ID
29117
Beskrivning
Study ID: 101468/249 Clinical Study ID: 101468/249 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: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome; Restless Legs Syndrome (RLS)
Nyckelord
Versioner (1)
- 2018-02-26 2018-02-26 -
Rättsinnehavare
GlaxoSmithKline (GSK)
Uppladdad den
26 februari 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857
Serious adverse events, Form D and Vitals
- StudyEvent: ODM
Beskrivning
Serious adverse experience
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Person Reporting SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1519255
Beskrivning
AEGIS Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
Beskrivning
Onset Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826806
Beskrivning
End Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826793
Beskrivning
Outcome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
Experience Course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
Experience Course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
Intensity (maximum)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Action Taken
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
Relationship to Investigational Drug
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
If Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
Patient withdrawal
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beskrivning
Serious adverse experience
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Abatement of SAE
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0547047
Beskrivning
If investigational product was interrupted, stopped or dose reduced:
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Beskrivning
If investigational product was interrupted, stopped or dose reduced:
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0034897
Beskrivning
Assessment of SAE association
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1710056
Beskrivning
Please provide relevant abnormal laboratory data below
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Laboratory Data
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beskrivning
Laboratory Data
Datatyp
float
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0587081
Beskrivning
Laboratory Data
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1519795
Beskrivning
Laboratory Data
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0086715
Beskrivning
Remarks
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0947611
Beskrivning
Randomization code
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0805701
Beskrivning
Randomization Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0805701
Beskrivning
Investigator’s Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator's name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
GSK Medical Monitor’s Signature
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C1708968
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C1521743
Beskrivning
Monitor's Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Beskrivning
Form D
Alias
- UMLS CUI-1
- C1306577
Beskrivning
Cause of Death
Datatyp
text
Alias
- UMLS CUI [1]
- C0007465
Beskrivning
Date of death
Datatyp
date
Alias
- UMLS CUI [1]
- C1148348
Beskrivning
Post-mortem
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004398
Beskrivning
Post-mortem findings
Datatyp
text
Alias
- UMLS CUI [1]
- C0004398
Beskrivning
Physician’s Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C0807938
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Orthostatic vital signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Orthostatic vital signs
Datatyp
integer
Alias
- UMLS CUI [1]
- C0518766
Beskrivning
Time Vitals Taken
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Beskrivning
Blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Pulse
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
Dose and meal information
Alias
- UMLS CUI-1
- C3174092
- UMLS CUI-2
- C0034869
- UMLS CUI-4
- C1998602
- UMLS CUI-5
- C0034869
Beskrivning
Time of last dose of study medication
Datatyp
time
Alias
- UMLS CUI [1]
- C0946444
Beskrivning
Date and time of last meal
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0578574
- UMLS CUI [1,2]
- C0011008
Beskrivning
Time of in-clinic study medication dose
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013227
Beskrivning
Medical Procedures
Alias
- UMLS CUI-1
- C0199171
Beskrivning
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Adverse experiences
Alias
- UMLS CUI-1
- C0877248
Similar models
Serious adverse events, Form D and Vitals
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0547047 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0587081 (UMLS CUI [2])
C1519795 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C1521743 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0034869 (UMLS CUI-2)
C1998602 (UMLS CUI-4)
C0034869 (UMLS CUI-5)
C0011008 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])