ID

35484

Beschrijving

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

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  1. 06-03-19 06-03-19 -
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GlaxoSmithKline

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6 maart 2019

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

Engels

Week 4

1 Formulieren  
  1. StudyEvent: ODM
    1. Week 4
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beschrijving

Study Coordinating Center, Identification number

Datatype

integer

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

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschrijving

Person Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschrijving

Date of visit

Datatype

date

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

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.
Beschrijving

Experimental drug, Medication Summary

Datatype

text

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

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.
Beschrijving

Restless Legs Syndrome, Score

Datatype

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0449820
WPAI
Beschrijving

WPAI

Alias
UMLS CUI-1
C4053845
Please remove the appropriate WPAI from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete it.
Beschrijving

Work Productivity and Activity Impairment General Health V2.0 Questionnaire

Datatype

text

Alias
UMLS CUI [1]
C3639722
Vital Signs
Beschrijving

Vital Signs

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

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Sitting Blood Pressure (after 5 minutes sitting) - Systolic
Beschrijving

Systolic Pressure, Sitting position

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure (after 5 minutes sitting) - Distolic
Beschrijving

Diastolic blood pressure, Sitting position

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Medical Procedures
Beschrijving

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.
Beschrijving

Medical procedure

Datatype

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Beschrijving

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.
Beschrijving

Concomitant Agent

Datatype

text

Alias
UMLS CUI [1]
C2347852
Adverse Experiences
Beschrijving

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.
Beschrijving

Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C0877248
RAMOS Randomization and Dispensing
Beschrijving

RAMOS Randomization and Dispensing

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0947323
Randomisation number
Beschrijving

Randomization, Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Container number
Beschrijving

Experimental drug, Containers, Identifier

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
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Similar models

Week 4

1 Formulieren
  1. StudyEvent: ODM
    1. Week 4
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Work Productivity and Activity Impairment General Health V2.0 Questionnaire
Item
Please remove the appropriate WPAI from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete it.
text
C3639722 (UMLS CUI [1])
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
RAMOS Randomization and Dispensing
C0034656 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
Randomization, Numbers
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Experimental drug, Containers, Identifier
Item
Container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
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