Employment Status
Alias
- UMLS CUI-1
- C0242271
- UMLS CUI-2
- C1442488
Description
Employment status, Baseline
Data type
text
Alias
- UMLS CUI [1,1]
- C0242271
- UMLS CUI [1,2]
- C1442488
Description
Part-time Employment, Hours worked per week
Data type
integer
Alias
- UMLS CUI [1,1]
- C0682294
- UMLS CUI [1,2]
- C2584953
Description
Volunteer work, Unpaid work, Hours worked per week
Data type
integer
Alias
- UMLS CUI [1,1]
- C2367294
- UMLS CUI [1,2]
- C0557361
- UMLS CUI [1,3]
- C2584953
Description
Retirement, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0035345
- UMLS CUI [1,2]
- C0011008
Description
If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work answer question
Data type
text
Alias
- UMLS CUI [1]
- C0421456
Description
RAMOS Randomization and Dispensing
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0947323
Similar models
Baseline
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
C0162316 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0549262 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C1832603 (UMLS CUI [2])
C0031809 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0013144 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0037313 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0428883 (UMLS CUI [2])
C3850050 (UMLS CUI [2])
C3850068 (UMLS CUI [3])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0449244 (UMLS CUI [1,4])
C1442488 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C1442488 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C0422727 (UMLS CUI [1,3])
C1442488 (UMLS CUI-2)
C1442488 (UMLS CUI [1,2])
C2584953 (UMLS CUI [1,2])
C0557361 (UMLS CUI [1,2])
C2584953 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0947323 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])