ID

35489

Descrizione

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

versioni (1)
  1. 06/03/19 06/03/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

6 marzo 2019

DOI

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Licenza

Creative Commons BY-NC 3.0
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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

Inglese

Week 8

1 moduli  
  1. StudyEvent: ODM
    1. Week 8
Administrative data
Descrizione

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Descrizione

Study Coordinating Center, Identification number

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Descrizione

Clinical Trial Subject Unique Identifier

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Descrizione

Person Initials

Tipo di dati

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Descrizione

Date of visit

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Study Medication Record Since Last Visit
Descrizione

Study Medication Record Since Last Visit

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C2734539
Please complete the study medication record in the Study Medication Section at the back of this book.
Descrizione

Experimental drug, Medication Summary

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2734539
RLS Rating Scale
Descrizione

RLS Rating Scale

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0449820
Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
Descrizione

Restless Legs Syndrome, Score

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0449820
Paient Rated Scales
Descrizione

Paient Rated Scales

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0035258
UMLS CUI-3
C0679830
Remove the following scales from appropriate visit in the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Descrizione

Questionnaires; Restless Legs Syndrome; patient assessment

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0679830
Vital Signs
Descrizione

Vital Signs

Alias
UMLS CUI-1
C0518766
Pulse (after 5 minutes sitting)
Descrizione

Heart rate

Tipo di dati

integer

Unità di misura
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Sitting Blood Pressure (after 5 minutes sitting) - Systolic
Descrizione

Systolic Pressure, Sitting position

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure (after 5 minutes sitting) - Distolic
Descrizione

Diastolic blood pressure, Sitting position

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Medical Procedures
Descrizione

Medical Procedures

Alias
UMLS CUI-1
C0199171
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Descrizione

Medical procedure

Tipo di dati

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Descrizione

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
Descrizione

Concomitant Agent

Tipo di dati

text

Alias
UMLS CUI [1]
C2347852
Adverse Experiences
Descrizione

Adverse Experiences

Alias
UMLS CUI-1
C0877248
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

Adverse Event

Tipo di dati

text

Alias
UMLS CUI [1]
C0877248
Laboratory Evaluation
Descrizione

Laboratory Evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0220825
Date of blood sample
Descrizione

Collection of blood specimen for laboratory procedure, Date in time

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Descrizione

Laboratory Procedures, Laboratory specimen identification label

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C4273937
Were any clinically significant abnormalities detected?
Descrizione

If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Follow-up.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1704258
Urine Dipstick
Descrizione

Urine Dipstick

Alias
UMLS CUI-1
C0430370
UMLS CUI-2
C0456984
What was the result of the urine dipstick performed at this visit?
Descrizione

If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this book, send a sample to Quest Diagnostics for further evaluation and repeat at Follow-up.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
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Similar models

Week 8

1 moduli
  1. StudyEvent: ODM
    1. Week 8
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Study Medication Record Since Last Visit
C0304229 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
Experimental drug, Medication Summary
Item
Please complete the study medication record in the Study Medication Section at the back of this book.
text
C0304229 (UMLS CUI [1,1])
C2734539 (UMLS CUI [1,2])
Item Group
RLS Rating Scale
C0035258 (UMLS CUI-1)
C0449820 (UMLS CUI-2)
Restless Legs Syndrome, Score
Item
Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
text
C0035258 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Paient Rated Scales
C0034394 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
C0679830 (UMLS CUI-3)
Questionnaires; Restless Legs Syndrome; patient assessment
Item
Remove the following scales from appropriate visit in the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
text
C0035258 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0679830 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Heart rate
Item
Pulse (after 5 minutes sitting)
integer
C0018810 (UMLS CUI [1])
Systolic Pressure, Sitting position
Item
Sitting Blood Pressure (after 5 minutes sitting) - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic blood pressure, Sitting position
Item
Sitting Blood Pressure (after 5 minutes sitting) - Distolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Medical Procedures
C0199171 (UMLS CUI-1)
Medical procedure
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
text
C0199171 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Agent
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
text
C2347852 (UMLS CUI [1])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Adverse Event
Item
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.
text
C0877248 (UMLS CUI [1])
Item Group
Laboratory Evaluation
C0022885 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Collection of blood specimen for laboratory procedure, Date in time
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Procedures, Laboratory specimen identification label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C0022885 (UMLS CUI [1,1])
C4273937 (UMLS CUI [1,2])
Laboratory Procedures, Abnormality
Item
Were any clinically significant abnormalities detected?
boolean
C0022885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Urine Dipstick
C0430370 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
Item
What was the result of the urine dipstick performed at this visit?
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Urine dipstick test, Test Result
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Negative (1)
CL Item
Positive (2)
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