ID

29078

Descrizione

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)

Keywords

versioni (1)
  1. 23/02/18 23/02/18 -
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GlaxoSmithKline (GSK)

Caricato su

23 febbraio 2018

DOI

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Licenza

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

Inglese

Assessment Week2

1 moduli  
  1. StudyEvent: ODM
    1. Assessment Week2
Administration
Descrizione

Administration

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Patient number
Descrizione

Patient number

Tipo di dati

integer

Alias
UMLS CUI [1]
C1830427 (undefined)
Visit date
Descrizione

Visit date

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303 (Date of visit)
SNOMED
406543005
Center Number
Descrizione

Center Number

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1301943 (Institution name)
SNOMED
398321007
UMLS CUI [1,2]
C0600091 (Identifier)
SNOMED
118522005
LOINC
LP31795-5
IRLS Rating Scale
Descrizione

IRLS Rating Scale

Alias
UMLS CUI-1
C0681889 (rating scale)
UMLS CUI-2
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
Please complete the IRLS Rating Scale
Descrizione

IRLS Rating Scale

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0681889 (rating scale)
UMLS CUI [1,2]
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
Orthostatic vital signs
Descrizione

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766 (Vital signs)
LOINC
LP30605-7
Orthostatic vital signs
Descrizione

Orthostatic vital signs

Tipo di dati

integer

Alias
UMLS CUI [1]
C0518766 (Vital signs)
LOINC
LP30605-7
Time Vitals Taken
Descrizione

Time Vitals Taken

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0518766 (Vital signs)
LOINC
LP30605-7
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Blood pressure systolic/diastolic
Descrizione

Blood pressure

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0005823 (Blood Pressure)
SNOMED
75367002
mmHg
Pulse
Descrizione

Pulse

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117 (Pulse Rate)
SNOMED
78564009
beats/min
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Descrizione

Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.

Alias
UMLS CUI-1
C0199171 (Medical procedure)
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
Descrizione

Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.

Alias
UMLS CUI-1
C2347852 (Concomitant Agent)
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
Descrizione

Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.

Alias
UMLS CUI-1
C0877248 (Adverse event)
LOINC
MTHU014542
Clinical Global Impressions
Descrizione

Clinical Global Impressions

Alias
UMLS CUI-1
C3639708 (Clinical global impression scale)
If the patient requires a dose reduction between this and the next visit please complete the Study Medication Record and Dose Reductions Due To Adverse Experiences pages at the back of this book.
Descrizione

If the patient requires a dose reduction between this and the next visit please complete the Study Medication Record and Dose Reductions Due To Adverse Experiences pages at the back of this book.

Alias
UMLS CUI-1
C0178602 (Dosage)
SNOMED
260911001
LOINC
LP7180-5
UMLS CUI-2
C0547047 (Decrease)
SNOMED
260370003
Ramos Dispensing
Descrizione

Ramos Dispensing

Alias
UMLS CUI-1
C0034656 (Randomization)
UMLS CUI-2
C0947323 (Dispensing medication)
SNOMED
373784005
Container Numbers:
Descrizione

Container numbers

Tipo di dati

integer

Alias
UMLS CUI [1]
C0180098 (Containers)
SNOMED
706437002
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Similar models

Assessment Week2

1 moduli
  1. StudyEvent: ODM
    1. Assessment Week2
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
IRLS Rating Scale
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
IRLS Rating Scale
Item
Please complete the IRLS Rating Scale
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Orthostatic vital signs
C0518766 (UMLS CUI-1)
Item
Orthostatic vital signs
integer
C0518766 (UMLS CUI [1])
Orthostatic vital signs
Code List
Orthostatic vital signs
CL Item
After 10 minutes semi-supine (1)
CL Item
After erect for 1 minute (2)
Time Vitals Taken
Item
Time Vitals Taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure
Item
Blood pressure systolic/diastolic
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
C0199171 (UMLS CUI-1)
Item Group
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
C2347852 (UMLS CUI-1)
Item Group
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
C0877248 (UMLS CUI-1)
Item Group
Clinical Global Impressions
C3639708 (UMLS CUI-1)
Item Group
If the patient requires a dose reduction between this and the next visit please complete the Study Medication Record and Dose Reductions Due To Adverse Experiences pages at the back of this book.
C0178602 (UMLS CUI-1)
C0547047 (UMLS CUI-2)
Item Group
Ramos Dispensing
C0034656 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
Container numbers
Item
Container Numbers:
integer
C0180098 (UMLS CUI [1])
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