ID

29086

Beschrijving

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)

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

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23 februari 2018

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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

Engels

Assessment Week12

1 Formulieren  
  1. StudyEvent: ODM
    1. Assessment Week12
Administration
Beschrijving

Administration

Alias
UMLS CUI-1
C1320722
Patient number
Beschrijving

Patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Visit date
Beschrijving

Visit date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Center Number
Beschrijving

Center Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
IRLS Rating Scale
Beschrijving

IRLS Rating Scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
Please complete the IRLS Rating Scale
Beschrijving

IRLS Rating Scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale. • Hospital Anxiety and Depression Scale (HADS). • Patient Satisfaction Question.
Beschrijving

Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale. • Hospital Anxiety and Depression Scale (HADS). • Patient Satisfaction Question.

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0035258
UMLS CUI-3
C0679830
Vital signs
Beschrijving

Vital signs

Alias
UMLS CUI-1
C0518766
Weight (without shoes)
Beschrijving

Weight

Datatype

integer

Maateenheden
  • kg / lbs
Alias
UMLS CUI [1]
C0005910
kg / lbs
Orthostatic vital signs
Beschrijving

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Orthostatic vital signs
Beschrijving

Orthostatic vital signs

Datatype

integer

Alias
UMLS CUI [1]
C0518766
Time Vitals Taken
Beschrijving

Time Vitals Taken

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Blood pressure systolic/diastolic
Beschrijving

Blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Beschrijving

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

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
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

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
Clinical Global Impressions
Beschrijving

Clinical Global Impressions

Alias
UMLS CUI-1
C3639708
Laboratory evaluation
Beschrijving

Laboratory evaluation

Alias
UMLS CUI-1
C0022885
Date of blood sample:
Beschrijving

Date of blood sample

Datatype

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Were any clinically significant abnormalities detected?
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C1853129
Is the patient a female of child-bearing potential?
Beschrijving

If ’Yes’, please perform a pregnancy dipstick test and record result below.

Datatype

boolean

Alias
UMLS CUI [1]
C0430056
Pregnancy?
Beschrijving

If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Followup.

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Assessment Week12

1 Formulieren
  1. StudyEvent: ODM
    1. Assessment Week12
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale. • Hospital Anxiety and Depression Scale (HADS). • Patient Satisfaction Question.
C0034394 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
C0679830 (UMLS CUI-3)
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight (without shoes)
integer
C0005910 (UMLS CUI [1])
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
Laboratory evaluation
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample:
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory abnormalities
Item
Were any clinically significant abnormalities detected?
boolean
C1853129 (UMLS CUI [1])
Pregnancy dipstick
Item
Is the patient a female of child-bearing potential?
boolean
C0430056 (UMLS CUI [1])
Pregnancy
Item
Pregnancy?
boolean
C0032961 (UMLS CUI [1])
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