ID

29079

Beschreibung

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)

Stichworte

Versionen (1)
  1. 23.02.18 23.02.18 -
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GlaxoSmithKline (GSK)

Hochgeladen am

23. Februar 2018

DOI

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Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

Englisch

Assessment Week3

1 Formulare  
  1. StudyEvent: ODM
    1. Assessment Week3
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Patient number
Beschreibung

Patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Visit date
Beschreibung

Visit date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Center Number
Beschreibung

Center Number

Datentyp

integer

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

IRLS Rating Scale

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

IRLS Rating Scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Orthostatic vital signs
Beschreibung

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Orthostatic vital signs
Beschreibung

Orthostatic vital signs

Datentyp

integer

Alias
UMLS CUI [1]
C0518766
Time Vitals Taken
Beschreibung

Time Vitals Taken

Datentyp

time

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

Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse
Beschreibung

Pulse

Datentyp

integer

Maßeinheiten
  • 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.
Beschreibung

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.
Beschreibung

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.
Beschreibung

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
Beschreibung

Clinical Global Impressions

Alias
UMLS CUI-1
C3639708
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.
Beschreibung

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
UMLS CUI-2
C0547047
Ramos Dispensing
Beschreibung

Ramos Dispensing

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0947323
Container Numbers:
Beschreibung

Container numbers

Datentyp

integer

Alias
UMLS CUI [1]
C0180098
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Ähnliche Modelle

Assessment Week3

1 Formulare
  1. StudyEvent: ODM
    1. Assessment Week3
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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