ID

35489

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-03-06 2019-03-06 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 mars 2019

DOI

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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)

Engelsk

Week 8

1 Formulär  
  1. StudyEvent: ODM
    1. Week 8
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beskrivning

Study Coordinating Center, Identification number

Datatyp

integer

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

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beskrivning

Person Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beskrivning

Date of visit

Datatyp

date

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

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.
Beskrivning

Experimental drug, Medication Summary

Datatyp

text

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

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.
Beskrivning

Restless Legs Syndrome, Score

Datatyp

text

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

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
Beskrivning

Questionnaires; Restless Legs Syndrome; patient assessment

Datatyp

text

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

Vital Signs

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

Heart rate

Datatyp

integer

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

Systolic Pressure, Sitting position

Datatyp

integer

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

Diastolic blood pressure, Sitting position

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Medical Procedures
Beskrivning

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.
Beskrivning

Medical procedure

Datatyp

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Beskrivning

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.
Beskrivning

Concomitant Agent

Datatyp

text

Alias
UMLS CUI [1]
C2347852
Adverse Experiences
Beskrivning

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.
Beskrivning

Adverse Event

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Laboratory Evaluation
Beskrivning

Laboratory Evaluation

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

Collection of blood specimen for laboratory procedure, Date in time

Datatyp

date

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

Laboratory Procedures, Laboratory specimen identification label

Datatyp

text

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

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

Datatyp

boolean

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

Urine Dipstick

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

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.

Datatyp

text

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

Week 8

1 Formulär
  1. StudyEvent: ODM
    1. Week 8
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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